ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
Torrent Pharmaceuticals Limited
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
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.
1.2 Maintenance of Healing of EE
Esomeprazole magnesium delayed-release capsules are 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 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 capsules 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.
1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are 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 Delayed-Release Capsules 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 delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommeded Dosage in Adults by Indication
Table 1 shows the recommended adult dosage of Esomeprazole magnesium delayed-release capsules 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 treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Adults by indication | ||
Adult Indication | Recommended Dosage of Esomeprazole Magnesium delayed-release capsules | Treatment Duration |
Healing of EE | 20 mg or 40 mg 1 once daily | 4 to 8 weeks 2 |
Maintenance of Healing of EE | 20 mg once daily | Controlled studies do not extend beyond 6 months 4 weeks; if symptoms do not resolve |
Treatment of Symptomatic GERD | 20 mg once daily | completely, consider an additional 4 weeks Controlled studies do not extend beyond 6 months |
Risk Reduction of NSAID-Associated Gastric Ulcer | 20 mg or 40 mg 1 once daily | |
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy) | Esomeprazole magnesium 40 mg once daily 1 Amoxicillin 1,000 mg twice daily 3 Clarithromycin 500 mg twice daily 3 Starting dosage is 40 mg twice daily 4 ; individualize the regimen to patient needs. | 10 days 10 days 10 days |
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome | Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)]. | 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) [see Use in Specific Populations (8.6)].
- 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)].
- 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) [see Use in Specific Populations (8.6)].
2.2 Recommended Dosage in Pediatric Patients by Indication
Table 2 shows the recommended dosage of esomeprazole magnesium in pediatric patients by indication.
Table 2: Recommended Dosage of Esomeprazole Magnesium in Pediatric Patients by Indication | |||
Indication | Patient Age | Recommended Dosage | Duration |
Healing of EE |
12 years to 17 years | Esomeprazole Magnesiumdelayed-release capsules:20 mg or 40 mg once daily | 4 to 8 Weeks |
Treatment of Symptomatic GERD |
12 years to 17 years | Esomeprazole Magnesiumdelayed-release capsules:20 mg once daily | 4 weeks |
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