Flector

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Side Effects & Adverse Reactions

CARDIOVASCULAR EFFECTS

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

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 does increase the risk of serious GI events (seeGI WARNINGS).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (seeCONTRAINDICATIONS).

Hypertension

NSAIDs, including Flector® Patch, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Flector® Patch, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Flector® Patch should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including Flector® Patch, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of Flector® Patch in patients with advanced renal disease. Therefore, treatment with Flector® Patch is not recommended in these patients with advanced renal disease. If Flector® Patch therapy is initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Flector® Patch. Flector® Patch should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (seeCONTRAINDICATIONS andPRECAUTIONS - Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including Flector® Patch, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, Flector® Patch should be avoided because it may cause premature closure of the ductus arteriosus.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).

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

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History

There is currently no drug history available for this drug.

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Other Information

Flector® Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.

Diclofenac epolamine is a non-opioid analgesic chemically designated as 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C20H24Cl2N2O3 (molecular weight 411.3), an n-octanol/water partition coefficient of 8 at pH 8.5, and the following structure:

Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water.

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Flector Manufacturers

Physicians Total Care, Inc.

Flector | Physicians Total Care, Inc.

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).

The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.

Flector® patch should not be applied to damaged or non-intact skin.

Flector® patch should not be worn when bathing or showering.

No Recall
Rebel Distributors Corp

Flector | Rebel Distributors Corp

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).

The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.

Flector® patch should not be applied to damaged or non-intact skin.

Flector® patch should not be worn when bathing or showering.
HANDLING AND DISPOSAL
Patients and caregivers should wash their hands after applying, handling or removing the patch. Eye contact should be avoided.

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Flector | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.
Flector® patch should not be applied to damaged or nonintact skin.
Flector® patch should not be worn when bathing or showering.

No Recall
H.j. Harkins Company, Inc.

Flector | H.j. Harkins Company, Inc.

2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall
Stat Rx Usa Llc

Flector | Stat Rx Usa Llc

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).

The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.

Flector® patch should not be applied to damaged or non-intact skin.

Flector® patch should not be worn when bathing or showering.
HANDLING AND DISPOSAL
Patients and caregivers should wash their hands after applying, handling or removing the patch. Eye contact should be avoided.

No Recall
Unit Dose Services

Flector | Unit Dose Services

2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall
King Pharmaceuticals, Inc.

Flector | King Pharmaceuticals, Inc.

2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall
Bryant Ranch Prepack

Flector | Bryant Ranch Prepack

2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall
Rebel Distributors Corp

Flector | Rebel Distributors Corp

2.1 General Instructions
The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.
2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall
Remedyrepack Inc.

Flector | Remedyrepack Inc.

The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day. (2) Flector Patch should not be applied to damaged or non-intact skin. (2)

The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.

Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

No Recall