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 Pharmaceuticals,Inc.

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. Esomeprazole magnesium delayed-release capsules, USP are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, are size 4 hard gelatin capsule having yellow cap and pink body imprinted as 20 mg on the body with white ink and 1154 on the cap with black ink, containing off white to cream colored granules. They are supplied as follows. NDC 68071-4213-1 Bottles of 10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep Esomeprazole Magnesium Delayed-Release Capsules, USP container tightly closed. Dispense in a tight container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Esomeprazole Magnesium (ee so MEP ra zol 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:
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). E

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
NUCARE PHARMACEUTICALS,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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic
Investigations 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 is a proton pump inhibitor indicated for the
following: (1)
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
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) (2)
Patients with severe liver impairment-do not exceed dose of 20 mg (2)
(2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg (3)
CONTRAINDICATIONS
Patients with known hypers