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:

STAT Rx USA LLC

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 and other treatment options before deciding to use naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). 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 Naproxen sodium 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 sodium is contraindicated in patients with known hypersensitivity to naproxen and naproxen sodium. Naproxen sodium should not be given to patients who have expe

Product summary:

Naproxen Sodium Tablets USP, 550 mg is available as white, unscored, capsule shaped, film coated tablets imprinted "H 2" Bottles of 20 - NDC # 16590-165-20 Bottles of 30 - NDC # 16590-165-30 Bottles of 60 - NDC # 16590-165-60 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Revised September 2009 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA 30501

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

STAT Rx USA LLC
----------
MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDSS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a 'coronary artery
bypass graft (CABG).'
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called 'corticosteroids' and 'anticoagulants'
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines should not be used

Summary of Product characteristics

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
STAT RX USA LLC
----------
NAPROXEN SODIUM TABLETS, USP
RX ONLY
09/09
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 sodium 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 sodium is a member of the arylacetic acid group of
nonsteroidal anti-inflammatory drugs.
The chemical name for naproxen sodium is (-)-Sodium
6-methoxy-α-methyl-2-naphthaleneacetate. It has
the following structural formula:
Naproxen sodium is a white to creamy, crystalline solid, freely
soluble in water at neutral pH.
Each film coated tablet, for oral administration, contains 275 mg or
550 mg naproxen sodium, equivalent
to 250 mg or 500 mg naproxen with 25 mg (about 1 mEq) or 50 mg (about
2 mEq) of sodium
respectively. In addition, each tablet contains the following inactive
ingredients: colloidal silicon
dioxide, croscarmellose sodium hydrogenated vegetable oil, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone (K-30) and sodium lauryl sulfate.
The film coating contains: hydroxypropyl methylcellulose 2910,
methacrylic acid copolymer, povidone
(K-30), simethicone emulsion, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The