ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Bryant Ranch Prepack

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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. 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 GERD in adults and children 1 year or older. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric u

Produktu pārskats:

NDC: 71335-1722-1: 90 Capsules in a BOTTLE NDC: 71335-1722-2: 30 Capsules in a BOTTLE NDC: 71335-1722-3: 60 Capsules in a BOTTLE NDC: 71335-1722-4: 10 Capsules in a BOTTLE NDC: 71335-1722-5: 20 Capsules in a BOTTLE NDC: 71335-1722-6: 120 Capsules in a BOTTLE NDC: 71335-1722-7: 180 Capsules in a BOTTLE

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Bryant Ranch Prepack
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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 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 bone fracture if
you take esomeprazole magnesium delayed-rel

Produkta apraksts

ESOMEPRAZOLE MAGNESIUM - ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
BRYANT RANCH PREPACK
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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, 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 40 mg
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
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or 40 mg
Once daily for up to 6 months
_H.PYROLI_ ERADICATION_(Triple Theraphy)_
Esomeprazole Magnesium
Delayed-Release Capsules
40 mg
Once daily for 10 days
Amoxicillin
1000 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)
occurred).( 4)
WARNINGS AND PRECAUTIONS
• Gastric Malignancy: In adults, symptomatic response does not
preclude the pr