naproxen- Naproxen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naproxen (UNII: 57Y76R9ATQ) (Naproxen - UNII:57Y76R9ATQ)

Available from:

Watson Labs

INN (International Name):

Naproxen

Pharmaceutical form:

TABLET

Composition:

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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen tablets are indicated: - For relief of mild to moderate pain For relief of mild to moderate pain - For relief of signs and symptoms of juvenile arthritis For relief of signs and symptoms of juvenile arthritis - For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of rheumatoid arthritis - For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of osteoarthritis - For treatment of primary dysmenorrhea For treatment of primary dysmenorrhea - For acute or long-term use in the relief of signs and symptoms of the following: Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis For acute or long-

Product summary:

Naproxen Tablets USP are supplied as follows: 250 mg tablets: White to off-white, round, convex tablet debossed WATSON in an arc around the top edge and 821 across the bottom on one side and plain on the other side, in bottles of 100. 375 mg tablets: Gray, capsule-shaped tablet debossed WATSON over 822 on one side and plain on the other side, in bottles of 100 and 500. 500 mg tablets: White to off-white, capsule-shaped tablet debossed WATSON over 791 on one side and plain on the other side, in bottles of 100 and 500. Store at 20o -25o C (68o -77o F). [See USP controlled room temperature.] Dispense in a well-closed, light-resistant container as defined in USP/NF. Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Revised: August 2005

Patient Information leaflet

Watson Labs
----------
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” 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 use 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
pr

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
WATSON LABS
----------
NAPROXEN TABLETS USP
REVISED: AUGUST 2005
RX ONLY
BOXED WARNING
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 and CLINICAL TRIALS.)
Naproxen is contraindicated for the treatment of peri-operative pain
in the setting of coronary
artery bypass graft (CABG) surgery (see WARNINGS).
1
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 member of the arylacetic acid group of nonsteroidal
anti-inflammatory drugs.
The chemical name for naproxen is
(+)-_(S_)-6-Methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
C
H 0
MW=230.26
Naproxen is a practically 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.
Each tablet for oral administration contains 250 mg, 375 mg or 500 mg
of naproxen. In addition, each
1
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-inflammatory
drug.
14
14
3
tablet contains the following inactive ingredients: croscarmellose
sodium, magnesium stearate,
povidone, synthetic black iron oxide (375 mg only), synthetic red iron
oxide (375 mg only) and synthetic
yellow iron oxide (375 mg only).
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyret