NAPROXEN tablet EC-NAPROXEN- naproxen tablet, delayed release NAPROXEN SODIUM DS- naproxen sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Woodward Pharma Services LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis NAPROXEN Tablets and NAPROXEN SODIUM are also indicated for: the relief of signs and symptoms of: - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM 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)] .

Product summary:

NAPROXEN (naproxen) tablets 500 mg: yellow, capsule-shaped tablets, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100. Supplied as: NDC 69784-505-01 100’s (bottle) Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. EC-NAPROXEN (naproxen) delayed-release tablets 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. Packaged in light-resistant bottles of 100. Supplied as: NDC 69784-501-01 100’s (bottle) 500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. Packaged in light-resistant bottles of 100. Supplied as: NDC 69784-500-01 100’s (bottle) Store at 15°C to 30°C (59°F to 86°F) in well-closed containers; dispense in light-resistant containers. NAPROXEN SODIUM (naproxen sodium) Tablets 550 mg: dark blue, oblong-shaped tablets, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100. Supplied as: NDC 69784-550-01 100’s (bottle) Store at 15° to 30°C (59° to 86°F) in well-closed containers.

Authorization status:

New Drug Application

Patient Information leaflet

NAPROXEN- NAPROXEN TABLET
EC-NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NAPROXEN SODIUM DS- NAPROXEN SODIUM TABLET
Woodward Pharma Services LLC
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Non-Steroidal 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:
•
any time 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.
•

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
EC-NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NAPROXEN SODIUM DS- NAPROXEN SODIUM TABLET
WOODWARD PHARMA SERVICES LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS, EC-
NAPROXEN AND NAPROXEN SODIUM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR NAPROXEN, EC-NAPROXEN AND NAPROXEN SODIUM.
NAPROXEN (NAPROXEN) TABLETS,
EC-NAPROXEN (NAPROXEN DELAYED-RELEASE TABLETS),
NAPROXEN SODIUM (NAPROXEN SODIUM 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 TABLETS, EC-NAPROXEN AND NAPROXEN SODIUM 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)
RECENT MAJOR CHANGES
Boxed Warning 05/2016
Warnings and Precautions (5.1, 5.5) 05/2016
INDICATIONS AND USAGE
NAPROXEN Tablets, EC-NAPROXEN, and NAPROXEN SODIUM are non-steroidal
anti-inflammatory drugs
indicated for: (1)
the relief of the signs and symptoms of: (1)
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
NAPROXEN Tablets and NAPROXEN SODIUM are also indicated for: (1)
the relief of signs and symptoms of: (1)
tendonitis
bursitis
acute gout
the management of: (1)
pain
primary