ESOMEPRAZOLE MAGNESIUM capsule, delayed release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

थमां उपलब्ध:

Aphena Pharma Solutions - Tennessee, LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsule

उत्पाद समीक्षा:

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg, are size 4 capsule with pink opaque cap imprinted with 'RB66' and pink opaque body imprinted with '20 mg' in black ink containing off-white to brownish colored beads. They are supplied as follows: Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg, are size 3 capsule with pink opaque cap imprinted with 'RB67' and pink opaque body imprinted with '40 mg' in black ink containing off-white to brownish colored beads. They are supplied as follows: For bottle of 30's and 90's: Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] This package is child-resistant. Keep out of reach of children. For bottle of 1000's: Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Medication Guide available at https://www.sunpharma.com/usa/products
Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um)
Delayed-Release Capsules, USP
Rx only
What is the most important information I should know about
esomeprazole magnesium delayed-release
capsules, USP?
Esomeprazole magnesium delayed-release capsules, USP may help your
acid-related symptoms, but you
could still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules, USP can cause serious
side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, USP, may
develop a kidney problem called acute tubulointerstitial nephritis
that can happen at any time during
treatment with esomeprazole magnesium delayed-release capsules, USP.
Call your doctor right away if
you have a decrease in the amount that you urinate or if you have
blood in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your
intestines.
Call your doctor right away if you have watery stools or stomach pain
that does not go away. You may
or may not have a fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people
who take multiple daily doses of PPI medicines and for a long period
of time (a year or longer). Tell
your doctor if you have a bone fracture, especially in the hip, wrist,
or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body's
immune cells attack other cells or organs in the body). Some people
who take PPI medicines, including
esomeprazole magnesium delayed-release capsules, USP, may develop
certain types of lupus
erythematosus or have worsening of the lupus they already have. Call
your doctor right away if you

उत्पाद विशेषताएं

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
HEALING OF EE (1 YEAR AND OLDER) (2)
EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR) (2)
Adults (2)
20 mg or 40 mg once daily for 4 to 8 weeks;
some (2)
patients may require an additional 4 to 8 weeks
(2)
12 years to 17 years (2)
20 mg or 40 mg once daily for 4 to 8 weeks (2)
1 month to 11 years (2)
see full prescribing information for weight-
based (2)
dosing and duration of treatment (2.2) (2)
MAINTENANCE OF HEALING OF EE (2)
Adults (2)
20 mg once daily. Controlled studies do not
extend beyond 6 months (2)
TREATMENT OF SYMPTOMATIC GERD (2)
Adults (2)
20 mg once daily once daily for 4 weeks some
patients (2)
may require an additional 4 weeks (2)
12 years to 17 years (2)
20 mg once daily for 4 weeks (2)
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.9) 03/2022
Esomeprazole magnesium is a proton pump inhibitor (PPI).
Esomeprazole magnesium delayed-release capsules are indicated for the:
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 12
years to 17 years of age. (1.1)
Maintenance of healing of EE in adults. (1.2)
Short-term treatment of heartburn and other symptoms associated GERD
in adults and pediatric
patients 12 years to 17 years of age. (1.3)
Risk reduction of nonsteroidal anti-inflammatory drugs
(NSAID)-associated gastric ulcer in adults at
risk for developing gastric ulcers due to age (60 years and older)
and/