ESOMEPRAZOLE MAGNESIUM capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

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 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 magnes

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, are hard gelatin capsules with a blue opaque color cap imprinted with the Glenmark logo ‘G’ in black ink and a blue opaque color body imprinted with ‘557’ in black ink. They are available as: Bottles of 30 with child-resistant closure, NDC 68462-390-30 Bottles of 90 with child-resistant closure, NDC 68462-390-90 Bottles of 1,000, NDC 68462-390-10 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, are hard gelatin capsules with a blue opaque color cap imprinted with the Glenmark logo ‘G’ in black ink and a blue opaque color body imprinted with ‘558’ in black ink. They are available as: Bottles of 30 with child-resistant closure, NDC 68462-391-30 Bottles of 90 with child-resistant closure, NDC 68462-391-90 Bottles of 1,000, NDC 68462-391-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Keep this and all medications out of the reach of children. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
Glenmark Pharmaceuticals Inc., USA
----------
MEDICATION GUIDE
Esomeprazole Magnesium
(ES-oh-MEP-ra-zole mag-NEE-zee-um)
delayed-release capsules, for oral use
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, 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 sun.
Talk to your doctor abou

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
GLENMARK PHARMACEUTICALS INC., USA
----------
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:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR)
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 mg 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 ULCER
Adults
20 mg or 40 mg once daily for up to 6 months
_H.PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
Adults
Esomeprazole magnesium delayed-release capsules 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 INCLUDING ZOLLINGER-ELLISON
SYNDROME
Adults
Starting dosage is 40 mg twice daily (varies with the individual
patient) as long as clinically indicated.
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.
Short-term treatment in the h