Topical pain relief:

Indications for: FLECTOR

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

Adults and Children:

<6yrs: not established. ≥6yrs: use lowest effective dose for shortest duration. Apply 1 topical system to clean, dry, intact skin on most painful area twice daily. May tape edges down if topical system begins to peel off. Wash hands after application. Remove during bathing/showering.

FLECTOR Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Non-intact or damaged skin (eg, dermatitis, eczema, burns, wounds, lesions).

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

FLECTOR Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Avoid eyes, mucosa. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

FLECTOR Classification:

NSAID (benzeneacetic acid deriv.).

FLECTOR Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with hepatotoxic drugs (eg, acetaminophen, antibiotics, antiepileptics).

Adverse Reactions:

Application site reactions (eg, pruritus, dermatitis, burning), GI events (eg, nausea, dysgeusia, dyspepsia); cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia. Children: also headache.

Generic Drug Availability:

YES

How Supplied:

Topical system—30