NAPROXEN tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Carilion Materials Management

INN (Alþjóðlegt nafn):

NAPROXEN

Samsetning:

NAPROXEN 375 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen tablets or naproxen sodium tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as naproxen tablets or naproxen sodium tablets are indicated: Naproxen as naproxen tablets or naproxen sodium tablets are also indicated: Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients:

Vörulýsing:

Product: 68151-2895 NDC: 68151-2895-0 1 TABLET in a PACKAGE

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

NAPROXEN- NAPROXEN TABLET
Carilion Materials Management
----------
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:
o
with increasing doses of NSAIDs
o
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:
o
any time during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”; or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 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
medical condit

Vara einkenni

NAPROXEN- NAPROXEN TABLET
CARILION MATERIALS MANAGEMENT
----------
NAPROXEN TABLETS, USP
NAPROXEN SODIUM TABLETS, USP
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Naproxen USP is a propionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical names for naproxen USP and naproxen sodium USP are
(S)-6-methoxy-α-methyl-2-
naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic
acid, sodium salt, respectively.
Naproxen USP and naproxen sodium USP have the following structures,
respectively:
Naproxen USP has a molecular weight of 230.26 and a molecular formula
of C
H O . Naproxen
sodium USP has a molecular weight of 252.23 and a molecular formula of
C
H NaO .
Naproxen USP is an odorless, white to off-white crystalline substance.
It is lipid-soluble, practically
insoluble in water at low pH and freely soluble in water at high pH.
The octanol/water partition
coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium USP
is a white to creamy white,
crystalline solid, freely soluble in water at neutral pH.
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. (_SEE WARNINGS_).
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS ARE CONTRAINDICATED IN
THE SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (_SEE CONTRAINDICATIONS,_
_WARNINGS_).
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