FLECTOR

DICLOFENAC EPOLAMINE

Manufacturer: IBSA Pharma Inc.

Score: 144.0

Quick Summary

Diclofenac Epolamine Topical System 1.3% is a nonsteroidal anti-inflammatory drug (NSAID) used for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. The drug works by inhibiting cyclooxygenase (COX-1 and COX-2) and reducing prostaglandin synthesis, which mediates inflammation and pain. The recommended dose is one topical system to the most painful area twice a day. However, the drug has important safety information, including a boxed warning for the risk of serious cardiovascular and gastrointestinal events, and contraindications such as known hypersensitivity to diclofenac or any components of the drug product, history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, and use in the setting of coronary artery bypass graft (CABG) surgery.

Key Clinical Findings and Indications

Treatment of acute pain due to minor strains, sprains, and contusions
Nonsteroidal anti-inflammatory drug (NSAID)
Inhibits cyclooxygenase (COX-1 and COX-2) and reduces prostaglandin synthesis
Indicated for adults and pediatric patients 6 years and older

Important Safety Information

Warning

Risk of serious cardiovascular and gastrointestinal events

Contraindications

Known hypersensitivity to diclofenac or any components of the drug product
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
Use in the setting of coronary artery bypass graft (CABG) surgery
Use on non-intact or damaged skin

Adverse Reactions

Cardiovascular thrombotic events
Gastrointestinal bleeding, ulceration, and perforation
Hepatotoxicity
Hypertension
Heart failure and edema
Renal toxicity and hyperkalemia
Anaphylactic reactions
Serious skin reactions
Hematologic toxicity

Dosing Recommendations

General Guidance

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

Acute pain due to minor strains, sprains, and contusions

Adult Dose

One topical system to the most painful area twice a day

Pediatric Dose

One topical system to the most painful area twice a day for pediatric patients 6 years and older

Special Population Considerations

Pregnancy

Use of NSAIDs, including diclofenac epolamine topical system 1.3%, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction
Limit dose and duration of use between 20 and 30 weeks of gestation, and avoid use at 30 weeks of gestation and later in pregnancy

Nursing Mothers

Pediatric Use

Safety and effectiveness established in pediatric patients 6 years and older
Not investigated in pediatric patients less than 6 years old

Geriatric Use

Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions
Start dosing at the low end of the dosing range, and monitor patients for adverse effects

Similar Drugs

Diclofenac sodium

DICLOFENAC SODIUM

Medsource Pharmaceuticals

Similarity: 87.0%