Flector Patch

• Generic Name: diclofenac epolamine topical patch
• Brand Name: Flector Patch

Flector Patch (Diclofenac Epolamine Topical Patch) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Flector Patch Side Effects Center

What Is Flector Patch?

Flector Patch (diclofenac epolamine) contains a nonsteroidal anti-inflammatory medication (NSAID) used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

What Are Side Effects of Flector Patch?

Side effects of Flector Patch include:

• dryness
• itching
• peeling
• scaling
• burning
• redness, or
• other skin irritation where the patch is applied

Other side effects of Flector Patch include:

• nausea
• vomiting
• diarrhea
• constipation
• upset stomach
• heartburn
• gas, or
• dizziness

Dosage for Flector Patch

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

What Drugs, Substances, or Supplements Interact with Flector Patch?

Flector Patch may interact with alcohol, other NSAIDs, blood thinners, cyclosporine, lithium, methotrexate, diuretics (water pills), steroids, or heart or blood pressure medications. Tell your doctor all medications and supplements you use.

Flector Patch During Pregnancy or Breastfeeding

Starting at 30 weeks gestation, Flector Patch and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. It is not known whether this drug is excreted in human milk. Consult your doctor before breastfeeding.

Additional Information

Our Flector patch Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Flector Patch Consumer Information

Get emergency medical help if you have signs of an allergic reaction (runny or stuffy nose, hives, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using diclofenac and call your doctor at once if you have:

• a skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• heartburn, gas, stomach pain, nausea, vomiting;
• diarrhea, constipation; or
• mild itching, burning, redness, or other skin irritation where the patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Flector Patch (Diclofenac Epolamine Topical Patch)

 

Flector Patch Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled trials during the premarketing development of FLECTOR PATCH, approximately 600 patients with minor sprains, strains, and contusions were treated with FLECTOR PATCH for up to two weeks.

Adverse Events Leading To Discontinuation Of Treatment

In the controlled trials, 3% of patients in both the FLECTOR PATCH and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the FLECTOR PATCH and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Localized Reactions

Overall, the most common adverse events associated with FLECTOR PATCH treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of FLECTOR PATCH. A majority of patients treated with FLECTOR PATCH had adverse events with a maximum intensity of "mild" or "moderate."

Table 1. Common Adverse Events (by body system and preferred term) in ≥ 1% of Patients treated with FLECTOR PATCH or Placebo Patch*

Category	Diclofenac N=572		Placebo N=564
	N	Percent	N	Percent
Application Site Conditions	64	11	70	12
Pruritus	31	5	44	8
Dermatitis	9	2	3	<1
Burning	2	<1	8	1
Other†	22	4	15	3
Gastrointestinal Disorders	49	9	33	6
Nausea	17	3	11	2
Dysgeusia	10	2	3	<1
Dyspepsia	7	1	8	1
Other‡	15	3	11	2
Nervous System Disorders	13	2	18	3
Headache	7	1	10	2
Paresthesia	6	1	8	1
Somnolence	4	1	6	1
Other§	4	1	3	<1
* The table lists adverse events occurring in placebo-treated patients because the placebo-patch was comprised of the same ingredients as FLECTOR PATCH except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients. † Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles. ‡ Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth. § Includes: hypoesthesia, dizziness, and hyperkinesias.

Foreign labeling describes that dermal allergic reactions may occur with FLECTOR PATCH treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

DRUG INTERACTIONS

See Table 2 for clinically significant drug interactions with diclofenac.

Table 2: Clinically Significant Drug Interactions with Diclofenac

Drugs That Interfere with Hemostasis
Clinical Impact:	Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:	Monitor patients with concomitant use of FLECTOR PATCH with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Aspirin
Clinical Impact:	Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention:	Concomitant use of FLECTOR PATCH and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. FLECTOR PATCH is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:	NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:	During concomitant use of FLECTOR PATCH and ACE-inhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of FLECTOR PATCH and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact:	Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of FLECTOR PATCH with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact:	The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Intervention:	During concomitant use of FLECTOR PATCH and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact:	NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of FLECTOR PATCH and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact:	Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During concomitant use of FLECTOR PATCH and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of FLECTOR PATCH and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention:	During concomitant use of FLECTOR PATCH and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact:	Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention:	The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact:	Concomitant use of FLECTOR PATCH and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:	During concomitant use of FLECTOR PATCH and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.

Read the entire FDA prescribing information for Flector Patch (Diclofenac Epolamine Topical Patch)

&Copy; Flector Patch Patient Information is supplied by Cerner Multum, Inc. and Flector Patch Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.