ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT)

Tilgjengelig fra:

Dr. Reddy's Laboratories Inc

INN (International Name):

Esomeprazole Magnesium

Sammensetning:

Esomeprazole 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.  Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 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 capsul

Produkt oppsummering:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to brown colored pellets filled in Size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's. Bottles of 30 NDC 43598-509-30 Bottles of 90 NDC 43598-509-90 Bottles of 1000 NDC 43598-509-10 Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to brown colored pellets filled in Size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's. Bottles of 30 NDC 43598-510-30 Bottles of 90 NDC 43598-510-90 Bottles of 1000 NDC 43598-510-10 Store at 20°-25°C (68°-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. 

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Dr. Reddy's Laboratories Inc
----------
Dispense with Medication Guide available at:
www.drreddys.com/medguide/esomeprazolecaps.pdf
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 joi

Preparatomtale

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DR. REDDY'S LABORATORIES 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)
INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole
magnesium delayed-release
capsules are indicated for the:
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 12
years to 17 years of age. (1.1)
Maintenance of healing of EE in adults. (1.2)
Short-term treatment of heartburn and other symptoms associated GERD
in adults and pediatric
patients 12 years to 17 years of age. (1.3)
Risk reduction of nonsteroidal anti-inflammatory drugs
(NSAID)-associated gastric ulcer in adults at risk
for developing gastric ulcers due to age (60 years and older) and/or
documented history of gastric
ulcers. (1.4)
_Helicobacter pylori_ eradication in adult patients to reduce the risk
of duodenal ulcer recurrence in
combination with amoxicillin and clarithromycin. (1.5)
Long-term treatment of pathological hypersecretory conditions,
including Zollinger-Ellison syndrome in
adults. (1.6)
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
Adults
20 mg or 40 mg once daily for 4 to 8 weeks; some patients may require
an additional 4 to 8 weeks
12 years to 17
years
20 mg or 40 mg1 once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EE
Adults
20 mg once daily. Controlled studies do not extend beyond 6 months
TREATMENT OF SYMPTOMATIC GERD
Adults
20 mg once daily once daily for 4 weeks some patients may require an
additional 4 weeks
12 years to 17
years
20 mg once daily for 4 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC U