ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM — esomeprazole magnesium granule, for suspension, extended release
Cipla USA Inc.

1 INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis (EE)

Adults

Esomeprazole magnesium for delayed release oral suspension is 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 for delayed release oral suspension may be considered.

Pediatric Patients 12 Years to 17 Years of Age

Esomeprazole magnesium for delayed release oral suspension is 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.

Pediatric Patients 1 Year to 11 Years of Age

Esomeprazole magnesium for delayed release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age.

Pediatric Patients 1 Month to Less Than 1 Year of Age

Esomeprazole magnesium for delayed release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

1.2 Maintenance of Healing of EE

Esomeprazole magnesium for delayed release oral suspension is indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

1.3 Treatment of Symptomatic GERD

Adults

Esomeprazole magnesium for delayed release oral suspension is 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 for delayed release oral suspension are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

Pediatric Patients 1 Year to 11 Years of Age

Esomeprazole magnesium for delayed release oral suspension is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.

1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer

Esomeprazole magnesium for delayed release oral suspension is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Triple Therapy

Esomeprazole magnesium for delayed release oral suspension in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].

1.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Esomeprazole magnesium for delayed release oral suspension is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults by Indication

Table 1 shows the recommended adult dosage of Esomeprazole magnesium for delayed release oral suspension by indication.

The duration of esomeprazole magnesium treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. Esomeprazole magnesium for delayed release oral suspension should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1: Recommended Dosage of Schedule for Esomeprazole magnesium for delayed release oral suspension in Adults by indication.

1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].
2 Most patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be required to achieve healing [see Clinical Studies (14.1)].
3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.
4 A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].
Adults Indication	Recommended Dosage of Esomeprazole magnesium for delayed release oral suspension	Treatment Duration
Healing of EE	20 mg or 40 mg1 once daily	4 to 8 weeks 2
Maintenance of Healing of EE	20 mg once daily	Controlled studies do not extend beyond 6 months
Treatment of Symptomatic GERD	20 mg once daily	4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks
Risk Reduction of NSAID-Associated Gastric Ulcer	20 mg or 40 mg1 once daily	Controlled studies do not extend beyond 6 months
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy)	Esomeprazole magnesium 40 mg once daily1	10 days
	Amoxicillin 1000 mg twice daily3	10 days
	Clarithromycin 500 mg twice daily3	10 days
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome	Starting dosage is 40 mg twice daily 4 ; individualize the regimen to patient needs. Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)].	As long as clinically indicated