ESOMEPRAZOLE MAGNESIUM capsule, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Disponible desde:

Bryant Ranch Prepack

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Healing of Erosive Esophagitis Esomeprazole magnesium is 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 may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium is 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 is 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)

Resumen del producto:

NDC: 71335-1148-1: 30 Capsules in a BOTTLE NDC: 71335-1148-2: 10 Capsules in a BOTTLE NDC: 71335-1148-3: 60 Capsules in a BOTTLE NDC: 71335-1148-4: 90 Capsules in a BOTTLE NDC: 71335-1148-5: 42 Capsules in a BOTTLE NDC: 71335-1148-6: 120 Capsules in a BOTTLE NDC: 71335-1148-7: 180 Capsules in a BOTTLE NDC: 71335-1148-8: 20 Capsules in a BOTTLE

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed
release
Bryant Ranch Prepack
----------
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, USP before
you start taking esomeprazole magnesium delayed-release capsules, USP
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, USP?
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, may
develop a kidney problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with Esomeprazole magnesium. 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 bone
f

Ficha técnica

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
BRYANT RANCH PREPACK
----------
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, 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
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)
Patients with severe liver impairment-do not exceed dose of 20 mg. (2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole magnesium delayed-release capsules, USP: 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 response does not precl