Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Accord Healthcare, Inc.,
ORAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate is 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 is 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 ch
100 mg: Hydroxychloroquine sulfate tablets, USP 100 mg are white to off white, peanut shaped, biconvex, film coated tablets, debossed with “H2” on one side and plain on the other side. Bottles of 100 tablets with a child-resistant closure (NDC16729-561-01). 200 mg: Hydroxychloroquine sulfate tablets, USP 200 mg are white to off white, peanut shaped, biconvex, film coated tablet debossed with"H11" on one side and plain on the other side. Bottles of 100 tablets with a child-resistant closure (NDC 16729-485-01). Bottles of 500 tablets (NDC 16729-485-16). 300 mg: Hydroxychloroquine sulfate tablets, USP 300 mg are white to off white, peanut shaped, biconvex, film coated tablets, debossed with “H3” on one side and plain on the other side. Bottles of 100 tablets with a child-resistant closure (NDC16729-562-01). 400 mg: Hydroxychloroquine sulfate tablets, USP 400 mg are white to off white, peanut shaped, biconvex, film coated tablets, debossed with “H” and “4” on either side of break-line on one side and break-line on the other side. Bottles of 100 tablets with a child-resistant closure (NDC16729-563-01). Bottles of 500 tablets (NDC16729-563-16). Dispense in a tight, light-resistant container as defined in the USP/NF. Store at room temperature up to 30°C (86°F) and allow for excursions between 15°C and 30°C(59°F and 86°F).
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET ACCORD HEALTHCARE, INC., ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE HYDROXYCHLOROQUINE SULFATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYDROXYCHLOROQUINE SULFATE TABLETS. HYDROXYCHLOROQUINE SULFATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1955 INDICATIONS AND USAGE Hydroxychloroquine sulfate is 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 is 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. DOSAGE AND ADMINISTRATION Malaria in Adult and Pediatric Patients ( 2.2): Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: Adults: 400 mg once a week Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week Прочетете целия документ