Flectorpatch

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Important Safety Information

Cardiovascular (CV) risk

  • NSAIDs cause an increased risk of serious CV thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use
  • FLECTOR Patch is contraindicated in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal (GI) risk

  • NSAIDs cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events

FLECTOR Patch is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. FLECTOR Patch 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 Patch should not be applied to non-intact or damaged skin resulting from any etiology, e.g., exudative dermatitis, eczema, infected lesions, burns, or wounds

Avoid the use of FLECTOR Patch in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If FLECTOR Patch 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 Patch. If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur, FLECTOR Patch should be discontinued immediately

NSAIDs, including FLECTOR Patch, can lead to new onset or worsening of pre-existing 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 Patch in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If FLECTOR Patch 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 Patch 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 Patch should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity

Avoid use of NSAIDs, including FLECTOR Patch, in pregnant women starting at 30 weeks of gestation

Anemia has occurred in NSAID-treated patients. If a patient treated with FLECTOR Patch has any signs or symptoms of anemia, monitor hemoglobin or hematocrit

NSAIDs, including FLECTOR Patch, may increase the risk of bleeding events

Do not use combination therapy with FLECTOR Patch 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 Patch 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

Safety and effectiveness in pediatric patients have not been established

Indication

FLECTOR Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions

Please see Full Prescribing Information & Medication Guide.