IMPORTANT SAFETY INFORMATION AND INDICATION
FLECTOR is contraindicated in patients with known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. FLECTOR is also contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
FLECTOR should not be applied to non-intact or damaged skin resulting from any etiology, eg, exudative dermatitis, eczema, infected lesions, burns, or wounds.
Avoid the use of FLECTOR in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If FLECTOR is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Elevations of one or more liver tests may occur during therapy with FLECTOR. If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur, FLECTOR should be discontinued immediately.
NSAIDs, including FLECTOR, can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Monitor blood pressure during the initiation of NSAID treatment and throughout the course of therapy.
Fluid retention and edema have been observed in some patients treated with NSAIDs. Avoid the use of FLECTOR in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If FLECTOR is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Avoid the use of FLECTOR in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.
Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma. Patients should seek emergency help if an anaphylactic reaction occurs.
NSAIDs, including diclofenac, can cause serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal and may occur without warning. FLECTOR should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Avoid use of NSAIDs, including FLECTOR, in pregnant women starting at 30 weeks of gestation.
Anemia has occurred in NSAID-treated patients. If a patient treated with FLECTOR has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including FLECTOR, may increase the risk of bleeding events.
Do not use combination therapy with FLECTOR and an oral NSAID unless the benefit outweighs the risk.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Overall, the most common adverse events associated with FLECTOR were skin reactions at the site of treatment. Other common adverse events included gastrointestinal disorders, such as nausea, dysgeusia and dyspepsia, and nervous system disorders, such as headache, paresthesia, and somnolence.
FLECTOR is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
FLECTOR® is a registered trademark of IBSA Institut Biochimique SA, licensed by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.