DICLOFENAC SODIUM- diclofenac sodium tablet, film coated, extended release
Mylan Pharmaceuticals Inc.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
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Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS).
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Diclofenac sodium extended-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).
Gastrointestinal Bleeding, Ulceration, and Perforation
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NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS).
DESCRIPTION
Diclofenac sodium extended-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium extended-release tablets are available as film-coated tablets of 100 mg (yellow) for oral administration. Diclofenac sodium, USP is a faintly yellowish white to light beige crystalline powder and is sparingly soluble in water at 25�C. The chemical name is Sodium [o -(2,6-dichloroanilino)phenyl]acetate. The molecular weight is 318.13. Its molecular formula is C14 H10 Cl2 NNaO2
The inactive ingredients in diclofenac sodium extended-release tablets include: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hydroxyethyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.
Meets USP Dissolution Test 4.
CLINICAL PHARMACOLOGY
Mechanism of Action
Diclofenac sodium extended-release tablets have analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium extended-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).
Diclofenac sodium extended-release tablets are indicated:
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For relief of the signs and symptoms of osteoarthritis
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For relief of the signs and symptoms of rheumatoid arthritis
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, and other treatment options before deciding to use diclofenac sodium extended-release 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 extended-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 mg daily.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where diclofenac sodium extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.
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.
