Drug Catalog - Product Detail
HYDROXYCHLOROQUINE TB 200MG 10X10 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00904-6508-61 | MAJOR PHARMACEUTICALS | 100 | 200MG | TABLET |
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Description
DESCRIPTION Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino] pentyl] ethylamino] ethanol sulfate (1:1). Hydroxychloroquine sulfate has the following structural formula: Each tablet for oral administration contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg hydroxychloroquine). Inactive ingredients: Dibasic calcium phosphate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, sodium bicarbonate, and titanium dioxide. Hydroxychloroquine Sulfate Chemical Structure
How Supplied
HOW SUPPLIED Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, off white tablets, scored and debossed GG 260 on one side and plain on the reverse side, film coated white and supplied as: 50 Tablets in unit dose blisters per box, NDC 0904-6508-06 (5 cards of 10 tablets each) 100 Tablets in unit dose blisters per box, NDC 0904-6508-61 (10 cards of 10 tablets each) Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.
Indications & Usage
INDICATIONS AND USAGE Malaria Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P, vivax . Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria •Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria. •Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. •Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. •Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY – Microbiology ). Prior to prescribing hydroxychloroquine sulfate for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria). Lupus Erythematosus Hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus, in adults. Rheumatoid Arthritis Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
Dosage and Administration
DOSAGE AND ADMINISTRATION One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base. Take hydroxychloroquine sulfate with a meal or a glass of milk. One tablet of 200 mg of hydroxychloroquine sulfate is equivalent to 155 mg base. Take hydroxychloroquine sulfate with a meal or a glass of milk. Malaria Prophylaxis Adults: 400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. Weight-based dosing in adults and pediatric patients : 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), once weekly on the same day of the week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. Treatment of Uncomplicated Malaria Adults: 800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base). Weight based dosage in adults and pediatric patients : 13 mg/kg (10 mg/kg base), not to exceed 800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose. Hydroxychloroquine sulfate film-coated tablets cannot be divided, therefore they should not be used to treat patients who weigh less than 31 kg. For radical cure of P. vivax and P. malariae infections, concomitant therapy with an 8-aminoquinoline compound is necessary.