INDICATIONS AND USAGE Malaria Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated Malaria due to P. falclparum, P. Malariae, P. ovale, and P. vlvax. Hydroxychloroquine sulfate tablets are indicated for the prophylaxis of Malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria â€¢ Hydroxychloroquine sulfate tablets are not recommended for the treatment of complicated Malaria. â€¢ Hydroxychloroquine sulfate tablets are not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species ( see CLINICAL PHARMACOLOGY - Microbiology ). Hydroxychloroquine sulfate tablets are not recommended for the treatment of Malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. â€¢ Hydroxychloroquine sulfate tablets are not recommended for Malaria prophylaxis in geographic areas where chloroquine resistance occurs. â€¢ Hydroxychloroquine sulfate tablets do not prevent relapses of P. vivaxor P. ovale because it is not active againstthe hypnozoite forms of these parasites. Forradical cure of P. vivaxand P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology ). Prior to prescribing hydroxychloroquine sulfate tablets 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 tablets are indicated for the treatment of chronic discoid Lupus erythematosus and systemic Lupus erythematosus in adults. Rheumatoid Arthritis Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic Rheumatoid Arthritis in adults.
Ipca Laboratories Limited
HOW SUPPLIED Hydroxychloroquine sulfate tablets, USP are white to off white, capsule-shaped, film coated debossed with "HCQS" on one side and plain on the reverse side and are available in bottles of 10, 100, 500 and 1000. Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). NDC 63304-296-03 Bottles of 10 NDC 63304-296-01 Bottles of 100 NDC 63304-296-05 Bottles of 500 NDC 63304-296-10 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20Â° - 25Â°C (68Â° - 77Â°F) excursions permitted to 15Â° - 30Â°C (59Â° - 86Â°F) [See USP Controlled Room Temperature].
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