ESOMEPRAZOLE MAGNESIUM capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cisen Pharmaceutical Co., Ltd.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults Esomeprazole magnesium delayed-release capsules is 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 NEXIUM may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules is 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 is indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults Esomeprazole magnesium delayed-release capsules is 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 capsules is indicated for short-term treatment (4

Product summary:

Esomeprazole magnesium delayed-release capsules, USP 20 mg - opaque, hard gelatin, with opaque caramel cap printed “C4” and opaque white body printed “20 mg”. They are supplied as follows: NDC 71256-003-01 unit of use bottles of 30 NDC 71256-003-02 bottles of 90 Esomeprazole magnesium delayed-release capsules, USP 40 mg - opaque, hard gelatin, with opaque caramel cap printed “C3” and opaque white body printed “40 mg”. They are supplied as follows: NDC 71256-004-01 unit of use bottles of 30 NDC 71256-004-02 bottles of 90 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed- release capsules product package is subdivided.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
Cisen Pharmaceutical Co., Ltd.
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MEDICATION GUIDE
MEDICATION GUIDE
Esomeprazole Magnesium Delayed-Release Capsules, USP, for oral use
What is the most important information I should know about
Esomeprazole Magnesium Delayed-Release
Capsules?
Esomeprazole magnesium delayed-release capsules may help your
acid-related symptoms, but you could
still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules can cause serious side
effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including NEXIUM, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with NEXIUM. 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 NEXIUM, may develop certain types of lupus erythematosus or
have worsening of the
lupus they already have. Call your doctor right away if you have new
or worsening joint pain or a
rash on your cheeks or arms that gets worse in the sun.
Talk to your doctor about your risk of these serious side effects.
Esomeprazole magnesium delayed-release capsules can have other serious
s

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
CISEN PHARMACEUTICAL CO., LTD.
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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
Contraindications ( 4)
10/2020
Warnings and Precautions, Acute Tubulointerstitial Nephritis
(5.2) 11/2020
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules is a proton pump
inhibitor (PPI).
Esomeprazole magnesium delayed-release capsules is 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/or documented history of gastric ulcers. ( 1.4)
• _Helicobacter pylori_ eradication in adult patients to reduce the
risk of
duodenal ulcer recurrence in combination with amoxicillin and
clarithromycin. ( 1.5)
• Long-term treatment of pathological hypersecretory conditions,
including
Zollinger-Ellison syndrome in adults. ( 1.6)
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR)
Adults
20 mg or 40 mg once daily for 4 to 8 weeks; some patients may
require an additional 4 to 8 weeks
12 years to 17 years
20 mg or 40 mg once daily for 4 to 8 weeks
1 month to 11 years
see full prescribing information for weight-based dos