Authorized generic of Flector® (diclofenac epolamine) topical system 1.3%

diclofenac epolamine topical system 1.3%

INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.

IMPORTANT SAFETY INFORMATION

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 the treatment and may increase with duration of use.
• DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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.

CONTRAINDICATIONS

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
• 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
• In the setting of coronary artery bypass graft (CABG) surgery
• On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
• Heart Failure and Edema: Avoid use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
• Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
• Exacerbation of Asthma Related to Aspirin Sensitivity: DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
• Serious Skin Reactions: Discontinue DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% at first appearance of skin rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.
• Fetal Toxicity: Limit use of NSAIDs, including DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
• Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  

ADVERSE REACTIONS

The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo-treated adult patients were pruritus (5% and 8%, respectively) and nausea (3% and 2%, respectively). The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treated pediatric patients were headache (9%) and application site pruritus (7%).

DRUG INTERACTIONS

• Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly using DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% with drugs that interfere with hemostasis. Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and analgesic doses of aspirin is not generally recommended.
• ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
• ACE Inhibitors and ARBs: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
• Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
• Digoxin: Concomitant use with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% may increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels

USE IN SPECIFIC POPULATIONS

• Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% in women who have difficulties conceiving.

Please see full Prescribing Information, including BOXED WARNING at https://yaralpharma.com/wp-content/uploads/2023/01/Diclofenac-Epolamine-PI-10-2025.pdf

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