HYDROXYCHLOROQUINE SULFATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)

Disponible des:

Accord Healthcare, Inc.,

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET
ACCORD HEALTHCARE, INC.,
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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