Lupin Limited

Lupin Limited Drugs

• Levonorgestrel And Ethi...
  

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  Levonorgestrel And Ethinyl Estradiol

  

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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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• 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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• 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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