NAPROXEN tablet, delayed release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Carilion Materials Management

INN（国际名称）:

NAPROXEN

组成:

NAPROXEN 500 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 Delayed-Release Tablets and other treatment options before deciding to use Naproxen Delayed-Release Tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Naproxen Delayed-Release Tablets are indicated: Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen Delayed-Release Tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY, DOSAGE AND ADMINISTRATION ). Naproxen delayed-release tablets are contraindicated in the following patients:

產品總結:

Product: 68151-2609 NDC: 68151-2609-0 1 TABLET, DELAYED RELEASE in a PACKAGE

授权状态:

Abbreviated New Drug Application

资料单张

Carilion Materials Management
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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:
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
anytime 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
older age
o
o
longer use of NSAIDs
poor health
o
smoking
o
advanced liver disease
o
drinking alcohol
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 conditions, including if
you:
•

产品特点

NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
CARILION MATERIALS MANAGEMENT
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NAPROXEN DELAYED-RELEASE TABLETS USP
1005
1006
RX ONLY
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 non-steroidal anti-
inflammatory drugs.
The chemical name for naproxen, USP is
(+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
C
H O M.W. 230.26
Naproxen, USP is a practically 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, USP at pH 7.4 is 1.6 to 1.8.
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 DELAYED-RELEASE 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 EVENTS (_SEE
WARNINGS_).
14
14
3
Naproxen Delayed-Release Tablets USP are available as enteric-coated,
white to off-white tablets
containing 375 mg or 500 mg of naproxen, USP for oral administration.
The inactive ingredients are:
antifoam DC 1510, corn starch, croscarmellose sodium, FD&C Blue # 2
Aluminum Lake, magnesium
stearate, methacrylic acid copolymer-dispersion, povidone,