ESOMEPRAZOLE MAGNESIUM DR- esomeprazole magnesium capsule, delayed release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Advanced Rx Pharmacy of Tennessee, LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

1.1 Healing of Erosive Esophagitis (EE) Adults 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 EE in adults. 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with

उत्पाद समीक्षा:

Esomeprazole magnesium delayed-release capsules USP, 40 mg are white opaque size ‘3’ hard gelatin capsule imprinted with “H” on cap and ‘E3’ on body filled with off white to pale yellow pellets. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
Esomeprazole Magnesium (es'' oh mep' ra zole mag nee' zee um)
Delayed-Release Capsules, USP
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 right
away if you have a decrease in the amount that you urinate or if you
have blood in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right
away if you have watery stools or stomach pain that does not go away.
You may or may not have
a fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in
people who take multiple daily doses of PPI medicines and for a long
period of time (a year or
longer). Tell your doctor if you have a bone fracture, especially in
the hip, wrist, or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the
body’s immune cells attack other cells or organs in the body). Some
people who take PPI
medicines, including esomeprazole magnesium delayed-release capsules,
may develop certain
types of lupus erythematosus or have worsening of the lupus they
already have. Call your doctor
right away if you have new or worsening joint pain or a rash on your
cheeks or arms that gets
worse

उत्पाद विशेषताएं

ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
ESOMEPRAZOLE MAGNESIUM DR 40MG CAPSULE
1. INDICATIONS AND USAGE
1.1 Healing of Erosive Esophagitis (EE)
Adults
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 EE in adults. 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.
Pediatric Patients 12 Years to 17 Years of Age
Esomeprazole magnesium delayed-release capsules are indicated for the
short-term
treatment (4 to 8 weeks) for the healing of EE in pediatric patients
12 years to 17 years
of age.
1.2 Maintenance of Healing of EE
Esomeprazole magnesium delayed-release capsules are indicated for the
maintenance of
healing of EE in adults. Controlled studies do not extend beyond 6
months.
1.3 Treatment of Symptomatic GERD
Adults
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.
Pediatric Patients 12 Years to 17 Years of Age
Esomeprazole magnesium delayed-release capsules are indicated for
short-term
treatment (4 weeks) of heartburn and other symptoms associated with
GERD in
pediatric patients 12 years to 17 years of age.
1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs
(NSAID)-Associated Gastric
Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the
reduction in
the occurrence of gastric ulcers associated with continuous NSAID
therapy in adult
patients at risk for developing gastric ulcers. Patients are
considered to be at risk due to
their age (60 years and older) and/or documented history of gastric
ulcers. Controlled
studies do not extend beyond 6 months.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal
Ulcer Recurrence
Eradicati