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:

NuCare Pharmceuticals,Inc.

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 blue cap and dark blue body imprinted with RDY on cap and 492 on body w NDC 68071-4825-6 BOTTLES OF 60 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
NuCare Pharmceuticals,Inc.
----------
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 interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, may
develop a kidney problem called acute interstitial 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.
•
Bone fractures. People who take multiple daily doses of PPI 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

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
NUCARE PHARMCEUTICALS,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, Fundic Gland Polyps (5.12) 06/2018
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)
_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
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
_H. PYLORI_ ERADICATION
_(Triple Therapy):_
40 mg
Once daily
Esomeprazole magnesium
Amoxicillin
Clarithromycin
40 mg
1000
mg
500
mg
Once daily
for 10 days
Twice daily
for 10 days
Twice daily
for 10 days
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 (P