Capsfenac Pak

Generic name: diclofenac sodium and capsaicin
Dosage form: kit

1. INDICATIONS AND USAGE

Diclofenac Sodium topical solution, 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

2. DOSAGE AND ADMINISTRATION

General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNING AND PRECAUTIONS (5.2)]

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 Diclofenac Sodium topical solution, 1.5% w/w to clean, dry skin.

To avoid spillage, dispense Diclofenac Sodium topical solution, 1.5% w/w 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread Diclofenac Sodium topical solution, 1.5% w/w 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 Diclofenac Sodium topical solution, 1.5% w/w in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.

Special Precautions

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Avoid showering/bathing for at least 30 minutes after the application of Diclofenac Sodium topical solution, 1.5% w/w to the treated knee.

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Wash and dry hands after use.

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Do not apply Diclofenac Sodium topical solution, 1.5% w/w to open wounds.

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Avoid contact of Diclofenac Sodium topical solution, 1.5% w/w with eyes and mucous membranes.

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Do not apply external heat and/or occlusive dressings to treated knees.

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Avoid wearing clothing over the Diclofenac Sodium topical solution, 1.5% w/w-treated knee(s) until the treated knee is dry.

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