NABUMETONE tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Direct_Rx

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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: Pre-existing Asthma:) Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Резиме производа:

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 100 and 500 750 mg-Beige colored, film-coated, oval-shaped biconvex tablets debossed with IG on one side and 258 on the other are supplied in bottles of 100 , and 500

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

NABUMETONE- NABUMETONE TABLET, FILM COATED
Direct_Rx
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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 about all of your
medical conditions, including if
you:
•
hav

Карактеристике производа

NABUMETONE- NABUMETONE TABLET, FILM COATED
DIRECT_RX
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NABUMETONE
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
NSAIDs1 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).
1Throughout this package insert, the term NSAID refers to a
non-aspirin non-steroidal anti-
inflammatory drug.
1Throughout this package insert, the term NSAID refers to a
non-aspirin non-steroidal anti-
inflammatory drug.
Nabumetone USP is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-
butanone. It has the following structure:
[structure]
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,
hydroxy 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).
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID)