Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
DIRECT RX
ORAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate tablets 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. 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 contain 200 mg of hydroxychloroquine sulfate, equivalent to 155 mg base, are 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: NDC 68382-096-01 in bottles of 100 tablets NDC 68382-096-05 in bottles of 500 tablets NDC 68382-096-30 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets 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.
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED DIRECT RX ---------- HYDROXYCHLOROQUINE SULFATE BOXED WARNING SECTION WARNING PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING HYDROXYCHLOROQUINE. DESCRIPTION SECTION Hydroxychloroquine sulfate is an odorless, white or practically white crystalline powder, freely soluble in water; practically insoluble in alcohol, in chloroform, and in ether. Chemically the drug is 2- [[4-[(7-Chloro-4-quinolyl) amino] pentyl] ethylamino] ethanol sulfate (1:1). Each hydroxychloroquine sulfate tablet intended for oral administration contains 200 mg of hydroxychloroquine sulfate equivalent to 155 mg base. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, starch, talc and titanium dioxide. CLINICAL PHARMACOLOGY SECTION 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 & USAGE SECTION Hydroxychloroquine sulfate tablets 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. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. CONTRAINDICATIONS SECTION 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 SECTION General Hydroxychloroquine sulfate tablets are not effective against chloroquine-resistant strains of P. falciparum. Children are especially sensitive to the 4-aminoquinoline compounds. A number Baca dokumen lengkapnya