HYDROXYCHLOROQUINE SULFATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aphena Pharma Solutions - Tennessee, LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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-aminoquinoline drug

Ürün özeti:

Hydroxychloroquine Sulfate Tablets, USP are white to off-white, capsule shaped film-coated tablets debossed with “A1” on one side and plain on the other side. Each film-coated tablet contains Hydroxychloroquine Sulfate, USP 100 mg (equivalent to 77.5 mg base). Bottles of 100 tablets NDC: 43598-133-01 Bottles of 500 tablets NDC: 43598-133-05 Hydroxychloroquine Sulfate Tablets, USP are white to off-white capsule shaped film-coated tablets debossed with “AC 384” on one side and plain on the other side. Each film-coated tablet contains 200 mg Hydroxychloroquine Sulfate, USP 300 mg (equivalent to 155 mg base). Bottles of 100 tablets NDC: 43598-721-01 Bottles of 500 tablets NDC: 43598-721-05 Hydroxychloroquine Sulfate Tablets, USP are yellow to pale yellow colored, capsule shaped, film-coated tablets debossed with “A3” on one side and plain on the other side. Each film-coated tablet contains Hydroxychloroquine Sulfate, USP 300 mg (equivalent to 232.5 mg base). Bottles of 100 tablets NDC: 43598-132-01 Bottles of 500 tablets NDC: 43598-132-05 Hydroxychloroquine Sulfate Tablets, USP are white to off-white, capsule shaped, film-coated tablets debossed with “A4” on one side and plain on the other side. Each film-coated tablet contains Hydroxychloroquine Sulfate, USP 400 mg (equivalent to 310 mg base). Bottles of 100 tablets NDC: 43598-131-01 Bottles of 500 tablets NDC: 43598-131-05    Dispense in a tight, light-resistant container as defined in the USP/NF.  Store at room temperature [20° to 25°C (68° to 77°F), allows excursions between 15° and 30°C (59° and 86°F)].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 Tablets are 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):
Hydroxychloroquine Sulfate Tablets are 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 doses for 4 weeks
after leaving the endemic area:
Adults: 400 mg once a week
Pediatric patients ≥ 31