NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: the management of: Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including naproxen tablets or naproxen sodium tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including naproxen tablets or naproxen sodium tablets, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of naproxen tablets or naproxen sodium tablets in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of dr

Product summary:

Naproxen Tablets, USP, 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. Packaged in light-resistant bottles of 100 and 500. 20’s (bottle): NDC 68788-6842-2 30’s (bottle): NDC 68788-6842-3 60’s (bottle): NDC 68788-6842-6 90’s (bottle): NDC 68788-6842-9 100’s (bottle): NDC 68788-6842-1 120’s (bottle): NDC 68788-6842-8 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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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:
•
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 surgery.
Before taking NSAIDS, tell your healthcare provider about all of your

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS.
NAPROXEN TABLETS AND 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._
•
•
•
INDICATIONS AND USAGE
Naproxen tablets and naproxen sodium tablets are non-steroidal
anti-inflammatory drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
•
•
•
•
Naproxen tablets and naproxen sodium tablets are also indicated for:
(1)
the relief of signs and symptoms of: (1)
•
•
•
the management of: (1)
•
•
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals. (2.1)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
Naproxen tablets
250 mg (one-half
tablet) 500 mg
twice daily
Naproxen sodium tablets 275 mg (one-half
tablet) 550 mg
twice daily
The dose may be adjusted up or down depending on the clinical response
of the patient. In patients who tolerate lower
doses well, the dose may be increased to naproxen 1500 mg/ day for up
to 6 months.
Polyarticular Juvenile Idiopathic Arthritis
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 and naproxen sodium 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 fa