ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

Esomeprazole Magnesium

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 capsul

Product summary:

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: Carton of 60 capsules (10 capsules each blister pack x 6), NDC 0904-6581-68 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. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Major Pharmaceuticals
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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:
1.
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.
2.
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.
3.
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 about your risk of these serious side effects.
Esomeprazole magnesium delayed-release

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
MAJOR PHARMACEUTICALS
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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)
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.9) 03/2022
INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole
magnesium delayed-release
capsules are indicated for the:
7.
8.
9.
10.
11.
12.
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 ULCER
Adults
20 mg or 40 mg once daily for up to 6
months2
_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 beyo