NAPROXEN SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

NAPROXEN SODIUM

Composition:

NAPROXEN SODIUM 550 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 21695-090-14 Bottles of 20: NDC 21695-090-20 Bottles of 28 NDC 21695-090-28 Bottles of 30 NDC 21695-090-30 Bottles of 56 NDC 21695-090-56 Bottles of 60 NDC 21695-090-60 Bottles of 90 NDC 21695-090-90 Store at 15° to 30°C (59° to 86°F) in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
REBEL DISTRIBUTORS CORP
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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 mechanism