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PENNSAID is indicated for the treatment of the pain of osteoarthritis of the knee(s).
DOSAGE AND ADMINISTRATION
General Dosing Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day.
Apply PENNSAID to clean, dry skin.
The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required.
After the priming procedure, PENNSAID is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee.
Application of PENNSAID in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
- Avoid showering/bathing for at least 30 minutes after the application of PENNSAID to the treated knee.
- Wash and dry hands after use.
- Do not apply PENNSAID to open wounds.
- Avoid contact of PENNSAID with eyes and mucous membranes.
- Do not apply external heat and/or occlusive dressings to treated knees.
- Avoid wearing clothing over the PENNSAID-treated knee(s) until the treated knee is dry.
- Protect the treated knee(s) from natural and artificial sunlight.
- Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with PENNSAID.
- Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
- Do not use combination therapy with PENNSAID and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
Dosage Forms And Strengths
PENNSAID (diclofenac sodium) topical solution: 2% w/w
Storage And Handling
PENNSAID (diclofenac sodium) topical solution 2% w/w, is supplied as a clear, colorless to faintly pink or orange solution containing 20 mg of diclofenac sodium per gram of solution, in a white polypropylene-dose pump bottle with a clear cap. Each pump actuation delivers 20 mg of diclofenac sodium in 1 gram of solution.
NDC Number & Size
112 g bottle ........... NDC # 75987-040-05
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Distributed by: Horizon Pharma USA Inc. Lake Forest, IL 60045. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2016
Additional PENNSAID Information
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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