NABUMETONE tablet film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Unit Dose Services

INN (Nama Internasional):

NABUMETONE

Komposisi:

NABUMETONE 750 mg

Jenis Resep:

PRESCRIPTION DRUG

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

NABUMETONE- NABUMETONE TABLET, FILM COATED
UNIT DOSE SERVICES
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NABUMETONE TABLETS USP
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:
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,
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).
1
1
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 anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory,
analgesic, and antipyretic pro