NAPROXEN SODIUM tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

New Horizon Rx Group, LLC

INN（国际名称）:

NAPROXEN SODIUM

组成:

NAPROXEN SODIUM 550 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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: Naproxen Sodium Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium. Naproxen Sodium Tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma). Naproxen Sodium Tablets, USP are contraindicated for the treatment of peri

產品總結:

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 30: NDC 58517-300-30 Store at 15° to 30°C (59° to 86°F) in well-closed containers. Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 1-855-465-5545 Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Rev. 11/13

授权状态:

Abbreviated New Drug Application

产品特点

NAPROXEN SODIUM - NAPROXEN SODIUM TABLET, FILM COATED
NEW HORIZON RX GROUP, LLC
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NAPROXEN SODIUM 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 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 C
H NaO .
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
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 mechanism of action of the naproxen
anion, like that of other NSAIDs