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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Naproxen as naproxen tablets are indicated: Naproxen tablets are contraindicated in the following patients:

Product summary:

NaproxenTablets, USP, 375 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 189” on obverse and “375” on the reverse. They are available as follows: Bottles of 20:            NDC 68788-6421-2 Bottles of 30:            NDC 68788-6421-3 Bottles of 60:            NDC 68788-6421-6 Bottles of 90:            NDC 68788-6421-9 Bottles of 100:            NDC 68788-6421- 1 Bottles of 120:            NDC 68788-6421-8 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers as defined in the USP. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA  382220 Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 06-2016-01 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
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.
Be

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
PREFERRED PHARMACEUTICALS INC.
----------
NAPROXEN TABLETS, USP
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
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 _(SEE WARNINGS)._
DESCRIPTION
Naproxen, USP is a propionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen, USP is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen,
USP has the following structure:
Naproxen, USP has a molecular weight of 230.26 and a molecular formula
of C
H O .
Naproxen, USP is an odorless, white to off-white crystalline
substance. It is lipid-soluble, practically
insoluble in water at low pH and freely soluble in water at high pH.
The octanol/water partition
coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8.
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 _(SEE WARNINGS)._
NAPROXEN TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT
(CABG) SURGERY _(SEE CONTRAINDICATIONS, WARNINGS)._
14
14
3
Naproxen, USP is available as white tablets containing 250 mg of
naproxen, USP, white tablets
containing 375 mg of naproxen, USP and white tablets containing 500 mg
of naproxen, USP for oral
administration. The inactive ingredients are croscarmellose sodium,
povidone and magnesium stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Naproxen has analgesic, anti-