NAPROXEN tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

REMEDYREPACK INC.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea Naproxen tablets and naproxen sodium 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,

ملخص المنتج:

Naproxen Tablets, USP, 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. Packaged in NDC: 70518-0807-00 30 in 1 BLISTER PACK NDC: 70518-0807-01 100 in 1 BOX NDC: 70518-0807-02 1 in 1 POUCH Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers. Naproxen Sodium Tablets, USP, 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ on the other side. Packaged in bottles of 100 and 500. Bottles of 100, NDC 68462-178-01 Bottles of 500, NDC 68462-178-05 Naproxen Sodium Tablets, USP, 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. Packaged in bottles of 100 and 500. Bottles of 100, NDC 68462-179-01 Bottles of 500, NDC 68462-179-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

NAPROXEN- NAPROXEN TABLET
REMEDYREPACK INC.
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MEDICATION GUIDE FOR NONSTEROIDAL
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:
•
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
NSAIDs should only be used:
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:
Before taking NSAIDS, tell your healthcare provider about all of your
medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take,
including prescription or over-the-counter
medicines, vitamins or herbal supplements. NSAIDs and some other
medicines can interact with each other
and cause serious side effects. Do not start taking any

خصائص المنتج

NAPROXEN- NAPROXEN TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS.
NAPROXEN TABLETS AND 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._
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 and naproxen sodium 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)
INDICATIONS AND USAGE
Naproxen tablets and naproxen sodium tablets are non-steroidal
anti-inflammatory drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
rheumatoid arthritis
os te oarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen tablets and naproxen sodium tablets are also indicated for:
(1)
the relief of signs and symptoms of: (1)
te ndonitis
burs itis
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 (one-half
tablet) 5