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Diclofenac Epolamine

FDA Drug Information • Also known as: Diclofenac Epolamine, Flector, Licart

Brand Names
Diclofenac Epolamine, Flector, Licart
Dosage Form
POWDER
Product Type
BULK INGREDIENT

⚠ Boxed Warning (Black Box)

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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 ( 5.1 ) DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) 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 ( 5.2 ) 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 [ see Warnings and Precautions (5.1) ]. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ] . 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 [ see Warnings and Precautions (5.2) ].

Description

11 DESCRIPTION DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system 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. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20 H 24 Cl 2 N 2 O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure: Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water. Chemical Structure

What Is Diclofenac Epolamine Used For?

1 INDICATIONS AND USAGE DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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. 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. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consist with the individual patient treatment goals ( 2.1 ) The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for adults and pediatric patients 6 years and older is one (1) topical system to the most painful area twice a day. ( 2 ) DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% should not be applied to damaged or non-intact skin. ( 2 ) 2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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. 2.2 Special Precautions Inform patients that, if DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% when bathing or showering. Wash your hands after applying, handling or removing the topical system. Avoid eye contact. Do not use combination therapy with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.12) ] 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) ( 6.1 ). The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3 % treated pediatric patients were headache (9%) and application site pruritus (7%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Yaral Pharma Professional Information Service at 1-866-218-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Adult Clinical Trials Experience In controlled trials during the premarketing development of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, approximately 600 patients with minor sprains, strains, and contusions were treated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for up to two weeks. Adverse Events Leading to Discontinuation of Treatment In the controlled trials, 3% of patients in both the DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and placebo groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning. Common Adverse Events Overall, the most common adverse events associated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%. A majority of patients treated with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% or Placebo The table lists adverse events occurring in placebo-treated patients because the placebo-was comprised of the same ingredients as DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients. 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 Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles. 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 Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth. 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 Includes: hypoesthesia, dizziness, and hyperkinesias. 4 1 3 <1 Foreign labeling describes that dermal allergic reactions may occur with DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treatment. Additionally,...

Drug Interactions

7 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 (5.12) ]. 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 (5.2) ]. Intervention: Concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see Warnings and Precautions (5.12) ]. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% 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 (5.6) ] . When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically...

Contraindications

4 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 [ see Warnings and Precautions (5.7 , 5.9 ) ] 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 [ see Warnings and Precautions (5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions (5.1) ] DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. Known hypersensitivity to diclofenac or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 ) For use on non-intact or damaged skin ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary Use of NSAIDs, including DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% use between about 20 and 30 weeks of gestation, and avoid DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, diclofenac epolamine administered orally to pregnant rats and rabbits during the period of organogenesis produced embryotoxicity at approximately 3 and 7 times, respectively, the topical exposure from the maximum recommended human dose (MRHD) of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3%. In rats, increased incidences of skeletal anomalies and maternal toxicity were also observed at this dose. Diclofenac epolamine administered orally to both male and female rats prior to mating and throughout the mating period, and during gestation and lactation in females produced embryotoxicity at doses approximately 3 and 7 times, respectively, the topical exposure from the MRHD (see Data ) . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular...

Overdosage

10 OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.6 ) ]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING The DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is supplied in resealable envelopes, each containing 5 topical systems (10 cm × 14 cm), with 6 envelopes per box (NDC 76420-673-30 [relabeled from NDC 82347-0405-5]). Each individual topical system is debossed with "YARAL < DICLOFENAC EPOLAMINE TOPICAL SYSTEM > 1.3%". The product is intended for topical use only. Keep out of reach of children and pets. Envelopes should be sealed at all times when not in use. Curad® Hold Tite™ is a trademark of Medline Industries, Inc., and Surgilast® Tubular Elastic Dressing is a trademark of Derma Sciences, Inc. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.