Arthritis/rheumatic disorders:

Indications for: Diclofenac Sodium Delayed-Release

Acute or chronic therapy of osteoarthritis or rheumatoid arthritis. Ankylosing spondylitis.

Adult Dosage:

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 Dosage:

Not established.

Diclofenac Sodium Delayed-Release Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Diclofenac Sodium Delayed-Release 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 Classification:

NSAID (benzeneacetic acid deriv.).

Diclofenac Sodium Delayed-Release 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).

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.


Formerly known under the brand name Voltaren-XR, Voltaren.

How Supplied:

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