Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-Release Tablets and other treatment options before deciding to use Diclofenac Sodium DelayedRelease Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Delayed-Release Tablets, USP, are indicated: 

• For relief of signs and symptoms of osteoarthritis
• For relief of signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-Release Tablets and other treatment options before deciding to use Diclofenac Sodium DelayedRelease Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with Diclofenac Sodium Delayed-Release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).

For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).

For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25 mg dose at bedtime if necessary

Different formulations of Diclofenac (Diclofenac sodium enteric-coated tablets; Diclofenac sodium extended-release tablets, Diclofenac potassium immediate-Release tablets) are not necessarily bioequivalent even if the milligram strength is the same.

In patients taking Diclofenac Sodium Delayed-Release Tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:

• Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.
• Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus

Additional adverse experiences reported occasionally include:

• Body as a Whole: fever, infection, sepsis
• Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope
• Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
• Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
• Metabolic and Nutritional: weight changes
• Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
• Respiratory System: asthma, dyspnea
• Skin and Appendages: alopecia, photosensitivity, sweating increased
• Special Senses: blurred vision
• Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure

Other adverse reactions, which occur rarely are:

• Body as a Whole: anaphylactic reactions, appetite changes, death
• Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
• Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis
• Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
• Metabolic and Nutritional: hyperglycemia
• Nervous System: convulsions, coma, hallucinations, meningitis
• Respiratory System: respiratory depression, pneumonia
• Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
• Special Senses: conjunctivitis, hearing impairment

Diclofenac Sodium Delayed-Release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac Sodium Delayed-Release Tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Diclofenac Sodium Delayed-Release Tablets, USP are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings].

Cardiovascular Effects
Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

See package insert for complete information.