HYDROXYCHLOROQUINE SULFATE- hydroxychloroquine sulfate tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

DIRECT RX

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

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.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

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