Drug Name:
ALDARA Rx

Generic Name and Formulations:
Imiquimod 5%; crm.
Company:
Bausch Health Companies Inc.
Therapeutic Use:
Indications for ALDARA:
Actinic keratoses on face or scalp. Superficial basal cell carcinoma when surgery is impractical (see literature).
Adult:
≥18yrs: Keratoses: apply to affected area ≤25cm2 on face or scalp (not both) and rub in before bedtime 2 times per week; max 16 weeks. Caution with repeated treatments. Basal cell carcinoma: apply to biopsy-confirmed area (see literature) ≤2cm and rub in before bedtime 5 times per week; max 6 weeks. Both: wash off with soap and water 8 hours later.
Children:
<18yrs: not recommended.
Warnings/Precautions:
Immunosuppressed. Not for use in treating urethral, intravaginal, cervical, rectal, or intra-anal warts. Not for use on unhealed lesions due to other therapies (drug or surgical). Do not occlude. Avoid eyes, lips, nostrils, sun or UV light exposure. May exacerbate inflammatory skin conditions. May suspend for several days if irritation occurs. Pregnancy (Cat.C). Nursing mothers.
Pharmacological Class:
Immune response modifier.
Adverse Reactions:
Local and remote reactions (eg, erythema, erosion, flaking, scabbing, edema, itching, burning, soreness), headache, flu-like symptoms, myalgia, hypo- or hyperpigmentation, hyperkeratosis.
How Supplied:
Single-use packets—12, 24
Indications for ALDARA:
External genital warts. Perianal warts.
Adult:
Apply thin layer to warts and rub in before bedtime 3 times per week; wash off with soap and water 6–10 hours later; max 16 weeks. Avoid sexual contact while cream is on skin.
Children:
Not recommended.
Warnings/Precautions:
Immunosuppressed. Not for use in treating urethral, intravaginal, cervical, rectal, or intra-anal warts. Not for use on unhealed lesions due to other therapies (drug or surgical). Do not occlude. Avoid eyes, lips, nostrils, sun or UV light exposure. May exacerbate inflammatory skin conditions. May suspend for several days if irritation occurs. Pregnancy (Cat.C). Nursing mothers.
Pharmacological Class:
Immune response modifier.
Interactions:
Concomitant use of diaphragms or condoms: not recommended.
Adverse Reactions:
Local and remote reactions (eg, erythema, erosion, excoriation, edema, itching, burning, soreness), headache, flu-like symptoms, myalgia, hypo- or hyperpigmentation.
How Supplied:
Single-use packets—12, 24
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