HYDROXYCHLOROQUINE SULFATE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

hydroxychloroquine sulfate (UNII: 8Q2869CNVH) (hydroxychloroquine - UNII:4QWG6N8QKH)

Tilgjengelig fra:

Rising Pharma Holdings, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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-

Produkt oppsummering:

Hydroxychloroquine sulfate tablets, USP contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of base). White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘L7’ on one side and plain on the other side. Bottles of 100: NDC 16571-687-01  Bottles of 500: NDC 16571-687-50 Dispense in a tight, light-resistant container as defined in the USP/NF.  Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
RISING PHARMA HOLDINGS, 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 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.
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 wee