NAPROXEN- naproxen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 190” on obverse and “500” on the reverse. They are available as follows: 35356-682-30 35356-682-60 35356-682-90

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
----------
Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
Rev. 10-2008
MEDGUIDE
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(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”
•
drinking alcohol
and “anticoagulants”
•
longer use
•
older age
•
smoking
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
for the shortest time needed
•
at the lowest dose possible for your treatment
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 medicin

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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