FLECTOR Patch significantly reduced pain beginning at Hour 41,2
FLECTOR Patch provided a 75% improvement from baseline at Day 3 vs 59% with placebo (P<.001)1
*Last observation carried forward.
In a separate 14-day study of minor soft tissue injury
FLECTOR Patch significantly reduced pain vs. placebo over the course of a 14-day study in patients with minor soft tissue injury1
Location of injury|| included in clinical trials 1-3
Indication
FLECTOR Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Important Safety Information
Cardiovascular (CV) risk
- FLECTOR Patch, like other NSAIDs, may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk
- FLECTOR Patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
Gastrointestinal (GI) risk
- NSAIDs, including FLECTOR Patch, 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 are at greater risk for serious GI events
FLECTOR Patch is contraindicated in patients with known hypersensitivity to diclofenac. FLECTOR Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
FLECTOR Patch should not be applied to nonintact or damaged skin resulting from any etiology, eg, exudative dermatitis, eczema, infected lesion, burns, or wounds.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
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. Blood pressure should be monitored closely with all NSAIDs.
Fluid retention and edema have been observed in some patients taking NSAIDs, including FLECTOR Patch. FLECTOR Patch should be used with caution in patients with fluid retention or heart failure.
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 may cause renal toxicity. Use FLECTOR Patch with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction and those taking ACE inhibitors. FLECTOR Patch is not recommended in patients with advanced renal disease.
Use caution when initiating treatment with FLECTOR Patch in patients with considerable dehydration.
NSAIDs, including FLECTOR Patch, can cause serious skin adverse events 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 signs of hypersensitivity.
Anaphylaxis type reactions have been reported with NSAID products, including diclofenac products, such as FLECTOR Patch. Patients should seek immediate emergency assistance if they have swelling of the face or throat or have difficulty breathing.
FLECTOR Patch should be avoided in late pregnancy.
Anemia is sometimes seen in patients receiving NSAIDs. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.
Do not use combination therapy with FLECTOR Patch and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
Safety and effectiveness in pediatric patients have not been established.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.
Please see Full Prescribing Information.
Study description
Data on File, Pfizer Inc. (7-day study) and Joussellin 2003. A multicenter, randomized, placebo-controlled, parallel-group study evaluated the efficacy and tolerability of FLECTOR Patch (n=68) vs placebo patch (n=66) applied once daily in adult patients with a minor ankle sprain that occurred less than 48 hours prior to study entry, with a spontaneous pain score assessed by the patient of at least 50 mm on a VAS of 100 mm. The primary efficacy variable, pain on movement, was assessed by the patient using a VAS during the 6 hours following the first treatment application and at Days 1, 2, 3, and 7.
Data on File, Pfizer Inc. (14-day study). A double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of FLECTOR Patch (n=207) vs placebo patch (n=211) applied every 12 hours to the painful site of a minor soft-tissue injury (strain, sprain, or contusion) that occurred within 7 days of study entry with a pain-intensity score of 5 or more assessed by the patient on a categorical pain scale (from 0=no pain to 10=extreme pain). The primary efficacy end point was patient-assessed pain intensity on a visual analog scale (VAS) of 0-10 twice daily for 14 days or until pain resolution, and expressed as a proportion of the baseline pain score. Patients treated with FLECTOR Patch (n=192) experienced improved mean pain scores, 40.4% of baseline score vs patients using placebo patch (n=192), 47.4% of baseline score over the course of the study (P=.009).
References
1. Data on file. Pfizer Inc, New York, NY.2. Joussellin É. Flector Tissugel® in the treatment of painful ankle sprain [in French]. J Traumatol Sport. 2003;20:1S5-1S9.
3. Jenoure PJ, Rostan A, Gremion G, et al. Multicenter, double-blind, controlled clinical study on diclofenac Tissugel plaster in patients with epicondylitis [in Italian]. Med Sport (Roma). 1997;50(3):285-292.
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