NAPROXEN ORAL SUSPENSION- naproxen oral suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novitium Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naproxen oral suspension is 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 oral suspension is 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 Cardiovascular Thrombotic Events)] Risk Summary Use of NSAIDs, including naproxen oral suspension, can cause premature closure of the fetal ductus arteriosus a

Product summary:

Naproxen oral suspension, USP: 125 mg/5 mL (contains 39 mg sodium) is available as: NDC 70954-151-10: 500 mL white colored light-resistant bottles. Storage 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]. Avoid excessive heat above 40°C (104°F). Dispense in light-resistant containers. Shake gently before use.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Novitium Pharma LLC
----------
MEDICATION GUIDE
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.
How should I take naproxen oralsuspension?
Use ONLY a calibrated m

Summary of Product characteristics

NAPROXEN ORAL SUSPENSION - NAPROXEN ORAL SUSPENSION
NOVITIUM PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR NAPROXEN ORAL
SUSPENSION.
NAPROXEN ORAL SUSPENSION, 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 ORAL SUSPENSION IS 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 oral suspension is a non-steroidal anti-inflammatory drug
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 dose for shortest duration consistent with
individual patient treatment goals. (2)
(2)
RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, AND ANKYLOSING
SPONDYLITIS
Naproxen
oralsuspension
250 mg (10 mL)
twice daily
or 375 mg (15 mL)
twice daily
or 500 mg (20 mL)
twice daily
The dose may be adjusted up or down depending on the clinical