February 11, 2016
Recommended Topic Related To:

Picato

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Picato




Indications
Dosage
How Supplied

INDICATIONS

Picato® gel is indicated for the topical treatment of actinic keratosis.

DOSAGE AND ADMINISTRATION

For topical use only; Picato® gel is not for oral, ophthalmic, or intravaginal use.

Avoid transfer of Picato® gel to periocular area [see WARNINGS AND PRECAUTIONS].

Avoid application near and around the mouth and lips.

For the treatment of actinic keratosis on the face or scalp Picato® gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.

For the treatment of actinic keratosis on the trunk or extremities Picato® gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.

Picato® gel may be applied to the affected area, up to one contiguous skin area of approximately 25 cm² (e.g., 5 cm x 5 cm) using one unit dose tube. After spreading evenly over the treatment area, the gel should be allowed to dry for 15 minutes. Patients should wash their hands immediately after applying Picato® gel and take care not to transfer the applied drug to other areas, including the eye. Patients should avoid washing and touching the treated area for a period of 6 hours after application of Picato® gel. Following this time, patients may wash the area with a mild soap.

HOW SUPPLIED

Dosage Forms And Strengths

Gel, 0.015% or 0.05%, in a clear colorless gel base.

Storage And Handling

Picato® gel is a clear colorless gel and is supplied in unit dose laminate tubes containing a nominal fill weight of 0.47 g, with a deliverable weight of 0.25 g. The tubes should be discarded after single use.

Picato® gel is available in 2 dosage strengths: 0.015% and 0.05%.

Dosage Strength Number of unit dose tubes per carton NDC#
0.015 % 3 50222-502-47
0.05 % 2 50222-503-47

Store Picato® gel in a refrigerator at 36°F – 46°F (2°C – 8°C); excursions permitted between 32°F – 59°F (0°C – 15°C) (see USP for controlled cold temperature). Protect from freezing.

Manufactured by: LEO Laboratories Ltd. (LEO Pharma), 285 Cashel Road, Dublin 12, Ireland or DPT Laboratories, Ltd., 307 E. Josephine Street, San Antonio, TX 78215, USA Distributed by: LEO Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054, USA. For more information call 1-877-494-4536. Revised: October 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/15/2015

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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