Amedra Pharmaceuticals Llc

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2.1 Dosage

Dosing of ALBENZA will vary depending upon the indication. ALBENZA tablets may be crushed or chewed and swallowed with a drink of water. ALBENZA chewable tablets are also available for children and patients who may experience swallowing difficulties. ALBENZA tablets and ALBENZA chewable tablets should be taken with food [see Clinical Pharmacology (12.3)].

Table 1: ALBENZA Dosage  Indication  Patient Weight  Dose  Duration  Hydatid Disease  60 kg or greater  400 mg twice daily, with meals  28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles  Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)  Neurocysticercosis  60 kg or greater  400 mg twice daily, with meals  8 to 30 days  Less than 60 kg  15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

2.2 Concomitant Medication to Avoid Adverse Reactions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions (5.3)].

2.3 Monitoring for Safety Before and During Treatment

Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients [see Warnings and Precautions (5.1)]. Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with ALBENZA in all patients [see Warnings and Precautions (5.5)]. Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)].

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Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy

Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.Narcolepsy seldom occurs in children under 12 years of age; however, when it does, DEXEDRINE may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. SPANSULE capsules may be used for once-a-day dosage wherever appropriate.

Attention Deficit Disorder with Hyperactivity

The SPANSULE capsule formulation is not recommended for pediatric patients younger than 6 years of age.In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.SPANSULE capsules may be used for once-a-day dosage wherever appropriate.Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

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For Treatment of Toxoplasmosis: The dosage of DARAPRIM for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.

The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks.

The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM.

For Treatment of Acute Malaria: DARAPRIM is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, DARAPRIM at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. DARAPRIM is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein DARAPRIM must be used alone in semi-immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.

For Chemoprophylaxis of Malaria: Adults and pediatric patients over 10 years – 25 mg (1 tablet) once weekly Children 4 through 10 years – 12.5 mg (1/2 tablet) once weekly Infants and children under 4 years – 6.25 mg (1/4 tablet) once weekly.

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Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy

Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, DEXEDRINE tablets may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily, daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening: additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity

Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening: additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

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Selection of the appropriate Adrenaclick dosage strength is determined according to patient body weight.

Patients greater than or equal to 30 kg (approximately 66 pounds or more): Adrenaclick 0.3 mg Patients 15 to 30 kg (33 pounds to 66 pounds): Adrenaclick 0.15 mg

Inject Adrenaclick intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary.

Each Adrenaclick contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from Adrenaclick are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.

With severe persistent anaphylaxis, repeat injections with an additional Adrenaclick may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].

The epinephrine solution in the viewing window of Adrenaclick should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see How Supplied/Storage and Handling (16.2)].