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ALDARA CREAM (IMIQUIMOD): PRESCRIBING INFORMATION
Aldara (Imiquimod) Cream 5% is an immune response modifier for topical administration. Each gram contains 50 mg of Imiquimod in an off-white oil-in-water vanishing cream base consisting of cetyl alcohol, isostearic acid, stearyl alcohol, polysorbate 60, white petrolatum, sorbitan monostearate, xanthan gum, glycerin, purified water, methylparaben, benzyl alcohol, and propylparaben.
Chemically, imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C14H16N4 and a molecular weight of 240.3.
INDICATIONS AND USAGE
Aldara cream indications and usage
DOSAGE AND ADMINISTRATION
Aldara cream dosage and administration
DOSAGE FORMS AND STRENGTHS
Aldara (Imiquimod) cream is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Aldara (Imiquimod) topical cream is supplied in a box of 24 packets each.
WARNINGS AND PRECAUTIONS
Aldara cream warnings and precautions
Aldara cream adverse reactions
USE IN SPECIFIC POPULATIONS
Aldara cream use in specific populations
Topical overdosing of Imiquimod (Aldara) cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions.
The most clinically serious adverse event reported following multiple oral imiquimod doses of > 200 mg (equivalent to imiquimod content of > 16 packets) was hypotension, which resolved following oral or intravenous fluid administration.
Aldara cream clinical pharmacology
Aldara cream nonclinical toxicology
Aldara cream clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Imiquimod (Aldara) topical cream 5%, is supplied in single-use packets which contain 250 mg of the cream. Available as: box of 24 packets. Store at 4-25°C (39-77°F).
Keep out of reach of children.
Manufactured by 3M Health Care
Distributed by Graceway Pharmaceuticals
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