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:

Preferred Pharmaceuticals, Inc.

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, 40 mg are blue opaque size ‘2’ hard gelatin capsule imprinted with ‘H’ on cap and ‘71’ on body filled with off white to pale yellow pellets.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
PREFERRED PHARMACEUTICALS, 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)
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 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
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