PENNSAID® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION
- PENNSAID is contraindicated in patients:
- With a known hypersensitivity to diclofenac or any components of the drug product
- Who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients
- In the setting of coronary artery bypass graft (CABG) surgery
WARNINGS AND PRECAUTIONS
- Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
- There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as PENNSAID, increases the risk of serious GI events.
- Elevation of one or more liver tests may occur during therapy with NSAIDs. Measure transaminases at baseline and periodically in patients receiving long-term therapy with PENNSAID. PENNSAID should be discontinued immediately if abnormal liver tests persist or worsen or if clinical signs and/or symptoms consistent with liver disease develop.
- Hypertension can occur with NSAID treatment. Monitor blood pressure closely with PENNSAID treatment.
- Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
- Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury, and renal toxicity. Use PENNSAID with caution in patients at greatest risk of this reaction.
- Anaphylactic reactions may occur in patients with or without known hypersensitivity to PENNSAID and in patients with aspirin-sensitive asthma.
- PENNSAID can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
- Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
- Do not:
- Apply PENNSAID to open wounds
- Shower for at least 30 minutes after applying PENNSAID
- Wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry
- Wash and dry hands before and after use. Avoid contact of PENNSAID with the eyes and mucous membranes
- Protect treated knee(s) from natural or artificial sunlight
- Wait until the treated knee(s) is completely dry before applying sunscreen, insect repellent, lotion, moisturizer, cosmetics, or other topical medication
- Concurrent use with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
- See full Prescribing Information for a list of clinically important drug interactions.
- The most common adverse reactions to PENNSAID 1.5% or PENNSAID 2% in clinical trials were: application site reactions such as dryness, exfoliation, erythema, pruritus, pain, induration, rash, scabbing, contact dermatitis characterized by skin erythema and induration, contact dermatitis with vesicles; urinary tract infection; contusion; sinus congestion; nausea; dyspepsia; abdominal pain; flatulence; diarrhea; constipation; edema.
USE IN SPECIFIC POPULATIONS
- PENNSAID should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including PENNSAID, in women who have difficulties conceiving or who are undergoing investigation of infertility.
- Safety and efficacy of PENNSAID in pediatric patients has not been established.
For further information on PENNSAID, please see full Prescribing Information, including Boxed Warning and the Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.