NABUMETONE tablet film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Cardinal Health

ІПН (Міжнародна Ім'я):

NABUMETONE

Склад:

NABUMETONE 500 mg

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

NABUMETONE- NABUMETONE TABLET, FILM COATED
CARDINAL HEALTH
----------
NABUMETONE TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of
use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at
greater risk (see WARNINGS).
Nabumetone tablets are contraindicated for the treatment of
peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery (see 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 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 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. 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 pharmacologic studies. As
with ot