HYDROXYCHLOROQUINE SULFATE tablet

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Sun Pharmaceutical Industries, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the: Limitations of Use: Hydroxychloroquine sulfate tablets are 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 tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults. Hydroxychloroquine sulfate tablets are 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 tablets during pregnancy. Encourage patients to register by contacting 1-877-311-8972.

Sommarju tal-prodott:

Hydroxychloroquine sulfate tablets, USP contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg  base). Hydroxychloroquine sulfate tablets are white, to off-white, circular biconvex film coated tablets debossed with “347” on one side. The tablets are available in: Dispense in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [See USP for Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, 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 antimalarial and antirheumatic
indicated for the:
•
•
•
•
•
Limitations of Use (1.1):
Hydroxychloroquine sulfate tablets are NOT recommended for the:
•
•
•
•
•
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 mg/kg up to 400 mg, once a week
• Treatment of Uncomplicated Malaria: See Full Prescribing
Information (FPI) for complete dosing
information.
Rheumatoid Arthritis in Adults (2.3):
• Initial dosage: 400 mg to 600 mg daily
• Chronic dosage: 200 mg once daily or 400 mg once daily (or in two
divided doses)
Systemic Lupus Erythematosus in Adults (2.4):
• 200 mg once daily or 400 mg once daily (or in two divided doses)
Chronic Discoid Lupus Erythematosus in Adults (2.5):
• 200 mg once daily or 400 mg once daily (or in two divided doses)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg of hydroxychloroquine sulfate (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
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