NAPROXEN tablet, delayed release

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 delayed-release tablets are indicated for: The relief of the signs and symptoms of: Naproxen delayed-release tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including naproxen delayed-release tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including naproxen, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of naproxen delayed-release 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 drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. In animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal har

Product summary:

Naproxen Delayed-Release Tablets USP are supplied as follows: 375 mg: White to off-white, capsule-shaped, enteric-coated, unscored tablets imprinted on one side in blue ink with 93-5. They are available; in bottles of 20 (NDC 68788-7072-2) in bottles of 30 (NDC 68788-7072-3) in bottles of 60 (NDC 68788-7072-6) in bottles of 90 (NDC 68788-7072-9) in bottles of 100 (NDC 68788-7072-1) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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 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 surgery.
Before taking NSAIDs, tell your healthcare provider about all of your

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN DELAYED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN
DELAYED-RELEASE TABLETS.
NAPROXEN DELAYED-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._
•
•
•
INDICATIONS AND USAGE
Naproxen delayed-release tablets are non-steroidal anti-inflammatory
drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
•
•
•
•
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals. (2.1) (2)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis (2)
Naproxen Delayed-Release Tablets (2)
375 mg or 500 mg (2)
twice daily (2)
To maintain the integrity of the enteric coating, the naproxen
delayed-release tablet should not be broken, crushed or
chewed during ingestion. (2)
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. (2)
Acute Gout
Naproxen delayed-release tablets are not recommended because of the
delay in absorption. (2)
DOSAGE FORMS AND STRENGTHS
Naproxen Delayed-Release Tablets USP: 375 mg and 500 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if abnormal liver tests
persist or worsen or if clinical signs and symptoms of liver disease
develop. (5.3)
Hypertension: Patients taking some antihypertensive medications may
have impaired response to these therapies when
taking NSAIDs. Monitor blood pressure. (5.4, 7)
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS CARDIOVA