HYDROXYCHLOROQUINE SULFATE - hydroxychloroquine sulfate tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Physicians Total Care, Inc.

Designación común internacional (DCI):

HYDROXYCHLOROQUINE SULFATE

Composición:

HYDROXYCHLOROQUINE 200 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

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 10, 100, 500 and 1000. 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° - 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
----------
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.
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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 child