PENNSAID (diclofenac sodium topical solution) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

General Instructions

For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.

Apply PENNSAID (diclofenac sodium topical solution) to clean, dry skin.

To avoid spillage, dispense PENNSAID (diclofenac sodium topical solution) 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread PENNSAID (diclofenac sodium topical solution) evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.

To treat the other knee, if symptomatic, repeat the procedure.

Application of PENNSAID (diclofenac sodium topical solution) 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 (diclofenac sodium topical solution) to the treated knee.
• Wash and dry hands after use.
• Do not apply PENNSAID (diclofenac sodium topical solution) to open wounds.
• Avoid contact of PENNSAID (diclofenac sodium topical solution) with eyes and mucous membranes.
• Do not apply external heat and/or occlusive dressings to treated knees.
• Avoid wearing clothing over the PENNSAID (diclofenac sodium topical solution) -treated knee(s) until the treated knee is dry.
• Protect the treated knee(s) from 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 (diclofenac sodium topical solution) .

Dosage Forms and Strength

1.5% w/w topical solution

Storage and Handling

PENNSAID (diclofenac sodium topical solution) is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap.

NDC Number & Size

15 mL bottle (physician sample) NDC # 23635-310-11

150 mL bottle NDC # 23635-310-15

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 01/2010

Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.