NABUMETONE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NABUMETONE (UNII: LW0TIW155Z) (NABUMETONE - UNII:LW0TIW155Z)

Available from:

STAT Rx USA LLC

INN (International Name):

NABUMETONE

Composition:

NABUMETONE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or 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, General, Preexisting Asthma ). Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Nabumetone Tablets USP: 500 mg–White film-coated, oval-shaped biconvex tablets debossed with IG on one side and 257 on the other are supplied: in bottles of 60 - NDC 42549-523-60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NABUMETONE - NABUMETONE TABLET, FILM COATED
STAT RX USA LLC
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NABUMETONE TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at a greater risk
(See WARNINGS).
Nabumetone tablets are contraindicated for the treatment of
peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see 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).
Through out this package insert, the term NSAID refers to a
non-aspirin non-steroidal antiinflammatory
drug.
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2- naphthalenyl)-2-butanone.
It has the following structure:
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 2400 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: microcrystalline
cellulose, sodium starch glycolate,
hydroxyl propyl methyl cellulose, sodium lauryl sulphate, colloidal
silicon dioxide and magnesium
stearate. The 500 mg tablets also contain opadry white (Titanium
dioxide, Hypromellose 3cP,
Hypromellose 6cP, Macrogol and Polysorbate 80) and the 750 mg tablets
contain opadry beige
(Hypromellose 6cP, titanium dioxide, iron oxide yellow, iron oxide red
and Macrogol).
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CLINICAL PHARMACOLOGY
Nabumetone is a