CATAFLAM- diclofenac potassium tablet, sugar coated
Novartis Pharmaceuticals Corporation
ARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
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).
CATAFLAM� is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).
Gastrointestinal Bleeding, Ulceration, and Perforation
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
CATAFLAM� (diclofenac potassium immediate-release tablets) is a benzeneacetic acid derivative. CATAFLAM is available as immediate-release tablets of 50 mg (light brown) for oral administration. Diclofenac potassium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25�C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14 H10 Cl2 NKO2
CLINICAL PHARMACOLOGY
Mechanism of Action
Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of CATAFLAM, 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 CATAFLAM� (diclofenac potassium immediate-release tablets) and other treatment options before deciding to use CATAFLAM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).
CATAFLAM is indicated:
For treatment of primary dysmenorrhea
For relief of mild to moderate pain
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of CATAFLAM� (diclofenac potassium immediate-release tablets) and other treatment options before deciding to use CATAFLAM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).
After observing the response to initial therapy with CATAFLAM, the dose and frequency should be adjusted to suit an individual patient's needs.
For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg three times a day. With experience, physicians may find that in some patients an initial dose of 100 mg of CATAFLAM, followed by 50-mg doses, will provide better relief.
For the relief of osteoarthritis the recommended dosage is 100-150 mg/day in divided doses, 50 mg twice a day or three times a day.
For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, 50 mg three times a day or four times a day.
Different formulations of diclofenac [Voltaren� (diclofenac sodium enteri-coated tablets); Voltaren� -XR (diclofenac sodium extended-release tablets); CATAFLAM� (diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.
HOW SUPPLIED
CATAFLAM � (diclofenac potassium immediate-release tablets)
