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Diclofenac Sodium Delayed-release Generic Name & Formulations
Legal Class
Rx
General Description
Diclofenac sodium 25mg, 50mg, 75mg; e-c tabs.
Pharmacological Class
NSAID (benzeneacetic acid deriv.).
See Also
How Supplied
Contact supplier
Manufacturer
Diclofenac Sodium Delayed-release Indications
Indications
Acute or chronic therapy of osteoarthritis or rheumatoid arthritis. Ankylosing spondylitis.
Diclofenac Sodium Delayed-release Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Osteoarthritis: 50mg 2–3 times daily or 75mg twice daily. Rheumatoid arthritis: 50mg 3–4 times daily or 75mg twice daily. Ankylosing spondylitis: 25mg 4 times daily, with an additional 25mg at bedtime if necessary.
Children
Not established.
Diclofenac Sodium Delayed-release Contraindications
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Diclofenac Sodium Delayed-release Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Diclofenac Sodium Delayed-release 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 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
Diclofenac Sodium Delayed-release Pharmacokinetics
See Literature
Diclofenac Sodium Delayed-release 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. Potentiated by CYP2C9 inhibitors (eg, voriconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need dose adjustments. Caution with other hepatotoxic drugs (eg, acetaminophen, certain antibiotics, antiepileptics).
Diclofenac Sodium Delayed-release Adverse Reactions
Adverse Reactions
GI upset, anemia, dizziness, edema, headache, pruritus, rash (may be serious), tinnitus; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia.
Diclofenac Sodium Delayed-release Clinical Trials
See Literature
Diclofenac Sodium Delayed-release Note
Notes
Formerly known under the brand name Voltaren-XR, Voltaren.
Diclofenac Sodium Delayed-release Patient Counseling
See Literature
