HYDROXYCHLOROQUINE SULFATE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Preferred Pharmaceuticals, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Hydroxychloroquine sulfate tablet in indicated in adult and pediatric patients for the: Limitations of Use: Hydroxychloroquine sulfate tablet is not recommended for: For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1 . Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults. Hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clin

Ringkasan produk:

Hydroxychloroquine sulfate Tablets, USP contain 200 mg of hydroxychloroquine sulfate, USP (equivalent to 155 mg base). White to off-white, capsule-shaped, biconvex, film-coated tablets debossed with "ZC38" on one side and plain on other side, and are supplied as follows: 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/NF. Keep out of the reach of children.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
PREFERRED 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.
HYDROXYCHLOROQUIN SULFATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets is an antimalarial and
antirheumatic indicated for the:
•
•
•
•
•
LIMITATIONS OF USE (1.1):
Hydroxychloroquine sulfate Tablets 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):
•
$$Unorderedlist
- Adults: 400 mg once a week
- Pediatric patients ≥ 31 kg: 6.5 mg/kg up to
400 mg, once a week
•
•
RHEUMATOID ARTHRITIS IN ADULTS (2.3):
•
•
SYSTEMIC LUPUS ERYTHEMATOSUS IN ADULTS (2.4):
•
CHRONIC DISCOID LUPUS ERYTHEMATOSUS IN ADULTS (2.5):
•
DOSAGE FORMS AND STRENGTHS
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)
Treatm