NAPROXEN AND ESOMEPRAZOLE MAGNESIUM tablet, delayed release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ), ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

から入手可能:

Dr. Reddy's Laboratories Limited

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.   • juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers.   Limitations of Use :  • Do not substitute naproxen and esomeprazole magnesium delayed-release tablet with the single-ingredient products of naproxen and esomeprazole magnesium. • Naproxen and esome

製品概要:

Naproxen and esomeprazole magnesium delayed-release tablets (375 mg naproxen/20 mg esomeprazole magnesium) are off white to yellow colored modified capsule shaped, biconvex, film-coated tablets printed with R 289 in black ink on one side and plain on other side, supplied as: Bottles of 60 NDC 55111-289-60 Naproxen and esomeprazole magnesium delayed-release tablets (500 mg naproxen/20 mg esomeprazole magnesium) are off white to yellow colored modified capsule shaped, biconvex, film-coated tablets printed with R 701 in black ink on one side and plain on other side, supplied as: Bottles of 60 NDC 55111-701-60 Storage : Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM- NAPROXEN AND ESOMEPRAZOLE
MAGNESIUM TABLET, DELAYED RELEASE
Dr. Reddy's Laboratories Limited
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Naproxen and Esomeprazole Magnesium Delayed-Release Tablets
(na-PROX-en- ES-oh-MEP-ra-zole)
What is the most important information I should know about naproxen
and esomeprazole magnesium
delayed-release tablets?
You should take naproxen and esomeprazole magnesium delayed-release
tablets exactly as prescribed, at
the lowest dose possible and for the shortest time needed.
Naproxen and esomeprazole magnesium delayed-release tablets may help
your acid-related symptoms,
but you could still have serious stomach problems. Talk with your
healthcare provider.
Naproxen and esomeprazole magnesium delayed-release tablets contains
naproxen, a nonsteroidal anti-
inflammatory drug (NSAID) and esomeprazole magnesium, a proton pump
inhibitor (PPI) medicine.
Naproxen and esomeprazole magnesium delayed-release tablets 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 naproxen and esomeprazole magnesium delayed-release
tablets right before or after a heart
surgery called a “coronary artery bypass graft (CABG).”
Avoid taking naproxen and esomeprazole magnesium delayed-release
tablets 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”,

製品の特徴

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM- NAPROXEN AND ESOMEPRAZOLE
MAGNESIUM TABLET, DELAYED RELEASE
DR. REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN AND
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DELAYED-
RELEASE TABLETS.
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2010
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
• 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. (5.1)
• NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS ARE
CONTRAINDICATED
IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY.(4, 5.1)
• NSAIDS, INCLUDING NAPROXEN, A COMPONENT OF NAPROXEN AND
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE TABLETS, 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. (5.2)
INDICATIONS AND USAGE
Naproxen and esomeprazole magnesium delayed-release tablets are a
combination of naproxen, a non-
steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium,
a proton pump inhibitor (PPI)
indicated in adult patients, requiring naproxen for symptomatic relief
of arthritis and esomeprazole
magnesium to decrease the risk of developing naproxen associated
gastric ulcers.
The naproxen component of naproxen and esomeprazole magnesium
del