NAPROXEN tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Aidarex Pharmaceuticals LLC

Designació comuna internacional (DCI):

NAPROXEN

Composición:

NAPROXEN 375 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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: -   •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 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 Naproxen as naproxen tablets or naproxen sodium tablets are also in

Resumen del producto:

375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 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 containers. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Aidarex Pharmaceuticals LLC
----------
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:
•
owith increasing doses of NSAIDs
•
owith 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:
•
oany time during use
•
owithout warning symptoms
•
othat may cause death
•
The risk of getting an ulcer or bleeding increases with:
•
opast history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
•
otaking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”; or “SNRIs”
•
oincreasing doses of NSAIDs
•
olonger use of NSAIDs
•
osmoking
•
odrinking alcohol
•
oolder age
•
opoor health
•
oadvanced liver disease
•
obleeding problems
•
NSAIDs should only be used:
•
oexactly as prescribed
•
oat the lowest dose possible for your treatment
•
ofor 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

Fitxa tècnica

NAPROXEN- NAPROXEN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
NAPROXEN TABLETS, USP
NAPROXEN SODIUM TABLETS, USP
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•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_).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•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 (_SEE WARNINGS_).
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 w