NAPROXEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)

Tilgjengelig fra:

McKesson Contract Packaging

INN (International Name):

NAPROXEN

Sammensetning:

NAPROXEN 500 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NAPROXEN- NAPROXEN TABLET
MCKESSON CONTRACT PACKAGING
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NAPROXEN 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).
Naproxen 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
Naproxen is a propionic acid derivative related to the arylacetic acid
group of non-steroidal anti-
inflammatory drugs.
The chemical name for naproxen is
(+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
C
H O M.W. 230.26
Naproxen is a practically odorless, white to off-white crystalline
substance. It is lipid-soluble,
practically insoluble in water at low pH and freely soluble in water
at high pH. The octanol/water
partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen tablets USP are available as mottled light-red tablets
containing 250 mg of naproxen; mottled
peach tablets containing 375 mg of naproxen; and mottled light-red
tablets containing 500 mg of
naproxen for oral administration. In addition, each tablet contains
the following inactive ingredients:
corn starch, croscarmellose sodium, magnesium stearate, povidone, red
ferric oxide, and yellow ferric
oxide.
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CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a n