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Picato Generic Name & Formulations
Legal Class
Rx
General Description
Ingenol mebutate 0.015%, 0.05%; topical gel.
Pharmacological Class
Cell death inducer.
How Supplied
Single-use tubes 0.015%—3; 0.05%—2
Manufacturer
Picato Indications
Indications
Topical treatment of actinic keratosis.
Picato Dosage and Administration
Adult
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.
Children
<18yrs: not established.
Picato Contraindications
Not Applicable
Picato Boxed Warnings
Not Applicable
Picato Warnings/Precautions
Warnings/Precautions
Avoid in 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. Severe skin reactions. Do not use until skin is healed from previous drug or surgical treatment. Monitor for skin cancer in those with risk factors. Pregnancy. Nursing mothers: avoid accidental transfer to infants.
Picato Pharmacokinetics
See Literature
Picato Interactions
Not Applicable
Picato Adverse Reactions
Adverse Reactions
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, non-melanoma skin cancer.
Picato Clinical Trials
See Literature
Picato Note
Not Applicable
Picato Patient Counseling
See Literature
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