Diclofenac 1.5% Dosage & Rx Info

Diclofenac 1.5% Generic Name & Formulations

Legal Class

General Description

Diclofenac sodium 1.5%; topical soln.

Pharmacological Class

NSAID (benzeneacetic acid deriv.).

How Supplied

Soln 1.5%—contact supplier; Pump 2%—112g

Manufacturer

Various generic manufacturers

Generic Availability

Soln 1.5% (YES); Pump 2% (NO)

Mechanism of Action

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Diclofenac 1.5% Indications

Indications

To treat signs/symptoms of osteoarthritis of the knee(s).

Diclofenac 1.5% Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Apply to clean, dry skin. Initially dispense 10 drops; spread evenly around front, back and sides of the knee; repeat until 40 drops have been applied and knee is completely covered with solution. Usual dose: 40 drops/knee 4 times daily. Wash hands. Wait until area is dry before skin-to skin contact, dressing or applying other topical products (eg, sunscreen, insect repellent, lotion, moisturizer, cosmetics, medications).

Children

Not established.

Diclofenac 1.5% Contraindications

Contraindications

Aspirin allergy. Coronary artery bypass graft surgery.

Diclofenac 1.5% Boxed Warnings

Boxed Warning

Risk of serious cardiovascular and gastrointestinal events.

Diclofenac 1.5% Warnings/Precautions

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 1^st sign of rash or any other hypersensitivity. Do not apply to open wounds, infections, inflammations, exfoliative dermatitis. Avoid eyes, mucous membranes, external heat and/or occlusive dressings, sunlight. Elderly. Debilitated. Labor & delivery. 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.

Diclofenac 1.5% Pharmacokinetics

Elimination

Renal, biliary.

Diclofenac 1.5% Interactions

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 other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).

Diclofenac 1.5% Adverse Reactions

Adverse Reactions

Application site reactions (eg, dry skin, contact dermatitis, pruritus, vesicles), GI upset; cardiovascular thrombotic events, GI ulcer/bleed, edema, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia.

Diclofenac 1.5% Clinical Trials

See Literature

Diclofenac 1.5% Note

Notes

Formerly known under the brand name Pennsaid.

Diclofenac 1.5% Patient Counseling