NAPROXEN tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Preferred Pharmaceuticals Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Naproxen Tablets USP, 500 mg , are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 190” on obverse and “500” on the reverse. They are available as follows: Bottles of 14:            NDC 68788-7090-7 Bottles of 15:            NDC 68788-7090-5 Bottles of 20:            NDC 68788-7090-2 Bottles of 30:            NDC 68788-7090-3 Bottles of 40:            NDC 68788-7090-4 Bottles of 60:            NDC 68788-7090-6 Bottles of 90:            NDC 68788-7090-9 Bottles of 100:           NDC 68788-7090-1 Bottles of 120:           NDC 68788-7090-8 Store at 20° to 25°C (68° to 77°F); excursions permitted between 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.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(Naproxen Tablets)
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 healthcare provider a

Produkta apraksts

NAPROXEN- NAPROXEN TABLET
PREFERRED PHARMACEUTICALS INC.
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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._
•
•
•
INDICATIONS AND USAGE
Naproxen tablets are non-steroidal anti-inflammatory drugs 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 (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 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 naproxen 1,500
mg/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.
Acute Gout
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