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:

Mylan Institutional Inc.

INN (International Name):

ESOMEPRAZOLE MAGNESIUM

Composition:

ESOMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 erosive esophagitis. 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. Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. 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 and children 1 year or older. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or d

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules, USP are available containing 22.25 mg or 44.50 mg of esomeprazole magnesium, USP equivalent to 20 mg or 40 mg of esomeprazole, respectively. The 20 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M150 in black ink on the cap and body. They are available as follows: NDC 42292-009-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 40 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M151 in black ink on the cap and body. They are available as follows: NDC 42292-010-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
Mylan Institutional Inc.
----------
MEDICATION GUIDE
Esomeprazole Magnesium Delayed-Release Capsules, USP
(es″ oh mep′ ra zole mag nee′ zee um)
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules before you
start taking esomeprazole magnesium delayed-release capsules and each
time you get a refill. There may be
new information. This information does not take the place of talking
with your doctor about your medical
condition or your treatment.
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 esomeprazole magnesium
delayed-release capsules, may develop
a kidney problem called acute tubulointerstitial nephritis that can
happen at any time during treatment
with esomeprazole magnesium delayed-release capsules. Call your doctor
if you have a decrease in
the amount that you urinate or if you have blood in your urine.
•
Diarrhea. Esomeprazole magnesium delayed-release capsules may increase
your risk of getting severe
diarrhea. This diarrhea may be caused by an infection ( Clostridium
difficile) in your intestines.
•
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
What are esomeprazole magnesium delayed-release capsules?
Esomeprazole magnesium delayed-release capsules are a prescription
medicine called a proton pump
inhibitor (PPI). Esomeprazole magnesium delayed-release capsules
reduce the amount of acid in your
stomach.
Esomeprazole magnesium delayed-release capsules are used in adults:
•
for 4 to 8 wee

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
MYLAN INSTITUTIONAL INC.
----------
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
Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2)
11/2020
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are a proton pump
inhibitor indicated for the
following:
Treatment of gastroesophageal reflux disease (GERD). ( 1.1)
Risk reduction of NSAID-associated gastric ulcer. ( 1.2)
_H. pylori_ eradication to reduce the risk of duodenal ulcer
recurrence. (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison
Syndrome. (1.4)
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
20 mg or 40 mg
Once daily for 4 to 8 weeks
12 to 17 years
20 mg or 40 mg
Once daily for up to 8 weeks
1 to 11 years
10 mg or 20 mg
Once daily for up to 8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or 40 mg
Once daily for up to 6 months
_H. PYLORI_ ERADICATION _(Triple Therapy):_
Esomeprazole Magnesium
Delayed-Release Capsules
40 mg
Once daily for 10 days
Amoxicillin
1000 mg
Twice daily for 10 days
Clarithromycin
500 mg
Twice daily for 10 days
PATHOLOGICAL HYPERSECRETORY CONDITIONS
40 mg
Twice daily
See full prescribing information for administration options. ( 2)
Patients with severe liver impairment-do not exceed dose of 20 mg. (
2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have
occurred). ( 4)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic res