NAPROXEN - naproxen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Citron Pharma LLC

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of naproxen tablets USP and other treatment options before deciding to use naproxen tablets USP. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ) . Naproxen tablets USP are indicated: - For the relief of the signs and symptoms of rheumatoid arthritis  - For the relief of the signs and symptoms of osteoarthritis  - For the relief of the signs and symptoms of ankylosing spondylitis  - For the relief of the signs and symptoms of juvenile arthritis  Naproxen tablets USP are also indicated: - For relief of the signs and symptoms of tendonitis  - For relief of the signs and symptoms of bursitis  - For relief of the signs and symptoms of acute gout  - For the management of pain  - For the management of primary dysmenorrhea Naproxen tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic

Product summary:

Naproxen Tablets USP, 250 mg are yellow colored mottled, biconvex, beveled edged round shape, uncoated tablets debossed with ‘T’ & ‘18’ on either side of breakline on one side and other side plain.                Bottles of 100                          NDC 57237-214-01                Bottles of 500                          NDC 57237-214-05                Bottles of 1,000                       NDC 57237-214-99 Naproxen Tablets USP, 375 mg are yellow colored mottled, biconvex, oval shaped, uncoated tablets debossed with ‘T’ & ‘19’ on one side and other side plain.                 Bottles of 100                          NDC 57237-215-01                Bottles of 500                          NDC 57237-215-05                Bottles of 1,000                       NDC 57237-215-99 Naproxen Tablets USP, 500 mg are yellow colored mottled, biconvex, capsule shaped, uncoated tablets debossed with ‘T’ & ‘20’ on either side of breakline on one side and other side plain.                 Bottles of 100                          NDC 57237-216-01                Bottles of 500                          NDC 57237-216-05 Store at 20° to 25°C (68° to 77°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers.  Distributed by: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/22/2009 Made in India Issued: 06/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Citron Pharma LLC
----------
MEDICATION GUIDE FOR NON-STEROIDAL 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
•
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 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
medical condit

Summary of Product characteristics

NAPROXEN - NAPROXEN TABLET
CITRON PHARMA LLC
----------
NAPROXEN TABLETS USP
RX ONLY
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
• 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 IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG)
SURGERY (SEE CONTRAINDICATIONS, WARNINGS).
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 is a propionic acid derivative related to the arylacetic acid
group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
Naproxen has a molecular weight of 230.26 and a molecular formula of C
H O .
Naproxen USP is a white to off-white, practically odorless,
crystalline powder. 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 at pH 7.4 is 1.6 to 1.8.
Naproxen tablets USP are available as yellow tablets containing 250
mg, 375 mg, and 500 mg of
14
14
3
naproxen for oral administration. The inactive ingredients are corn
starch, ferric oxide, lactose
monohydrate, magnesium stearate, povidone, and sodium starch
glycolate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Naproxen has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of