Esomeprazoledosage

1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 2 Controlled studies do not extend beyond 6 months. 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). Population Recommended Adult and Pediatric Dosage 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 1 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 1 once daily for 4 to 8 weeks 1 month to 11 years see full prescribing information for weight-based dosing and duration of treatment 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 1 year to 11 years 10 mg once daily for up to 8 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults Esomeprazole magnesium 40 mg 1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days 3 Clarithromycin 500 mg twice daily for 10 days 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily 4 (varies with the individual patient) as long as clinically indicated. Preparation and Administration Information Mix packets with water to create an oral suspension. Oral suspension can be administered through a nasogastric or gastric tube.

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 Esomeprazole magnesium for delayed release oral suspension in Adults by Indication Adult Indication Recommended Dosage of Esomeprazole magnesium for delayed release oral suspension Treatment Duration 4 A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 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 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 mg 1 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 daily 1 10 days Amoxicillin 1000 mg twice daily 3 10 days Clarithromycin 500 mg twice daily 3 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. As long as clinically indicated 1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 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. 3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.

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 1 Dosages over 1 mg/kg/day have not been studied 2 Dosages over 1.33 mg/kg/day have not been studied Indication Patient Age Recommended Dosage Duration Healing of EE 12 years to 17 years Esomeprazole magnesium for delayed release oral suspension: 20 mg or 40 mg once daily 4 to 8 Weeks 1 year to 11 years 1 Esomeprazole magnesium for delayed release oral suspension: Less than 20 kg 10 mg once daily 20 kg and greater 10 mg or 20 mg once daily 8 weeks Treatment of EE due to Acid-Mediated GERD 1 month to less than 1 year2 Esomeprazole magnesium for delayed release oral suspension: 3 kg to 5 kg 2.5 mg once daily Greater than 5 kg to 7.5 kg 5 mg once daily Greater than 7.5 kg to 12 kg 10 mg once daily Up to 6 weeks Treatment of Symptomatic GERD 12 years to 17 years Esomeprazole magnesium for delayed release oral suspension: 20 mg once daily 4 weeks 1 year to 11 years Esomeprazole magnesium for delayed release oral suspension: 10 mg once daily 1 Up to 8 weeks

2.3 Preparation and

Administration Instructions Take esomeprazole magnesium for delayed release oral suspension at least one hour before meals. Antacids may be used concomitantly with esomeprazole magnesium for delayed release oral suspension. Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. Esomeprazole magnesium For Delayed Release Oral Suspension Administer Esomeprazole magnesium for delayed release oral suspension orally or via a nasogastric or gastric tube, as described below. Oral Administration For the 10 mg strength, the contents of a packet should be emptied into a container containing 15 mL of water. If two packets are needed, mix in a similar way add twice the required amount of water. Stir the packet contents into the water. Leave 2 to 3 minutes to thicken. Stir and drink within 30 minutes. If any of the contents remain after drinking, add more water, stir, and drink immediately. Administration via Nasogastric or Gastric Tube: For the 10 mg packet strength, add at least 15 mL of water to the catheter-tipped syringe. Immediately shake the catheter-tipped syringe and leave 2 to 3 minutes to thicken. Shake the catheter-tipped syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes. Refill the catheter-tipped syringe with an equal amount of water (15 mL). Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.