NABUMETONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of nabumetone tablets, USP 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, USP 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 ). Nabumeto

Product summary:

Nabumetone Tablets, USP: Nabumetone tablets USP, 500 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘465’ on other side. Bottles of 20 NDC70934-847-20 Bottles of 60 NDC70934-847-60 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]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Revised: 11/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Denton Pharma, Inc. DBA Northwind Pharmaceuticals
----------
Medication Guide
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
Inflammatory 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

Summary of Product characteristics

NABUMETONE- NABUMETONE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
NABUMETONE TABLETS USP
RX ONLY
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).
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. It has the following structure:
Nabumetone, USP 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.
Each tablet, for oral administration contains either 500 mg or 750 mg
of nabumetone,
USP. In addition, each tablet contains the following inactive
ingredients: hypromellose,
microcrystalline cellulose, sodium lauryl sulfate, sodium starch
glycolate, polyethylene
1
1
microcrystalline cellulose, sodium lauryl sulfate, sodium starch
glycolate, polyethylene
glycol and titanium dioxide.
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-
inflammatory, analgesic, and antipyretic properties in pharma