NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Liberty Pharmaceuticals, Inc.

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP is 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 Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen. Naproxen Tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type rea

Product summary:

Naproxen Tablets, USP: 500 mg : white, capsule-shaped, biconvex, debossed with “IP 190” on obverse and “500” on the reverse. Bottles of 14 NDC: 0440-7852-14 Bottles of 20 NDC: 0440-7852-20 Bottles of 30 NDC: 0440-7852-30 Bottles of 60 NDC: 0440-7852-60 Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
LIBERTY PHARMACEUTICALS, INC.
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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 fate. This risk may increase with
duration of use. Patient
with cardiovascular disease or risk factor for cardiovascular disease
may be at great risk (see
WARNINGS).
Naproxen as Naproxen Tablets, USP is contraindicated for the treatment
of peri0operative
pain in the setting of coronary artery bypass graft (CABG) surgery
(see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause increased risk of serious gastrointestinal adverse event
including, 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 proprionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the
following structure:
Naproxen has a molecular weight of 230.26 and a molecular formula of C
H O .
Naproxen is an 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 white tablets containing 250 mg
of naproxen, white tablets
containing 375 mg of naproxen and white tablets containing 500 mg of
naproxen for oral administration.
The inactive ingredients are Croscarmellose Sodium, Povidone and
Magnesium Stearate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
14
14
3
The mechanism of action of the naproxen anion, like that of other
NSAIDs, is not completely understood
but m