Esomeprazoledosage

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 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 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 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 once daily for up to 6 months Controlled studies do not extend beyond 6 months. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults NEXIUM 40 mg once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. Clarithromycin 500 mg twice daily for 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C). (varies with the individual patient) as long as clinically indicated. Preparation and Administration Information

Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce.

Mix packets with water to create an oral suspension.

Opened capsules can be administered through a nasogastric tube and 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 NEXIUM by indication. The duration of NEXIUM treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. NEXIUM should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1: Recommended Dosage of NEXIUM in Adults by Indication Adult Indication Recommended Dosage of NEXIUM d elayed-release capsules and NEXIUM for delayed-release oral suspension Treatment Duration Healing of EE 20 mg or 40 mg A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). once daily 4 to 8 weeks 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. 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 once daily Controlled studies do not extend beyond 6 months H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy) NEXIUM 40 mg once daily 10 days Amoxicillin 1000 mg twice daily Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 10 days Clarithromycin 500 mg twice daily 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Starting dosage is 40 mg twice daily A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C).; individualize the regimen to patient needs. Dosages of up to 240 mg/day have been administered. As long as clinically indicated

2.2 Recommended

Dosage in Pediatric Patients by Indication Table 2 shows the recommended dosage of NEXIUM in pediatric patients by indication.

Table 2: Recommended Dosage of NEXIUM in Pediatric Patients by Indication Indication Patient Age Recommended Dosage Duration Healing of EE 12 years to 17 years NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension: 20 mg or 40 mg once daily 4 to 8 Weeks 1 year to 11 years Dosages over 1 mg/kg/day have not been studied NEXIUM 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 year Dosages over 1.33 mg/kg/day have not been studied NEXIUM 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 NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension: 20 mg once daily 4 weeks 1 year to 11 years NEXIUM for delayed-release oral suspension: 10 mg once daily 1 Up to 8 weeks

2.3 Preparation and

Administration Instructions

Take NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension at least one hour before meals.

Antacids may be used concomitantly with NEXIUM.

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. NEXIUM Delayed-Release Capsules Administer NEXIUM delayed-release capsules orally or via a nasogastric tube, as described below. Oral Administration

Swallow NEXIUM delayed-release capsules whole; do not chew or crush the capsules.

For patients who have difficulty swallowing capsules, NEXIUM delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods has not been evaluated and is not recommended. 1. Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. 2. Open the NEXIUM delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce. 3. Mix the granules with the applesauce. 4. Administer the mixture immediately. Do not chew or crush the granules 5. Discard any remaining mixture. Do not store the mixture for future use. Administration via Nasogastric Tube 1. Open the NEXIUM delayed-release capsule and empty the granules into a 60 mL catheter-tipped syringe. 2. Mix the granules with 50 mL of water. 3. Replace the plunger and shake the catheter-tipped syringe vigorously for 15 seconds. 4. Hold the catheter-tipped syringe with the tip up and check for any granules remaining in the tip. 5. Attach the catheter-tipped syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. 6. After administering the granules, flush the nasogastric tube with additional water. 7. Use the mixture immediately after preparation. Do not administer the granules if they have dissolved or disintegrated. NEXIUM For Delayed-Release Oral Suspension Administer NEXIUM for delayed-release oral suspension orally or via a nasogastric or gastric tube, as described below. Oral Administration 1. Empty the contents of a 2.5 mg or 5 mg NEXIUM packet into a container containing 5 mL of water. For the 10 mg, 20 mg, and 40 mg strengths, 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. 2. Stir the packet contents into the water. 3. Leave 2 to 3 minutes to thicken. 4. Stir and drink within 30 minutes. 5. If any of the contents remain after drinking, add more water, stir, and drink immediately. Administration via Nasogastric or Gastric Tube 1. Add 5 mL of water to a catheter-tipped syringe and then add the contents of a 2.5 mg or 5 mg NEXIUM packet. For the 10 mg, 20 mg, and 40 mg packet strengths, add at least 15 mL of water to the catheter-tipped syringe. 2. Immediately shake the catheter-tipped syringe and leave 2 to 3 minutes to thicken. 3. Shake the catheter-tipped syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes. 4. Refill the catheter-tipped syringe with an equal amount of water (5 mL or 15 mL). 5. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.