NABUMETONE- nabumentone tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

INN (International Name):

NABUMETONE

Sammensetning:

NABUMETONE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets, USP. 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 the signs and symptoms of rheumatoid arthritis. - For relief of the signs and symptoms of osteoarthritis. Nabumetone is 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, General, Preexisting Asthma ). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Produkt oppsummering:

Nabumetone Tablets, USP, for oral administration, are available as 500 mg Oval-shaped, white film coated tablets, debossed “ E 145" on one side, plain on the other side and supplied as: NDC 0185-0145-01 bottles of 100 NDC 0185-0145-05 bottles of 500 750 mg Oval-shaped, white film coated tablets, debossed “ E 146" on one side, plain on the other side and supplied as: NDC 0185-0146-01 bottles of 100 NDC 0185-0146-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

REMEDYREPACK INC.
----------
MEDICATION GUIDE
for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Nabumetone Tablets, USP
(nah-BYOO-meh-tone)
What is the most important information I should know about medicines
called Non-Steroidal 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
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
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 healt

Preparatomtale

NABUMETONE- NABUMENTONE TABLET
REMEDYREPACK INC.
----------
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
WARNINGSand 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 (GI) events (see WARNINGS).
DESCRIPTION
Nabumetone is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-butanone.
It has the following structure:
NABUMETONE
Nabumetone is a white to off-white crystalline substance with a
molecular weight of 228.3. 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.
TABLETS FOR ORAL ADMINISTRATION
Each oval-shaped, film-coated tablet contains 500 mg or 750 mg of
nabumetone. Inactive ingredients
consist of colloidal silicon dioxide, croscarmellose sodium,
hypromellose, magnesium stearate,
microcrystalline cellulose, titanium dioxide, polyethylene glycol 400,
polysorbate 80 and sodium
lauryl sulfate.
CLINICAL PHARMACOLOGY
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 is not known. However, the ability to
inhibit prostaglandin synthesis may be
involved in the anti-inflammatory effect.