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:

DIRECT RX

INN (الاسم الدولي):

NAPROXEN SODIUM

تركيب:

NAPROXEN SODIUM 550 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 contraind

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 100: NDC 53746-193-01 Bottles of 500: NDC 53746-193-05 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 100: NDC 53746-194-01 Bottles of 500: NDC 53746-194-05 Store at 15° to 30°C (59° to 86°F) in well-closed containers. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 10-2008

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

DIRECT RX
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Revised: 1/2020
Document Id: 9ca99dc1-7125-65e1-e053-2a95a90a0be3
34391-3
Set id: 16705fc3-5379-4557-94b6-fc5bfbbbc6d1
Version: 3
Effective Time: 20200121
DIRECT RX

خصائص المنتج

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
DIRECT RX
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NAPROXEN SODIUM
BOXED WARNING
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 SECTION
Naproxen, USP is a propionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen sodium, USP is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid,
sodium salt. Naproxen sodium, USP has the following structure:
[Structural Formula]
Naproxen sodium, USP has a molecular weight of 252.23 and a molecular
formula of C14H13NaO3.
Naproxen sodium, USP is a white to creamy white, crystalline solid,
freely soluble in water at neutral
pH.
Naproxen sodium, USP is available as blue tablets containing 275 mg of
naproxen sodium, USP and as
blue tablets containing 550 mg of naproxen sodium, USP for oral
administration. The inactive
ingredients are croscarmellose sodium, macrogol, magnesium stearate,
polyvinly alcohol, povidone,
talc, titanium dioxide and FD&C Blue #2.
CLINICAL PHARMACOLOGY SECTION
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
ab