NAPROXEN AND ESOMEPRAZOLE MAGNESIUM tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Ajanta Pharma USA Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 tablets with the single-ingredient products of naproxen and esomeprazole magnesium. - Naproxen and esomeprazo

Resumen del producto:

Naproxen and esomeprazole magnesium delayed-release tablets 375 mg/20 mg are yellow colored, oval shaped, biconvex film-coated tablets with NE 375 imprinted with black ink on one side and plain on other side, supplied as: NDC 27241-202-60      Bottles of 60 tablets Naproxen and esomeprazole magnesium delayed-release tablets 500 mg/20 mg are yellow colored, oval shaped, biconvex film-coated tablets with NE 500 imprinted with black ink on one side and plain on other side, supplied as: NDC 27241-203-60      Bottles of 60 tablets Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

DELAYED RELEASE
Ajanta Pharma USA Inc.
----------
Medication Guide
Naproxen (na prox' en) and Esomeprazole Magnesium
(es'' oh mep' ra zole mag nee' zee um)
Delayed-Release Tablets
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”,
“SSRIs”, or “SNRIs”
•
increasing doses of

Fitxa tècnica

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM - NAPROXEN AND ESOMEPRAZOLE
MAGNESIUM TABLET, DELAYED RELEASE
AJANTA PHARMA USA INC.
----------
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)
(5.10) 4/2021, 3/2022
Fetal Toxicity
(5.11) 4/2021
Hypomagnesemia and Mineral Metabolism (5.24)
3/2022
INDICATIONS AND USAGE
Naproxen and esomeprazole magnesium delayed-release tablet is a
combination of naproxen, a non-
steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium,
a proton pump inhibitor (PPI)
indicated in adult and adolescent patients 12 years of age