NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

RPK Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen Tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea Naproxen tablets 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) ] Risk Sum

Product summary:

Product: 53002-3113 NDC: 53002-3113-1 10 TABLET in a BOTTLE NDC: 53002-3113-2 14 TABLET in a BOTTLE NDC: 53002-3113-3 15 TABLET in a BOTTLE NDC: 53002-3113-4 20 TABLET in a BOTTLE NDC: 53002-3113-5 30 TABLET in a BOTTLE NDC: 53002-3113-6 60 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

                                RPK Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 5/2021
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?
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (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 rea
                                
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Summary of Product characteristics

                                NAPROXEN- NAPROXEN TABLET
RPK PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN
TABLETS.
NAPROXEN 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 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
Warnings and Precautions ( 5.10, 5.11)
04/2021
INDICATIONS AND USAGE
Naproxen tablets are non-steroidal anti-inflammatory drugs indicated
for:
the relief of the signs and symptoms of: (1)
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of: (1)
pain
primary dysmenorrhea
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
375 mg
500 mg
twice daily
twice daily
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
                                
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