Diclofenac Epolamine topical system 1.3%
Prescriber visit fee for new prescriptions
Low systemic exposure, suitable for diverse patients and pain sites.
Pain relief achieved within 4 hours, sustained for 7 days with twice-daily application.
Patented patch technology delivers NSAID power for 12 hours.
Prescriber visit fee for new prescriptions
A Different Way to Treat Pain
For many patients suffering from acute pain due to a strain or sprain, an oral medication may deliver relief systemically when only localized action is needed. That’s why Diclofenac Epolamine Topical System 1.3% is a prescription NSAID topical system designed to deliver powerful pain-reducing medicine directly to where it hurts. Its targeted delivery offers low potential for systemic exposure compared to oral options.
Understanding Acute Pain
Acute pain is short-term pain, often described as a stabbing, burning, or squeezing sensation. It results from minor injuries, including strains, sprains, and contusions (bruises). While acute pain may be brief, it is a signal of tissue damage. The goal of treatment is to reduce the pain, redness, swelling, and heat (inflammation) associated with these injuries.
Adding Support to Your Pain Regimen
Many individuals are seeking alternatives to traditional oral pain relievers. Adding a topical NSAID system to your pain management toolbox may provide extra support when you need it most. Diclofenac Epolamine Topical System 1.3% offers a 12-hour, mess-free patch application with localized absorption, giving you a proven choice for treating acute pain exactly where it hurts.
IMPORTANT SAFETY INFORMATION
Diclofenac epolamine topical system 1.3% contains diclofenac epolamine, which is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions
INDICATIONS AND USAGE
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
- 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 occursExacerbation 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 - Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation
- Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia
ADVERSE REACTIONS
Most common adverse reactions for diclofenac epolamine topical system 1.3% are application site pruritus and other application site reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Yaral Pharma Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information, including Boxed Warning, at www.yaralpharma.com.
REFERENCES: 1. diclofenac epolamine topical system 1.3% [package insert]. Parsippany, NJ: Yaral Pharma Inc; 2020. 2. J.-M. Coudreuse et al.; Curr Med Research Opin.; 2010; 26(9):2221-8. 3. K.D. Rainsford
et al., Curr Med Research Opin.; 2018; 35(6): 989-1002