NABUMETONE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Amneal Pharmaceuticals of New York LLC

INN (International ime):

NABUMETONE

Sastav:

NABUMETONE 500 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 signs and symptoms of osteoarthritis and rheumatoid arthritis. Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or product 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 ).

Proizvod sažetak:

Nabumetone Tablets USP are available as follows: 500 mg: White, oval-shaped, unscored, film-coated tablet debossed with the numbers “93” on one face of the tablet and “15” on the other. They are available in bottles of 100 tablets (NDC 0115-1657-01) and 1000 tablets (NDC 0115-1657-03). 750 mg: Beige, oval-shaped, unscored, film-coated tablet debossed with the numbers “93” on one face of the tablet and “16” on the other. They are available in bottles of 100 tablets (NDC 0115-1658-01) and 1000 tablets (NDC 0115-1658-03). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Distributed by: Impax Generics Hayward, CA 94544 Rev. V 6/2016

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Amneal Pharmaceuticals of New York LLC
----------
Medication Guide for Nonsteroidal 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 effect,
including:
•
Increased risk of a heart attack or
stroke that can lead to death. The
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
healthcare provider about all of

Svojstava lijeka

NABUMETONE- NABUMETONE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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, USP is a naphthylalkanone designated chemically as
4-(6-methoxy-2-naphthalenyl)-2-
butanone. It has the following structure:
C
H O M.W. 228.3
Nabumetone, USP 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 2,400 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: colloidal
silicon dioxide, hypromellose,
microcrystalline cellulose, polyethylene glycol, sodium lauryl
sulphate, sodium starch glycolate, talc,
and titanium dioxide. The 750 mg tablets also contain black iron
oxide, red iron oxide, and yellow iron
oxide.
CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory,
analgesic, and antipyretic properties in ph