NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Biomes Pharmaceuticals

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Naproxen Tablets 250 mg: white to off-white, round shaped tablet with “138” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-138-16 500’s (bottle): NDC 69150-138-15 1000's (bottle): NDC 69150-138-14 375 mg: white to off-white, oval shaped tablet with “139” debossed on one side and plain on other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-139-16 500’s (bottle): NDC 69150-139-15 1000's (bottle): NDC 69150-139-14 500 mg: white to off-white, capsule-shaped tablets with “140” debossed on one side and scored on the other side. Packaged in light-resistant bottles of 100, 500 and 1000. 100's (bottle): NDC 69150-140-16 500’s (bottle): NDC 69150-140-15 1000's (bottle): NDC 69150-140-14 Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers. Rx only Manufactured for: Biomes Pharmaceuticals LLC Lansing, MI 48912, USA Manufactured by: Marksans Pharma Ltd. Verna, Goa – 403 722, India Iss. 11/11 MG #31790

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
BIOMES PHARMACEUTICALS
----------
NAPROXEN - 138, 139, 140
BOXED WARNINGS
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 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 proprionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs. The chemical name for naproxen is
(S)-6-methoxy-_-methyl-2-naphthaleneacetic
acid. It has the following structure:
Naproxen has a molecular weight of 230.26 and a molecular formula of
C14H14O3. 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 are available as white tablets
containing 250 mg, 375 mg and 500
mg of naproxen for oral administration. The inactive ingredients are
croscarmellose sodium, povidone
and magnesium stearate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
PHARMACKINETICS
ABS ORPTION
DIS TRIBUTION
METABOLIS M
EXCRETION
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The mechanism of action of the naproxen anion, like that of other
NSAIDs, is not completely understood
but may