"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
DOSAGE AND ADMINISTRATION
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 to clean, dry skin.
To avoid spillage, dispense PENNSAID 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread PENNSAID 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 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 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).
Dosage Forms And Strengths
1.5% w/w topical solution
Storage And Handling
PENNSAID 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
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 10/2013
Last reviewed on RxList: 10/31/2013
This monograph has been modified to include the generic and brand name in many instances.
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