NAPROXEN SODIUM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Proficient Rx LP

INN（国际名称）:

NAPROXEN SODIUM

组成:

NAPROXEN SODIUM 550 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis • For relief of the signs and symptoms of tendonitis • For relief of the signs and symptoms of bursitis • For relief of the signs and symptoms of acute gout • For the management of pain • For the management of primary dysmenorrhea Naproxen Sodium Tablets, USP are contrain

產品總結:

Naproxen Sodium Tablets, USP 550 mg are blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse. They are available as follows: Bottles of 60: NDC 63187-121-60 Store at 15° to 30°C (59° to 86°F) in well-closed containers.

授权状态:

Abbreviated New Drug Application

资料单张

Proficient Rx LP
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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
•
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 about all of your

产品特点

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
PROFICIENT RX LP
----------
NAPROXEN SODIUM TABLETS, USP 275 MG AND 550 MG
RX ONLY
DESCRIPTION
Naproxen is a propionic acid derivative related to the arylacetic acid
group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen sodium is (S)-6-methoxy-
-methyl-2-naphthalene acetic acid, sodium
salt. Naproxen sodium has the following structure:
Naproxen sodium has a molecular weight of 252.23 and a molecular
formula of C14H13NaO3.
Naproxen sodium is a white to creamy white, crystalline solid, freely
soluble in water at neutral pH.
Naproxen Sodium Tablets, USP are available as blue tablets containing
275 mg of naproxen sodium and
as blue tablets containing 550 mg of naproxen sodium. The inactive
ingredients are
croscarmellose sodium, macrogol, magnesium stearate, polyvinly
alcohol, povidone, talc, titanium
dioxide and FD&C Blue #2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The sodium salt of naproxen has been developed as a more rapidly
absorbed formulation of naproxen
for use as an analgesic. The mechanism of action of the naproxen
anion, like that of other NSAIDs, is
not completely understood but may be related to prostaglandin
CARDIOVASCULAR RISK• NSAIDs may cause an increased risk of serious
cardiovascular
thrombotic events, myocardial infarction, and stroke, which can be
fatal. This risk may increase
with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular
disease may be at greater risk (see WARNINGS ).• Naproxen as
Naproxen Sodium Tablets, USP
is contraindicated for the treatment of peri-operative pain in the
setting of coronary artery bypass
graft (CABG) surgery (see WARNINGS ). GASTROINTESTINAL RISK • NSAIDs
cause an increased
risk of serious gastrointestinal adverse events including bleeding,
ulceration, and perforation of
the stomach or intestines, which can be fatal. These events can occur
at any time during u