Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals, Inc. Drugs

• Allergen Pack Dermatoph...
  

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  Allergen Pack Dermatophagoides Pteronyssinus Solution

  

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  Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.

  These doses can be given without regard to timing of meals.

  2.1 Osteoarthritis

  For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

  2.2 Rheumatoid Arthritis

  For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

  2.3 Juvenile Rheumatoid Arthritis

  For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

  For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2–8° C/ 35–45° F).

  2.4 Ankylosing Spondylitis

  For the management of the signs and symptoms of AS, the recommended dose of celecoxib is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

  2.5 Management of Acute Pain and Treatment of Primary Dysmenorrhea

  The recommended dose of celecoxib is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

  2.6 Special Populations

  Hepatic insufficiency: The daily recommended dose of celecoxib capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of celecoxib in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.5), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  Poor Metabolizers of CYP2C9 Substrates: Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use in Specific populations (8.8), and Clinical Pharmacology (12.5)].

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• Miconazole 3
  

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  Miconazole 3

  

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  The recommended starting dose of memantine hydrochloride tablet is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.

  Memantine hydrochloride tablets can be taken with or without food. If a patient misses a single dose of memantine hydrochloride tablets, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride tablet for several days, dosing may need to be resumed at lower doses and retitrated as described above.

  Special Populations

  Renal Impairment

  A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 to 29 mL/min based on the Cockroft-Gault equation).

  Hepatic Impairment

  Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].

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• Memantine
  

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  Memantine

  

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  To achieve maximum contraceptive effectiveness, Bekyree (desogestrel/ethinyl estradiol and ethinyl estradiol) tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Bekyree may be initiated using either a Sunday start or a Day 1 start. NOTE: Each wallet pack is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different "day label strips" are provided with each wallet pack in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.

  IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Bekyree should be considered.

  The use of Bekyree for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for Nursing mothers).

  If the patient starts on Bekyree postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days.

  SUNDAY START

  When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

  Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 green (inert) tablet daily for 2 days and 1 yellow (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28 tablet regimen on the next day (Sunday) after taking the last yellow tablet. [If switching from a Sunday start oral contraceptive, the first Bekyree (desogestrel/ethinyl estradiol and ethinyl estradiol) tablets should be taken on the second Sunday after the last tablet of a 21 day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

  If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the wallet pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that wallet pack and start a new wallet pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

  DAY 1 START

  Counting the first day of menstruation as "Day 1", tablets are taken without interruption as follows: One white tablet daily for 21 days, one green (inert) tablet daily for 2 days followed by 1 yellow (ethinyl estradiol) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28 tablet regimen on the next day after taking the last yellow tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.]

  If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or if the patient misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

  ALL ORAL CONTRACEPTIVES

  Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

  Use of oral contraceptives in the event of a missed menstrual period:

  If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

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• Arnica Montana 200c
  

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  Arnica Montana 200c

  

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  Ceftriaxone for injection may be administered intravenously or intramuscularly. However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Ceftriaxone for injection should be administered intravenously by infusion over a period of 30 minutes.

  Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone for injection must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

  There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

  Neonates

  Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone for injection (see CONTRAINDICATIONS).

  Ceftriaxone is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CONTRAINDICATIONS).

  Pediatric Patients

  For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 grams.

  For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.

  In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.

  Adults

  The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve > 90% target attainment. The total daily dose should not exceed 4 grams.

  If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone sodium has no activity against this organism.

  For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

  Generally, ceftriaxone therapy should be continued   for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required.

  When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

  No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

  DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE:

  PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

  The 10 gram vial should be reconstituted with 95 mL of an appropriate IV diluent in a suitable work area such as a laminar flow hood. The resulting solution will contain approximately 100 mg/mL of ceftriaxone.

  The container closure may be penetrated only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents. (A sterile substance which must be reconstituted prior to use may require a separate closure entry.) Use of this product is restricted to a suitable work area, such as a laminar flow hood.

  The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. If reconstitution is necessary, this time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package.

  Unused portions of solution held longer than the recommended time periods should be discarded.

  Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion.

  Transfer individual dose to appropriate intravenous solutions as soon as possible following reconstitution of the bulk package. The stability of the solution that has been transferred into a container varies according to diluent, concentration and temperature (see Compatibility and Stability). Concentrations between 10 mg/mL and 40 mg/mL are recommended; however lower concentrations may be used if desired.

  Compatibility and Stability:

  Ceftriaxone has been shown to be compatible with Flagyl® IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl® IV RTU® (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

  Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

  Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

  Ceftriaxone for injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility (see WARNINGS).

  Ceftriaxone sodium sterile powder should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and protected from light. After reconstitution, protection from normal light is not necessary. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

  Ceftriaxone for injection intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers:

  * Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only. Diluent Storage Room Temp. (25°C) Refrigerated (4°C) Sterile Water 2 days 10 days 0.9% Sodium Chloride Solution 2 days 10 days 5% Dextrose Solution 2 days 10 days 10% Dextrose Solution 2 days 10 days 5% Dextrose + 0.9% Sodium Chloride Solution* 2 days Incompatible 5% Dextrose + 0.45% Sodium Chloride Solution 2 days Incompatible

  The following intravenous ceftriaxone for injection solutions are stable at room temperature (25°C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container).

  After the indicated stability time periods, unused portions of solutions should be discarded.

  NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

  Ceftriaxone for injection reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state  (-20°C)   in PVC or polyolefin containers, remains stable for 26 weeks.

  Frozen solutions of ceftriaxone for injection should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

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• Cefixime
  

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  Cefixime

  

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  2.1 Adults

  The recommended dose of cefixime is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.2 Pediatric Patients (6 months or older)

  The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

  Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because cefixime for oral suspension is available in two different concentrations (100 mg/5 mL and 200 mg/5 mL).

  Table 1. Suggested doses for pediatric patients PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration Cefixime for Oral Suspension 100 mg/5 mL 200 mg/5 mL Patient Weight (kg) Dose/Day  (mg) Dose/Day  (mL) Dose/Day  (mL) 5 to 7.5 50 2.5 -- 7.6 to 10 80 4 2 10.1 to 12.5 100 5 2.5 12.6 to 20.5 150 7.5 4 20.6 to 28 200 10 5 28.1 to 33 250 12.5 6 33.1 to 40 300 15 7.5 40.1 to 45 350 17.5 9 45.1 or greater 400 20 10

  Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose.

  Otitis media should be treated with the suspension. Clinical trials of otitis media were conducted with the suspension, and the suspension results in higher peak blood levels than the tablet when administered at the same dose.

  Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media. [See CLINICAL PHARMACOLOGY (12.3)]

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.3 Renal Impairment

  Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

  Table 2. Doses for Adults with Renal Impairment * The preferred concentrations of oral suspension to use is 200 mg/5 mL for patients with this renal dysfunction Renal Dysfunction  Cefixime for Oral Suspension Creatinine Clearance (mL/min) 100 mg/5 mL 200 mg/5 mL Dose/Day (mL) Dose/Day (mL) 60 or greater Normal dose Normal dose 21 to 59*OR renal hemodialysis* 13 6.5 20 or less OR continuous peritoneal dialysis  8.6 4.4

  2.4 Reconstitution Directions for Oral Suspension

  Strength Bottle Size Reconstitution Directions 200 mg/5 mL 75 mL To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 100 mg/5 mL and 200 mg/5 mL 50 mL To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.

  After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

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• Wymzya Fe
  

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  Wymzya Fe

  

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  To achieve maximum contraceptive effectiveness, WYMZYA Fe must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of WYMZYA Fe is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking WYMZYA Fe on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on WYMZYA Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

  When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts WYMZYA Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of WYMZYA Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin WYMZYA Fe the next day. If switching from an implant or injection, the patient should start WYMZYA Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

  If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if WYMZYA Fe is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

  For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

  WYMZYA Fe may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. WYMZYA  Fe may be initiated after a first-trimester abortion; if the patient starts WYMZYA Fe immediately, additional contraceptive measures are not needed.

  For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

  DOSAGE AND ADMINISTRATION

  HOW TO TAKE WYMZYA Fe

  IMPORTANT POINTS TO REMEMBER

  1. BE SURE TO READ THESE DIRECTIONS:

  Before you start taking your pills Anytime you are not sure what to do

  2. THE PILL MAY BE SWALLOWED WHOLE OR CHEWED AND SWALLOWED. IF THE PILL IS CHEWED, YOU SHOULD DRINK A FULL GLASS (8 OUNCES) OF LIQUID IMMEDIATELY AFTER SWALLOWING.

  3. TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.

  4. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS.If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.

  5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

  6. IF YOU HAVE VOMITING (within 3 to 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE CERTAIN MEDICINES, including some antibiotics, or the herbal supplement St. John’s Wort, your pills may not work as well. Use a back-up method of birth control (such as condoms or spermicide) until you check with your healthcare provider.

  7. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

  8. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare provider.

  BEFORE YOU START TAKING YOUR PILLS

  1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL.

  It is important to take it at about the same time every day.

  2. LOOK AT YOUR PILL PACK:

  The pill pack has 21 "active" white pills (with hormones) to take for 3 weeks, followed by 7 “reminder” brown pills (without hormones) to take for 1 week.

  3. ALSO FIND:

  where on the pack to start taking pills, in what order to take the pills (follow the arrows), and the week numbers as shown in the picture above.

  4. BE SURE YOU HAVE READY AT ALL TIMES:

  ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up in case you miss pills. AN EXTRA, FULL PILL PACK. WHEN TO START THE FIRST PACK OF PILLS

  You have 2 choices of which day to start taking your first pack of pills. (See DAY 1 START or SUNDAY START directions below.) Decide with your healthcare provider which is the best day for you. Once you have decided which day you will begin taking your pills, immediately do the following: remove the Brief Summary from inside the pouch and look for the attached day label sheet; peel the label from the sheet which has the start day printed on the left hand side; place the label on the blister card over the pre-printed days of the week. Take your pill daily in the order indicated by the arrows on the blister card illustration shown above. Pick a time of day which will be easy to remember and take your pill at the same time each day.

  DAY 1 START:

  1. Take the first "active" white pill of the first pack during the first 24 hours of your period.

  2. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

  SUNDAY START:

  1. Take the first "active" white pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.

  2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms or spermicide are good back-up methods of birth control.

  WHAT TO DO DURING THE MONTH

  1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.

  2. WHEN YOU FINISH A PACK OF YOUR WYMZYA Fe:Start the next pack on the day after your last brown “reminder" pill. Do not wait any days between packs.

  3. WHEN YOU SWITCH FROM A DIFFERENT BRAND OF PILLS:If your previous brand had 21 pills, wait 7 days before starting WYMZYA Fe.If your previous brand had 28 pills, start taking WYMZYA Fe on the day after the last pill.

  WHAT TO DO IF YOU MISS PILLS

  The pill may not be as effective if you miss white “active” pills, and particularly if you miss the first few or the last few white “active” pills in a pack.

  If you MISS 1 white "active" pill:

  1. Take it as soon as you remember. Take the next pill at your regular time. This means you may

  take 2 pills in 1 day.

  2. You do not need to use a back-up birth control method if you have sex.

  If you MISS 2 white "active" pills in a row in WEEK 1 OR WEEK 2 of your pack:

  1. Take 2 pills on the day you remember and 2 pills the next day.

  2. Then take 1 pill a day until you finish the pack.

  3. You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.

  If you MISS 2 white "active" pills in a row in THE 3rd WEEK:

  1. If you are a Day 1 Starter:

  THROW OUT the rest of the pill pack and start a new pack that same day.

  If you are a Sunday Starter:

  Keep taking 1 pill every day until Sunday.

  On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

  2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.

  3. You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for those 7 days.

  If you MISS 3 OR MORE white "active" pills in a row (during the first 3 weeks):

  1. If you are a Day 1 Starter:

  THROW OUT the rest of the pill pack and start a new pack that same day.

  If you are a Sunday Starter:

  Keep taking 1 pill every day until Sunday.

  On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

  2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.

  3. You COULD BECOME PREGNANT if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up for the first 7 days after you restart your pills.

  If you forget any of the 7 brown "reminder" pills in Week 4:

  1. THROW AWAY the pills you missed.

  2. Keep taking 1 pill each day until the pack is empty.

  3. You do not need a back-up method of birth control.

  FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED:

  1. Use a BACK-UP METHOD anytime you have sex.

  2. KEEP TAKING ONE "ACTIVE" (WHITE) PILL EACH DAY until you can reach your healthcare provider.

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• Perindopril Erbumine
  

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  Perindopril Erbumine

  

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  Stable Coronary Artery Disease

  In patients with stable coronary artery disease, perindopril erbumine tablets should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased as tolerated, to a maintenance dose of 8 mg once daily. In elderly patients (>70 yrs), perindopril erbumine tablets should be given as a 2 mg dose once daily in the first week, followed by 4 mg once daily in the second week and 8 mg once daily for maintenance dose if tolerated.

  Hypertension

  Use in Uncomplicated Hypertensive Patients: In patients with essential hypertension, the recommended initial dose is 4 mg once a day. The dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled or to a maximum of 16 mg per day. The usual maintenance dose range is 4 to 8 mg administered as a single daily dose. perindopril erbumine tablets may also be administered in two divided doses. When once-daily dosing was compared to twice-daily dosing in clinical studies, the B.I.D. regimen was generally slightly superior, but not by more than about 0.5 to 1.0 mm Hg.

  Use in the Elderly Patients: As in younger patients, the recommended initial daily dosage of perindopril erbumine tablets for the elderly (>65 years) is 4 mg daily, given in one or two divided doses. The daily dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled, but experience with perindopril erbumine tablets is limited in the elderly at doses exceeding 8 mg. Dosages above 8 mg should be administered with caution and under close medical supervision. (See PRECAUTIONS: Geriatric Use.)

  Use in Concomitant Diuretics: If blood pressure is not adequately controlled with perindopril alone, a diuretic may be added. In patients currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of perindopril. To reduce likelihood of such reaction, the diuretic should, if possible, be discontinued 2 to 3 days prior to the beginning of perindopril erbumine tablets therapy. (See WARNINGS.) Then, if blood pressure is not controlled with perindopril erbumine tablets alone, the diuretic should be resumed.

  If the diuretic cannot be discontinued, an initial dose of 2 to 4 mg daily in one or in two divided doses should be used with careful medical supervision for several hours and until blood pressure has stabilized. The dosage should then be titrated as described above. (See WARNINGS and PRECAUTIONS: Drug Interactions.)

  After the first dose of perindopril erbumine tablets, the patient should be followed closely for the first two weeks of treatment and whenever the dose of perindopril erbumine tablets and/or diuretics is increased (See WARNINGS and PRECAUTIONS, Drug Interactions.) In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of perindopril erbumine tablets. To reduce the likelihood of hypotension, the dose of diuretic, if possible, can be adjusted which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of perindopril erbumine tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.  

  Dose Adjustment in Renal Impairment

  Kinetic data indicate that perindoprilat elimination is decreased in renally impaired patients, with a marked increase in accumulation when creatinine clearance drops below 30 mL/min. In such patients (creatinine clearance <30 mL/min), safety and efficacy of perindopril erbumine tablets have not been established. For patients with lesser degrees of impairment (creatinine clearance above 30 mL/min), the initial dosage should be 2 mg/day and dosage should not exceed 8 mg/day due to limited clinical experience. During dialysis, perindopril is removed with the same clearance as in patients with normal renal function.

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• Levetiracetam
  

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  Levetiracetam

  

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  Levetiracetam tablets are indicated as adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

  Adults 16 Years and Older

  In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see CLINICAL STUDIES), a consistent increase in response with increased dose has not been shown.

  Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients Ages 4 to <16 Years

  Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 10 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered.

  Levetiracetam tablets are given orally with or without food.

  Table 10: Levetiracetam Tablets Weight-Based Dosing Guide for Children Patient Weight Daily Dose

  20 mg/kg/day

  (BID dosing)

  40 mg/kg/day

  (BID dosing)

  60 mg/kg/day

  (BID dosing) 20.1-40 kg

  500 mg/day

  (1 x 250 mg

  tablet BID)

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  1500 mg/day

  (1 x 750 mg

  tablet BID) >40 kg

  1000 mg/day

  (1 x 500 mg

  tablet BID)

  2000 mg/day

  (2 x 500 mg

  tablets BID)

  3000 mg/day

  (2 x 750 mg

  tablets BID)

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients based on a daily dose of 20 mg/kg/day, 40 mg/kg/day or 60 mg/kg/day:

                                                   Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = -------------------------------------------------------------------

                                                                         100 mg/mL

  A household teaspoon or tablespoon is not an adequate measuring device. It is recommended that a calibrated measuring device be obtained and used. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

  Adult Patients with Impaired Renal Function

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended doses and adjustment for dose for adults are shown in Table 11. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the following formula:

                   [140-age (years)] x weight (kg)

  CLcr =--------------------------------------------- (x 0.85 for female patients)

                      72 x serum creatinine (mg/dL)

  Table 11: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group

  Creatinine Clearance

  (mL/min)

  Dosage

  (mg) Frequency Normal > 80 500 to 1,500 Every 12 h Mild 50 – 80 500 to 1,000 Every 12 h Moderate 30 – 50 250 to 750 Every 12 h Severe < 30 250 to 500 Every 12 h ESRD patients using dialysis --- 500 to 1,000 *Every 24 h

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• Cefdinir
  

  ×

  Cefdinir

  

  ---

  (see INDICATIONS AND USAGE for Indicated Pathogens)

  The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections. Cefdinir capsules may be taken without regard to meals.

  Adults and Adolescents (Age 13 years and Older) Type of Infection Dosage Duration Community-Acquired Pneumonia  300 mg q12h  10 days Acute Exacerbations of Chronic Bronchitis  300 mg q12h  5 to 10 days or Acute Maxillary Sinusitis  600 mg q24h  10 days 300 mg q12h  10 days or Pharyngitis/Tonsillitis  600 mg q24h  10 days 300 mg q12h  5 to 10 days or Uncomplicated Skin and Skin Structure Infections  600 mg q24h  10 days 300 mg q12h  10 days

  Patients With Renal Insufficiency:

  For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

  Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

                                                                                       (weight) (140 – age)

                                                             Males: CLcr = ——————————

                                                                                       (72) (serum creatinine)

                                                             Females: CLcr = 0.85 x above value

  where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)

  The following formula may be used to estimate creatinine clearance in pediatric patients:

                                                                                          body length or height

                                                             CLcr  =      K x ——————————

                                                                                          serum creatinine

  where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

  In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

  For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

  Patients on Hemodialysis:

  Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

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• Ethambutol Hydrochlorid...
  

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  Ethambutol Hydrochloride

  

  ---

  Ethambutol hydrochloride should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

  Ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

  Initial Treatment

  In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 15 mg/ kg (7 mg/lb) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.

  Retreatment

  In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 25 mg/kg (11 mg/lb) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in-vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride administration, decrease the dose to 15 mg/kg (7 mg/lb) of body weight, and administer as a single oral dose once every 24 hours.

  During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.

  See Table for easy selection of proper weight-dose tablet(s).

  Weight-Dose Table

  15 mg/kg (7 mg/lb) Schedule

  Weight Range

  Daily Dose

  Pounds

  Kilograms

  -----------------

  In mg Under 85 lbs. Under 37 kg

  -----------------

  500 85 – 94.5 37 – 43

  -----------------

  600 95 – 109.5  43 – 50

  -----------------

  700 110 – 124.5 50 – 57

  -----------------

  800 125 – 139.5 57 – 64

  -----------------

  900 140 – 154.5 64 – 71

  -----------------

  1000 155 – 169.5  71 – 79

  -----------------

  1100 170 – 184.5 79 – 84

  -----------------

  1200 185 – 199.5 84 – 90 

  -----------------

  1300 200 – 214.5  90 – 97

  -----------------

  1400 215 and Over Over 97

  -----------------

  1500

  25 mg/kg (11 mg/lb) Schedule

  Under 85 lbs. Under 38 kg

  -----------------

  900 85 – 92.5 38 – 42

  -----------------

  1000 93 – 101.5 42 – 45.5

  -----------------

  1100 102 – 109.5 45.5 – 50

  -----------------

  1200 110 – 118.5 50 – 54

  -----------------

  1300 119 – 128.5  54 – 58

  -----------------

  1400 129 – 136.5 58 – 62

  -----------------

  1500 137 – 146.5 62 – 67

  -----------------

  1600 147 – 155.5 67 – 71

  -----------------

  1700 156 – 164.5 71 – 75

  -----------------

  1800 165 – 173.5 75 – 79

  -----------------

  1900 174 – 182.5 79 – 83

  -----------------

  2000 183 – 191.5 83 – 87

  -----------------

  2100 192 – 199.5 87 – 91

  -----------------

  2200 200 – 209.5  91 – 95 

  -----------------

  2300 210 – 218.5 95 – 99

  -----------------

  2400 219 and Over Over 99

  -----------------

  2500

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• Cefdinir
  

  ×

  Cefdinir

  

  ---

  (see INDICATIONS AND USAGE for Indicated Pathogens)

  The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals.

  Pediatric Patients (Age 6 Months Through 12 Years) Type of Infection Dosage Duration Acute Bacterial Otitis Media 7 mg/kg q12h or 5 to 10 days 14 mg/kg q24h 10 days Acute Maxillary Sinusitis 7 mg/kg q12h or 10 days 14 mg/kg q24h 10 days Pharyngitis/Tonsilitis 7 mg/kg q12h or 5 to 10 days 14 mg/kg q24h 10 days Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART Weight   125 mg/5 mL  250 mg/5 mL 

  a Pediatric patients who weight ≥43 kg should receive the maximum daily dose of 600 mg.

  9 kg/20 lbs  2.5 mL q12h or 5 mL q24h  Use 125 mg/5 mL product  18 kg/40 lbs  5 mL q12h or 10 mL q24h  2.5 mL q12h or 5 mL q24h  27 kg/60 lbs  7.5 mL q12h or 15 mL q24h  3.75 mL q12h or 7.5 mL q24h  36 kg/80 lbs  10 mL q12h or 20 mL q24h  5 mL q12h or 10 mL q24h  ≥43 kg a/95 lbs  12 mL q12h or 24 mL q24h  6 mL q12h or 12 mL q24h 

  Patients With Renal Insufficiency:

  For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

  Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance (CLcr) in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function.

                                                                                      (weight) (140 – age)

                                                      Males:  CLcr =   ————————————

                                                                                      (72) (serum creatinine)

                                                     Females:   CLcr = 0.85 x above value

  where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.(3)

  The following formula may be used to estimate creatinine clearance in pediatric patients:

                                                                             body length or height

                                                       CLcr = K x ———————————

                                                                              serum creatinine

  where K = 0.55 for pediatric patients older than 1 year(4) and 0.45 for infants (up to 1 year)(5).

  In the above equation, creatinine clearance is in mL/min/1.73 m2, body length or height is in centimeters, and serum creatinine is in mg/dL.

  For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

  Patients on Hemodialysis:

  Hemodialysis removes cefdinir from the body. In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given. Subsequent doses (300 mg or 7 mg/kg) are then administered every other day.

  Directions for Mixing Final Concentration  Final Volume(mL)  Amount of Water  Directions  125 mg/5 mL   60  35 mL  Tap bottle to loosen the powder, then add water in 2   100  58 mL  portions. Shake well after each aliquot.  250 mg/5 mL   60  35 mL  Tap bottle to loosen the powder, then add water in 2  100  58 mL  portions. Shake well after each aliquot. 

  After mixing, the suspension can be stored at 20°-25°C (68°-77°F). The container should be kept tightly closed, and the suspension should be shaken well before each administration. The suspension may be used for 10 days, after which any unused portion must be discarded.

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• Cefprozil
  

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  Cefprozil

  

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  Cefprozil for oral suspension is administered orally.

  Population/Infection  Dosage (mg)  Duration (days)

  a In the treatment of infections due to Streptococcus pyogenes, cefprozil for oral suspension should be administered for at least 10 days.

  b Not to exceed recommended adult doses.

  ADULTS (13 years and older)       UPPER RESPIRATORY TRACT          Pharyngitis/Tonsillitis  500 q24h  10 a         Acute Sinusitis  250 q12h or  10          (For moderate to severe infections, the higher dose should be used)  500 q12h      LOWER RESPIRATORY TRACT          Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial         Exacerbation of Chronic Bronchitis  500 q12h  10      SKIN AND SKIN STRUCTURE          Uncomplicated Skin and Skin Structure Infections  250 q12h or  10  500 q24h or  500 q12h CHILDREN (2 years-12 years)      UPPER RESPIRATORY TRACT b         Pharyngitis/Tonsillitis  7.5 mg/kg q12h  10 a     SKIN AND SKIN STRUCTURE b         Uncomplicated Skin and Skin Structure Infections  20 mg/kg q24h  10  INFANTS & CHILDREN (6 months-12 years)      UPPER RESPIRATORY TRACT b         Otitis Media  15 mg/kg q12h  10          (See INDICATIONS AND USAGE and CLINICAL STUDIES)         Acute Sinusitis  7.5 mg/kg q12h or  10          (For moderate to severe infections, the higher dose should be used)  15 mg/kg q12h

  Renal Impairment:

  Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

  Creatinine Clearance (mL/min)  Dosage (mg)  Dosing Interval * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120  standard  standard  0-29* 50% of standard  standard

  Hepatic Impairment:

  No dosage adjustment is necessary for patients with impaired hepatic function.

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• Uncoated Aspirin
  

  ×

  Uncoated Aspirin

  

  ---

  2.1 Important Administration Instructions

  Cefuroxime axetil tablets USP and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see CLINICAL PHARMACOLOGY (12.3)] . Administer cefuroxime axetil tablets USP tablets as described in the appropriate dosage guidelines [see DOSAGE AND ADMINISTRATION (2.2)]. Administer cefuroxime axetil tablets USP with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets USP whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see DOSAGE AND ADMINISTRATION (2.2)].

  2.2 Dosage for cefuroxime axetil tablets USP

  Administer cefuroxime axetil tablets USP as described in the dosage guidelines table below with or without food.

  Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets USP Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10a Secondary bacterial infections of acute bronchitis 250 or 500 mg every 12 hours 5 to 10 Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole)b Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10

  2.5 Dosage in Patients with Impaired Renal Function

  A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY (12.3)].

  Table 4. Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to ˂30 Standard individual dose given every 24 hours ˂10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis

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• Homeopathic Leg Cramp F...
  

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  Homeopathic Leg Cramp Formula

  

  ---

  2.1 Adults

  Vancomycin Hydrochloride Capsules USP are used in treating C. difficile-associated diarrhea and staphylococcal enterocolitis.

  C. difficile-associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days. Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

  2.2 Pediatric Patients

  The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

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• Mefenamic Acid
  

  ×

  Mefenamic Acid

  

  ---

  Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

  After observing the response to initial therapy with mefenamic acid, the dose and frequency should be adjusted to suit an individual patient's needs.

  For the relief of acute pain in adults and adolescents ≥14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week.4

  For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. Clinical studies indicate that effective treatment can be initiated with the start of menses and should not be necessary for more than 2 to 3 days.5

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• Metformin Hydrochloride...
  

  ×

  Metformin Hydrochloride

  

  ---

  There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended-release tablets or any other pharmacologic agent. Dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin hydrochloride extended-release tablets in adults is 2500 mg.

  Metformin hydrochloride extended-release tablets should be taken with a full glass of water once daily with the evening meal. Metformin hydrochloride extended-release tablets should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

  During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended-release tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride extended-release tablets, either when used as monotherapy or in combination with sulfonylurea or insulin.

  Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

  Short-term administration of metformin hydrochloride extended-release tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

  Recommended Dosing Schedule

  The usual starting dose of metformin hydrochloride extended-release tablets is 1000 mg taken with a full glass of water once daily with the evening meal, although 500 mg may be utilized when clinically appropriate. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2500 mg once daily with the evening meal (see CLINICAL PHARMACOLOGY, Clinical Studies).

  In randomized trials, patients currently treated with immediate-release metformin were switched to metformin hydrochloride extended-release tablets. Results of this trial suggest that patients receiving immediate-release metformin treatment may be safely switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2500 mg once daily. Following a switch from immediate-release metformin to metformin hydrochloride extended-release tablets, glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY, Clinical Studies).

  Pediatrics –

  There is no pediatric information available for metformin hydrochloride extended-release tablets.

  Transfer From Other Antidiabetic Therapy

  When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

  Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients

  If patients have not responded to four weeks of the maximum dose of metformin monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (also known as glibenclamide). With concomitant metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see Package Insert of the respective sulfonylurea).

  If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin.

  Concomitant Metformin and Insulin Therapy in Adult Patients

  The current insulin dose should be continued upon initiation of metformin hydrochloride extended-release tablets therapy. Metformin therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride extended-release tablets should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose for metformin hydrochloride extended-release tablets is 2500 mg. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride extended-release tablets. Further adjustment should be individualized based on glucose-lowering response.

  Specific Patient Populations

  Metformin hydrochloride extended-release tablets are not recommended for use in pregnancy, and are not recommended in patients below the age of 17 years.

  The initial and maintenance dosing of metformin hydrochloride extended-release tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride extended-release tablets.

  Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly (see WARNINGS).

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• Norethindrone And Ethin...
  

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  Norethindrone And Ethinyl Estradiol And Ferrous Fumarate

  

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  To achieve maximum contraceptive effectiveness, norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

  When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg the next day. If switching from an implant or injection, the patient should start norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg on the day of implant removal or, if using an injection, the day the next injection would be due.

  If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

  For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

  norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg may be initiated after a first-trimester abortion; if the patient starts norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets 0.4 mg/35 mcg immediately, additional contraceptive measures are not needed.

  For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

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• Metaxalone
  

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  Metaxalone

  

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  2.1 Hypertension

  The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with ramipril alone, a diuretic can be added.

  2.3 Heart Failure Post-Myocardial Infarction

  For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ramipril is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily. After one week at the starting dose, increase dose (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart.

  After the initial dose of ramipril, observe the patient under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. If possible, reduce the dose of any concomitant diuretic as this may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ramipril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension [see WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7.1)].

  2.4 General Dosing Information

  Generally, swallow ramipril capsules whole. The ramipril capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of applesauce or mixed in 4 oz. (120 mL) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, consume the mixture in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.

  Concomitant administration of ramipril with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium [see WARNINGS AND PRECAUTIONS (5.8)].

  2.5 Dosage Adjustment

  Renal Impairment

  Establish baseline renal function in patients initiating ramipril. Usual regimens of therapy with ramipril may be followed in patients with estimated creatinine clearance >40 mL/min. However, in patients with worse impairment, 25 % of the usual dose of ramipril is expected to produce full therapeutic levels of ramiprilat [see USE IN SPECIFIC POPULATIONS (8.6)].

  Hypertension

  For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.

  Heart Failure Post-Myocardial Infarction

  For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. The dose may be increased to 1.25 mg twice daily, and up to a maximum dose of 2.5 mg twice daily depending on clinical response and tolerability.

  Volume Depletion or Renal Artery Stenosis

  Blood pressure decreases associated with any dose of ramipril depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, initiate dosing at 1.25 mg once daily. Adjust dosage according to blood pressure response.

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• Dorzolamide Hydrochlori...
  

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  Dorzolamide Hydrochloride Solution Drops

  

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  Lisinopril monotherapy is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide monotherapy is effective in doses of 12.5 to 50 mg per day. In clinical trials of lisinopril/hydrochlorothiazide combination therapy using lisinopril doses of 10 to 80 mg and hydrochlorothiazide doses of 6.25 to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.

  The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide may be associated with either or both dose-independent or dose-dependent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.

  To minimize dose-dependent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

  Dose Titration Guided by Clinical Effect

  A patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, depending on current monotherapy dose. Further increases of either or both components should depend on clinical response with blood pressure measured at the interdosing interval to ensure that there is an adequate antihypertensive effect at that time. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. After addition of the diuretic it may be possible to reduce the dose of lisinopril. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen may achieve similar or greater blood-pressure control without electrolyte disturbance if they are switched to lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg.

  In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of lisinopril. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). If the patient's blood pressure is not controlled with lisinopril alone, diuretic therapy may be resumed.

  If the diuretic cannot be discontinued, an initial dose of 5 mg of lisinopril should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (See WARNINGS and PRECAUTIONS, Drug Interactions).

  Concomitant administration of lisinopril and hydrochlorothiazide with potassium supplements, potassium salt substitutes or potassium-sparing diuretics may lead to increases of serum potassium (See PRECAUTIONS).

  Replacement Therapy

  The combination may be substituted for the titrated individual components.

  Use in Renal Impairment

  Regimens of therapy with lisinopril and hydrochlorothiazide tablets need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.7 m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablets are not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).

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• Famotidine
  

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  Famotidine

  

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  Duodenal Ulcer:

  Acute Therapy: 

  The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

  Maintenance Therapy:

  The recommended adult oral dose is 20 mg once a day at bedtime.

  Benign Gastric Ulcer:

  Acute Therapy: 

  The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

  Gastroesophageal Reflux Disease (GERD):

  The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

  Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD):

  See PRECAUTIONS, Pediatric Patients <1 year of age.

  The studies described in PRECAUTIONS, Pediatric Patients <1 year of age  suggest the following starting doses in pediatric patients <1 year of age:

  Gastroesophageal Reflux Disease (GERD):

  0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

  Dosage for Pediatric Patients 1-16 years of age:

  See PRECAUTIONS, Pediatric Patients 1-16 years of age.

  The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age  suggest the following starting doses in pediatric patients 1-16 years of age:

  Peptic Ulcer:

  0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

  Gastroesophageal Reflux Disease With or Without Esophagitis Including Erosions and Ulcerations:

  1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

  While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

  Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas):

  The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

  Oral Suspension:

  Famotidine for Oral Suspension may be substituted for famotidine tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of purified water as directed.

  Directions for Preparing Famotidine for Oral Suspension:

  Prepare suspension at time of dispensing. Slowly add 46 mL of purified water. Shake vigorously for 5-10 seconds immediately after adding the water and immediately before use.

  Stability of Famotidine for Oral Suspension:

  Unused constituted oral suspension should be discarded after 30 days.

  Concomitant Use of Antacids:

  Antacids may be given concomitantly if needed.

  Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency:

  In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

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• Riastap
  

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  Riastap

  

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  Swallow duloxetine delayed-release capsules USP whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules USP can be given without regard to meals. If a dose of duloxetine delayed-release capsules USP is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules USP at the same time.

  2.1 Dosage for Treatment of Major Depressive Disorder

  Administer duloxetine delayed-release capsules USP at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.1)].

  2.2 Dosage for Treatment of Generalized Anxiety Disorder

  Adults

  For most patients, initiate duloxetine delayed-release capsules USP 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].

  Pediatric use information for patient's ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain

  Administer duloxetine delayed-release capsules USP 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see CLINICAL STUDIES (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.

  Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see DOSAGE AND ADMINISTRATION (2.6), USE IN SPECIFIC POPULATIONS (8.10), and CLINICAL PHARMACOLOGY (12.3)].

  2.5 Dosage for Treatment of Chronic Musculoskeletal Pain

  Administer duloxetine delayed-release capsules USP 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see CLINICAL STUDIES (14.5)].

  2.6 Dosing in Special Populations

  Hepatic Impairment

  Avoid use in patients with chronic liver disease or cirrhosis [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.9)].

  Severe Renal Impairment

  Avoid use in patients with severe renal impairment, GFR <30 mL/min [see WARNINGS AND PRECAUTIONS (5.14) and USE IN SPECIFIC POPULATIONS (8.10)].

  2.7 Discontinuing Duloxetine Delayed-release Capsules

  Adverse reactions after discontinuation of duloxetine delayed-release capsules USP, after abrupt or tapered discontinuation, include: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [see WARNINGS AND PRECAUTIONS (5.7)].

  2.8 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules USP. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules USP before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4)].

  2.9 Use of Duloxetine Delayed-release Capsules with Other MAOIs such as Linezolid or Methylene Blue

  Do not start duloxetine delayed-release capsules USP in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4)].

  In some cases, a patient already receiving duloxetine delayed-release capsules USP therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.4)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.4)].

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• Nitrofurantoin
  

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  Nitrofurantoin

  

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  Use the lowest effective dose for the patient.

  2.1 Dosage in Adults

  The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].

  2.2 Geriatric or Debilitated Patients

  The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.

  2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

  In patients with severe hepatic impairment or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see WARNING AND PRECAUTIONS (5.7)].

  2.4 Use with CNS Depressants

  Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].

  2.5 Administration with Food

  Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see CLINICAL PHARMACOLOGY (12.3)].

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• Xylocaine Mpf
  

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  Xylocaine Mpf

  

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  Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed.

  Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose.

  2.1 Mania

  Divalproex sodium delayed-release tablets are administered orally. The recommended initial dose is 750 mg daily in divided doses. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In placebo-controlled clinical trials of acute mania, patients were dosed to a clinical response with a trough plasma concentration between 50 and 125 mcg/mL. Maximum concentrations were generally achieved within 14 days. The maximum recommended dosage is 60 mg/kg/day.

  There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during divalproex sodium delayed-release tablets treatment of an acute manic episode. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no data to support the benefits of divalproex sodium delayed-release tablets in such longer-term treatment. Although there are no efficacy data that specifically address longer-term antimanic treatment with divalproex sodium delayed-release tablets, the safety of divalproex sodium delayed-release tablets in long-term use is supported by data from record reviews involving approximately 360 patients treated with divalproex sodium delayed-release tablets for greater than 3 months.

  2.2 Epilepsy

  Divalproex sodium delayed-release tablets are administered orally. Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures. As the divalproex sodium delayed-release tablets dosage are titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see DRUG INTERACTIONS (7.2)].

  Complex Partial Seizures

  For adults and children 10 years of age or older.

  Monotherapy (Initial Therapy):

  Divalproex sodium delayed-release tablets have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made.

  The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.

  Conversion to Monotherapy:

  Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of divalproex sodium delayed-release tablets therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency.

  Adjunctive Therapy:

  Divalproex sodium delayed-release tablets may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. If the total daily dose exceeds 250 mg, it should be given in divided doses.

  In a study of adjunctive therapy for complex partial seizures in which patients were receiving either carbamazepine or phenytoin in addition to valproate, no adjustment of carbamazepine or phenytoin dosage was needed [see CLINICAL STUDIES (14.2)]. However, since valproate may interact with these or other concurrently administered AEDs as well as other drugs, periodic plasma concentration determinations of concomitant AEDs are recommended during the early course of therapy [see DRUG INTERACTIONS (7)].

  Simple and Complex Absence Seizures

  The recommended initial dose is 15 mg/kg/day, increasing at one week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases. The maximum recommended dosage is 60 mg/kg/day. If the total daily dose exceeds 250 mg, it should be given in divided doses.

  A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect. However, therapeutic valproate serum concentrations for most patients with absence seizures is considered to range from 50 to 100 mcg/mL. Some patients may be controlled with lower or higher serum concentrations [see CLINICAL PHARMACOLOGY (12.3)].

  As the divalproex sodium delayed-release tablets dosage are titrated upward, blood concentrations of phenobarbital and/or phenytoin may be affected [see DRUG INTERACTIONS (7.2)].

  Antiepilepsy drugs should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.

  In epileptic patients previously receiving Depakene® (valproic acid) therapy, divalproex sodium delayed-release tablets should be initiated at the same daily dose and dosing schedule. After the patient is stabilized on divalproex sodium delayed-release tablets, a dosing schedule of two or three times a day may be elected in selected patients.

  2.3 Migraine

  Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches in adults.

  Divalproex sodium delayed-release tablets are administered orally. The recommended starting dose is 250 mg twice daily. Some patients may benefit from doses up to 1,000 mg/day. In the clinical trials, there was no evidence that higher doses led to greater efficacy.

  2.4 General Dosing Advice

  Dosing in Elderly Patients

  Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced in these patients. Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse reactions. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence. The ultimate therapeutic dose should be achieved on the basis of both tolerability and clinical response [see WARNINGS AND PRECAUTIONS (5.14), USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL PHARMACOLOGY (12.3)].

  Dose-Related Adverse Reactions

  The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia) may be dose-related. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males) [see WARNINGS AND PRECAUTIONS (5.8)]. The benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse reactions.

  G.I. Irritation

  Patients who experience G.I. irritation may benefit from administration of the drug with food or by slowly building up the dose from an initial low level.

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• Tri-lo-marzia
  

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  Tri-lo-marzia

  

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  Oral Contraception

  To achieve maximum contraceptive effectiveness, Tri-Lo-Marzia must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Tri-Lo-Marzia is available in the wallet containing 28 tablets which is preset for a Sunday Start. Day 1 Start is also provided.

  Sunday Start

  When taking Tri-Lo-Marzia the first white "active" tablet should be taken on the first Sunday after menstruation begins. If the menstrual period begins on Sunday, the first white "active" tablet should be taken that day. Take one white, light blue or blue "active" tablet daily for 21 days followed by one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

  If the patient misses one (1) white, light blue, or blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) blue "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  Day 1 Start

  The dosage of Tri-Lo-Marzia for the initial cycle of therapy is one white, light blue or blue "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one green "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

  If the patient misses one (1) white, light blue, or blue "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) white or light blue "active" tablets in Week 1 or Week 2, the patient should take two (2) "active" tablets the day she remembers and two (2) "active" tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills. If the patient misses two (2) blue "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  When switching from another oral contraceptive, Tri-Lo-Marzia s should be started on the same day that a new pack of the previous oral contraceptive would have been started.

  The use of Tri-Lo-Marzia for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGSconcerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers.") The possibility of ovulation and conception prior to initiation of medication should be considered.

  (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

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• Cephalexin For Suspensi...
  

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  Cephalexin For Suspension

  

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  Cephalexin is administered orally.

  Adults – The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

  Pediatric Patients – The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

  Cephalexin Suspension Weight 125 mg/ 5 mL 10 kg (22 lb) ½to 1 tsp q.i.d. 20 kg (44 lb) 1 to 2 tsp q.i.d. 40 kg (88 lb) 2 to 4 tsp q.i.d. Weight 250 mg/ 5 mL 10 kg (22 lb) ¼ to ½ tsp q.i.d. 20 kg (44 lb) ½ to 1 tsp q.i.d. 40 kg (88 lb) 1 to 2 tsp q.i.d. or Weight 125 mg/ 5 mL 10 kg (22 lb) 1 to 2 tsp b.i.d. 20 kg (44 lb) 2 to 4 tsp b.i.d. 40 kg (88 lb) 4 to 8 tsp b.i.d. Weight 250 mg/ 5 mL 10 kg (22 lb) ½ to 1 tsp b.i.d. 20 kg (44 lb) 1 to 2 tsp b.i.d. 40 kg (88 lb) 2 to 4 tsp b.i.d.

  In severe infections, the dosage may be doubled.

  In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

  In the treatment of β-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

  Directions for Mixing

  For Cephalexin for Oral Suspension, USP 125 mg/5 mL:

  Bottle size Reconstitution directions 100 mL Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition 200 mL Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

  For Cephalexin for Oral Suspension, USP 250 mg/5 mL:

  Bottle size Reconstitution directions 100 mL Add 66 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition. 200 mL Add 132 mL of water in two portions to the dry mixture in the bottle. Shake well after each addition.

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• Cephalexin
  

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  Cephalexin

  

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  Cephalexin is administered orally.

  Adults:

  The adult dosage ranges from 1 to 4 g daily in divided doses. The usual adult dose is 250 mg every 6 hours. For the following infections, a dosage of 500 mg may be administered every 12 hours: streptococcal pharyngitis, skin and skin structure infections, and uncomplicated cystitis in patients over 15 years of age. Cystitis therapy should be continued for 7 to 14 days. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. If daily doses of Cephalexin greater than 4 g are required, parenteral cephalosporins, in appropriate doses, should be considered.

  Pediatric Patients:

  The usual recommended daily dosage for pediatric patients is 25 to 50 mg/kg in divided doses. For streptococcal pharyngitis in patients over 1 year of age and for skin and skin structure infections, the total daily dose may be divided and administered every 12 hours.

  In severe infections, the dosage may be doubled.

  In the therapy of otitis media, clinical studies have shown that a dosage of 75 to 100 mg/kg/day in 4 divided doses is required.

  In the treatment of ß-hemolytic streptococcal infections, a therapeutic dosage of cephalexin should be administered for at least 10 days.

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• Vancomycin
  

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  Vancomycin

  

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  2.1 General Considerations

  Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.

  Amlodipine and valsartan tablets may be administered with or without food.

  Amlodipine and valsartan tablets may be administered with other antihypertensive agents.

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with amlodipine and valsartan tablets.

  A patient who experiences dose-limiting adverse reactions on either component alone may be switched to amlodipine and valsartan tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to amlodipine and valsartan tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.

  2.3 Replacement Therapy

  For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of amlodipine and valsartan tablets containing the same component doses.

  2.4 Initial Therapy

  A patient may be initiated on amlodipine and valsartan tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is amlodipine and valsartan tablets 5/160 mg once daily in patients who are not volume-depleted.

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• Cefprozil
  

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  Cefprozil

  

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  Cefprozil tablets are administered orally.

  Population/Infection  Dosage (mg)  Duration (days) 

  a In the treatment of infections due to Streptococcus pyogenes, cefprozil tablets should be administered for at least 10 days.

  b Not to exceed recommended adult doses.

   ADULTS (13 years and older)       UPPER RESPIRATORY TRACT           Pharyngitis/Tonsillitis  500 q24h  10 a          Acute Sinusitis  250 q12h or  10           (For moderate to severe infections, the higher dose should be used)  500 q12h      LOWER RESPIRATORY TRACT           Secondary Bacterial Infection of Acute Bronchitis and         Acute Bacterial Exacerbation of Chronic Bronchitis  500 q12h  10      SKIN AND SKIN STRUCTURE           Uncomplicated Skin and Skin Structure Infections  250 q12h or  10  500 q24h or  500 q12h   CHILDREN (2 years-12 years)      UPPER RESPIRATORY TRACT b         Pharyngitis/Tonsillitis  7.5 mg/kg q12h  10 a     SKIN AND SKIN STRUCTUREb         Uncomplicated Skin and Skin Structure Infections  20 mg/kg q24h  10   INFANTS & CHILDREN (6 months-12 years)      UPPER RESPIRATORY TRACTb         Otitis Media  15 mg/kg q12h  10          (See INDICATIONS AND USAGE and CLINICAL STUDIES)         Acute Sinusitis  7.5 mg/kg q12h or  10          (For moderate to severe infections, the higher dose should be used)  15 mg/kg q12h 

  Renal Impairment:

  Cefprozil may be administered to patients with impaired renal function. The following dosage schedule should be used.

  Creatinine Clearance (mL/min)  Dosage (mg)  Dosing Interval  * Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after the completion of hemodialysis. 30-120  standard  standard  0-29 * 50% of standard  standard 

  Hepatic Impairment:

  No dosage adjustment is necessary for patients with impaired hepatic function.

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• Bupropion Hydrochloride...
  

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  Bupropion Hydrochloride

  

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  2.1 General Considerations

  Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 10 mg.

  Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan and amlodipine tablets is 80/10 mg once daily.

  The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see ADVERSE REACTIONS (6.1)].

  Telmisartan and amlodipine tablets may be taken with or without food.

  2.2 Replacement Therapy

  Patients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan and amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan and amlodipine tablets if blood pressure control has not been satisfactory.

  2.3 Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive Monotherapy

  Telmisartan and amlodipine tablets may be used to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone.

  Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to telmisartan and amlodipine tablets 40/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response [see ADVERSE REACTIONS (6.1)].

  2.4 Initial Therapy

  A patient may be initiated on telmisartan and amlodipine tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of telmisartan and amlodipine tablet is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on telmisartan and amlodipine tablet 80/5 mg once daily.

  Initial therapy with telmisartan and amlodipine tablet is not recommended in patients ≥75 years old or with hepatic impairment [see DOSAGE AND ADMINISTRATION (2.5), WARNINGS AND PRECAUTIONS (5.4), and USE IN SPECIFIC POPULATIONS (8.5,8.6)].

  Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with telmisartan and amlodipine tablets [see WARNINGS AND PRECAUTIONS (5.2)].

  2.5 Dosing in Specific Populations

  Renal Impairment

  No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

  Hepatic Impairment

  In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients with hepatic impairment.

  Patients 75 Years of Age and Older

  In most patients, initiate amlodipine therapy at 2.5 mg. Titrate slowly in patients 75 years of age and older.

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• Wymzya Fe
  

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  Wymzya Fe

  

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  To achieve maximum contraceptive effectiveness, WYMZYA Fe must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of WYMZYA Fe is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking WYMZYA Fe on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on WYMZYA Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

  When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts WYMZYA Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of WYMZYA Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin WYMZYA Fe the next day. If switching from an implant or injection, the patient should start WYMZYA Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

  If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if WYMZYA Fe is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed.

  For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

  WYMZYA Fe may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. WYMZYA  Fe may be initiated after a first-trimester abortion; if the patient starts WYMZYA Fe immediately, additional contraceptive measures are not needed.

  For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

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• Ceftazidime
  

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  Ceftazidime

  

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  Adults

  Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

  GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection Daily Dose (grams) Frequency and Route Gonococcal urethritis/ cervicitis in males and females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in females 0.5 0.5 gram IM (single dose) Rectal gonorrhea in males 1 1 gram IM (single dose) Uncomplicated infections 2 1 gram every 12 hours IM or IV Moderate to severe infections 3 to 6 1 to 2 grams every 8 hours IM or IV Infections commonly needing antibiotics in higher dosage (e.g., septicemia) 6 to 8 2 grams every 6 to 8 hours IV Life-threatening infections Up to 12 2 grams every 4 hours IV

  If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

  Cesarean Section Patients

  The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

  Neonates, Infants, and Children

  The following dosage schedule is recommended:

  Neonates (birth to 1 month) 

  0 to 1 week of age                    50 mg/kg per dose every 12 hours IV

  1 to 4 weeks of age                  50 mg/kg per dose every 8 hours IV

  It is not necessary to differentiate between premature and normal-gestational age infants.

  Infants and Children (1 month to 12 years)

  For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

  Geriatric Use

  This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

  Impaired Renal Function

  see PRECAUTIONS, General.

  NOTE: As with antibiotic therapy in general, administration of cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

  Preparation of Cefotaxime for Injection

  Cefotaxime for injection for IM or IV administration should be reconstituted as follows:

  Strength Diluent (mL) Withdrawable Volume (mL) Approximate Concentration (mg/mL) 500 mg vial* (IM) 2 2.2 230 1g vial* (IM) 3 3.4 300 2g vial* (IM) 5 6.0 330 500 mg vial* (IV) 10 10.2 50 1g vial* (IV) 10 10.4 95 2g vial* (IV) 10 11.0 180

  Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

  For intramuscular use

  Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

  For intravenous use

  Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. For other diluents, see COMPATIBILITY AND STABILITY section.

  NOTE: Solutions of cefotaxime for injection must not be admixed with aminoglycoside solutions. If cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

  A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

  IM Administration

  As with all IM preparations, cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

  IV Administration

  The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to discontinue temporarily the administration of other solutions at the same site.

  For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed below.

  Compatibility and Stability

  Solutions of cefotaxime for injection reconstituted as described above (Preparation of cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

  Strength Reconstituted Concentration mg/mL Stability at or below 22°C Stability under Refrigeration (at or below 5°C) Original Containers Plastic Syringes 500 mg vial IM 230 12 hours 7 days 5 days 1g vial IM 300 12 hours 7 days 5 days 2g vial IM 330 12 hours 7 days 5 days 500 mg vial IV 50 24 hours 7 days 5 days 1g vial IV 95 24 hours 7 days 5 days 2g vial IV 180 12 hours 7 days 5 days

  Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

  Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% Travasol® (Amino Acid) Injection without Electrolytes.

  NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5 to 7 range. Solutions of cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Fenofibrate
  

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  Fenofibrate

  

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  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules, and should continue this diet during treatment with fenofibrate. Fenofibrate capsules can be given without regard to meals.

  Patients should be advised to swallow fenofibrate capsules whole. Do not open, crush, dissolve or chew capsules.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 130 mg once daily.

  2.2 Primary Hypercholesterolemia and Mixed Dyslipidemia

  The initial dose of fenofibrate capsules is 130 mg per day.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 43 to 130 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 130 mg per day.

  2.4 Impaired Renal Function

  Treatment with fenofibrate should be initiated at a dose of 43 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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• Zetonna
  

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  Zetonna

  

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  2.1 Recommended Dosing

  Levetiracetam extended-release tablet is administered once daily.

  Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day.

  2.2 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                      [140-age (years)] x weight (kg)

       CLcr =     ---------------------------------------- x (0.85 for female patients

                      72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                              CLcr  (mL/min)

  CLcr  (mL/min/1.73 m2) =          ---------------------- x 1.73

                                              BSA subject (m2)

  Table 1: Dosage Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency Normal > 80 1000 to 3000 Every 24 hours Mild 50 to 80 1000 to 2000 Every 24 hours Moderate 30 to 50 500 to 1500 Every 24 hours Severe < 30 500 to 1000 Every 24 hours

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• Extra Strength Acetamin...
  

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  Extra Strength Acetaminophen

  

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  The recommended initial dose of calcium acetate capsule for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 capsules with each meal.

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• Pravastatin Sodium
  

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  Pravastatin Sodium

  

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  2.1 General Dosing Information

  The patient should be placed on a standard cholesterol-lowering diet before receiving pravastatin sodium and should continue on this diet during treatment with pravastatin sodium [see NCEP Treatment Guidelines for details on dietary therapy].

  2.2 Adult Patients

  The recommended starting dose is 40 mg once daily. If a daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once daily is recommended. In patients with significant renal impairment, a starting dose of 10 mg daily is recommended. Pravastatin sodium can be administered orally as a single dose at any time of the day, with or without food. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient's response to therapy and established treatment guidelines.

  2.3 Pediatric Patients

  Children (Ages 8 to 13 Years, Inclusive)

  The recommended dose is 20 mg once daily in children 8 to 13 years of age. Doses greater than 20 mg have not been studied in this patient population.

  Adolescents (Ages 14 to 18 Years)

  The recommended starting dose is 40 mg once daily in adolescents 14 to 18 years of age. Doses greater than 40 mg have not been studied in this patient population.

  Children and adolescents treated with pravastatin should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult goals for LDL-C [see INDICATIONS AND USAGE (1.2)].

  2.4 Concomitant Lipid-Altering Therapy

  Pravastatin sodium may be used with bile acid resins. When administering a bile-acid-binding resin (e.g., cholestyramine, colestipol) and pravastatin, pravastatin sodium should be given either 1 hour or more before or at least 4 hours following the resin. [See CLINICAL PHARMACOLOGY (12.3).]

  2.5 Dosage in Patients Taking Cyclosporine

  In patients taking immunosuppressive drugs such as cyclosporine concomitantly with pravastatin, therapy should begin with 10 mg of pravastatin sodium once-a-day at bedtime and titration to higher doses should be done with caution. Most patients treated with this combination received a maximum pravastatin sodium dose of 20 mg/day. In patients taking cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once daily [see WARNINGS AND PRECAUTIONS (5.1) and DRUG INTERACTIONS (7.1)].

  2.6 Dosage in Patients Taking Clarithromycin

  In patients taking clarithromycin, therapy should be limited to 40 mg of pravastatin sodium once daily [see DRUG INTERACTIONS (7.2)].

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• Norethindrone
  

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  Norethindrone

  

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  2.1 Important Administration Instructions

  Levetiracetam oral solution is given orally with or without food. The levetiracetam oral solution dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  1 Month to < 6 Months:

  Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

  6 Months to <4 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

  4 Years to < 16 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

                                               Daily dose (mg/kg/day) x patient weight (kg)

  Total daily dose (mL/day) = --------------------------------------------------------------------------------

                                                                   100 mg/mL

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to < 16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam oral solution dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

                          [140-age (years)] x weight (kg)

  CLcr =  ---------------------------------------------------------------------- (x 0.85 for female patients)

                         72 x serum creatinine (mg/dL)

  Then CLcr is adjusted for body surface area (BSA) as follows:

                                            CLcr (mL/min)

  CLcr (mL/min/1.73 m2)= -------------------------- x 1.73

                                          BSA subject (m2)

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73 m2) Dosage (mg) Frequency * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Normal > 80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ----- 500 to 1000* Every 24 hours*

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• Prevacid
  

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  Prevacid

  

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  2.1 Dosage in Adults

  Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [See WARNINGS AND PRECAUTIONS (5.1)]. The total dose of zolpidem tartrate extended-release tablets should not exceed 12.5 mg once daily immediately before bedtime.

  The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

  2.2 Special Populations

  Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate extended-release tablet USP in both of these patient populations is 6.25 mg once daily immediately before bedtime [See WARNINGS AND PRECAUTIONS (5.1); USE IN SPECIFIC POPULATIONS (8.5)].

  2.3 Use with CNS Depressants

  Dosage adjustment may be necessary when zolpidem tartrate extended-release tablets USP are combined with other CNS depressant drugs because of the potentially additive effects [See WARNINGS AND PRECAUTIONS (5.1)].

  2.4 Administration

  Zolpidem tartrate extended-release tablets USP should be swallowed whole, and not be divided, crushed, or chewed. The effect of zolpidem tartrate extended-release tablets USP may be slowed by ingestion with or immediately after a meal.

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• Lisinopril
  

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  Lisinopril

  

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  2.1 Hypertension

  Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give greater effect.

  Use with diuretics in adults

  If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (eg, hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril.

  The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day.

  Pediatric Patients 6 years of age and older with hypertension

  For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m2, the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily. Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see CLINICAL PHARMACOLOGY (12.3)].

  Lisinopril tablet USP is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m2 [see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.1)].

  2.2 Heart Failure

  The recommended starting dose for lisinopril, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.

  Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see WARNINGS AND PRECAUTIONS (5.4), and DRUG INTERACTIONS (7.1)]. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  2.3 Reduction of Mortality in Acute Myocardial Infarction

  In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets USP 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks.

  Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see WARNINGS AND PRECAUTIONS (5.4)]. If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril should be withdrawn.

  2.4 Dose in Patients with Renal Impairment

  No dose adjustment of lisinopril is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril to half of the usual recommended dose i.e., hypertension, 5 mg; systolic heart failure, 2.5 mg and acute MI, 2.5 mg. Up titrate as tolerated to a maximum of 40 mg daily. For patients on hemodialysis or creatinine clearance < 10 mL/min, the recommended initial dose is 2.5 mg once daily [see USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

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• Loperamide Hydrochlorid...
  

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  Loperamide Hydrochloride

  

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  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.

  In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.

  The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.

  When used in streptococcal infections, therapy should be continued for 10 days.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)

  If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk.

  Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment.

  Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.

  Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg by mouth twice a day for 7 days.

  Nongonococcal urethritis (NGU) caused by C. trachomatis or U. urealyticum: 100 mg by mouth twice a day for 7 days.

  Syphilis – early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.

  Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.

  Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.

  Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.

  For prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.

  Inhalational anthrax (post-exposure):

  ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.

  CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.

  Mixing Directions:

  Tap bottle lightly to loosen powder. Add 50 mL of water to the bottle to make a total volume of 60 mL. Shake well.

  This prescription, when in suspension, will maintain its potency for two weeks when kept at room temperature. Retain in carton until finished. Shake well before each use. Discard unused portion after two weeks.

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• Gatifloxacin Solution D...
  

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  Gatifloxacin Solution Drops

  

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  Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

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• Rifampin
  

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  Rifampin

  

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  Rifampin can be administered by the oral route (see INDICATIONS AND USAGE ). See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

  Tuberculosis

  Adults

  10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral

  Pediatric Patients

  10-20 mg/kg, not to exceed 600 mg/day, oral

  It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water.

  Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g. RIFATER®*) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial  treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

  Following the initial phase, treatment should be continued with rifampin and isoniazid (e.g. RIFAMATE®**) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

  Meningococcal Carriers

  Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

  Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

  Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.

  Preparation of Extemporaneous Oral Suspension

  For pediatric and adult patients in whom capsule swallowing is difficult or where lower doses are needed, a liquid suspension may be prepared as follows:

  Rifampin 1% w/v suspension (10 mg/mL) can be compounded using one of four syrups–Simple Syrup (Syrup NF), Simple Syrup (Humco Laboratories), Syrpalta®+ Syrup (Emerson Laboratories), or Raspberry Syrup (Humco Laboratories).

  Empty the contents of four rifampin capsules 300 mg or eight rifampin capsules 150 mg onto a piece of weighing paper. If necessary, gently crush the capsule contents with a spatula to produce a fine powder. Transfer the rifampin powder blend to a 4-ounce amber glass or plastic (high density polyethylene [HDPE], polypropylene, or polycarbonate) prescription bottle. Rinse the paper and spatula with 20 mL of one of the above-mentioned syrups, and add the rinse to the bottle. Shake vigorously. Add 100 mL of syrup to the bottle and shake vigorously.

  This compounding procedure results in a 1% w/v suspension containing 10 mg rifampin/mL. Stability studies indicate that the suspension is stable when stored at room temperature (25 ± 3°C) or in a refrigerator (2 to 8°C) for four weeks. This extemporaneously prepared suspension must be shaken well prior to administration.

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• Rabeprazole Sodium
  

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  Rabeprazole Sodium

  

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  2.1 Healing of Erosive or Ulcerative GERD in Adults

  The recommended adult oral dose is one rabeprazole sodium delayed-release tablets 20 mg to be taken once daily for four to eight weeks [See INDICATIONS AND USAGE (1.1)]. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.

  2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults

  The recommended adult oral dose is one rabeprazole sodium delayed-release tablet 20 mg to be taken once daily [see INDICATIONS AND USAGE (1.2)].

  2.3 Treatment of Symptomatic GERD in Adults

  The recommended adult oral dose is one rabeprazole sodium delayed-release tablet 20 mg to be taken once daily for 4 weeks [see INDICATIONS AND USAGE (1.3)]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. The recommended adolescent dosing is one rabeprazole sodium delayed-release tablets 20 mg to be taken once daily for 8 weeks.

  2.4 Healing of Duodenal Ulcers in Adults

  The recommended adult oral dose is one rabeprazole sodium delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks [see INDICATIONS AND USAGE (1.5)]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

  2.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

  TABLE 1 THREE DRUG REGIMEN* Rabeprazole sodium delayed-release tablet 20 mg Twice Daily for 7 Days 

  All three medications should be taken twice daily with the morning and evening meals.

  * It is important that patients comply with the full 7-day regimen. [See  CLINICAL STUDIES section (14.5)] Amoxicillin  1000 mg Twice Daily for 7 Days  Clarithromycin  500 mg Twice Daily for 7 Days 

  2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

  The dosage of rabeprazole sodium delayed-release tablets in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with rabeprazole sodium delayed-release tablets for up to one year.

  2.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older

  The recommended oral dose for adolescents 12 years of age and older is one 20 mg delayed-release tablet once daily for up to 8 weeks [see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.7)].

  2.9 Elderly, Renal and Hepatic Impaired Patients

  No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.

  2.10 Administration Recommendations

  TABLE 2 ADMINISTRATION RECOMMENDATIONS Formulation Population Instructions Delayed- Adults and  Swallow tablets whole. Do not chew,  Release  adolescents 12  crush or split tablets.  Tablet  years of age and older  Tablets can be taken with or without food. 

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• Heartburn Relief
  

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  Heartburn Relief

  

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  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules, and should continue this diet during treatment. Fenofibric acid delayed-release capsules can be taken without regard to meals. Patients should be advised to swallow fenofibric acid delayed-release capsules whole. Do not open, crush, dissolve, or chew capsules. Serum lipids should be monitored periodically.

  2.2 Severe Hypertriglyceridemia

  The initial dose of fenofibric acid delayed-release capsules is 45 to 135 mg once daily. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 135 mg once daily.

  2.3 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The dose of fenofibric acid delayed-release capsules is 135 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibric acid delayed-release capsules should be initiated at a dose of 45 mg once daily in patients with mild to moderate renal impairment and should only be increased after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibric acid delayed-release capsules should be avoided in patients with severely impaired renal function [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].

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• Berkley And Jensen Alle...
  

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  Berkley And Jensen Allergy Relief

  

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  THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.

  Adults

  The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.

  For Pediatric Patients above Eight Years of Age

  The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used.

  Uncomplicated Gonococcal Infections in Adults (Except Anorectal Infections in Men)

  100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.

  Acute Epididymo-orchitis Caused by N. gonorrhoeae

  100 mg, by mouth, twice a day for at least 10 days.

  Primary and Secondary Syphilis

  300 mg a day in divided doses for at least 10 days.

  Uncomplicated Urethral, Endocervical, or Rectal Infection in Adults Caused by Chlamydia trachomatis

  100 mg, by mouth, twice a day for at least 7 days.

  Nongonococcal Urethritis Caused by C. trachomatis and U. urealyticum

  100 mg, by mouth, twice a day for at least 7 days.

  Acute Epididymo-orchitis Caused by C. trachomatis

  100 mg, by mouth, twice a day for at least 10 days.

  Inhalational Anthrax (Post-Exposure)

  ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 pounds (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose.

  When used in streptococcal infections, therapy should be continued for 10 days.

  Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.) If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.

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• Abacavir Sulfate
  

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  Abacavir Sulfate

  

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  A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. Abacavir sulfate, lamivudine and zidovudine tablets can be taken with or without food.

  2.1 Adults and Adolescent Patients

  The recommended oral dose of abacavir sulfate, lamivudine and zidovudine tablet is one tablet twice daily.

  Abacavir sulfate, lamivudine and zidovudine tablet is not recommended in adolescents who weigh less than 40 kg because it is a fixed-dose tablet and cannot be dose adjusted.

  2.2 Dosage Adjustment

  Because it is a fixed-dose combination, abacavir sulfate, lamivudine and zidovudine tablets should not be prescribed for:

  patients requiring dosage adjustment such as those with creatinine clearance <50 mL/min, patients with hepatic impairment.

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• Fenofibrate
  

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  Fenofibrate

  

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  2.1 General Considerations

  Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate, and should continue this diet during treatment with fenofibrate. Fenofibrate tablets can be given without regard to meals.

  The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, thiazide diuretics and beta-blockers, are sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia.

  Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate if lipid levels fall significantly below the targeted range.

  Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.

  2.2 Primary Hypercholesterolemia or Mixed Dyslipidemia

  The initial dose of fenofibrate is 145 mg once daily.

  2.3 Severe Hypertriglyceridemia

  The initial dose is 48 to 145 mg per day. Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 145 mg once daily.

  2.4 Impaired Renal Function

  Treatment with fenofibrate should be initiated at a dose of 48 mg per day in patients having mild to moderately impaired renal function, and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate should be avoided in patients with severe renal impairment [see USE IN SPECIFIC POPULATIONS (8.6)  and CLINICAL PHARMACOLOGY (12.3)]

  2.5 Geriatric Patients

  Dose selection for the elderly should be made on the basis of renal function [see USE IN SPECIFIC POPULATIONS (8.5)].

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• Flu And Severe Cold And...
  

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  Flu And Severe Cold And Cough Nighttime

  

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  The following is a summary of the instructions given to the patient in the "HOW TO TAKE THE PILL" section of the DETAILED PATIENT PACKAGE LABELING.

  The patient is given instructions in five (5) categories:

  IMPORTANT POINTS TO REMEMBER: The patient is told (a) that she should take one pill every day at the same time, (b) many women have spotting or light bleeding or gastric distress during the first one to three cycles, (c) missing pills can also cause spotting or light bleeding, (d) she should use a back-up method for contraception if she has vomiting or diarrhea or takes some concomitant medications, and/or if she has trouble remembering the pill, (e) if she has any other questions, she should consult her physician. BEFORE SHE STARTS TAKING HER PILLS : She should decide what time of day she wishes to take the pill, check whether her pill pack has 28 pills, and note the order in which she should take the pills (diagrammatic drawings of the pill pack are included in the patient insert). WHEN SHE SHOULD START THE FIRST PACK: The Day-One start is listed as the first choice and the Sunday start (the Sunday after her period starts) is given as the second choice. If she uses the Sunday start she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. WHAT TO DO DURING THE CYCLE: The patient is advised to take one pill at the same time every day until the pack is empty. If she is on the 28 day regimen, she should start the next pack the day after the last inactive tablet and not wait any days between packs. WHAT TO DO IF SHE MISSES A PILL OR PILLS: The patient is given instructions about what she should do if she misses one, two or more than two pills at varying times in her cycle for both the Day-One and the Sunday start. The patient is warned that she may become pregnant if she has unprotected intercourse in the seven days after missing pills. To avoid this, she must use another birth control method such as condom, foam, or sponge in these seven days.

  DOSAGE AND ADMINISTRATION

  How To Take The Pill

  The instructions given in the COMBINATION DETAILED PATIENT LABELING AND BRIEF SUMMARY insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.

  Instructions on how to use the wallet for the (28 Tablets) are included in the BRIEF SUMMARY PATIENT PACKAGE INSERT.

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• Pirmella 135
  

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  Pirmella 135

  

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  To achieve maximum contraceptive effectiveness, Pirmella 1/35 must be taken exactly as directed and at intervals not exceeding 24 hours. Pirmella 1/35 is available in a wallet which is preset for a Sunday Start. Day 1 Start is also available.

  Sunday Start

  When taking Pirmella 1/35, the first "active" tablet should be taken on the first Sunday after menstruation begins. If period begins on Sunday, the first "active" tablet should be taken that day. Take one active tablet daily for 21 days followed by one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

  If the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) "active" tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  Day 1 Start

  The dosage of Pirmella 1/35, for the initial cycle of therapy is one "active" tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one green "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

  If the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) "active" tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as condoms or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  The use of Pirmella 1/35 for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers"). The possibility of ovulation and conception prior to initiation of medication should be considered.

  (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

  ADDITIONAL INSTRUCTIONS

  Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

  Use of oral contraceptives in the event of a missed menstrual period:

  1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.

  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

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• Daysee
  

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  Daysee

  

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  Take one tablet by mouth at the same time every day. The dosage of Daysee is one light blue tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one mustard ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Daysee must be taken exactly as directed and at intervals not exceeding 24 hours.

  Instruct the patient to begin taking Daysee on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first light blue tablet is taken that day. One light blue tablet should be taken daily for 84 consecutive days, followed by one mustard tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a light blue tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard tablets are taken.

  Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Daysee, following the same schedule: 84 days taking a light blue tablet followed by 7 days taking a mustard tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a light blue tablet daily for 7 consecutive days. If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

  For patient instructions regarding missed pills, see FDA-Approved Patient Labeling.

  For postpartum women who are not breastfeeding, start Daysee no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Daysee postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a light blue tablet for 7 consecutive days.

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• Levonorgestrel And Ethi...
  

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  Levonorgestrel And Ethinyl Estradiol

  

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  To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours.

  The dosage of levonorgestrel and ethinyl estradiol tablets is one white tablet daily for 21 consecutive days, followed by one orange inert tablet daily for 7 consecutive days, according to the prescribed schedule.

  It is recommended that levonorgestrel and ethinyl estradiol tablets be taken at the same time each day.

  During The First Cycle Of Use

  The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking levonorgestrel and ethinyl estradiol tablets on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).

  Sunday start:

  The patient is instructed to begin taking levonorgestrel and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days, followed by one orange inert tablet daily for seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on levonorgestrel and ethinyl estradiol tablets until a white tablet has been taken daily for 7 consecutive days, and a nonhormonal back-up method of birth control should be used during those 7 days.

  Day 1 start:

  During the first cycle of medication, the patient is instructed to begin taking levonorgestrel and ethinyl estradiol tablets during the first 24 hours of her period (day one of her menstrual cycle). One white tablet should be taken daily for 21 consecutive days, followed by one orange inert tablet daily for seven consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no back-up contraception is necessary. If levonorgestrel and ethinyl estradiol tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on levonorgestrel and ethinyl estradiol tablets until after the first 7 consecutive days of administration, and a nonhormonal back-up method of birth control should be used during those 7 days.

  After the first cycle of use

  The patient begins her next and all subsequent courses of tablets on the day after taking her last orange tablet. She should follow the same dosing schedule: 21 days on white tablets followed by 7 days on orange tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

  Switching from another hormonal method of contraception

  When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts levonorgestrel and ethinyl estradiol tablets. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of levonorgestrel and ethinyl estradiol tablets on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin levonorgestrel and ethinyl estradiol tablets the next day. If switching from an implant or injection, the patient should start levonorgestrel and ethinyl estradiol tablets on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

  If spotting or breakthrough bleeding occurs

  If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

  Risk of pregnancy if tablets are missed

  While there is little likelihood of ovulation occurring if only one or two white tablets are missed, the possibility of ovulation increases with each successive day that scheduled white tablets are missed. Although the occurrence of pregnancy is unlikely if levonorgestrel and ethinyl estradiol tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

  The risk of pregnancy increases with each active (white) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.

  Use after pregnancy, abortion or miscarriage

  Levonorgestrel and ethinyl estradiol tablets may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONSconcerning thromboembolic disease). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet taking.

  Levonorgestrel and ethinyl estradiol tablets may be initiated immediately after a first trimester abortion or miscarriage. If the patient starts levonorgestrel and ethinyl estradiol tablets immediately, back-up contraception is not needed.

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• Kurvelo
  

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  Kurvelo

  

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  To achieve maximum contraceptive effectiveness, Kurvelo (levonorgestrel and ethinyl estradiol tablets, 0.15 mg/0.03 mg) must be taken exactly as directed and at intervals not exceeding 24 hours.

  The dosage of Kurvelo is one light orange tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule.

  It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

  During the first cycle of medication, the patient is instructed to begin taking Kurvelo on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (light orange) is taken that day. One light orange tablet should be taken daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of light orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Kurvelo until a light orange tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on light orange tablets - 7 days on pink inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a light orange tablet daily for 7 consecutive days.

  When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Kurvelo. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Kurvelo on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Kurvelo the next day. If switching from an implant or injection, the patient should start Kurvelo on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

  If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Kurvelo is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

  For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below.

  Any time the patient misses two or more light orange tablets, she should also use another method of contraception until she has taken a light orange tablet daily for seven consecutive days. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking light orange tablets again on the proper day.

  If breakthrough bleeding occurs following missed light orange tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two light orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled light orange tablets are missed.

  Kurvelo may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see "CONTRAINDICATIONS," "WARNINGS" and "PRECAUTIONS" concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

  In the case of first trimester abortion, if the patient starts Kurvelo immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

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• Nexium
  

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  Nexium

  

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  Depression

  Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time, at the lowest dose that will maintain remission.

  Usual Adult Dose

  Hospitalized Patients

  Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250 to 300 mg/day.

  Outpatients

  Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day.

  Adolescent and Geriatric Patients

  Initially, 30 to 40 mg/day; it is generally not necessary to exceed 100 mg/day.

  Childhood Enuresis

  Initially, an oral dose of 25 mg/day should be tried in children aged 6 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.

  A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.

  The safety and effectiveness of imipramine hydrochloride tablets as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.

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• Skyla
  

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  Skyla

  

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  To achieve maximum contraceptive effectiveness, Enskyce must be taken exactly as directed and at intervals not exceeding 24 hours. Enskyce is available in the wallet which is preset for a Sunday Start. Day 1 Start is also provided.

  Day 1 Start

  The dosage of Enskyce for the initial cycle of therapy is one light orange "active" tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day.

  The use of Enskyce for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS  concerning thromboembolic disease. See also (PRECAUTIONS , Nursing Mothers) If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) light orange "active" tablet in Weeks 1, 2, or 3, the light orange "active" tablet should be taken as soon as she remembers. If the patient misses two (2) light orange "active" tablets in Week 1 or Week 2, the patient should take two (2) light orange "active" tablets the day she remembers and two (2) light orange "active" tablets the next day; and then continue taking one (1) light orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) light orange "active" tablets in the third week or misses three (3) or more light orange "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Sunday Start

  When taking Enskyce, the first light orange "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first light orange "active" tablet is taken on that day. If switching directly from another oral contraceptive, the first light orange "active" tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One light orange "active" tablet daily for 21 days, then one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a light orange "active" tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

  The use of Enskyce for contraception may be initiated 4 weeks postpartum. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also (PRECAUTIONS,  Nursing Mothers).

  If the patient starts on Enskyce postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light orange "active" tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) light orange active tablet in Weeks 1, 2, or 3, the light orange "active" tablet should be taken as soon as she remembers. If the patient misses two (2) light orange "active" tablets in Week 1 or Week 2, the patient should take two (2) light orange "active" tablets the day she remembers and two (2) light orange "active" tablets the next day; and then continue taking one (1) light orange "active" tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) light orange "active" tablets in the third week or misses three (3) or more light orange "active" tablets in a row, the patient should continue taking one light orange "active" tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS

  Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

  Use of oral contraceptives in the event of a missed menstrual period:

  If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

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• Meloxicam
  

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  Meloxicam

  

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  2.1 General Instructions

  Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [See WARNINGS AND PRECAUTIONS (5.4)].

  After observing the response to initial therapy with meloxicam tablets, adjust the dose to suit an individual patient's needs.

  In adults, the maximum recommended daily oral dose of meloxicam tablets is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [See WARNINGS AND PRECAUTIONS (5.6), USE IN SPECIFIC POPULATIONS (8.7), and CLINICAL PHARMACOLOGY (12.3)].

  Meloxicam oral suspension 7.5 mg/5 mL or 15 mg/10 mL may be substituted for meloxicam tablets 7.5 mg or 15 mg, respectively.

  Meloxicam tablets may be taken without regard to timing of meals.

  2.2 Osteoarthritis

  For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

  2.3 Rheumatoid Arthritis

  For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

  2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

  To improve dosing accuracy in smaller weight children, the use of the meloxicam oral suspension is recommended. For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam is 0.125 mg/kg once daily up to a maximum of 7.5 mg. There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in these clinical trials.

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• Minocycline Hydrochlori...
  

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  Minocycline Hydrochloride

  

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  The recommended dosage of minocycline hydrochloride extended-release tablet is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

  The following table shows tablet strength and body weight to achieve approximately 1 mg/kg.

  Table 1: Dosing Table for Minocycline Hydrochloride Extended-release Tablets Patient's Weight (lbs.) Patient's Weight (kg) Tablet Strength (mg) Actual mg/kg Dose 99 - 109 45 - 49 45 1 - 0.92 110 - 131 50 - 59 55 1.10 - 0.93 132 - 157 60 - 71 65 1.08 - 0.92 158 - 186 72 - 84 80 1.11 - 0.95 187 - 212 85 - 96 90 1.06 - 0.94 213 - 243 97 - 110 105 1.08 - 0.95 244 - 276 111 - 125 115 1.04 - 0.92 277 - 300 126 - 136 135 1.07 - 0.99

  Minocycline hydrochloride extended-release tablets may be taken with or without food [see CLINICAL PHARMACOLOGY (12.3) ]. Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration.

  In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see WARNINGS AND PRECAUTIONS (5.4)] .

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• Azo
  

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  Azo

  

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  Hypertension

  The recommended initial dosage of trandolapril tablets for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg.

  Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with trandolapril tablets monotherapy, a diuretic may be added.

  In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of trandolapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with trandolapril tablets (see WARNINGS). Then, if blood pressure is not controlled with trandolapril tablets alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg trandolapril tablets should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS).

  Concomitant administration of trandolapril tablets with potassium supplements, potassium salt substitutes, or potassium sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS).

  Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction

  The recommended starting dose is 1 mg, once daily. Following the initial dose, all patients should be titrated (as tolerated) toward a target dose of 4 mg, once daily. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose.

  Dosage Adjustment in Renal Impairment or Hepatic Cirrhosis

  For patients with a creatinine clearance <30 mL/min. or with hepatic cirrhosis, the recommended starting dose, based on clinical and pharmacokinetic data, is 0.5 mg daily. Patients should subsequently have their dosage titrated (as described above) to the optimal response.

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• Niacin
  

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  Niacin

  

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  Niacin extended-release tablets should be taken at bedtime, after a low-fat snack, and doses should be individualized according to patient response. Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy. The recommended dose escalation is shown in Table 1 below.

  Table 1. Recommended Dosing Week(s) Daily Dose Niacin Dosage * After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate, increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Daily dose should not be increased more than 500 mg in a 4-week period, and doses above 2000 mg daily are not recommended. Women may respond at lower doses than men. INITIAL  1 to 4 500 mg 1 Niacin extended-release tablet, 500 mg at bedtime TITRATIONSCHEDULE 5 to 8 1000 mg 1 Niacin extended-release tablet, 1000 mg  or 2  Niacin extended-release tablets, 500 mg at bedtime * 1500 mg 2 Niacin extended-release tablets, 750 mg or 3  Niacin extended-release tablets, 500 mg at bedtime * 2000 mg 2 Niacin extended-release tablets, 1000 mg or  4  Niacin extended-release tablets, 500 mg at bedtime

  Maintenance Dose

  The daily dosage of niacin extended-release tablets should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower niacin extended-release tablets doses than men [see CLINICAL STUDIES (14.2)].

  Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.

  Tolerance to flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of niacin extended-release tablets USP ingestion.

  Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin [see WARNINGS AND PRECAUTIONS (5)]. Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule (see Table 1), and the dose should subsequently be individualized based on patient response.

  If niacin extended-release tablets therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase (see Table 1).

  Niacin extended-release tablets should be taken whole and should not be broken, crushed or chewed before swallowing.

  Dosage in Patients with Renal or Hepatic Impairment

  Use of niacin extended-release tablets in patients with renal or hepatic impairment has not been studied. Niacin extended-release tablet is contraindicated in patients with significant or unexplained hepatic dysfunction. Niacin extended-release tablets should be used with caution in patients with renal impairment [see WARNINGS AND PRECAUTIONS (5)].

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• Phenytoin Sodium
  

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  Phenytoin Sodium

  

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  The following recommended dosages for imipramine pamoate capsules should be modified as necessary by the clinical response and any evidence of intolerance.

  Initial Adult Dosage

  Outpatients

  Therapy should be initiated at 75 mg/day. Dosage may be increased to 150 mg/day which is the dose level at which optimum response is usually obtained. If necessary, dosage may be increased to 200 mg/day.

  Dosage higher than 75 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

  As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

  Hospitalized Patients

  Therapy should be initiated at 100 to 150 mg/day and may be increased to 200 mg/day. If there is no response after two weeks, dosage should be increased to 250 to 300 mg/day.

  Dosage higher than 150 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

  As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

  Adult Maintenance Dosage

  Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission after which the dosage should gradually be decreased.

  The usual maintenance dosage is 75 to 150 mg/day. The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

  In cases of relapse due to premature withdrawal of the drug, the effective dosage of imipramine should be reinstituted.

  Adolescent and Geriatric Patients

  Therapy in these age groups should be initiated with Tofranil™, brand of imipramine hydrochloride tablets, at a total daily dosage of 25 to 50 mg, since imipramine pamoate capsules are not available in these strengths. Dosage may be increased according to response and tolerance, but it is generally unnecessary to exceed 100 mg/day in these patients. Imipramine pamoate capsules may be used when total daily dosage is established at 75 mg or higher.

  The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

  As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

  Adolescent and geriatric patients can usually be maintained at lower dosage. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission after which the dosage should gradually be decreased.

  The total daily maintenance dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

  In cases of relapse due to premature withdrawal of the drug, the effective dosage of imipramine should be reinstituted.

  Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with imipramine pamoate. Conversely, at least 14 days should be allowed after stopping imipramine pamoate before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

  Use of Imipramine Pamoate with Other MAOIs, such as Linezolid or Methylene Blue

  Do not start imipramine pamoate in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

  In some cases, a patient already receiving imipramine pamoate therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, imipramine pamoate should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with imipramine pamoate may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with imipramine pamoate is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

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• Pirmella 777
  

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  Pirmella 777

  

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  To achieve maximum contraceptive effectiveness, Pirmella Tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Pirmella Tablets are available in a wallet which is preset for Sunday Start. Day 1 Start is available.

  Sunday Start

  When taking Pirmella 7/7/7 and Pirmella 1/35, the first "active" tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first "active" tablet should be taken that day. Take one active tablet daily for 21 days followed by one green "reminder" tablet daily for 7 days. After 28 tablets have been taken, a new course is started the next day (Sunday). For the first cycle of a Sunday Start regimen, another method of contraception such as a condom or spermicide should be used until after the first 7 consecutive days of administration.

  If the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) "active" tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should continue taking one tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  Day 1 Start

  The dosage of Pirmella 7/7/7 and Pirmella 1/35, for the initial cycle of therapy is one "active" tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1" followed by one green "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

  If the patient misses one (1) "active" tablet in Weeks 1, 2, or 3, the tablet should be taken as soon as she remembers. If the patient misses two (2) "active" tablets in Week 1 or Week 2, the patient should take two (2) tablets the day she remembers and two (2) tablets the next day; and then continue taking one (1) tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) "active" tablets in the third week or misses three (3) or more "active" tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

  Complete instructions to facilitate patient counseling on proper pill usage may be found in the Detailed Patient Labeling ("How to Take the Pill" section).

  The use of Pirmella 7/7/7 and Pirmella 1/35 for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers). The possibility of ovulation and conception prior to initiation of medication should be considered.

  (See Discussion of Dose-Related Risk of Vascular Disease from Oral Contraceptives.)

  ADDITIONAL INSTRUCTIONS

  Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

  Use of oral contraceptives in the event of a missed menstrual period:

  1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.

  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

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• Simvastatin
  

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  Simvastatin

  

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  2.1 Recommended Dosing

  The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, simvastatin tablets USP can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.

  2.2 Restricted Dosing for 80 mg

  Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of simvastatin tablets USP should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see WARNINGS AND PRECAUTIONS (5.1)].

  Patients who are currently tolerating the 80-mg dose of simvastatin tablets USP who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.

  Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of simvastatin tablets USP, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of simvastatin tablets USP should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.

  2.3 Coadministration with Other Drugs

  Patients taking Verapamil, Diltiazem or Dronedarone

  The dose of simvastatin tablets USP should not exceed 10 mg/day[see WARNINGS AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7.3),and CLINICAL PHARMACOLOGY (12.3)].

  Patients taking Amiodarone, Amlodipine or Ranolazine

  The dose of simvastatin tablets USP should not exceed 20 mg/day[see WARNINGS AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7.3),and CLINICAL PHARMACOLOGY (12.3)] .

  2.4 Patients with Homozygous Familial Hypercholesterolemia

  The recommended dosage is 40 mg/day in the evening [see DOSAGE AND ADMINISTRATION, Restricted Dosing for 80 mg (2.2)]. Simvastatin tablets USP should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

  Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of simvastatin tablets USP should be reduced by 50% if initiating lomitapide. Simvastatin tablets USP dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken simvastatin tablets USP 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

  2.5 Adolescents (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia

  The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines1 and CLINICAL STUDIES (14.2)]. Adjustments should be made at intervals of 4 weeks or more.

  2.6 Patients with Renal Impairment

  Because simvastatin tablets USP do not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin tablets USP are administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see WARNINGS AND PRECAUTIONS (5.1) and CLINICAL PHARMACOLOGY (12.3)].

  2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products

  Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients [see WARNINGS AND PRECAUTIONS (5.1)].

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• Diazepam
  

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  Diazepam

  

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  Adult Hypertensive Patients

  Losartan potassium tablets may be administered with other antihypertensive agents, and with or without food.

  Dosing must be individualized. The usual starting dose of losartan potassium tablets is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients ) and patients with a history of hepatic impairment (see PRECAUTIONS, General). Losartan potassium tablets can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.

  If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).

  If blood pressure is not controlled by losartan potassium tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).

  No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.

  Pediatric Hypertensive Patients greater than or equal to 6 years of age

  The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension — Volume-Depleted Patients.)

  Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).

  Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)

  Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-PlusTM** and Ora-Sweet SF TM** .Add 190 mL of the 50/50 OraPlus TM/Ora-Sweet SF TM** mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.

  Hypertensive Patients with Left Ventricular Hypertrophy

  The usual starting dose is 50 mg of losartan potassium tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium tablets should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).

  Nephropathy in Type 2 Diabetic Patients

  The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). Losartan potassium tablets may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).

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• Gilotrif
  

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  Gilotrif

  

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  2.1 Adult Patients

  The recommended oral dose of lamivudine tablets in HIV-1-infected adults is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen[see WARNINGS AND PRECAUTIONS (5.2)]. Lamivudine tablets may be taken with or without food.

  2.2 Pediatric Patients

  Lamivudine is available as a scored tablet for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing lamivudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow lamivudine tablets, the oral solution formulation should be prescribed. The recommended oral dosage of lamivudine tablets for HIV-1-infected pediatric patients is presented in Table 1.

  Table 1: Dosing Recommendations for Lamivudine Tablets Scored (150 mg) in Pediatric Patients Weight (kg) Twice-daily Dosing Regimen Using Scored 150-mg Tablet AM Dose PM Dose Total Daily Dose 14 to <20 ½ tablet (75 mg)  ½ tablet (75 mg)  150 mg >20 to <25 ½ tablet (75 mg)  1 tablet (150 mg)  225 mg >25 1 tablet (150 mg)  1 tablet (150 mg)  300 mg

  Additional pediatric use information for patients aged 3 months and above is approved for ViiV Healthcare Company's EPIVIR® (lamivudine) tablets and oral solution.  However, due to ViiV Healthcare Company's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  2.3 Patients with Renal Impairment

  Dosing of lamivudine tablets are adjusted in accordance with renal function. Dosage adjustments are listed in Table 2 [see CLINICAL PHARMACOLOGY (12.3)]. 

  Table 2: Adjustment of Dosage of Lamivudine in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥50 150 mg twice daily or 300 mg once daily  30 to 49 150 mg once daily  15 to 29 150 mg first dose, then 100 mg once daily  5 to 14 150 mg first dose, then 50 mg once daily  <5 50 mg first dose, then 25 mg once daily 

  No additional dosing of lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.

  Although there are insufficient data to recommend a specific dose adjustment of lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.

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• Ceftriaxone
  

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  Ceftriaxone

  

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  Ceftriaxone for injection may be administered intravenously or intramuscularly.

  Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone for injection is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone for injection must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone for injection and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

  There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

  Neonates

  Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone for injection (see CONTRAINDICATIONS).

  Ceftriaxone for injection is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CONTRAINDICATIONS).

  Pediatric Patients

  For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 grams.

  For the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended (see INDICATIONS AND USAGE).

  For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.

  In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours). The usual duration of therapy is 7 to 14 days.

  Adults

  The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, in order to achieve > 90% target attainment. The total daily dose should not exceed 4 grams.

  If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftriaxone sodium has no activity against this organism.

  For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.

  For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

  Generally, ceftriaxone for injection therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4 to 14 days; in complicated infections, longer therapy may be required.

  When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

  No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

  Directions For Use

  Intramuscular Administration:

  Reconstitute ceftriaxone for injection powder with the appropriate diluent (see DOSAGE AND ADMINISTRATION: Compatibility and Stability).

  Inject diluent into vial, shake vial thoroughly to form solution. Withdraw entire contents of vial into syringe to equal total labeled dose.

  After reconstitution, each 1 mL of solution contains approximately 250 mg or 350 mg equivalent of ceftriaxone according to the amount of diluent indicated below. If required, more dilute solutions could be utilized. A 350 mg/mL concentration is not recommended for the 250 mg vial since it may not be possible to withdraw the entire contents.

  As with all intramuscular preparations, ceftriaxone for injection should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel.

  Amount of Diluent to be Added Vial Dosage Size 250 mg/mL 350 mg/mL 250 mg 0.9 mL -- 500 mg 1.8 mL 1.0 mL 1 g 3.6 mL 2.1 mL 2 g 7.2 mL 4.2 mL

  Intravenous Administration:

  Ceftriaxone for injection should be administered intravenously by infusion over a period of 30 minutes. Concentrations between 10 mg/mL and 40 mg/mL are recommended; however, lower concentrations may be used if desired. Reconstitute vials with an appropriate IV diluent (see DOSAGE AND ADMINISTRATION: Compatibility and Stability).

  Vial Dosage Size Amount of Diluent to be Added 250 mg 2.4 mL 500 mg 4.8 mL 1 g 9.6 mL 2 g 19.2 mL

  After reconstitution, each 1 mL of solution contains approximately 100 mg equivalent of ceftriaxone. Withdraw entire contents and dilute to the desired concentration with the appropriate IV diluent.

  Compatibility and Stability

  Ceftriaxone has been shown to be compatible with Flagyl®* IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W). No compatibility studies have been conducted with the Flagyl®* IV RTU® (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

  Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with ceftriaxone in admixtures.  When any of these drugs are to be administered concomitantly with ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

  Do not use diluents containing calcium, such as Ringer's solution or Hartmann's solution, to reconstitute ceftriaxone for injection vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result.

  Ceftriaxone for injection solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility (see WARNINGS).

  Ceftriaxone for injection sterile powder should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and protected from light. After reconstitution, protection from normal light is not necessary. The color of solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

  Ceftriaxone for injection intramuscular solutions remain stable (loss of potency less than 10%) for the following time periods:

  Storage Diluent Concentration mg/mL Room Temp. (25°C) Refrigerated (4°C) Sterile Water for Injection 100250, 350 2 days24 hours 10 days3 days 0.9% Sodium Chloride Solution 100250, 350 2 days24 hours 10 days3 days 5% Dextrose Solution 100250, 350 2 days24 hours 10 days3 days Bacteriostatic Water+ 0.9% Benzyl Alcohol 100250, 350 24 hours24 hours 10 days3 days 1% Lidocaine Solution(without epinephrine) 100250, 350 24 hours24 hours 10 days3 days

  Ceftriaxone for injection intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable (loss of potency less than 10%) for the following time periods stored in glass or PVC containers:

  *Data available for 10 to 40 mg/mL concentrations in this diluent in PVC containers only.

  Storage Diluent Room Temp. (25°C) Refrigerated (4°C) Sterile Water 2 days 10 days 0.9% Sodium Chloride Solution 2 days 10 days 5% Dextrose Solution 2 days 10 days 10% Dextrose Solution 2 days 10 days 5% Dextrose + 0.9% Sodium Chloride Solution* 2 days Incompatible 5% Dextrose + 0.45% Sodium Chloride Solution 2 days Incompatible

  The following intravenous ceftriaxone for injection solutions are stable at room temperature (25°C) for 24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium Bicarbonate (glass container), Freamine III (glass container), Normosol-M in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose (glass container), 5% Mannitol (glass container), 10% Mannitol (glass container).

  After the indicated stability time periods, unused portions of solutions should be discarded.

  NOTE: Parenteral drug products should be inspected visually for particulate matter before administration.

  Ceftriaxone for injection reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution at concentrations between 10 mg/mL and 40 mg/mL, and then stored in frozen state (-20°C) in PVC or polyolefin containers, remains stable for 26 weeks.

  Frozen solutions of ceftriaxone for injection should be thawed at room temperature before use. After thawing, unused portions should be discarded. DO NOT REFREEZE.

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• Levonorgestrel And Ethi...
  

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  Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol

  

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  Take one tablet by mouth at the same time every day. The dosage of levonorgestrel and ethinyl estradiol tablet and ethinyl estradiol tablet is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one mustard ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours.  

  Instruct the patient to begin taking levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets on the first Sunday after the onset of menstruation.  If menstruation begins on a Sunday, the first orange tablet is taken that day. One orange tablet should be taken daily for 84 consecutive days, followed by one mustard tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the mustard tablets are taken.

  Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a mustard tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days.

  If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.

  For patient instructions regarding missed pills, see PATIENT COUNSELING INFORMATION (17.2).

  For postpartum women who are not breastfeeding, start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets no earlier than four to six weeks postpartum. If the patient starts on levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.

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• Hex-o-prep
  

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  Hex-o-prep

  

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  2.1 General Considerations

  Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine, valsartan and hydrochlorothiazide tablets. The maximum recommended dose of amlodipine, valsartan and hydrochlorothiazide tablets is 10/320/25 mg.

  2.2 Add-on / Switch Therapy

  Amlodipine, valsartan and hydrochlorothiazide tablets may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

  A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of amlodipine, valsartan and hydrochlorothiazide tablets may be switched to amlodipine, valsartan and hydrochlorothiazide tablets containing a lower dose of that component to achieve similar blood pressure reductions.

  2.3 Replacement Therapy

  Amlodipine, valsartan and hydrochlorothiazide tablets may be substituted for the individually titrated components.

  2.4 Use with Other Antihypertensive Drugs

  Amlodipine, valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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• Valsartan And Hydrochlo...
  

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  Valsartan And Hydrochlorothiazide

  

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  2.1 General Considerations

  The usual starting dose is valsartan and hydrochlorothiazide tablets USP, 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

  2.2 Add-On Therapy

  A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with valsartan and hydrochlorothiazide tablets USP.

  A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets USP containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets USP should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320/25 mg.

  2.3 Replacement Therapy

  Valsartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.

  2.4 Initial Therapy

  Valsartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].

  2.5 Use with Other Antihypertensive Drugs

  Valsartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

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• Cefadroxil
  

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  Cefadroxil

  

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  Cefadroxil for oral suspension is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

  Adults

  Urinary Tract Infections

  For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

  For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).

  Skin and Skin Structure Infections

  For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

  Pharyngitis and Tonsillitis

  Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis— 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

  Children

  For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil for oral suspension should be administered for at least 10 days.

  See chart for total daily dosage for children.

  DAILY DOSAGE OF CEFADROXIL FOR ORAL SUSPENSION Child’s Weight  lbs  kg  250 mg/5 mL  500 mg/5 mL  10  4.5  ½ tsp  - 20  9.1  1 tsp  - 30  13.6  1½ tsp  - 40  18.2  2 tsp  1 tsp  50  22.7  2½ tsp  1¼ tsp  60  27.3  3 tsp  1½ tsp  70 & above  31.8 +  -- 2 tsp 

  Renal Impairment

  In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below.

  Creatinine Clearances  Dosage Interval  0 to 10 mL/min  36 hours  10 to 25 mL/min  24 hours  25 to 50 mL/min  12 hours 

  Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

  Reconstitution Directions for Oral Suspension  Bottle Size  Reconstitution Directions  100 mL  Suspend in a total of 67 mL water.  Method: Tap bottle lightly to loosen powder.  Add 67 mL of water in two portions.  Shake well after each addition.  75 mL  Suspend in a total of 51 mL water.  Method: Tap bottle lightly to loosen powder.  Add 51 mL of water in two portions.  Shake well after each addition.  50 mL  Suspend in a total of 34 mL water.  Method: Tap bottle lightly to loosen powder..  Add 34 mL of water in two portions.  Shake well after each addition 

  After reconstitution, store in refrigerator. Shake well before using.

  Keep container tightly closed. Discard unused portion after 14 days.

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• Personal Care Antifunga...
  

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  Personal Care Antifungal

  

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  Although the occurrence of pregnancy is unlikely if levonorgestrel and ethinyl estradiol tablets are taken according to directions, if withdrawal bleeding does not occur while taking white (inactive) tablets, the possibility of pregnancy must be considered. Appropriate diagnostic measures to rule out pregnancy should be taken at the time of any missed menstrual period. Levonorgestrel and ethinyl estradiol tablets should be discontinued if pregnancy is confirmed.

  The dosage of levonorgestrel and ethinyl estradiol tablets is one pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets. To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours. Ideally, the tablets should be taken at the same time of the day on each day of active treatment. The tablets should not be removed from the protective blister packaging and outer wallet to avoid damage to the product. The wallet should be kept in the foil pouch until dispensed to the patient.

  During the first cycle of medication, the patient is instructed to begin taking levonorgestrel and ethinyl estradiol tablets on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (pink) is taken that day. One pink tablet should be taken daily for 84 consecutive days, followed by 7 days on which a white (inert) tablet is taken. Withdrawal bleeding should occur during the 7 days following discontinuation of pink active tablets. During the first cycle, contraceptive reliance should not be placed on levonorgestrel and ethinyl estradiol tablets until a pink (active) tablet has been taken daily for 7 consecutive days and a non-hormonal backup method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient begins her next and all subsequent 91-day courses of tablets without interruption on the same day of the week (Sunday) on which she began her first course, following the same schedule: 84 days on which pink tablets are taken followed by 7 days on which white tablets are taken. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a pink tablet daily for 7 consecutive days.

  If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding may be transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider.

  For patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING. Any time the patient misses two or more pink tablets, she should also use another method of non-hormonal back-up contraception until she has taken a pink tablet daily for seven consecutive days. If the patient misses one or more white tablets, she is still protected against pregnancy provided she begins taking pink tablets again on the proper day. The possibility of ovulation increases with each successive day that scheduled pink tablets are missed. The risk of pregnancy increases with each active (pink) tablet missed.

  In the nonlactating mother, levonorgestrel and ethinyl estradiol tablets may be initiated no earlier than day 28 postpartum, for contraception due to the increased risk for thromboembolism. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (See CONTRAINDICATIONS, WARNINGSand PRECAUTIONSconcerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. Levonorgestrel and ethinyl estradiol tablets may be initiated immediately after a first-trimester abortion; if the patient starts levonorgestrel and ethinyl estradiol tablets immediately, additional contraceptive measures are not needed.

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• Losartan Potassium And ...
  

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  Losartan Potassium And Hydrochlorothiazide

  

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  Hypertension

  Dosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.

  Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as losartan potassium and hydrochlorothiazide tablets.

  To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

  The side effects (see WARNINGS) of losartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

  Replacement Therapy:

  The combination may be substituted for the titrated components.

  Dose Titration by Clinical Effect:

  A patient whose blood pressure is not adequately controlled with losartan monotherapy (see above) or hydrochlorothiazide alone, may be switched to losartan and hydrochlorothiazide tablets, 50 mg/12.5 mg once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of losartan and hydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of losartan and hydrochlorothiazide 100 mg/25 mg once daily.

  A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to losartan and hydrochlorothiazide tablets 100 mg/12.5 mg once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of losartan and hydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of losartan and hydrochlorothiazide 100 mg/25 mg once daily. A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to losartan and hydrochlorothiazide tablets 50 mg/12.5 mg once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to losartan and hydrochlorothiazide tablets 50 mg/12.5 mg should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of losartan and hydrochlorothiazide 50 mg/12.5mg once daily or one tablet of losartan and hydrochlorothiazide 100 mg/25 mg once daily.

  The usual dose of losartan and hydrochlorothiazide is one tablet of losartan and hydrochlorothiazide 50 mg/12.5 mg once daily. More than two tablets of losartan and hydrochlorothiazide 50 mg/12.5 mg once daily or more than one tablet of losartan and hydrochlorothiazide 100 mg/25 mg once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.

  Use in Patients with Renal Impairment:

  The usual regimens of therapy with losartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so losartan and hydrochlorothiazide tablets are not recommended.

  Patients with Hepatic Impairment:

  Losartan and hydrochlorothiazide tablets are not recommended for titration in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given.

  Severe Hypertension

  The starting dose of losartan and hydrochlorothiazide tablets for initial treatment of severe hypertension is one tablet of losartan and hydrochlorothiazide 50 mg/ 12.5 mg once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to losartan and hydrochlorothiazide tablets 50 mg/ 12.5 mg after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of losartan and hydrochlorothiazide 100 mg/ 25 mg once daily. The maximum dose is one tablet of losartan and hydrochlorothiazide 100 mg/ 25 mg once daily. Losartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension- Volume-Depleted Patients).

  Hypertensive Patients with Left Ventricular Hypertrophy

  Treatment should be initiated with losartan potassium tablets 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or losartan and hydrochlorothiazide tablets 50 mg/ 12.5 mg substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, losartan potassium tablets 100 mg and hydrochlorothiazide 12.5 mg or losartan and hydrochlorothiazide tablets 100 mg/ 12.5 mg may be substituted, followed by losartan potassium tablets 100 mg and hydrochlorothiazide 25 mg or losartan and hydrochlorothiazide tablets 100 mg/ 25 mg. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).

  Losartan potassium and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

  Losartan potassium and hydrochlorothiazide tablets may be administered with or without food.

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• Lovastatin
  

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  Lovastatin

  

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  The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets USP and should continue on this diet during treatment with lovastatin tablets USP (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets USP should be given with meals.

  Adult Patients

  The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

  Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin tablets if cholesterol levels fall significantly below the targeted range.

  Dosage in Patients taking Danazol, Diltiazem, Dronedarone or Verapamil

  In patients taking danazol, diltiazem, dronedarone or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day (see CLINICAL PHARMACOLOGY, Pharmacokinetics, WARNINGS, Myopathy/Rhabdomyolysis, PRECAUTIONS, Drug Interactions, Other Drug Interactions).

  Dosage in Patients taking Amiodarone

  In patients taking amiodarone concomitantly with lovastatin, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).

  Adolescent Patients (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia

  The recommended dosing range of lovastatin is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines 4, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.

  Concomitant Lipid-Lowering Therapy

  Lovastatin tablets USP are effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).

  Dosage in Patients with Renal Insufficiency

  In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).

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• Equate Aspirin Chewable...
  

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  Equate Aspirin Chewable

  

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  [see INDICATIONS AND USAGE (1)]

  Azithromycin tablets USP can be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

  2.2 Mycobacterial Infections

  Prevention of Disseminated MAC Infections

  The recommended dose of azithromycin for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of azithromycin may be combined with the approved dosage regimen of rifabutin.

  Treatment of Disseminated MAC Infections

  Azithromycin should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider.

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• Levetiracetam
  

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  Levetiracetam

  

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  2.1 Important Administration Instructions

  Levetiracetam tablets are given orally with or without food. The levetiracetam dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

  Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

  Levetiracetam tablets should be swallowed whole. Levetiracetam tablets should not be chewed or crushed.

  2.2 Dosing for Partial Onset Seizures

  Adults 16 Years and Older

  Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

  Pediatric Patients

  Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  4 Years to < 16 Years:

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

  For levetiracetam tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg twice daily).

  For levetiracetam tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000 mg (1500 mg twice daily).

  Levetiracetam Oral Solution Weight-Based Dosing Calculation For Pediatric Patients

  The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

  2.3 Dosing for Myoclonic Seizures in Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

  2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

  Adults 16 Years and Older

  Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

  Pediatric Patients Ages 6 to <16 Years

  Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see DOSAGE AND ADMINISTRATION (2.1)]. Only whole tablets should be administered.

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  Levetiracetam tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for dose for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment * Following dialysis, a 250 to 500 mg supplemental dose is recommended. Group Creatinine Clearance (mL/min/1.73 m2) Dosage (mg) Frequency Normal >80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe <30 250 to 500 Every 12 hours ESRD patients using dialysis ----- 500 to 1000* Every 24 hours*

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• Ciprofloxacin
  

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  Ciprofloxacin

  

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  Adults

  Ciprofloxacin for oral suspension should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

  * Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure. ADULT DOSAGE GUIDELINES Infection  Severity  Dose  Frequency  Usual Durations*  Urinary Tract  Acute Uncomplicated  250 mg  q 12 h  3 days  Mild/Moderate  250 mg  q 12 h  7 to 14 days  Severe/Complicated  500 mg  q 12 h  7 to 14 days  Chronic Bacterial  Mild/Moderate  500 mg  q 12 h  28 days  Prostatitis  Lower Respiratory Tract  Mild/Moderate  500 mg  q 12 h  7 to 14 days  Severe/Complicated  750 mg  q 12 h  7 to 14 days  Acute Sinusitis  Mild/Moderate  500 mg  q 12 h  10 days  Skin and  Mild/Moderate  500 mg  q 12 h  7 to 14 days  Skin Structure  Severe/Complicated  750 mg  q 12 h  7 to 14 days  Bone and Joint  Mild/Moderate  500 mg  q 12 h  ≥ 4 to 6 weeks  Severe/Complicated  750 mg  q 12 h  ≥ 4 to 6 weeks  Intra-Abdominal†  Complicated  500 mg  q 12 h  7 to 14 days  Infectious Diarrhea  Mild/Moderate/Severe  500 mg  q 12 h  5 to 7 days  Typhoid Fever  Mild/Moderate  500 mg  q 12 h  10 days  Urethral and Cervical  Uncomplicated  250 mg  single dose  single dose  Gonococcal Infections Inhalational anthrax(post-exposure)‡ 500 mg q h 12 60 days

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.

  Conversion of IV to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet q 12 h 200 mg IV q 12 h 500 mg Tablet q 12 h 400 mg IV q 12 h 750 mg Tablet q 12 h 400 mg IV q 8 h

  Adults with Impaired Renal Function

  Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis 250 – 500 mg q 24 h (after dialysis) or Peritoneal dialysis

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)

  72 x serum creatinine (mg/dL)

  Women: 0.85 x the value calculated for men.

  The serum creatinine should represent a steady state of renal function.

  In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

  Pediatrics

  Ciprofloxacin for oral suspension should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, IV or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg IV every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.⁶For a discussion of ciprofloxacin serum concentrations in various human populations, see  Inhalational Anthrax In Adults and Pediatrics, Additional Information. Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post-Exposure)† Intravenous 10 mg/kg(maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg(maximum 500 mg per dose) Every 12 hours

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).

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• Voriconazole
  

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  Voriconazole

  

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  2.1 How to Take Drospirenone and Ethinyl Estradiol Tablets

  Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

  To achieve maximum contraceptive effectiveness, drospirenone and ethinyl estradiol tablets must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

  2.2 How to Start Drospirenone and Ethinyl Estradiol Tablets

  Instruct the patient to begin taking drospirenone and ethinyl estradiol tablets either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

  Day 1 Start

  During the first cycle of drospirenone and ethinyl estradiol tablets use, instruct the patient to take one yellow drospirenone and ethinyl estradiol tablets daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow drospirenone and ethinyl estradiol tablet daily for 21 consecutive days, followed by one white to off-white tablet daily on Days 22 through 28. Drospirenone and ethinyl estradiol tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone and ethinyl estradiol tablets can be taken without regard to meals. If Drospirenone and ethinyl estradiol tablets are first taken later than the first day of the menstrual cycle, drospirenone and ethinyl estradiol tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  Sunday Start

  During the first cycle of drospirenone and ethinyl estradiol tablets use, instruct the patient to take one yellow drospirenone and ethinyl estradiol tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow drospirenone and ethinyl estradiol tablet daily for 21 consecutive days, followed by one white to off-white tablet daily on Days 22 through 28. Drospirenone and ethinyl estradiol tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone and ethinyl estradiol tablets can be taken without regard to meals. Drospirenone and ethinyl estradiol tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient should begin her next and all subsequent 28-day regimens of drospirenone and ethinyl estradiol tablets on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow tablets on the next day after ingestion of the last white to off-white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of drospirenone and ethinyl estradiol tablets is started later than the day following administration of the last white to off-white tablet, the patient should use another method of contraception until she has taken a yellow drospirenone and ethinyl estradiol tablets daily for seven consecutive days.

  When Switching from a Different Birth Control Pill

  When switching from another birth control pill, drospirenone and ethinyl estradiol tablets should be started on the same day that a new pack of the previous oral contraceptive would have been started.

  When Switching from a Method Other Than a Birth Control Pill

  When switching from a transdermal patch or vaginal ring, drospirenone and ethinyl estradiol tablets should be started when the next application would have been due. When switching from an injection, drospirenone and ethinyl estradiol tablets should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, drospirenone and ethinyl estradiol tablets should be started on the day of removal.

  Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking drospirenone and ethinyl estradiol tablets, instruct the patient to continue taking drospirenone and ethinyl estradiol tablets by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

  Although the occurrence of pregnancy is low if drospirenone and ethinyl estradiol tablets are taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue drospirenone and ethinyl estradiol tablets if pregnancy is confirmed.

  The risk of pregnancy increases with each active yellow tablet missed. For additional patient instructions regarding missed pills, see the "What to Do if You Miss Pills"  section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white to off-white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of yellow tablets on the proper day.

  For postpartum women who do not breastfeed or after a second trimester abortion, start drospirenone and ethinyl estradiol tablets no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts drospirenone and ethinyl estradiol tablets postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken drospirenone and ethinyl estradiol tablets for 7 consecutive days.

  2.3 Advice in Case of Gastrointestinal Disturbances

  In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.

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• Enoxaparin Sodium
  

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  Enoxaparin Sodium

  

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  The recommended dosage is one drop in the affected eye(s) once daily in the evening.

  Bimatoprost ophthalmic solution, 0.03% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.

  Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.

  Bimatoprost ophthalmic solution, 0.03% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

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• Sunmark Pain Reliever
  

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  Sunmark Pain Reliever

  

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  The usual starting dose of telmisartan is 40 mg once a day; blood pressure response is dose related over the range of 20 to 80 mg. Patients with depletion of intravascular volume should have the condition corrected or telmisartan tablets should be initiated under close medical supervision (see WARNINGS, Hypotension in Volume-Depleted Patients). Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision (see PRECAUTIONS).

  Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily.

  To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. The side effects (see WARNINGS) of telmisartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of telmisartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects. Telmisartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Telmisartan and hydrochlorothiazide tablets may be administered with or without food.

  Replacement Therapy

  The combination may be substituted for the titrated components.

  Dose Titration by Clinical Effect

  Telmisartan and hydrochlorothiazide tablets are available as tablets containing either telmisartan 40 mg and hydrochlorothiazide 12.5 mg, or telmisartan 80 mg and hydrochlorothiazide 12.5 mg or 25 mg. A patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg (see above) may be switched to telmisartan and hydrochlorothiazide tablets, telmisartan 80 mg/hydrochlorothiazide 12.5 mg once daily, and finally titrated up to 160/25 mg, if necessary.

  A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide may be switched to telmisartan 80 mg/hydrochlorothiazide 12.5 mg or telmisartan 80 mg/hydrochlorothiazide 25 mg tablets once daily. The clinical response to telmisartan and hydrochlorothiazide tablets should be subsequently evaluated and if blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to 160/25 mg, if necessary. Those patients controlled by 25 mg hydrochlorothiazide but who experience hypokalemia with this regimen, may be switched to telmisartan 80 mg/ hydrochlorothiazide 12.5 mg tablets once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response.

  Patients with Renal Impairment

  The usual regimens of therapy with telmisartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so telmisartan and hydrochlorothiazide tablets are not recommended.

  Patients with Hepatic Impairment

  Telmisartan and hydrochlorothiazide tablets are not recommended for patients with severe hepatic impairment. Patients with biliary obstructive disorders or hepatic insufficiency should have treatment started under close medical supervision using the 40/12.5 mg combination (see PRECAUTIONS).

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• Fallback Solo
  

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  Fallback Solo

  

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  The sooner you take emergency contraception, the better it works. You should use Fallback Solo within 72 hours (3 days) after you have had unprotected sex.

  Fallback Solo is a backup or emergency method of birth control you can use when:

  your regular birth control was used incorrectly or failed you did not use any birth control method

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• Quetiapine Fumarate
  

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  Quetiapine Fumarate

  

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  2.1 Important Administration Instructions

  Quetiapine fumarate tablets can be taken with or without food.

  2.2 Recommended Dosing

  The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].

  Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not applicable Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.Increase in increments of 25 mg to 50 mgdivided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) Day 1: 25 mg twice daily. Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg. Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.Based on response and tolerability, may be administered three times daily. 400 to 800mg/day 800 mg/day Schizophrenia-Maintenance N/A* 400 to  800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.Day 2: Twice daily dosing totaling 200 mg. Day 3: Twice daily dosing totaling 300 mg. Day 4: Twice daily dosing totaling 400 mg. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to  800mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily. Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg. Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.Based on response and tolerability, may be administered three times daily. 400 to 600mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime. Day 1: 50 mgDay 2: 100 mgDay 3: 200 mgDay 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy-Adults Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800mg/day 800 mg/day

  Maintenance Treatment for Schizophrenia and Bipolar I Disorder

  Maintenance Treatment:

  Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].

  2.3 Dose Modifications in Elderly Patients

  Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.

  Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.

  2.4 Dose Modifications in Hepatically Impaired Patients

  Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.

  2.5 Dose Modifications when used with CYP3A4 Inhibitors

  Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].

  2.6 Dose Modifications when used with CYP3A4 Inducers

  Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].

  2.7 Reinitiation of Treatment in Patients Previously Discontinued

  Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.

  2.8 Switching from Antipsychotics

  There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.

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• Amlodipine Besylate
  

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  Amlodipine Besylate

  

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  2.1 Adults

  The usual initial antihypertensive oral dose of amlodipine besylate tablet is 5 mg once daily and the maximum dose is 10 mg once daily.

  Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablet USP to other antihypertensive therapy.

  Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

  Angina

  The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

  Coronary artery disease 

  The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see CLINICAL STUDIES (14.4)].

  2.2 Children

  The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see CLINICAL PHARMACOLOGY (12.4), CLINICAL STUDIES (14.1)].

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• Irbesartan
  

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  Irbesartan

  

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  Irbesartan Tablets USP may be administered with other antihypertensive agents and with or without food.

  Hypertension

  The recommended initial dose of irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily.

  A low dose of a diuretic may be added, if blood pressure is not controlled by irbesartan tablets USP alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing.

  No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment.

  Nephropathy in Type 2 Diabetic Patients

  The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of irbesartan tablets USP on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies).

  Volume- and Salt-Depleted Patients

  A lower initial dose of irbesartan tablets USP (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients).

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• Irbesartan And Hydrochl...
  

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  Irbesartan And Hydrochlorothiazide

  

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  2.1 General Considerations

  The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. [See ADVERSE REACTIONS (6).]

  Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

  Irbesartan and hydrochlorothiazide tablets may be administered with or without food.

  Irbesartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

  Renal Impairment The usual regimens of therapy with irbesartan and hydrochlorothiazide tablets may be followed as long as the patient's creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so irbesartan-hydrochlorothiazide is not recommended.

  Hepatic Impairment No dosage adjustment is necessary in patients with hepatic impairment.

  2.2 Add-On Therapy

  In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of irbesartan and hydrochlorothiazide tablets, in order of increasing mean effect, are (irbesartan-hydrochlorothiazide) 150/12.5 mg, 300/12.5 mg, and 300/25 mg. The largest incremental effect will likely be in the transition from monotherapy to 150/12.5 mg. [See CLINICAL STUDIES (14.2).]

  2.3 Replacement Therapy

  Irbesartan and hydrochlorothiazide tablets may be substituted for the titrated components.

  2.4 Initial Therapy

  The usual starting dose is irbesartan and hydrochlorothiazide tablets, 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 300/25 mg tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Irbesartan and hydrochlorothiazide tablet is not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].

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• Levofloxacin
  

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  Levofloxacin

  

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  2.1 Dosage in Adult Patients with Normal Renal Function

  The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.

  These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].

  Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE ( 1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE ( 1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES ( 14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection* Dosed Every 24 hours Duration (days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)# 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kgÞ,ß Pediatric patients < 50 kg  and ≥ 6 months of ageÞ,ß 500 mg see Table 2  below (2.2) 60ß 60ß Plague, adult and pediatric  patients > 50 kgà Pediatric patients < 50 kg and ≥ 6 months of age 500 mg see Table 2  below (2.2) 10 to 1410 to 14

  2.2 Dosage in Pediatric Patients

  The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

  Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see INDICATIONS AND USAGE ( 1.13)] and Yersinia pestis [see INDICATIONS AND USAGE ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES ( 14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose Freq. Once every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 500 mg 24 hr 60 days§ Pediatric patients < 50 kg and ≥ 6 months  of age 8 mg/kg(not to exceed 250 mg per dose) 12 hr 60 days§ Plague¶ Pediatric patients  > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients  < 50 kg  and ≥ 6 months of age 8 mg/kg(not to exceed 250 mg per dose) 12 hr 10 to 14 days

  2.3 Dosage Adjustment in Adults with Renal Impairment

  Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

  No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

  In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].

  Table 3 shows how to adjust dose based on creatinine clearance.

  Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in Normal  Renal Function  Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic  Ambulatory Peritoneal  Dialysis (CAPD) 750 mg 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then500 mg every 48 hours 500 mg 500 mg initial dose, then 250 mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then250 mg every 48 hours 250 mg No dosage adjustment required 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available

  2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

  Levofloxacin Tablets

  Levofloxacin tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].

  2.5 Administration Instructions

  Food and Levofloxacin Tablets

  Levofloxacin tablets can be administered without regard to food.

  Hydration for Patients Receiving Levofloxacin Tablets

  Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].

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• Quinapril
  

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  Quinapril

  

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  Hypertension

  Monotherapy

  The recommended initial dosage of quinapril in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2 to 6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40 to 80 mg and divided doses give a somewhat greater effect at the end of the dosing interval.

  Concomitant Diuretics

  If blood pressure is not adequately controlled with quinapril monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril tablets (see WARNINGS). Then, if blood pressure is not controlled with quinapril tablets alone, diuretic therapy should be resumed.

  If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril should be used with careful medical supervision for several hours and until blood pressure has stabilized.

  The dosage should subsequently be titrated (as described above) to the optimal response (see WARNINGS, PRECAUTIONS, and Drug Interactions).

  Renal Impairment

  Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows:

  Creatinine Clearance Maximum Recommended Initial Dose >60 mL/min 10 mg 30-60 mL/min 5 mg 10-30 mL/min 2.5 mg <10 mL/min Insufficient data fordosage recommendation

  Patients should subsequently have their dosage titrated (as described above) to the optimal response.

  Elderly (≥65 years)

  The recommended initial dosage of quinapril tablets in elderly patients is 10 mg given once daily followed by titration (as described above) to the optimal response.

  Following the initial dose of quinapril tablets, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostatis and, if present, until blood pressure stabilizes. The appearance of hypotension, orthostatis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretics.

  DOSE ADJUSTMENTS IN PATIENTS WITH RENAL IMPAIRMENT OR HYPONATREMIA

  Pharmacokinetic data indicate that quinapril elimination is dependent on level of renal function. In patients with renal impairment, the recommended initial dose of quinapril is 5 mg in patients with a creatinine clearance above 30 mL/min and 2.5 mg in patients with a creatinine clearance of 10 to 30 mL/min. There is insufficient data for dosage recommendation in patients, with a creatinine clearance less than 10 mL/min. (See WARNINGS, and PRECAUTIONS, Drug Interactions).

  If the initial dose is well tolerated, quinapril may be administered the following day as a twice daily regimen. In the absence of excessive hypotension or significant deterioration of renal function, the dose may be increased at weekly intervals based on clinical and hemodynamic response.

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• Nikki
  

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  Nikki

  

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  2.1 How to Take Nikki

  Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

  To achieve maximum contraceptive effectiveness, Nikki must be taken exactly as directed, in the order directed on the wallet. Single missed pills should be taken as soon as remembered.

  2.2 How to Start Nikki

  Instruct the patient to begin taking Nikki either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

  Day 1 Start

  During the first cycle of Nikki use, instruct the patient to take one pink Nikki daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Nikki can be taken without regard to meals. If Nikki is first taken later than the first day of the menstrual cycle, Nikki should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  Sunday Start

  During the first cycle of Nikki use, instruct the patient to take one pink Nikki daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Nikki can be taken without regard to meals. Nikki should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

  The patient should begin her next and all subsequent 28-day regimens of Nikki on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Nikki is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a pink Nikki daily for seven consecutive days.

  When switching from a different birth control pill

  When switching from another birth control pill, Nikki should be started on the same day that a new pack of the previous oral contraceptive would have been started.

  When switching from a method other than a birth control pill

  When switching from a transdermal patch or vaginal ring, Nikki should be started when the next application would have been due. When switching from an injection, Nikki should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Nikki should be started on the day of removal.

  Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Nikki, instruct the patient to continue taking Nikki by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

  Although the occurrence of pregnancy is low if Nikki is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Nikki if pregnancy is confirmed.

  The risk of pregnancy increases with each active pink tablet missed. For additional patient instructions regarding missed pills, see the "What to Do if You Miss Pills" section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day.

  For postpartum women who do not breastfeed or after a second trimester abortion, start Nikki no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Nikki postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Nikki for 7 consecutive days.

  2.3 Advice in Case of Gastrointestinal Disturbances

  In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.

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• Lamivudine And Zidovudi...
  

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  Lamivudine And Zidovudine

  

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  2.1 Adults and Adolescents Weighing = 30 kg

  The recommended oral dose of lamivudine and zidovudine tablets in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.

  2.2 Pediatric Patients

  The recommended oral dosage of scored lamivudine and zidovudine tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered twice daily.

  Before prescribing lamivudine and zidovudine tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a lamivudine and zidovudine tablets, the liquid oral formulations should be prescribed: EPIVIR® (lamivudine) Oral Solution and RETROVIR® (zidovudine) Syrup.

  2.3 Patients Requiring Dosage Adjustment

  Because lamivudine and zidovudine tablet is a fixed-dose combination tablet, it should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with reduced renal function (creatinine clearance less than 50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of lamivudine and zidovudine tablets are available for these populations.

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• Tramadol Hydrochloride
  

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  Tramadol Hydrochloride

  

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  Tramadol hydrochloride extended-release tablets USP should not be used in patients with:

  ●       creatinine clearance less than 30 mL/min,

  ●       severe hepatic impairment (Child-Pugh Class C)

  (See PRECAUTIONS, Use in Renal and Hepatic Disease).

  Tramadol hydrochloride extended-release tablet USP must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and DRUG ABUSE AND ADDICTION).

  Adults (18 years of age and over)

  Patients Not Currently on Tramadol Immediate-Release Products

  For patients not currently treated with tramadol immediate-release (IR) products, Tramadol hydrochloride extended-release tablet USP should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. Tramadol hydrochloride extended-release tablets USP should not be administered at a dose exceeding 300 mg per day.

  Patients Currently on Tramadol Immediate-Release Products

  For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of tramadol hydrochloride extended-release tablet USP rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with tramadol hydrochloride extended-release tablets USP, some patients maintained on tramadol IR products may not be able to convert to tramadol hydrochloride extended-release tablet USP. Tramadol hydrochloride extended-release tablet USP should not be administered at a dose exceeding 300 mg per day. The concomitant use of tramadol hydrochloride extended-release tablet USP with other tramadol products is not recommended (see WARNINGS).

  Individualization of Dose

  Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of tramadol hydrochloride extended-release tablet USP have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.

  In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol hydrochloride extended-release tablet USP should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

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• Tramadol Hydrochloride
  

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  Tramadol Hydrochloride

  

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  Tramadol hydrochloride extended-release tablets should not be used in patients with:

  ●       creatinine clearance less than 30 mL/min,

  ●       severe hepatic impairment (Child-Pugh Class C)

  (See PRECAUTIONS, Use in Renal and Hepatic Disease).

  Tramadol hydrochloride extended-release tablet must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and DRUG ABUSE AND ADDICTION).

  Adults (18 years of age and over)

  Patients Not Currently on Tramadol Immediate-Release Products

  For patients not currently treated with tramadol immediate-release (IR) products, Tramadol hydrochloride extended-release tablet should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. Tramadol hydrochloride extended-release tablets should not be administered at a dose exceeding 300 mg per day.

  Patients Currently on Tramadol Immediate-Release Products

  For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of tramadol hydrochloride extended-release tablet rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with tramadol hydrochloride extended-release tablets, some patients maintained on tramadol IR products may not be able to convert to tramadol hydrochloride extended-release tablet. Tramadol hydrochloride extended-release tablet should not be administered at a dose exceeding 300 mg per day. The concomitant use of tramadol hydrochloride extended-release tablet with other tramadol products is not recommended (see WARNINGS).

  Individualization of Dose

  Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of tramadol hydrochloride extended-release tablet have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.

  In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol hydrochloride extended-release tablet should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

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• Suprax
  

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  Suprax

  

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  2.1 Adults

  The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without regard to food.

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.2 Pediatric Patients (6 months or older)

  The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.

  Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Suprax for oral suspension is available in three different concentrations (100 mg/5 mL, 200 mg/5 mL, and 500 mg/5 mL).

  Table 1. Suggested doses for pediatric patients * The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges. PEDIATRIC DOSAGE CHART Doses are suggested for each weight range and rounded for ease of administration Suprax (cefixime) for Oral Suspension Suprax (cefixime) Chewable Tablet 100 mg/5 mL 200 mg/5 mL 500 mg/5 mL Patient Weight (kg) Dose/Day  (mg) Dose/Day  (mL) Dose/Day  (mL) Dose/Day  (mL) Dose 5 to 7.5* 50 2.5 -- -- -- 7.6 to 10* 80 4 2 -- -- 10.1 to 12.5 100 5 2.5 1 1 tablet of 100 mg 12.6 to 20.5 150 7.5 4 1.5 1 tablet of 150 mg 20.6 to 28 200 10 5 2 1 tablet of 200 mg 28.1 to 33 250 12.5 6 2.5 1 tablet of 100 mg and 1 tablet of 150 mg 33.1 to 40 300 15 7.5 3 2 tablets of 150 mg 40.1to 45 350 17.5 9 3.5 1 tablet of 150 mg and 1 tablet of 200 mg 45.1 or greater 400 20 10 4 2 tablets of 200 mg

  Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Suprax (cefixime) Chewable Tablets must be chewed or crushed before swallowing.

  Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose.

  Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media. [See CLINICAL PHARMACOLOGY (12.3)]

  In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days.

  2.3 Renal Impairment

  Suprax may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

  Table 2. Doses for Adults with Renal Impairment * The preferred concentrations of oral suspension to use are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction Renal Dysfunction  Suprax (cefixime) for Oral Suspension Tablet Chewable Tablet Creatinine Clearance (mL/min) 100 mg/5 mL 200 mg/5 mL 500 mg/5 mL 400 mg 200 mg Dose/Day (mL) Dose/Day (mL) Dose/Day (mL) Dose/Day Dose/Day 60 or greater Normal dose Normal dose Normal dose Normal dose Normal dose 21 to 59* OR renal hemodialysis* 13 6.5 2.6 Not Appropriate Not Appropriate 20 or less OR continuous peritoneal dialysis  8.6 4.4 1.8 0.5 tablet 1 tablet

  2.4 Reconstitution Directions for Oral Suspension

  Strength Bottle Size Reconstitution Directions 100 mg/5 mL and 200 mg/5 mL 100 mL To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 100 mg/5 mL and 200 mg/5 mL 75 mL To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 100 mg/5 mL and 200 mg/5 mL 50 mL To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 200 mg/5 mL 37.5 mL To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 200 mg/5 mL 25 mL To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 500 mg/5 mL 20 mL To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. 500 mg/5 mL 10 mL To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.

  After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

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• Losortan Potassium
  

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  Losortan Potassium

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine and benazepril hydrochloride capsule, USP is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.

  It is usually appropriate to begin therapy with amlodipine and benazepril hydrochloride capsules, USP only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine and benazepril hydrochloride capsule, USP is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient's clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment

  Amlodipine and benazepril hydrochloride capsules, USP are not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of amlodipine and benazepril hydrochloride capsules, USP are required in patients with CrCl greater than 30 mL/min/1.73 m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L). [see WARNINGS AND PRECAUTIONS (5.7), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

  2.3 Replacement Therapy

  Amlodipine and benazepril hydrochloride capsules, USP may be substituted for the titrated components.

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• Sertraline
  

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  Sertraline

  

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  Initial Treatment

  Dosage for Adults

  Major Depressive Disorder and Obsessive-Compulsive Disorder:

  Sertraline treatment should be administered at a dose of 50 mg once daily.

  Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder:

  Sertraline treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

  While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50 to 200 mg/day in the clinical trials demonstrating the effectiveness of sertraline for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week.

  Premenstrual Dysphoric Disorder:

  Sertraline treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.

  While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50 to 150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

  Sertraline should be administered once daily, either in the morning or evening.

  Dosage for Pediatric Population (Children and Adolescents)

  Obsessive-Compulsive Disorder:

  Sertraline treatment should be initiated with a dose of 25 mg once daily in children (ages 6 to 12) and at a dose of 50 mg once daily in adolescents (ages 13 to 17).

  While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25 to 200 mg/day in the clinical trials demonstrating the effectiveness of sertraline for pediatric patients (6 to 17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of sertraline, dose changes should not occur at intervals of less than 1 week.

  Sertraline should be administered once daily, either in the morning or evening.

  Maintenance/Continuation/Extended Treatment

  Major Depressive Disorder

  It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50 to 200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Posttraumatic Stress Disorder

  It is generally agreed that PTSD requires several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of sertraline has demonstrated that its efficacy in PTSD is maintained for periods of up to 28 weeks following 24 weeks of treatment at a dose of 50 to 200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.

  Social Anxiety Disorder

  Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of sertraline has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50 to 200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.

  Obsessive-Compulsive Disorder and Panic Disorder

  It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing sertraline for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking sertraline during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50 to 200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

  Premenstrual Dysphoric Disorder

  The effectiveness of sertraline in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.

  Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with sertraline.

  Conversely, at least 14 days should be allowed after stopping sertraline before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

  Use of Sertraline with other MAOIs such as Linezolid or Methylene Blue

  Do not start sertraline in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

  In some cases, a patient already receiving sertraline therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, sertraline should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with sertraline hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with sertraline is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

  Special Populations

  Dosage for Hepatically Impaired Patients

  The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

  Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to sertraline and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with sertraline during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

  Discontinuation of Treatment with Sertraline

  Symptoms associated with discontinuation of sertraline and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

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• Sirolimus
  

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  Sirolimus

  

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  2.1 Adult Patients

  [See INDICATIONS AND USAGE (1.1) and CLINICAL PHARMACOLOGY (12.3)]

  * DUE TO THE INDICATED ORGANISMS [see INDICATIONS AND USAGE ( 1.1)] Infection* Recommended Dose/Duration of Therapy Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial exacerbations of chronic obstructive pulmonary disease 500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 Acute bacterial sinusitis 500 mg once daily for 3 days Genital ulcer disease (chancroid) One single 1 gram dose Non-gonococcal urethritis and cervicitis One single 1 gram dose Gonococcal urethritis and cervicitis One single 2 gram dose

  Azithromycin tablets can be taken with or without food.

  2.2 Pediatric Patients

  1see dosing tables below for maximum doses evaluated by indication

  * DUE TO THE INDICATED ORGANISMS [see INDICATIONS AND USAGE ( 1.2)] Infection*  Recommended Dose/Duration of Therapy  Acute otitis media  30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.  Acute bacterial sinusitis  10 mg/kg once daily for 3 days.  Community-acquired pneumonia  10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.  Pharyngitis/tonsillitis  12 mg/kg once daily for 5 days. 

  Azithromycin for oral suspension can be taken with or without food.

  PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA(Age 6 months and above, [see USE IN SPECIFIC POPULATIONS (8.4)]) Based on Body Weight * Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established. OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)* Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5. Weight 100 mg/5 mL 200 mg/5 mL Kg Lbs. Day 1 Day 2 to 5 Day 1 Day 2 to 5 Total mL per Treatment Course Total mg per Treatment Course 5 11 2.5 mL; (½ tsp) 1.25 mL;(¼ tsp) 7.5 mL 150 mg 10 22 5 mL; (1tsp) 2.5 mL; (½ tsp) 15 mL 300 mg 20 44 5 mL; (1 tsp) 2.5 mL; (½ tsp) 15 mL 600 mg 30 66 7.5 mL; (1½ tsp) 3.75 mL; (¾ tsp) 22.5 mL 900 mg 40 88 10 mL; (2 tsp) 5 mL;(1 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL; (2½ tsp) 6.25 mL; (1¼ tsp) 37.5 mL 1500 mg * Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established. OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)* Dosing Calculated on 10 mg/kg/day. Weight 100 mg/5 mL 200 mg/5 mL Kg Lbs. Days 1 to 3 Days 1 to 3 Total mL per Treatment Course Total mg per Treatment Course 5 11 2.5 mL; (1/2 tsp) 7.5 mL 150 mg 10 22 5 mL; (1 tsp) 15 mL 300 mg 20 44 5 mL (1 tsp) 15 mL 600 mg 30 66 7.5 mL (1½ tsp) 22.5 mL 900 mg 40 88 10 mL (2 tsp) 30 mL 1200 mg 50 and above 110 and above 12.5 mL (2 ½ tsp) 37.5 mL 1500 mg OTITIS MEDIA: (1-Day Regimen) Dosing Calculated on 30 mg/kg as a single dose. Weight 200 mg/5 mL Kg Lbs. 1-Day Regimen Total mL per Treatment Course Total mg per Treatment Course 5 11 3.75 mL;(3/4 tsp) 3.75 mL 150 mg 10 22 7.5 mL;(1½ tsp) 7.5 mL 300 mg 20 44 15 mL;(3 tsp) 15 mL 600 mg 30 66 22.5 mL;(4½ tsp) 22.5 mL 900 mg 40 88 30 mL;(6 tsp) 30 mL 1200 mg 50 and above 110 and above 37.5 mL;(7½ tsp) 37.5 mL 1500 mg

  The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

  Pharyngitis/Tonsillitis

  The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

  PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS(Age 2 years and above, [see USE IN SPECIFIC POPULATIONS (8.4)]) Based on Body Weight PHARYNGITIS/TONSILLITIS: (5-Day Regimen) Dosing Calculated on 12 mg/kg/day for 5 days. Weight 200 mg/5 mL Kg Lbs. Day 1 to 5 Total mL per Treatment Course Total mg per Treatment Course 8 18 2.5 mL; (½ tsp) 12.5 mL 500 mg 17 37 5 mL; (1 tsp) 25 mL 1000 mg 25 55 7.5 mL; (1½ tsp) 37.5 mL 1500 mg 33 73 10 mL; (2 tsp) 50 mL 2000 mg 40 88 12.5 mL; (2½ tsp) 62.5 mL 2500 mg

  Constituting instructions for azithromycin oral suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:

  Amount of water to be added  Total volume after constitution (azithromycin content)  Azithromycin concentration after constitution  9 mL (300 mg)  15 mL (300 mg)  100 mg/5 mL  9 mL (600 mg)  15 mL (600 mg)  200 mg/5 mL  12 mL (900 mg)  22.5 mL (900 mg)  200 mg/5 mL  15 mL (1200 mg)  30 mL (1200 mg)  200 mg/5 mL 

  Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

  After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

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• Escitalopram
  

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  Escitalopram

  

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  Escitalopram tablets USP should be administered once daily, in the morning or evening, with or without food.

  2.1 Major Depressive Disorder

  Initial Treatment

  Adolescents:

  The recommended dose of escitalopram tablet USP is 10 mg once daily. A flexible-dose trial of escitalopram tablet USP (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablet USP [see CLINICAL STUDIES (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.

  Adults:

  The recommended dose of escitalopram tablet USP is 10 mg once daily. A fixed-dose trial of escitalopram tablets USP demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets USP, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see CLINICAL STUDIES (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.

  Maintenance Treatment

  It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram tablets USP 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram tablets USP during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see CLINICAL STUDIES (14.1)]. Nevertheless, the physician who elects to use escitalopram tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.2 Generalized Anxiety Disorder

  Initial Treatment

  Adults:

  The recommended starting dose of escitalopram tablet USP is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.

  Maintenance Treatment

  Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram tablets USP in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

  2.3 Special Populations

  10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

  No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram tablets USP should be used with caution in patients with severe renal impairment.

  2.4 Discontinuation of Treatment with Escitalopram Tablets USP

  Symptoms associated with discontinuation of escitalopram tablets USP and other SSRIs and SNRIs have been reported [see WARNINGS AND PRECAUTIONS (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets USP. Conversely, at least 14 days should be allowed after stopping escitalopram tablets USP before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4.1)].

  2.6 Use of Escitalopram Tablets USP with Other MAOIs such as Linezolid or Methylene Blue

  Do not start escitalopram tablets USP in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4.1)].

  In some cases, a patient already receiving escitalopram tablets USP therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram tablets USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram tablets USP may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.2)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets USP is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.2)].

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• Xtandi
  

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  Xtandi

  

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  2.1 Adult Hypertension

  The recommended starting dose of valsartan tablets is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day.

  The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

  No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of valsartan tablets in patients with hepatic or severe renal impairment.

  Valsartan tablets may be administered with other antihypertensive agents.

  Valsartan tablets may be administered with or without food.

  2.2 Pediatric Hypertension 6 to 16 Years of Age

  For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.

  For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of valsartan tablets, the use of a suspension is recommended. Follow the suspension preparation instructions below (see Preparation of Suspension) to administer valsartan as a suspension. When the suspension is replaced by a tablet, the dose of valsartan may have to be increased. The exposure to valsartan with the suspension is 1.6 times greater than with the tablet.

  No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2 [see Pediatric Use (8.4).

  Valsartan tablets is not recommended for patients <6 years old [see ADVERSE REACTIONS (6.1), CLINICAL STUDIES (14.1)].

  Preparation of Suspension (for 160 mL of a 4 mg/mL suspension)

  Add 80 mL of Ora-Plus®* oral suspending vehicle to an amber glass bottle containing 8 valsartan 80 mg tablets, and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF®* oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2 to 8°C/35 to 46°F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension.

  *Ora-Sweet SF® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.

  2.3 Heart Failure

  The recommended starting dose of valsartan tablets is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.

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• Jencycla
  

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  Jencycla

  

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  To achieve maximum contraceptive effectiveness, Jencycla must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See DETAILED PATIENT LABELING for detailed instruction.

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