HORIZON INFLAMMATION CARE RESOURCE CENTER

PENNSAID^® (DICLOFENAC SODIUM TOPICAL SOLUTION) 2% W/W (PENNSAID 2%) IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• PENNSAID is contraindicated in patients with:
  • known hypersensitivity to diclofenac or any component of the drug product
  • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs,
  • in the setting of CABG surgery.

WARNINGS AND PRECAUTIONS

• Use the lowest effective dose of PENNSAID 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 diclofenac, increases the risk of serious GI events. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.
• Elevation of one or more liver tests may occur during therapy with NSAIDs. PENNSAID should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. 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.
• Avoid use of PENNSAID in patients with severe heart failure unless benefits are expected to outweigh the risk.
• Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of PENNSAID in patients with advanced renal disease unless benefits are expect to outweigh risk of worsening renal function.
• Anaphylactic reactions may occur in patients with or without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.
• NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue PENNSAID at first appearance of skin rash or any other sign of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PENNSAID. Some of these events have been fatal or life-threatening. If early symptoms of hypersensitivity appear, such as fever or lymphadenopathy with or without rash, discontinue PENNSAID and evaluate the patient immediately.
• Limit use of NSAIDs, including PENNSAID between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of premature closure of the fetal ductus arteriosus and oligohydramnios/fetal renal dysfunction.
• Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
• Concurrent use of PENNSAID with oral NSAIDs should be avoided unless benefit outweighs risk and periodic laboratory evaluations are conducted.
• When applying PENNSAID, DO NOT: apply to open wounds, shower for at least 30 minutes after applying, wear clothing over the PENNSAID treated knee(s) until the treated knee(s) is dry. When applying PENNSAID, DO: 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.
• See full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

• The most common adverse reactions in the PENNSAID 1.5% or PENNSAID 2% 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; and edema.

USE IN SPECIFIC POPULATIONS

• Use of NSAIDs, including PENNSAID, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios. Limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy. Consider withdrawal of NSAIDs 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.

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.