NABUMETONE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Health Packaging

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 ). Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Prehľad produktov:

Nabumetone Tablets USP: 500 mg–White film-coated, oval-shaped biconvex tablets debossed with IG on one side and 257 on the other are supplied in: Unit dose packages of 30 (3 x 10) NDC 60687-630-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

NABUMETONE- NABUMETONE TABLET, FILM COATED
American Health Packaging
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
8463021/1223F
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
•
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 NS

Súhrn charakteristických

NABUMETONE- NABUMETONE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
NABUMETONE TABLETS, USP
RX ONLY
8463021/1223F
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, USP is a naphthylalkanone designated chemically as
4-(6-methoxy-2-
naphthalenyl)-2-butanone.
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 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,
1
1
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).
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal an