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:

Bryant Ranch Prepack

INN (International ime):

NABUMETONE

Sastav:

NABUMETONE 500 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NABUMETONE- NABUMETONE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
NABUMETONE TABLETS USP
1015
1016
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
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.
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].
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).
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1
15
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CLINICAL PHARMACOLOGY
Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory,
analgesic, and antipyretic propertie