Flector Patch (diclofenac epolamine): Side Effects & Warnings

Generic drug: diclofenac epolamine

Brand name: Flector Patch

What is Flector Patch (diclofenac epolamine), and how does it work?

Flector Patch (diclofenac epolamine) is an over the counter and prescription medicine used to treat the symptoms of Arthritis Pain, Acute Pain, Osteoarthritis, and Actinic Keratosis. Flector Patch may be used alone or with other medications.

Flector Patch belongs to a class of drugs called Topical Skin Products.

It is not known if Flector Patch is safe and effective in children younger than 6 years of age.

What are the side effects of Flector Patch?

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of
  serious cardiovascular thrombotic events, including myocardial infarction
  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 Bleeding, Ulceration, and Perforation

• NSAIDs cause an increased risk of serious gastrointestinal (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 may cause serious side effects including:

• runny or stuffy nose,
• hives,
• wheezing,
• difficult breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• leg swelling,
• shortness of breath,
• skin rash,
• swelling,
• rapid weight gain,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• nausea,
• upper stomach pain,
• itching,
• tired feeling,
• flu-like symptoms,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• little or no urination,
• swelling in your feet or ankles,
• tiredness,
• pale skin,
• unusual tiredness, and
• cold hands and feet

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Flector Patch include:

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

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Flector Patch. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Flector Patch?

General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with
individual patient treatment goals.

The recommended dose of Flector
is one (1) topical system to the most painful area twice a day both in adults
and pediatric patients 6 years of age and older.

Special Precautions

• Inform patients that if Flector
  begins to peel-off, the edges of the topical system may be taped down. If
  problems with adhesion persist, patients may overlay the topical system with a
  mesh netting sleeve, where appropriate (e.g. to secure topical systems 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 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 when
  bathing or showering.
• Wash your hands after applying,
  handling or removing the topical system.
• Avoid eye contact.
• Do not use combination therapy
  with Flector and an oral NSAID unless the benefit outweighs the risk and
  conduct periodic laboratory evaluations.

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

What drugs interact with Flector Patch?

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.

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.

Intervention:
Concomitant use of Flector Patch and analgesic doses of aspirin
is not generally recommended because of the increased risk of
bleeding.
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.
• 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.

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.

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.

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Is Flector Patch safe to use while pregnant or breastfeeding?

• Published literature reports that use of NSAIDs, including Flector
  Patch, after 30 weeks’ gestation increases the risk of premature closure of the fetal ductus arteriosus.
• Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive.
• Avoid use of NSAIDs, including Flector Patch, in pregnant women starting at 30 weeks of gestation (third trimester).
• Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk.
• There are no data on the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
  Flector Patch and any potential adverse effects on the breastfed infant from the
  Flector Patch or from the underlying maternal condition.