HYDROXYCHLOROQUINE SULFATE - hydroxychloroquine sulfate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydroxychloroquine Sulfate (UNII: 8Q2869CNVH) (Hydroxychloroquine - UNII:4QWG6N8QKH)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

Hydroxychloroquine Sulfate

Composition:

Hydroxychloroquine Sulfate 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Hydroxychloroquine Sulfate Tablets USP, 200 mg are white to off-white, coated, oval tablets marked WATSON on one side and a partial score on the reverse side with 698 on one side of the score and 200 on the other side of the score supplied as follows; Bottles of 100 NDC 42291-320-01 Bottles of 180 NDC 42291-320-18 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined by the USP. Certain manufacturing operations may have been performed by other firms. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07/11         AV Rev. 12/12 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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)
(salt). It has the following structural formula:
C H CLN O•H SO
MOLECULAR WEIG HT: 4 33.96
Each tablet, for oral administration, contains 200 mg of
hydroxychloroquine sulfate. In addition, each
tablet contains the following inactive ingredients: colloidal silicon
dioxide, dextrates, hypromellose,
magnesium stearate, maltodextrin, microcrystalline cellulose,
polydextrose, polyethylene glycol,
sodium starch glycolate, starch (corn), titanium dioxide, and
triacetin.
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 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
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.
18
26
3
2
4
WARNINGS
_GENERAL _- Hydroxychloroquine sulfate is not effective against
chloroquine-resistant strains of _P._
_falciparum._
Children are especially sensitive to the 4-aminoquinoline c