NAPROXEN AND ESOMEPRAZOLE MAGNESIUM tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Mylan Pharmaceuticals Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are 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 tablets is indicated for relief of signs and symptoms of: The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablets is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use: Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the following patients: Use of NSAIDs, including naproxen and esomeprazole magnesium delayed-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal and renal dysfunction leading to oligohydramnios and, i

Povzetek izdelek:

Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available containing 375 mg or 500 mg of naproxen, USP and 22.25 mg of esomeprazole magnesium, USP (amorphous) equivalent to 20 mg of esomeprazole providing for the following combinations: 375 mg/20 mg and 500 mg/20 mg. The 375 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE1 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4385-91 bottles of 60 tablets The 500 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE2 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4386-91 bottles of 60 tablets Storage: Store at 20° to 25°C (68° to 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, light-resistant container as defined in the USP using a child-resistant closure if package is subdivided. PHARMACIST: Dispense a Medication Guide with each prescription.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Naproxen and Esomeprazole Magnesium Delayed-Release Tablets
(na prox′ en es″ oh mep′ ra zole mag nee′ zee um)
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 contain
naproxen, a non-steroidal 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:
o
with increasing doses of NSAIDs
o
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:
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
longer

Lastnosti izdelka

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM- NAPROXEN AND ESOMEPRAZOLE
MAGNESIUM TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)
(5.10) 3/2022
Hypomagnesemia and Mineral Metabolism (5.24) 3/2022
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 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 of
developing naproxen-associated gastric ulcers.
The naproxen component of naproxen and esomeprazole magnesium
delayed-release tablets is indicated
for relief of signs and symptoms of:
•
•
The esomeprazole magnesium component of naproxen and esomeprazole
magnesium delayed-release
tablets is indicated to decrease the risk of developing
naproxen-associated gastric ulcers. (1)
Limitations of Use:
•
•
•
NON-STEROIDAL 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 B