ESOMEPRAZOLE MAGNESIUM capsule, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)

זמין מ:

Preferred Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg are white to cream to pale yellow colored pellets filled in size '4' hard gelatin capsules having dark blue opaque cap with '441' in black ink and white opaque body printed with '20 mg' in black ink and are supplied as follows: NDC 68788-7615-2 bottles of 20 capsules NDC 68788-7615-3 bottles of 30 capsules NDC 68788-7615-6 bottles of 60 capsules NDC 68788-7615-9 bottles of 90 capsules NDC 68788-7615-1 bottles of 100 capsules Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep Esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the Esomeprazole magnesium delayed-release capsules product package is subdivided.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Esomeprazole magnesium (es'' oh mep' ra zole 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:
•
A type of kidney problem (acute tubulointerstitial nephritis) . Some
people who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, may develop a
kidney problem called acute tubulointerstitial 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 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 shorte

מאפייני מוצר

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
PREFERRED 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, 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 are a proton pump
inhibitor indicated for the
following:
•
•
•
•
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
•
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and
anaphylaxis have occurred). (4)
WARNINGS AND PRECAUTIONS
•
•
•
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)
Esomeprazole magnesium delayed-release capsules, USP : 20 mg, and 40
mg. (3)
Gastric Malignancy: In adults, symptoma