Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Rebel Distributors Corp
ORAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate tablets, USP are 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 . Hydroxychloroquine sulfate tablets, USP are 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 are white, to off-white, capsule-shaped tablets, debossed with "HCQS" on one side and plain on the reverse side and are available in bottles of 30. Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). NDC 21695-486-30 Bottles of 30 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° - 25°C (68° - 77°F) excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects at 1-800-FDA-1088.
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED REBEL DISTRIBUTORS CORP ---------- HYDROXYCHLOROQUINE SULFATE TABLETS, USP RX ONLY *(Each tablet contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg of base) WARNING PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HYDROXYCHLOROQUINE SULFATE TABLETS, USP. DESCRIPTION Hydroxychloroquine sulfate, USP 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, USP has the following structural formula: Molecular Formula: C H ClN O.H SO Molecular Weight of 433.95 Each tablet, for oral administration, contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). In addition, each tablet contains the following Inactive Ingredients: colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized starch, talc, and titanium dioxide. CLINICAL PHARMACOLOGY 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 AND USAGE Hydroxychloroquine sulfate tablets, USP are 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_. Hydroxychloroquine sulfate tablets, USP are also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. 18 26 3 2 4 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. Läs hela dokumentet