ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Available from:

Unit Dose Services

INN (International Name):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Composition:

ESOMEPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP 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 USP are indicated for the reduction in the occurrence of gastric ulcers associated with conti

Product summary:

NDC:50436-3120-1 in a BOTTLE of 30 CAPSULE, DELAYED RELEASES

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Unit Dose Services
----------
MEDICATION GUIDE
Esomeprazole (ES-oh-MEP-ra-zole) Magnesium (mag-NEE-zee-um)
Delayed-Release Capsules USP
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:
•
. Esomeprazole magnesium delayed-release capsules may increase your
risk of getting severe
diarrhea. This diarrhea may be caused by an infection in your
intestines. Diarrhea(Clostridium
difficile)
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go
away.
•
. 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. Bone fractures
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 (PP

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
UNIT DOSE SERVICES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE
CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ESOMEPRAZOLE MAGNESIUM DELAYED-
RELEASE CAPSULES USP. ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES
USP, FOR ORAL USE INITIAL U.S.
APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic Investigations
for Neuroendocrine Tumors ( ) 03/2014
Contraindications ( ) 12/2014 Warnings and Precautions, Acute
Interstitial Nephritis ( ) 12/2014 Warnings and Precautions,
Cyanocobalamin (vitamin B-12) Deficiency ( ) 12/2014 5.10
4
5.3
5.4
INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-Release Capsules USP are a proton pump
inhibitor indicated for the following:
•
•
•
•
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
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
ERADICATION _H. PYLORI(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
•
•
•
•
•
•
Treatment of gastroesophageal reflux disease (GERD) ( ) 1.