HYDROXYCHLOROQUINE SULFATE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Sandoz Inc

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Hydroxychloroquine sulfate is indicated in adult and pediatric patients for the: Limitations of Use Hydroxychloroquine sulfate 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 is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate 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 clinical experience over decades of use a

Огляд продуктів:

Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, Off White, Standard Cup Tablet Core, Debossed GG 260 on One Side and Plain on the Reverse Side, Film Coated White NDC 0781-5994-01 bottles of 100 NDC 0781-5994-05 bottles of 500 Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
SANDOZ INC
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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
RECENT MAJOR CHANGES
Warnings and Precautions,
Risks Associated with Use in Porphyria (5.5)
---------------------------- 07/2023
INDICATIONS AND USAGE
Hydroxychloroquine sulfate is an antimalarial and antirheumatic
indicated for the:
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Limitations of Use (1.1):
Hydroxychloroquine sulfate is NOT recommended for the:
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DOSAGE AND ADMINISTRATION
Malaria in Adult and Pediatric Patients (2.2):
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Rheumatoid Arthritis in Adults (2.3):
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Systemic Lupus Erythematosus in Adults (2.4):
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Chronic Discoid Lupus Erythematosus in Adults (2.5):
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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)
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-ami