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ZYCLARA
Actinic keratoses
Warts
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Drug Name:

ZYCLARA Rx

Generic Name and Formulations:
Imiquimod 3.75%; topical cream; contains parabens.

Company:
Medicis Pharmaceuticals Corp

Therapeutic Use:

Indications for ZYCLARA:

Actinic keratoses on face and balding scalp in immunocompetent patients.

Adult:

≥18yrs: Apply thin film to affected area (face or balding scalp) and rub in once daily at bedtime; leave on for 8 hours, wash off with mild soap and water. Treat for two 2-week cycles separated by a 2-week no-treatment cycle. Max two packets per application and one treatment course per area. Apply to intact skin only; Interrupt if severe reaction occurs; do not extend treatment cycle due to missed doses or rest periods. Wash hands before/after application.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Immunosuppressed. Autoimmune conditions. Not for treating urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease, xeroderma pigmentosum, superficial basal cell carcinoma. Sun sensitivity. Avoid eyes, lips, nose, mouth, mucous membranes, sun or UV light (use sunscreen daily). Do not occlude. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Avoid concomitant other forms of imiquimod.

Pharmacological Class:

Immune response modifier.

Adverse Reactions:

Local inflammation (eg, erythema, crusting, erosion, weeping, edema), pruritus, flaking, scaling, dryness, flu-like symptoms (eg, headache, fatigue, nausea, fever, chills, myalgia), transient increase in lesion counts; exacerbation of skin inflammatory conditions (eg, graft vs. host disease), chest pain, lymphadenopathy, hypo- or hyperpigmentation.

How Supplied:

Single-use packets—28

Indications for ZYCLARA:

External genital warts. Perianal warts.

Adult:

Apply thin layer to warts and rub in once daily prior to bedtime; leave on for 8 hours. Wash off with mild soap and water. Continue until total clearance or for up to 8 weeks. Max one packet per application to treatment area. Interrupt if local skin reaction occurs; resume after several days or once the reaction subsides. Wash hands before/after application.

Children:

Not recommended.

Warnings/Precautions:

Immunosuppressed. Autoimmune conditions. Not for treating urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease, xeroderma pigmentosum, superficial basal cell carcinoma. Sun sensitivity. Avoid eyes, lips, nose, mouth, mucous membranes, sun or UV light (use sunscreen daily). Do not occlude. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Avoid concomitant other forms of imiquimod.

Pharmacological Class:

Immune response modifier.

Adverse Reactions:

Local inflammation (eg, erythema, crusting, erosion, weeping, edema), pruritus, flaking, scaling, dryness, flu-like symptoms (eg, headache, fatigue, nausea, fever, chills, myalgia), transient increase in lesion counts; exacerbation of skin inflammatory conditions (eg, graft vs. host disease), chest pain, lymphadenopathy, hypo- or hyperpigmentation.

How Supplied:

Single-use packets—28

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