NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

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 tablets 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 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 Naproxen is 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 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 after taking aspirin o

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Naproxen Tablets USP, 250 mg are Rose Color, Round, Unscored Tablets, Imprinted "250/M25" on one side and "MOVA" on other side and are availble in: Unit dose box of 100 (NDC 0904-5535-61) Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablets, Debossed "IP188/250" and are available in: Unit dose box of 100 (NDC 0904-6069-61) Bottles of 100 tablets (NDC 0904-6069-60) Bottles of 500 tablets (NDC 0904-6069-40) Naproxen Tablets USP, 375 mg are White, Oblong, Unscored Tablets; Debossed 'West-ward 347" and are available in: Bottles of 100 tablets (NDC 0904-5590-60) Bottles of 500 tablets (NDC 0904-5590-40) Naproxen Tablets USP, 375 mg are White, Oval, Unscored Tablets; Debossed "IP189/375" and are available in: Unit dose box of 100 (NDC 0904-5590-61) Naproxen Tablets USP, 375 mg are White, Capsule-Shape, Unscored Tablets, Imprinted "375/M37" on one side and "MOVA" on other side and are available in: Unit dose box of 100 (NDC 0904-5536-61) Naproxen Tablets USP, 500 mg are White, Oblong Tablets; Debossed "West-ward 348" and are available in: Bottles of 100 tablets (NDC 0904-5591-60) Bottles of 500 tablets (NDC 0904-5591-40) Naproxen Tablets USP, 500 mg are White, Oval Tablets; Debossed "IP190/500" and are available in: Unit dose box of 100 (NDC 0904-5591-61). Naproxen Tablets USP, 500 mg are White, Capsule-Shape, Unscored Tablets, Imprinted "500/M50" on one side and "MOVA" on other side and are availble in: Unit dose box of 100 (NDC 0904-5537-61)

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
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 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

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
NAPROXEN TABLETS, USP
ATTENTION DISPENSER: ACCOMPANYING MEDICATION GUIDE MUST BE DISPENSED
WITH THIS
PRODUCT.
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 tablets are 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-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, USP is an odorless, white to off-white crystalline
substance. It is lipid-soluble in
chloroform, practically insoluble in water at low pH and freely
soluable in water at high pH. The
octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to
1.8.
Each naproxen tablet intended for oral administration contains 250 mg
or 375 mg or 500 mg of naproxen.
In addition, each tablet contains following inactive ingredients:
colloidal silicon dioxide, magnesium
stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and
sodium starch glycolate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS :
14
14
3
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and a