NABUMETONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

direct rx

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). In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS].

Product summary:

Nabumetone tablets USP, 500 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘465’ on other side. Nabumetone tablets USP, 750 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘466’ on other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in well-closed container; dispense in light-resistant container. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Revised: 07/19

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

direct rx
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Medication Guide
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal
Antiinflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
• with increasing doses of NSAIDs
• with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG)."
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
• anytime during use
• without warning symptoms
• that may cause death
The risk of getting an ulcer or bleeding increases with:
• past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
• taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs”, or “SNRIs”
• increasing doses of NSAIDs
• longer use of NSAIDs
• smoking
• drinking alcohol
• older age
• poor health
• advanced liver disease
• bleeding problems
NSAIDs should only be used:
• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
• if you have had an asthma attack, hives, or other allergic
reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your
medical conditions, incl

Summary of Product characteristics

NABUMETONE- NABUMETONE TABLET
DIRECT RX
----------
NABUMETONE
BOXED WARNING
Cardiovascular Risk
• 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).
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-
naphthalenyl)-2-butanone. It has the following structure:
[structure1]
Nabumetone is a white or almost white crystalline substance with a
molecular weight of
228.3. It is nonacidic, freely soluble in acetone, sparingly soluble
in alcohol and in
methanol, practically insoluble in water. It has an
n-octanol:phosphate buffer partition
coefficient of 2400 at pH 7.4.
Tablets for Oral Administration: Each white coloured, oval shaped,
biconvex, film coated
tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients
consists of
hypromellose, microcrystalline cellulose, sodium lauryl sulfate,
sodium starch glycolate
and opadry white OY 58900 [hypromellose, polyethylene glycol 400, and
titanium
dioxide].
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 compo