PLAQUENIL- 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:

PLAQUENIL 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:

PLAQUENIL tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Bottles of 100 tablets (NDC 24987-562-10 & 24987-562-20). Dispense in a tight, light-resistant container as defined in the USP/NF. Store at room temperature up to 30° C (86° F). Distributed by Covis Pharmaceuticals, Inc. Cary, NC 27511 Revised May 2013 ©2013 Covis Pharmaceuticals Inc. All rights reserved.

Authorization status:

New Drug Application

Summary of Product characteristics

PLAQUENIL- HYDROXYCHLOROQUINE SULFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
PLAQUENIL®
HYDROXYCHLOROQUINE SULFATE, USP
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).
PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg
hydroxychloroquine sulfate,
equivalent to 155 mg base, and are for oral administration.
_Inactive Ingredients:_ Dibasic Calcium Phosphate, Hydroxypropyl
Methylcellulose, Magnesium Stearate,
Polyethylene glycol 400, Polysorbate 80, Corn Starch, 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
PLAQUENIL 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
PLAQUENIL is not effective against chloroquine-resistant strains of
_P. falciparum_.
BEFORE STARTING A LONG-TERM TREATMENT, BOTH EYES SHOULD BE CAREFULLY
EXAMINED FOR VISUAL ACUITY,
CENTRAL VISUAL FIELD AND COLOR VISION. EXAMINATION SHOULD ALSO INCLUDE
FUNDOSCOPY. THESE
EXAMINATIONS SHOULD BE REPEATED AT LEAST ANNUALLY. RETINAL TOXICITY IS
LARGELY DOSE-RELATED.
The risk of retinal damage is s