国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Northstar RxLLC
HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE 200 mg
ORAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate is indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae , P. ovale , and susceptible strains of P. falciparum . It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.
Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, off white tablets, scored and debossed GG 260 on one side and plain on the reverse side, film coated white and supplied as: NDC 16714-474-01 bottles of 100 Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED NORTHSTAR RXLLC ---------- HYDROXYCHLOROQUINE SULFATE TABLETS, USP RX ONLY WARNING PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HYDROXYCHLOROQUINE. DESCRIPTION Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl) amino] pentyl] ethylamino] ethanol sulfate (1:1). Hydroxychloroquine sulfate has the following structural formula: Each tablet for oral administration contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg hydroxychloroquine). Inactive ingredients: Dibasic calcium phosphate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, sodium bicarbonate, and titanium dioxide. ACTIONS The drug possesses antimalarial actions and also exerts a beneficial effect in lupus erythematosus (chronic discoid or systemic) and acute or chronic rheumatoid arthritis. The precise mechanism of action is not known. INDICATIONS Hydroxychloroquine sulfate is indicated for the suppressive treatment and treatment of acute attacks of malaria due to _Plasmodium vivax, P. malariae, P. ovale,_ and susceptible strains of _P. falciparum_. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. CONTRAINDICATIONS Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children. WARNINGS GENERAL Hydroxychloroquine sulfate is not effective against chloroquine-resistant strains of _P. falciparum_. Children are especially sensitive to the 4-aminoquinoline compounds. A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 g or 阅读完整的文件