Hydroxychloroquine Sulfate 200 MG Oral Tablet
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate tablets are an antiMalarial and antirheumatic indicated for the: Treatment of uncomplicated Malaria due to Plasmodium falciparum, Plasmodium Malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of Malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of Rheumatoid Arthritis in adults. ( 1.2 ) Treatment of systemic Lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid Lupus erythematosus in adults. ( 1.4 ) Limitations of Use (1.1): Hydroxychloroquine sulfate tablets are not recommended for the: Treatment of complicated Malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of Malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of Malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary. 1.1 Malaria Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the: Treatment of uncomplicated Malaria due to Plasmodium falciparum, Plasmodium Malariae, Plasmodium vivax, and Plasmodium ovale. Prophylaxis of Malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use: Hydroxychloroquine sulfate tablets are not recommended for: Treatment of complicated Malaria. Treatment of Malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4) ]. Treatment of Malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of Malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4) ]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1 . 1.2 Rheumatoid Arthritis Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic Rheumatoid Arthritis in adults. 1.3 Systemic Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic Lupus erythematosus in adults. 1.4 Chronic Discoid Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid Lupus erythematosus in adults.
amneal pharmaceuticals ny llc
CAPSULE WHITE AC54
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hydroxychloroquine sulfate tablet film coated
amneal pharmaceuticals ny llc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
HYDROXYCHLOROQUINE SULFATE Tablets USP, 200 mg are supplied as white to off-white, film-coated tablets debossed “AC54” on one side and plain on the other side. Each tablet contains 200 mg of
HYDROXYCHLOROQUINE SULFATE, USP equivalent to 155 mg base. They are available as: Bottles of 100: NDC 69238-1544-1 Bottles of 500: NDC 69238-1544-5 16.2 Storage Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature]. Keep out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP. Do not crush or divide
HYDROXYCHLOROQUINE SULFATE film-coated tablets.
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