HYDROXYCHLOROQUINE SULFATE- hydroxychloroquine sulfate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar RxLLC

INN (International Name):

HYDROXYCHLOROQUINE SULFATE

Composition:

HYDROXYCHLOROQUINE SULFATE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. 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.

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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