NAPROXEN- naproxen sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-Ward Pharmaceuticals Corp

INN (International Name):

NAPROXEN SODIUM

Composition:

NAPROXEN SODIUM 275 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen Sodium Tablets are indicated for: the relief of the signs and symptoms of:          • rheumatoid arthritis          • osteoarthritis          • ankylosing spondylitis          • Polyarticular Juvenile Idiopathic Arthritis Naproxen Sodium Tablets are also indicated for: the relief of signs and symptoms of:          • tendonitis          • bursitis          • acute gout the management of:          • pain          • primary dysmenorrhea Naproxen Sodium 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

Product summary:

Naproxen Sodium Tablets, USP 275mg are available as white, unscored, capsule shaped, film coated tablets imprinted “H 1” Supplied as: NDC 0143-9916-01 Bottles of 100’s Naproxen Sodium Tablets, USP 550 mg are available as white, unscored, capsule shaped, film coated tablets imprinted “H 2” Supplied as: NDC 0143-9908-01 Bottles of 100’s                    : NDC 0143-9908-05 Bottles of 500’s Store at 20-25°C(68-77°F) [See USP controlled room temperature]. Protect from light and moisture. Dispense in well-closed container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NAPROXEN- NAPROXEN SODIUM TABLET, FILM COATED
West-Ward Pharmaceuticals Corp
----------
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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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 surgery.
Before taking NSAIDS, tell

Summary of Product characteristics

NAPROXEN- NAPROXEN SODIUM TABLET, FILM COATED
WEST-WARD PHARMACEUTICALS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN SODIUM TABLETS 550 MG AND
275 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
NAPROXEN SODIUM TABLETS 550 MG AND
275 MG.
NAPROXEN SODIUM TABLETS 550 MG AND 275 MG, 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 TABLETS 550 MG AND 275 MG 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
Boxed Warning 05/2016
Warnings and Precautions (5.1, 5.5) 05/2016
INDICATIONS AND USAGE
Naproxen Sodium Tablets 550 mg and 275 mg are non-steroidal
anti-inflammatory drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
• rheumatoid arthritis (1)
• osteoarthritis (1)
• ankylosing spondylitis (1)
• polyarticular juvenile idiopathic arthritis (1)
Naproxen Sodium Tablets 550 mg and 275 mg are also indicated for: (1)
the relief of signs and symptoms of: (1)
• tendonitis (1)
• bursitis (1)
• acute gout (1)
the management of: (1)
• pain (1)
• primary dysmenorrhea (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest