Company:

Alpharma

Topical analgesic (NSAID)

Diclofenac epolamine 180mg; per patch.

Topical treatment of acute pain due to minor strains, sprains, and contusions.

Flector is a topical patch that contains 1.3% of diclofenac epolamine, a non-steroidal anti-inflammatory drug (NSAID). It measures approximately 10 x 14 cm. When applied to intact skin, it provides local analgesia as the drug is released into the skin. Although the exact mechanism by which NSAIDs alleviate pain has not been established, their ability to inhibit the activity of various prostaglandins may play a role.

Following application of a patch to the upper inner arm, peak plasma levels of diclofenac were noted 10–20 hours later. Diclofenac is highly protein-bound; it is eliminated by both renal and hepatic mechanisms.

The efficacy of Flector Patch in alleviating acute pain was demonstrated in two studies in patients with minor sprains, strains, and contusions. Patients were randomly assigned to receive either the Flector Patch or a patch that did not contain the active ingredient. In the first study, patients with ankle sprains were treated once daily for 1 week. In the second study, patients with sprains, strains, and contusions were treated twice daily for up to 2 weeks. Patients treated with the Flector Patch were found to have experienced a greater reduction in pain as compared to those randomized to placebo patch.

Use lowest effective dose for shortest possible duration. Apply 1 patch to clean, dry, intact skin on most painful area twice daily. May tape edges down if patch begins to peel off. Wash hands after application. Remove during bathing/showering.

Not recommended.

Aspirin triad/allergy. Perioperative pain for coronary artery bypass graft (CABG). Non-intact or damaged skin (eg, dermatitis, eczema, burns, wounds, lesions).

Advanced renal disease: not recommended. History of ulcer disease or GI bleed, or risks thereof (eg, concomitant corticosteroids, anticoagulants, smoking, alcohol use, prolonged NSAID therapy). Cardiovascular disease or risk. Hypertension. Heart failure. Fluid retention. Impaired renal or liver function. Monitor blood pressure and for thrombotic and GI events. Not a substitute for corticosteroids. Avoid eyes, mucosa. Handle and dispose of properly. Elderly (monitor renal function). Debilitated. Pregnancy (Cat.C; avoid in late pregnancy). Labor & delivery. Nursing mothers: not recommended.

Avoid concomitant aspirin. May potentiate lithium, methotrexate, warfarin. May antagonize antihypertensive (eg, ACEIs). Concomitant diuretics, ACEIs: increased risk of renal decompensation.

Skin reactions (eg, burning, dermatitis, pruritus), GI events (eg, nausea, dysgeusia, dyspepsia), headache, paresthesia, somnolence. Discontinue if rash or hepatic reaction occurs. See literature re: risk of cardiovascular events, Stevens-Johnson syndrome, toxic epidermal necrolysis, GI ulcer/bleed.

Patch—30

2/21/08