Alvogen, Inc.

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Carefully consider the potential benefits and risks of naproxen sodium and other treatment options before deciding to use Naproxen Sodium Controlled Release Tablets. 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 Naproxen Sodium Controlled Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of:

RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, AND ANKYLOSING SPONDYLITIS

The recommended starting dose of Naproxen Sodium Controlled Release Tablets in adults is two Naproxen Sodium Controlled Release 375 mg Tablets (750 mg) once daily, one Naproxen Sodium Controlled Release 750 mg Tablet (750 mg) once daily, or two Naproxen Sodium Controlled Release 500 mg Tablets (1000 mg) once daily. Patients already taking naproxen 250 mg, 375 mg, or 500 mg twice daily (morning and evening) may have their total daily dose replaced with Naproxen Sodium Controlled Release Tablets as a single daily dose.

During long-term administration, the dose of Naproxen Sodium Controlled Release Tablets may be adjusted up or down depending on the clinical response of the patient. In patients who tolerate lower doses of Naproxen Sodium Controlled Release Tablets well, the dose may be increased to two Naproxen Sodium Controlled Release 750 mg Tablets (1500 mg), or three Naproxen Sodium Controlled Release 500 mg Tablets (1500 mg) once daily for limited periods when a higher level of anti-inflammatory/analgesic activity is required. When treating patients, especially at the higher dose levels, the physician should observe sufficient increased clinical benefit to offset the potential increased risk (see CLINICAL PHARMACOLOGY). The lowest effective dose should be sought and used in every patient. Symptomatic improvement in arthritis usually begins within one week; however, treatment for two weeks may be required to achieve a therapeutic benefit.

A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see PRECAUTIONS). Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly it is prudent to use the lowest effective dose.

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Cefaclor is administered orally.

Adults -- The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as

pneumonia) or those caused by less susceptible organisms, doses may be doubled.

Pediatric Patients -- The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.

Cefaclor Suspension 20 mg/kg/day Weight 124 mg/5mL 250 mg/5mL 9 kg ½ tsp t.i.d. 18 kg 1 tsp t.i.d. ½ tsp t.i.d. 40 mg/kg/day 9 kg 1 tsp t.i.d. ½ tsp t.i.d. 18 kg 1 tsp t.i.d.

B.I.D. Treatment Option – For the treatment of

otitis media and pharyngitis, the total daily dosage

may be divided and administered every 12 hours.

Cefaclor Suspension 20 mg/kg/day Weight 187 mg/5mL 375 mg/5mL 9 kg ½ tsp b.i.d. 18 kg 1 tsp b.i.d. ½ tsp b.i.d. 40 mg/kg/day 9 kg 1 tsp b.i.d. ½ tsp b.i.d. 18 kg 1 tsp b.i.d.

Cefaclor may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged (see PRECAUTIONS).

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

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2.1 Dosage in Adult Patients

The dose of Moxifloxacin Hydrochloride is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infectiona

DoseEvery 24 hours

Durationb (days)

Acute Bacterial Sinusitis (1.1)

400 mg

10

Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)

400 mg

5

Community Acquired Pneumonia (1.3)

400 mg

7–14

Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)

400 mg

7

Complicated SSSI (1.5)

400 mg

7–21

Complicated Intra-Abdominal Infections (1.6)

400 mg

5–14

Plague (1.7)C

400 mg

10–14

a) Due to the designated pathogens [see Indications and Usage (1)]. b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Conversion of Intravenous to Oral Dosing in Adults

Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin Hydrochloride Injection may be switched to Moxifloxacin Hydrochloride Tablets when clinically indicated at the discretion of the physician.

2.2 Important Administration Instructions

With Multivalent Cations

Administer Moxifloxacin Hydrochloride Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

With Food

Moxifloxacin Hydrochloride Tablets can be taken with or without food, drink fluids liberally.

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Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and Acetaminophen Tablets are given orally.

Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength Maximal Daily Dose Oxycodone and Acetaminophen Tablets, USP,  7.5 mg/325 mg 8 Tablets Oxycodone and Acetaminophen Tablets, USP,  10 mg/325 mg 6 Tablets

Cessation of Therapy

In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

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The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily. Dorzolamide hydrochloride ophthalmic solution 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 minutes apart.

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• Apply and gently massage a thin layer of Azelaic Acid Gel into the affected areas on the face twice daily (morning and evening). • Use only very mild soaps or soapless cleansing lotion before application of Azelaic Acid Gel. • Cosmetics may be applied after the application of Azelaic Acid Gel has dried. • Avoid the use of occlusive dressings or wrappings. • Instruct patients to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages. • Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy. • Not for oral, ophthalmic or intravaginal use.

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2.1 Recommended Dosing

Initial Dose

Initiate treatment with one 4.6 mg/24 hours Rivastigmine Patch applied to the skin once daily [see Dosage and Administration (2.4)].Dose Titration 

Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)]. Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease Dementia

The effective dosage of Rivastigmine Patch is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.Interruption of Treatment

If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength Rivastigmine Patch. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours Rivastigmine Patch and titrate as described above.

2.2 Dosing in Specific Populations

Dosing Modifications in Patients with Hepatic Impairment

Consider using the 4.6 mg/24 hours Rivastigmine Patch as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Dosing Modifications in Patients with Low Body Weight

Carefully titrate and monitor patients with low body weight (<50 kg) for toxicities (e.g., excessive nausea, vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 hours Rivastigmine Patch if such toxicities develop.

2.3 Switching to Rivastigmine Patch from Rivastigmine Capsules or Rivastigmine Oral Solution

Patients treated with rivastigmine capsules or oral solution may be switched to Rivastigmine Patch as follows:

A patient who is on a total daily dose of <6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Rivastigmine Patch. A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours Rivastigmine Patch.

Instruct patients or caregivers to apply the first patch on the day following the last oral dose.

2.4 Important Administration Instructions

Rivastigmine Patch is for transdermal use on intact skin.

(a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

(b) Apply the Rivastigmine Patch once a day

Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. If sites on the back are not accessible, apply the patch to the upper arm or chest. Do not apply to a skin area where cream, lotion, or powder has recently been applied.

(c) Do not apply to skin that is red, irritated, or cut.

(d) Replace the Rivastigmine Patch with a new patch every 24 hours. Instruct patients to only wear one patch at a time (remove the previous day's patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.

(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.

(f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).

(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.

(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

2.1 Recommended Dosing

Initial Dose

Initiate treatment with one 4.6 mg/24 hours Rivastigmine Patch applied to the skin once daily [see Dosage and Administration (2.4)].Dose Titration 

Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)]. Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease Dementia

The effective dosage of Rivastigmine Patch is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.Interruption of Treatment

If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength Rivastigmine Patch. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours Rivastigmine Patch and titrate as described above.

2.2 Dosing in Specific Populations

Dosing Modifications in Patients with Hepatic Impairment

Consider using the 4.6 mg/24 hours Rivastigmine Patch as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Dosing Modifications in Patients with Low Body Weight

Carefully titrate and monitor patients with low body weight (<50 kg) for toxicities (e.g., excessive nausea, vomiting) and consider reducing the maintenance dose to the 4.6 mg/24 hours Rivastigmine Patch if such toxicities develop.

2.3 Switching to Rivastigmine Patch from Rivastigmine Capsules or Rivastigmine Oral Solution

Patients treated with rivastigmine capsules or oral solution may be switched to Rivastigmine Patch as follows:

A patient who is on a total daily dose of <6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Rivastigmine Patch. A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours Rivastigmine Patch.

Instruct patients or caregivers to apply the first patch on the day following the last oral dose.

2.4 Important Administration Instructions

Rivastigmine Patch is for transdermal use on intact skin.

(a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

(b) Apply the Rivastigmine Patch once a day

Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. If sites on the back are not accessible, apply the patch to the upper arm or chest. Do not apply to a skin area where cream, lotion, or powder has recently been applied.

(c) Do not apply to skin that is red, irritated, or cut.

(d) Replace the Rivastigmine Patch with a new patch every 24 hours. Instruct patients to only wear one patch at a time (remove the previous day's patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.

(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.

(f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).

(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.

(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

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Dosage should be adjusted according to each patient’s needs. It is recommended that Nifedipine Extended-Release Tablets be administered orally once daily on an empty stomach. Nifedipine Extended-Release Tablets is an extended-release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.

If discontinuation of Nifedipine Extended-Release Tablets is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.

Co-administration of nifedipine with grapefruit juice is to be avoided (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

Care should be taken when dispensing Nifedipine Extended-Release Tablets to assure that the extended-release dosage form has been prescribed.

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There is no fixed dosage regimen for the management of diabetes mellitus with acarbose or any other pharmacologic agent. Dosage of acarbose must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended dose of 100 mg t.i.d. acarbose should be taken three times daily at the start (with the first bite) of each main meal. Acarbose should be started at a low dose, with gradual dose escalation as described below, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

During treatment initiation and dose titration (see below), one-hour postprandial plasma glucose may be used to determine the therapeutic response to acarbose 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 postprandial plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of acarbose, either as monotherapy or in combination with sulfonylureas, insulin or metformin.

Initial Dosage

The recommended starting dosage of acarbose is 25 mg given orally three times daily at the start (with the first bite) of each main meal. However, some patients may benefit from more gradual dose titration to minimize gastrointestinal side effects. This may be achieved by initiating treatment at 25 mg once per day and subsequently increasing the frequency of administration to achieve 25 mg t.i.d.

Maintenance Dosage

Once a 25 mg t.i.d. dosage regimen is reached, dosage of acarbose should be adjusted at 4–8 week intervals based on one-hour postprandial glucose or glycosylated hemoglobin levels, and on tolerance. The dosage can be increased from 25 mg t.i.d. to 50 mg t.i.d. Some patients may benefit from further increasing the dosage to 100 mg t.i.d. The maintenance dose ranges from 50 mg t.i.d. to 100 mg t.i.d. However, since patients with low body weight may be at increased risk for elevated serum transaminases, only patients with body weight > 60 kg should be considered for dose titration above 50 mg t.i.d. (see PRECAUTIONS). If no further reduction in postprandial glucose or glycosylated hemoglobin levels is observed with titration to 100 mg t.i.d., consideration should be given to lowering the dose. Once an effective and tolerated dosage is established, it should be maintained.

Maximum Dosage

The maximum recommended dose for patients ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

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2.1 General Dosing Considerations

• Nevirapine Extended Release Tablets must be swallowed whole and must not be chewed, crushed, or divided.

• Nevirapine Extended Release Tablets can be taken with or without food.

Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.2 Adult Patients

Patients not currently taking immediate release Nevirapine Tablets  Patients must initiate therapy with one 200 mg immediate release Nevirapine Tablet daily for the first 14 days in combination with other antiretroviral agents (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg Nevirapine Extended Release Tablet once daily.

Switching Patients from immediate release Nevirapine Tablets to Nevirapine Extended Release Tablets  Patients already on a regimen of immediate release Nevirapine Tablets twice daily in combination with other antiretroviral agents can be switched to Nevirapine Extended Release Tablets 400 mg once daily in combination with other antiretroviral agents without the 14-day lead-in period of immediate release Nevirapine Tablets.

2.3 Pediatric Patients

Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.’s Viramune XR® (nevirapine) extended-release tablets. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4 Monitoring of Patients

Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests prior to beginning the 14-day lead-in period with immediate release Nevirapine Tablets, prior to initiation of Nevirapine Extended Release Tablets, and at two weeks after initiation of Nevirapine Extended Release Tablets therapy. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout Nevirapine Extended Release Tablets treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Patients already on a regimen of immediate release Nevirapine Tablets twice daily who switch to Nevirapine Extended Release Tablets once daily should continue with their ongoing clinical and laboratory monitoring.

2.5 Dosage Adjustment

Patients with Rash  Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)].Do not initiate therapy with Nevirapine Extended Release Tablets if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of immediate release Nevirapine Tablets until the rash has resolved [see Warnings and Precautions (5.2)].The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.

Patients with Hepatic Events  If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].

Patients with Dose Interruption For patients who interrupt Nevirapine Extended Release Tablets dosing for more than 7 days, restart the recommended lead-in dosing with immediate release Nevirapine Tablets, using one 200 mg tablet daily for the first 14 days.

Patients with Renal Impairment Patients with CrCL greater than or equal to 20 mL per min and not requiring dialysis do not require an adjustment in dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of immediate release Nevirapine Tablets following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)]. Nevirapine Extended Release Tablets have not been studied in patients with renal dysfunction.

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The dose is one drop of dorzolamide hydrochloride – timolol maleate in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).

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Each Pyridostigmine Bromide Extended release Tablet contains 180 mg pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. The immediate effect of a 180 mg Pyridostigmine Bromide Extended release Tablet is about equal to that of a 60 mg pyridostigmine bromide tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ times that of a 60 mg dose.

Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. One to three Pyridostigmine Bromide Extended release Tablets, 180 mg, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting tablets or syrup in conjunction with Pyridostigmine Bromide Extended release Tablets therapy.

Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on edrophonium chloride.

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Primaquine phosphate is recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. Primaquine phosphate should be administered concurrently in order to eradicate the exoerythrocytic parasites in a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.

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The recommended dosage of Gadopentetate dimeglumine Injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.

DOSE AND DURATION OF Gadopentetate dimeglumine INJECTION BY BODY WEIGHT

BODY WEIGHT

Total Volume, mL*

lb

kg

22

10

2

44

20

4

66

30

6

88

40

8

110

50

10

132

60

12

154

70

14

176

80

16

198

90

18

220

100

20

242

110

22

264

120

24

286

130

26

*Rate of injection: 10 mL/15 sec

Drug Handling:

To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush. The imaging procedure should be completed within 1 hour of injection of Gadopentetate dimeglumine Injection.

As with other gadolinium contrast agents, Gadopentetate dimeglumine Injection has not been established for use in magnetic resonance angiography.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

Pharmacy Bulk Package Preparation:  NOT FOR DIRECT INFUSION 

The Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device for filling empty sterile syringes.

a) The transfer of Gadopentetate dimeglumine Injection from the Pharmacy Bulk Package must be performed in an aseptic work area, such as a laminar flow hood, using aseptic technique.

b) Once the Pharmacy Bulk Package is punctured, it should not be removed from the aseptic work area during the entire 24 hour period of use.

c) The contents of the Pharmacy Bulk Package after initial puncture should be used within 24 hours.

d) Any unused Gadopentetate dimeglumine Injection must be discarded 24 hours after the initial puncture of the bulk package.

IV tubing and syringes used to administer Gadopentetate dimeglumine Injection must be discarded at the conclusion of the radiological examination.

Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.

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The recommended dosage of Gadopentetate dimeglumine Injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.

DOSE AND DURATION OF Gadopentetate dimeglumine INJECTION BY BODY WEIGHT

BODY WEIGHT

Total Volume, mL*

lb

kg

22

10

2

44

20

4

66

30

6

88

40

8

110

50

10

132

60

12

154

70

14

176

80

16

198

90

18

220

100

20

242

110

22

264

120

24

286

130

26

*Rate of injection: 10 mL/15 sec

Drug Handling:

To ensure complete injection of the contrast medium, the injection should be followed by a 5-mL normal saline flush. The imaging procedure should be completed within 1 hour of injection of Gadopentetate dimeglumine Injection.

As with other gadolinium contrast agents, Gadopentetate dimeglumine Injection has not been established for use in magnetic resonance angiography.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.

Any unused portion must be discarded in accordance with regulations dealing with the disposal of such materials.

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Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].

Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

Start therapy with 0.025 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

2.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure

Start therapy with 0.025 mg per day applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Estradiol Transdermal System, especially in women with an intact uterus.

2.4 Prevention of Postmenopausal Osteoporosis

Start therapy with 0.025 mg per day applied to the skin once weekly.

2.5 Application of the Estradiol Transdermal System

Site Selection

• The adhesive side of the Estradiol Transdermal System should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. • The Estradiol Transdermal System should not be applied to or near the breasts. • The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site. • The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the transdermal system off. • Application to areas where sitting would dislodge the Estradiol Transdermal System should also be avoided.

Application

• The Estradiol Transdermal System should be applied immediately after opening the pouch and removing the protective liner. • The Estradiol Transdermal System should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges. • If the system lifts, apply pressure to maintain adhesion. • In the event that a system should fall off reapply it to a different location. If the system cannot be reapplied, a new system should be applied for the remainder of the 7-day dosing interval. • Only one system should be worn at any one time during the 7-day dosing interval. • Swimming, bathing, or using a sauna while using the Estradiol Transdermal System has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

2.6 Removal of the Estradiol Transdermal System

• Removal of the Estradiol Transdermal System should be done carefully and slowly to avoid irritation of the skin. • Should any adhesive remain on the skin after removal of the Estradiol Transdermal System, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue. • Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

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2.1 Adults

Vancomycin hydrochloride capsules 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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Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and Acetaminophen Tablets are given orally.

Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength Maximal Daily Dose Oxycodone and Acetaminophen Tablets, USP,  7.5 mg/325 mg 8 Tablets Oxycodone and Acetaminophen Tablets, USP,  10 mg/325 mg 6 Tablets

Cessation of Therapy

In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

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2.1 Dosage Information

The dose of Ibandronate Sodium Tablet is one 150 mg tablet as ibandronic acid taken once monthly on the same date each month.

2.2 Important Administration Instructions

Instruct Patients to do the following:

• Take Ibandronate Sodium Tablets at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1]). Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.

• Swallow Ibandronate Sodium Tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking Ibandronate Sodium Tablets (see WARNINGS AND PRECAUTIONS [5.1]). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.

• Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking Ibandronate Sodium Tablets.

2.3 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of Ibandronate Sodium Tablets administration because co-administration of Ibandronate Sodium Tablets and calcium may interfere with the absorption of ibandronate sodium (see DRUGINTERACTIONS [7.1]).

2.4 Administration Instructions for Missed Once-Monthly Doses

If the once-monthly dose is missed, instruct patients to do the following:

• If the next scheduled Ibandronate Sodium Tablets day is more than 7 days away, take one Ibandronate Sodium Tablet 150 mg as ibandronic acid in the morning following the date that it is remembered.

• If the next scheduled Ibandronate Sodium Tablets day is only 1 to 7 days away, wait until the subsequent month’s scheduled Ibandronate Sodium Tablets day to take their tablet.

For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one Ibandronate Sodium Tablet 150 mg as ibandronic acid every month on their previous chosen day.

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There is currently no dosage information available for this product. We apologize for any inconvenience.

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Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

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Oxycodone hydrochloride tablets are intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.

Patients who have not been receiving opioid analgesics should be started on oxycodone hydrochloride tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their initial dose of oxycodone hydrochloride tablets. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.

For control of severe chronic pain, oxycodone hydrochloride tablets should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.

As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of oxycodone hydrochloride tablets, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.

Conversion from Fixed-Ratio Opioid /Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of oxycodone hydrochloride tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose oxycodone hydrochloride tablets should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.

Patients Currently on Opioid Therapy

If a patient has been receiving opioid-containing medications prior to taking oxycodone hydrochloride tablets, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.

In converting patients from other opioids to oxycodone hydrochloride tablets close observation and adjustment of dosage based upon the patient's response to oxycodone hydrochloride tablets is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone hydrochloride tablets may be necessary, especially in patients who have disease states that are changing rapidly.

Maintenance of Therapy

Continual reevaluation of the patient receiving oxycodone hydrochloride tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be reassessed as appropriate.

Cessation of Therapy

When a patient no longer requires therapy with oxycodone hydrochloride tablets or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of oxycodone hydrochloride tablets that treatment may be discontinued without risk of the opioid abstinence syndrome.

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Disulfiram should never be administered until the patient has abstained from alcohol for at least 12 hours.

Initial Dosage Schedule:  In the first phase of treatment, a maximum of 500 mg daily is given in a single dose for one to two weeks. Although usually taken in the morning, disulfiram may be taken on retiring by patients who experience a sedative effect. Alternatively, to minimize, or eliminate, the sedative effect, dosage may be adjusted downward.

Maintenance Regimen:  The average maintenance dose is 250 mg daily (range, 125 to 500 mg), it should not exceed 500 mg daily.

Note:  Occasionally patients, while seemingly on adequate maintenance doses of disulfiram, report that they are able to drink alcoholic beverages with impunity and without any symptomatology. All appearances to the contrary, such patients must be presumed to be disposing of their tablets in some manner without actually taking them. Until such patients have been observed reliably taking their daily disulfiram tablets (preferably crushed and well mixed with liquid), it cannot be concluded that disulfiram is ineffective.

Duration of Therapy:  The daily, uninterrupted administration of disulfiram must be continued until the patient is fully recovered socially and a basis for permanent self-control is established. Depending on the individual patient, maintenance therapy may be required for months or even years.

Trial with Alcohol:  During early experience with disulfiram, it was thought advisable for each patient to have at least one supervised alcohol-drug reaction. More recently, the test reaction has been largely abandoned. Furthermore, such a test reaction should never be administered to a patient over 50 years of age. A clear, detailed and convincing description of the reaction is felt to be sufficient in most cases.

However, where a test reaction is deemed necessary, the suggested procedure is as follows:After the first one to two weeks' therapy with 500 mg daily, a drink of 15 mL (1/2 oz) of 100 proof whiskey, or equivalent, is taken slowly. This test dose of alcoholic beverage may be repeated once only, so that the total dose does not exceed 30 mL (1 oz) of whiskey. Once a reaction develops, no more alcohol should be consumed. Such tests should be carried out only when the patient is hospitalized, or comparable supervision and facilities, including oxygen, are available.

Management of Disulfiram-Alcohol Reaction:  In severe reactions, whether caused by an excessive test dose or by the patient's unsupervised ingestion of alcohol, supportive measures to restore blood pressure and treat shock should be instituted. Other recommendations include: oxygen, carbogen (95% oxygen and 5% carbon dioxide), vitamin C intravenously in massive doses (1 g) and ephedrine sulfate. Antihistamines have also been used intravenously. Potassium levels should be monitored, particularly in patients on digitalis, since hypokalemia has been reported.

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2.1 Adults Patients

The recommended dose for nevirapine is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.

2.2 Pediatric Patients

The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.

2.3 Monitoring of Patients

Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

2.4 Dosage Adjustment

Patients with Rash Discontinue nevirapine if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning, Warnings and Precautions (5.2), and Patient Counseling Information (17.1)]. Do not increase nevirapine dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2) and Patient Counseling Information (17.1)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.

Patients with Hepatic Events If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine. Do not restart nevirapine after recovery [see Warnings and Precautions (5.1)].

Patients with Dose Interruption For patients who interrupt nevirapine dosing for more than 7 days, restart the recommended dosing, using one 200 mg tablet daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by one 200 mg tablet twice daily (150 mg/m2 twice daily for pediatric patients).

Patients with Renal Impairment Patients with CrCL greater than or equal to 20 mL/min do not require an adjustment in nevirapine dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].

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2.1 Recommended Dose

The recommended dose of exemestane in early and advanced breast cancer is one 25 mg tablet to be taken once daily after a meal.• adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy.• the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

2.2 Dose Modifications

Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane is 50 mg once daily after a meal [see Drug Interactions(7)and Clinical Pharmacology(12.3)].

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The suggested starting dose is between 0.2 mg/hr* and 0.4 mg/hr*. Doses between 0.4 mg/hr* and 0.8 mg/hr* have shown continued effectiveness for 10 to 12 hours daily for at least 1 month (the longest period studied) of intermittent administration. Although the minimum nitrate-free interval has not been defined, data show that a nitrate-free interval of 10-12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12 to 14 hours and a daily patch-off period of 10 to 12 hours.

*Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied Nitroglycerin Transdermal Delivery Systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour).

Although some well-controlled clinical trials using exercise tolerance testing have shown maintenance of effectiveness when patches are worn continuously, the large majority of such controlled trials have shown the development of tolerance (i.e., complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustment, even to levels much higher than generally used, did not restore efficacy.