HYDROXYCHLOROQUINE SULFATE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

ANI Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Hydroxychloroquine Sulfate Tablets 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 Tablets 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 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 i

Produkt oversigt:

Hydroxychloroquine Sulfate Tablets are available in the following strengths and packing configurations: Bottles of 30 tablets with child resistant closure (NDC 70954-172-10) Bottles of 100 tablets with child resistant closure (NDC 70954-172-20)               Bottles of 100 tablets with child resistant closure (NDC 70954-171-10) Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children. Store at room temperature between 20°C and 25°C (68°F and 77°F), allow excursions between 15°C and 30°C (59°F and 86°F).

Autorisation status:

New Drug Application

Produktets egenskaber

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
ANI 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
RECENT MAJOR CHANGES
Warnings and Precautions, Risks Associated with Use in Porphyria (5.5)
05/2023
INDICATIONS AND USAGE
Hydroxychloroquine Sulfate Tablets is an antimalarial and
antirheumatic indicated for the: (1)
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): (1)
Hydroxychloroquine Sulfate Tablets is NOT recommended for the: (1)
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): (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 d