NABUMETONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Altura Pharmaceuticals, Inc.

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 and other treatment options before deciding to use nabumetone. 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 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 , 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 are available as light yellow, oval shaped, film coated, unscored tablets, debossed “double triangle”“4098” on one side and “500” on the other side containing 500 mg of nabumetone. Nabumetone Tablets are available as dark yellow, oval shaped, film coated, unscored tablets, debossed “double triangle”“4099”on one side and “750” on the other side containing 750 mg of nabumetone. They are supplied by Altura Pharmaceuticals, Inc. as follows: PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure (as required). Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59-86°F) in well-closed container; dispense in light resistant container. Manufactured by: Par Pharmaceutical, Inc Spring Valley, NY 10977 Distributed by: Major Pharmaceuticals Livonia, MI 48150 This Product was Repackaged By: Altura Pharmaceuticals, Inc. 12540 McCann Drive Santa Fe Springs, CA 90670 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NABUMETONE - NABUMETONE TABLET
ALTURA PHARMACEUTICALS, INC.
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NABUMETONE TABLETS
BOXED WARNING
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
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).
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-butanone.
It has the following structure:
CHEMICAL STRUCTURE
C
H O
M.W. 228.3
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 nabumetone tablet, for oral administration, contains 500 mg or
750 mg of nabumetone and has the
following inactive ingredients: colloidal silicon dioxide, D&C yellow
#10 aluminum lake,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.
In addition, the 750 mg contains
FD&C yellow #6 aluminum lake.
CLINICAL PHARMACOLOGY
15
16
2
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic
and antipyretic properties in pharmacologic studies. As with other
nonsteroidal anti-inflammatory
agents, its mode of action