NAPROXEN SODIUM tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

متاح من:

Aidarex Pharmaceuticals LLC

INN (الاسم الدولي):

NAPROXEN SODIUM

تركيب:

NAPROXEN SODIUM 275 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis • For relief of the signs and symptoms of tendonitis • For relief of the signs and symptoms of bursitis • For relief of the signs and symptoms of acute gout • For the management of pain • For the management of primary dysmenorrhea Naproxen Sodium Tablets, USP are contrain

ملخص المنتج:

Naproxen Sodium Tablets, USP 275 mg are blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse. They are available as follows: Bottles of 60: NDC 33261-0084-60 Bottles of 90: NDC 33261-0084-90 Naproxen Sodium Tablets, USP 550 mg are blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse. They are available as follows: Bottles of 14: NDC 33261-0085-14 Bottles of 20: NDC 33261-0085-20 Bottles of 21: NDC 33261-0085-21 Bottles of 30: NDC 33261-0085-30 Bottles of 60: NDC 33261-0085-60 Bottles of 84: NDC 33261-0085-84 Bottles of 90: NDC 33261-0085-90 Bottles of 100: NDC 33261-0085-00 Bottles of 120: NDC 33261-0085-02 Store at 15° to 30°C (59° to 86°F) in well-closed containers.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
AIDAREX PHARMACEUTICALS LLC
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NAPROXEN SODIUM TABLETS, USP 275 MG AND 550 MG
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 as Naproxen Sodium Tablets, USP is
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).
DESCRIPTION
Naproxen is a propionic acid derivative related to the arylacetic acid
group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen sodium is (S)-6-methoxy-
-methyl-2-naphthalene acetic acid, sodium
salt. Naproxen sodium has the following structure:
Naproxen sodium has a molecular weight of 252.23 and a molecular
formula of C14H13NaO3.
Naproxen sodium is a white to creamy white, crystalline solid, freely
soluble in water at neutral pH.
Naproxen Sodium Tablets, USP are available as blue tablets containing
275 mg of naproxen sodium and
as blue tablets containing 550 mg of naproxen sodium. The inactive
ingredients are
croscarmellose sodium, macrogol, magnesium stearate, polyvinly
alcohol, povidone, talc, titanium
dioxide and FD&C Blue #2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The sodium salt of naproxen has been developed as a more rapidly
absorbed formulation of naproxen
for use as an analgesic. The mechan