ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT)

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

Esomeprazole Magnesium

Composition:

Esomeprazole 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis 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.   In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.   Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.   Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GER

Product summary:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light opaque purple cap and dark opaque purple body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s. Bottles of 30 NDC 55111-492-30 Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light opaque purple cap and dark opaque purple body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s. Bottles of 30 NDC 55111-493-30 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. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Dr. Reddy's Laboratories Limited
----------
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:
•
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.
•
Bone fractures. People who take multiple daily doses of Proton Pump
Inhibitor medicines for a
long period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist, or
spine. You should take esomeprazole magnesium delayed-release capsules
exactly as prescribed,
at the lowest dose possible for your treatment and for the shortest
time needed. Talk to your doctor
about your risk of bone fracture if you take esomeprazole magnesium
delayed-release capsules.
Esomeprazole magnesium delayed-release capsules can have other serious
side effects. See “What are the
possible side effects of esomeprazole magnesium delayed-release
capsules?”
What are esomeprazole magnesium delayed-release capsules?
Esomeprazole magnesium delayed-release capsules are a prescription
medicine called a proton pump
inhibitor (PPI)

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DR. REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE MAGNESIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESOMEPRAZOLE
MAGNESIUM.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with DiagnosticInvestigations
for Neuroendocrine Tumors (5.10) 03/2014
Contraindications (4) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions, Cyanocobalamin (vitamin B-12) Deficiency
(5.4) 12/2014
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsule USP is 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)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (1.4)
DOSAGE AND ADMINISTRATION INDICATION
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
12 to 17 years
1 to 11 years
20 mg or
40mg
20 mg or
40 mg
10 mg or
20 mg
Once daily for 4
to 8 weeks
Once daily for up
to 8 weeks
Once daily for up
to 8 weeks
1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight).
Once daily, up to 6
weeks for erosive esophagitis (EE) due to acid-mediated GERD only.
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or
40 mg
Once daily for up
to 6 months
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
Symptomatic response