Generic Name and Formulations:
Ingenol mebutate 0.015%, 0.05%; topical gel.
LEO Pharma Inc.
Indications for PICATO:
Topical treatment of actinic keratosis.
For topical use only; not for oral, ophthalmic, or intravaginal use. Face or scalp: apply 0.015% gel to the affected area once daily for 3 consecutive days. Trunk or extremities: apply 0.05% gel to the affected area once daily for 2 consecutive days. Limit application to one contiguous skin area of approximately 25cm2 using one unit dose tube. Allow treated area to dry for 15 minutes after application. Wash hands immediately after application; avoid inadvertent transfer of drug to other areas (eg, eyes). Avoid washing and touching treated area for 6 hours after application; following this time, may wash with mild soap.
<18yrs: not established.
Avoid treatment in the periocular area, near mouth or lips. Eye disorders (eg, severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema) can occur after exposure. Discontinue if significant hypersensitivity reactions occur. Administration not recommended until skin is healed from previous drug or surgical treatment. Severe skin reactions. Pregnancy (Cat.C). Nursing mothers.
Cell death inducer.
Local skin reactions (eg, erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration), application site pain/pruritus/irritation/infection, periorbital edema, nasopharyngitis, headache; hypersensitivity reactions.
Single-use tubes 0.015%—3; 0.05%—2
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