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.
Mylan Pharmaceuticals Inc.
ROUND WHITE M 373
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hydroxychloroquine Sulfate Tablets, USP are available containing 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg of base. The 200 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 373 on the other side. They are available as follows: NDC 0378-0373-01 bottles of 100 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Keep out of the reach of children.
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