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PENNSAID

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PENNSAID

INDICATIONS

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of the pain of osteoarthritis of the knee(s).

DOSAGE AND ADMINISTRATION

General Instructions

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.

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.

Apply PENNSAID to clean, dry skin.

Application of PENNSAID in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

Special Precautions

  • 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.
  • 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.
  • PENNSAID was not evaluated under the conditions of heat application, occlusive dressings overlay, or exercise; therefore, concurrent use of PENNSAID under these conditions is not recommended.
  • 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.
  • Do not use combination therapy with PENNSAID and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

HOW SUPPLIED

Dosage Forms And Strengths

2% w/w topical solution

Storage And Handling

PENNSAID 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 # 23635-510-12

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Distributed by: Mallinckrodt Brand Pharmaceuticals, Inc. Hazelwood, MO 63042 USA. Manufactured by: Nuvo Manufacturing Varennes, Quebec, J3X 1P7 Canada. Issued: 2014

Last reviewed on RxList: 1/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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