ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

INN (International Name):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Composition:

ESOMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsu

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg are white/white size ‘4’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with “I81” on body with gold tek ink. They are supplied as follows:             Bottles of 30                                      NDC 65862-783-30             Bottles of 90                                      NDC 65862-783-90             Bottles of 100                                    NDC 65862-783-01             Bottles of 1,000                                 NDC 65862-783-99             10 x 10 Unit-dose Capsules               NDC 65862-783-78 Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg are white/white size ‘2’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with "I82" on body with gold tek ink. They are supplied as follows:             Bottles of 30                                      NDC 65862-784-30             Bottles of 90                                      NDC 65862-784-90             Bottles of 100                                    NDC 65862-784-01             Bottles of 1,000                                 NDC 65862-784-99             10 x 10 Unit-dose Capsules               NDC 65862-784-78 Store at 20° to 25°C (68° 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. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aurobindo Pharma Limited
----------
Dispense with Medication Guide available at:
www.aurobindousa.com/medication-guides
MEDICATION GUIDE
Esomeprazole Magnesium Delayed-Release Capsules USP, for oral use
(es'' oh mep' ra zole mag nee' zee um)
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 in the su

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM - ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
AUROBINDO PHARMA LIMITED
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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)
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are 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
A maximum dosage of 20 mg once daily is recommended for patients with
severe liver impairment
(Child-Pugh Class C).
Controlled studies do not extend beyond 6 months.
Refer to the amoxicillin and clarithromycin prescribing information
for dosage adjustments in elderly and
renally-impaired patients.
A starting dosage of 20 mg twice daily is recommended for patients
with severe liver impairment (Child-
Pugh Class C).
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (12 YEARS AND OLDER)
Adults
20 mg or 40 mg once daily for 4 to 8 week