Aldara

Brand name:Aldara
Generic name: Imiquimod

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DESCRIPTION

For Dermatologic Use Only -Not for Ophthalmic Use.

AldaraTM is the brand name for imiquimod which is an immune response modifier. Each gram of the 5% cream contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben. Chemically, imiquimod is 1-(2-methylpropyl)-1 H-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C14H16N4,and a molecular weight of 240.3.

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INDICATIONS

Imiquimod 5% cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.

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What side effects may occur?

In controlled clinical trials, the most frequently reported adverse reactions were those of local skin and application site reactions; some patients also reported systemic reactions. These reactions were usually mild to moderate in intensity; however, severe reactions were reported with 3X/week application. These reactions were more frequent and more intense with daily application than with 3X/week application. Overall, in the 3X/week application clinical studies, 1.2% (4/327) of the patients discontinued due to local skin/application site reactions.The incidence and severity of local skin reactions during controlled clinical trials are shown in the following table.

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WARNINGS

Aldara cream has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and is not recommended for these conditions.

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PRECAUTIONS

General

Local skin reactions such as erythema, erosion, excoriation/flaking, and edema are common. Should severe local skin reaction occur, the cream should be removed by washing the treatment area with mild soap and water. Treatment with Aldara cream can be resumed after the skin reaction has subsided. There is no clinical experience with Aldara cream therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs; therefore, Aldara cream administration is not recommended until genital/perianal tissue is healed from any previous drug or surgical treatment. Imiquimod has the potential to exacerbate inflammatory conditions of the skin.

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PATIENT INFORMATION

Patients using Aldara 5% cream should receive the following information and instructions: The effect of Aldara 5% cream on the transmission of genital/ perianal warts is unknown. Aldara 5% cream may weaken condoms and vaginal diaphragms. Therefore, concurrent use is not recommended.

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OVERDOSE

Overdosage of Aldara 5% cream in humans is unlikely due to minimal percutaneous absorption. Animal studies reveal a rabbit dermal lethal imiquimod dose of greater than 1600 mg/m2. Persistent topical overdosing of Aldara 5% cream could result in severe local skin reactions. The most clinically serious adverse event reported following multiple oral imiquimod doses of >200 mg was hypotension which resolved following oral or intravenous fluid administration.

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