NAPROXEN SODIUM- naproxen sodium tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

NuCare Pharmaceuticals, Inc.

INN (שם בינלאומי):

NAPROXEN SODIUM

הרכב:

NAPROXEN SODIUM 550 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 so

leaflet_short:

Naproxen Sodium Tablets USP: 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. Packaged in bottles of 14 NDC 68071-3054-4 Bottles of 20 NDC 68071-3054-2 Bottles of 30 NDC 68071-3054-3 Bottles of 21 NDC 68071-3054-1 Bottles of 60 NDC 68071-3054-6 Bottles of 90 NDC 68071-3054-9 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. Manufactured by: Glenmark Pharmaceuticals Ltd., INDIA Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma.com/usa May 2016

מצב אישור:

Abbreviated New Drug Application

עלון מידע

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
NuCare Pharmaceuticals, Inc.
----------
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:
•
any time 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 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

מאפייני מוצר

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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 sol