ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

A-S Medication Solutions

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 ulcers associated with continuous NSAID therapy

Bidhaa muhtasari:

Product: 50090-5365 NDC: 50090-5365-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-5365-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
A-S Medication Solutions
----------
MEDICATION GUIDE
Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um)
Delayed-Release Capsules, USP
Rx only
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, USP may help your
acid-related symptoms, but you
could still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules, USP 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, USP, may develop a
kidney problem called acute interstitial nephritis that can happen at
any time during treatment with
esomeprazole magnesium delayed-release capsules, USP. 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, USP 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, USP exactly as
prescribed, at the lowest dose
possible for your treatment and for

Tabia za bidhaa

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
A-S MEDICATION SOLUTIONS
----------
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
INDICATIONS AND USAGE
•
•
•
•
DOSAGE AND ADMINISTRATION
GASTROESOPHAGEAL REFLUX DISEASE (GERD) (2)
Adults (2)
20 mg or 40 mg (2)
Once daily for 4 to 8 weeks (2)
12 to 17 years (2)
20 mg or 40 mg (2)
Once daily for up to 8 weeks (2)
1 to 11 years (2)
10 mg or 20 mg (2)
Once daily for up to 8 weeks (2)
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER (2)
20 mg or 40 mg (2)
Once daily for up to 6 months (2)
_H. PYLORI _ERADICATION _(Triple Therapy):_ (2)
Esomeprazole magnesium
delayed-release capsules (2)
40 mg (2)
Once daily for 10 days (2)
Amoxicillin (2)
1000 mg (2)
Twice daily for 10 days (2)
Clarithromycin (2)
500 mg (2)
Twice daily for 10 days (2)
PATHOLOGICAL HYPERSECRETORY CONDITIONS (2)
40 mg (2)
Twice daily (2)
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
•
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have
occurred). (4) (4)
WARNINGS AND PRECAUTIONS
Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018
Esomeprazole magnesium delayed-release capsules are 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)
INDICATION DOSE FREQUENCY
Esomeprazo