NAPROXEN SODIUM tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Available from:

Actavis Pharma, Inc.

INN (International Name):

NAPROXEN SODIUM

Composition:

NAPROXEN 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen sodium extended-release tablets are indicated for the treatment of: - rheumatoid arthritis (RA) - osteoarthritis (OA) - ankylosing spondylitis (AS) - tendinitis, bursitis - acute gout - primary dysmenorrhea (PD) - the relief of mild to moderate pain [see Warnings and Precautions  (5) ] . Naproxen is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 )] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 )] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions  (5.1) ] Risk Summary Use of NSAIDs, including naproxen, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to

Product summary:

Naproxen sodium extended-release tablets are available as follows: 375 mg: white, unscored, round tablet imprinted with “Andrx 825 ”, in bottles of 100, NDC 62037-825-01. Each tablet contains 412.5 mg naproxen sodium, USP equivalent to 375 mg naproxen. 500 mg: white, unscored, capsule-shaped tablet imprinted with “Andrx 826 ”; in bottles of 75, NDC 62037-826-75. Each tablet contains 550 mg naproxen sodium, USP equivalent to 500 mg naproxen. 750 mg: white, unscored, capsule-shaped, film-coated tablets printed with “A750 ” on one side and plain on the other side, in bottles of 30, NDC 62037-827-30. Each tablet contains 825 mg naproxen sodium, USP equivalent to 750 mg naproxen. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PHARMACIST: Dispense in a well-closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
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Medication Guide
Dispense with Medication Guide available at: www.tevausa.com/medguides
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass
graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to.
You may have an increased risk of another heart attack if you take
NSAIDs after a recent heart
attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from
the mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass s

Summary of Product characteristics

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN SODIUM
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NAPROXEN SODIUM EXTENDED-RELEASE TABLETS.
NAPROXEN SODIUM EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1976
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH
CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE
WITH DURATION
OF USE (5.1)
NAPROXEN IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
SURGERY (4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 4/2021
INDICATIONS AND USAGE
Naproxen sodium extended-release tablets are a nonsteroidal
anti-inflammatory drug indicated for the
treatment of:
rheumatoid arthritis (RA)(1)
osteoarthritis (OA)(1)
ankylosing spondylitis (AS)(1)
tendinitis, bursitis (1)
acute gout (1)
primary dysmenorrhea (PD)(1)
the relief of mild to moderate pain (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
(2)
RA, OA, and AS: The dosage is two 375 mg or 500 mg tablets once daily,
or one 750 mg tablet once
daily.
Management of Pain, PD, and Acute Tendinitis and Bursitis: The dosage
is two 500 mg tablets o