NABUMETONE- nabumetone tablet, film coated
Actavis Pharma, Inc.
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 and Precautions ].
Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ].
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS).
1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol: phosphate buffer partition coefficient of 2,400 at pH 7.4.
Each tablet, for oral administration, contains either 500 mg or 750 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide and triacetin. The 500 mg tablets also contain talc and the 750 mg tablets also contain iron oxide red.
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in pharmacologic studies. As with other non-steroidal anti-inflammatory agents, its mode of action is not known; however, the ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.
The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis. 6-methoxy-2-naphthylacetic acid (6MNA)
It is acidic and has an n-octanol: phosphate buffer partition coefficient of 0.5 at pH 7.4. INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone 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 nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient�s needs.
