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:

Alvogen Inc.

INN (International Name):

NAPROXEN SODIUM

Composition:

NAPROXEN 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen Sodium Controlled-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 Sodium Controlled-Release Tablets are 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 Sodium Controlled-Release Tablets, can cause premature closure o

Product summary:

Naproxen sodium 375 mg, 500 mg, and 750 mg are controlled-release tablets supplied as: 375 mg: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 47781-153-01. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen. 500 mg: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 47781-154-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen. 750 mg:  white, capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; NDC 47781-155-30.  Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen. Storage Store at room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. PHARMACIST:  Dispense in a well-closed container.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Alvogen Inc.
----------
MEDICATION GUIDE
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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
o taking medicines called "corticosteroids", "anticoagulants",
"SSRIs", or "SNRIs"
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical
conditions, including if you:
•
have liver or ki

Summary of Product characteristics

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN SODIUM
CONTROLLED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS.
NAPROXEN SODIUM CONTROLLED-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 SODIUM CONTROLLED-RELEASE TABLETS ARE 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)
INDICATIONS AND USAGE
Naproxen Sodium Controlled-Release Tablets is 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 once
daily. For patients requiri