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PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Plaquenil (Hydroxychloroquine Sulfate) is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1).

The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26ClN3O x H2SO4.

Plaquenil (Hydroxychloroquine Sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration.

Inactive Ingredients: Dibasic calcium phosphate USP, hypromellose USP, magnesium stearate NF, polyethylene glycol 400 NF, polysorbate 80 NF, corn starch, titanium dioxide USP, carnauba wax NF, shellac NF, black iron oxide NF.


CLINICAL PHARMACOLOGY

Plaquenil clinical pharmacology


PHARMACOKINETICS

Plaquenil pharmacokinetics


INDICATIONS AND USAGE

Plaquenil indications and usage


CONTRAINDICATIONS

Use of Hydroxychloroquine (Plaquenil) tablets is contraindicated in patients with known hypersensitivity to 4aminoquinoline compounds.


WARNINGS

Plaquenil warnings


SPECIAL WARNINGS

Plaquenil special warnings


PRECAUTIONS

Plaquenil precautions


DRUG INTERACTIONS

Plaquenil drug interactions


INFORMATION FOR PATIENTS

Patients should be informed of the early signs and symptoms of toxicity such as rash or visual changes. Patients must see their physicians promptly in case of the appearance of these or of any unusual effects. Periodic laboratory tests may be recommended in some patients. Patients should be fully informed of the potential risks of the use of Plaquenil (Hydroxychloroquine) tablets, especially in pregnancy and in children.


TOXICOLOGY

Plaquenil toxicology


NONCLINICAL TOXICOLOGY

Carcinogenesis, mutagenesis, impairment of fertility

Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of Plaquenil.

The mutagenic potential of hydroxychloroquine was not evaluated. However, chloroquine has been shown to be a catalytic inhibitor of DNA repair enzymes (topoisomerase II) and to produce weak genotoxic effects through this mode of action.


USE IN SPECIFIC POPULATIONS

Plaquenil use in specific populations


ADVERSE REACTIONS

Plaquenil adverse reactions


OVERDOSAGE

Plaquenil overdosage


DOSAGE AND ADMINISTRATION

Plaquenil dosage and administration


HOW SUPPLIED

Plaquenil (Hydroxychloroquine) 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.

Do not crush or divide Plaquenil film-coated tablets.

Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.

Storage

Store at room temperature [20° to 25°C (68° to 77°F), allows excursions between 15° and 30°C (59° and 86°F)].

Manufactured and distributed by Concordia Pharmaceuticals, Sanofi-Aventis pharmaceutical companies and their divisions.

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