NAPROXEN SODIUM tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

थमां उपलब्ध:

Proficient Rx LP

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: the management of: Naproxen sodium tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including naproxen sodium, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including naproxen sodium in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of naproxen sodium 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 harm when naproxen was ad

उत्पाद समीक्षा:

Naproxen Sodium Tablets USP, 550 mg are dark blue color, modified capsule shaped, film-coated tablets engraved with “T & 22” on either side of scoreline on one side & with scoreline on the other side.           Bottles of 15                       NDC 71205-479-15            Bottles of 30                       NDC 71205-479-30            Bottles of 60                       NDC 71205-479-60            Bottles of 90                       NDC 71205-479-90        Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED
Proficient Rx LP
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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
•
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.
Before taking NSAIDs, tell your

उत्पाद विशेषताएं

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN SODIUM TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN SODIUM
TABLETS.
NAPROXEN SODIUM 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 sodium tablets are non-steroidal anti-inflammatory drugs
indicated for: (1)
the relief of the signs and symptoms of: (1)
•
•
•
•
•
•
•
the management of: (1)
•
•
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 sodium tablets
275 mg
550 mg
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 naproxen sodium 1650 mg (equivalent to 1500 mg
naproxen) per day for up to 6 months.
Polyarticular Juvenile Idiopathic Arthritis
Naproxen tablets may not allow for the flexible dose titration needed
in pediatric patients with polyarticular juvenile
idiopathic arthritis. A liquid formulation may be more appropriate.
Recommended total daily dose of naproxen is
approximately 10 mg/kg given in 2 divided doses. Dosing with naproxen
tablets is not appropriate for children weighing
less than 50 kilograms.
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and
Bursitis
Recommended starting dose 550 mg of naproxen sodium as naproxen sodium
tablets followed by 550 mg every 12 hours
or 275 mg every 6 to 8 hours as required. The initial total daily dose
should not exceed 1375 mg of naproxen sodium.
Thereafter, the total daily dose should not exceed 1100 mg of naproxen
sodium. Naproxen sodium tablets are
reco