hydroxychloroquine sulfate tablet film coated
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.
sandoz inc
ROUND WHITE GG 260
GG 260 ROUND WHITE
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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: NDC 0781-1407-97 bottles of 100 NDC 0781-1407-52 bottles of 500 NDC 0781-1407-88 bottles of 1000 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.
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