HYDROXYCHLOROQUINE SULFATE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

HYDROXYCHLOROQUINE SULFATE

Samenstelling:

HYDROXYCHLOROQUINE SULFATE 200 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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-aminoquino

Product samenvatting:

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 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
MYLAN PHARMACEUTICALS 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 week
- Pediatric patients ≥ 31 kg: 6.5 m