Esomeprazole Dosage

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Usual Adult Dose for Gastroesophageal Reflux Disease

Esomeprazole Magnesium:
-20 mg orally once a day for 4 weeks

Esomeprazole Strontium:
-24.65 mg orally once a day for 4 to 8 weeks.

Comment:
-If symptoms do not resolve after 4 weeks, an additional 4 weeks may be considered.

GERD with Erosive Esophagitis:
Esomeprazole Sodium:
-20 mg or 40 mg IV injection once a day, over no less than 3 minutes; or IV infusion once a day, over no less than 10 to 30 minutes

Comment: Safety and efficacy of esomeprazole sodium IV for Injection for more than 10 days have not been demonstrated.

Uses: Short term treatment of heartburn and symptomatic gastroesophageal reflux disease; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route

Usual Adult Dose for Erosive Esophagitis

Healing:
-Esomeprazole Magnesium: 20 to 40 mg orally once a day for 4 to 8 weeks
-Esomeprazole Strontium: 24.65 to 49.3 mg orally once a day for 4 to 8 weeks
-An additional 4 to 8 week course of therapy may be considered in patients not healed after initial treatment.

Maintenance of healing:
-Esomeprazole Magnesium: 20 mg orally once a day
-Esomeprazole Strontium: 24.65 mg orally once a daily

Comments:
-Esomeprazole Sodium injection may be used as an alternative to oral therapy, if unable to use oral route.
-Maintenance of healing: Controlled studies did not extend beyond six months.

Uses: Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; to maintain symptom resolution and healing of erosive esophagitis

Usual Adult Dose for Helicobacter pylori Infection

Esomeprazole Magnesium:
Triple therapy:
-40 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Esomeprazole Strontium:
Triple therapy:
-49.3 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days

Comments:
-Susceptibility testing should be done in patients who fail therapy.
-If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
-Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Use: Triple therapy (esomeprazole plus amoxicillin and clarithromycin): Treatment of H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori

Usual Adult Dose for NSAID-Induced Gastric Ulcer

Esomeprazole Magnesium:
-20 mg to 40 mg orally once daily for up to 6 months

Esomeprazole Strontium:
-24.65 mg to 49.3 mg orally once a day for up to 6 months

Comment:
-Patients older than 60 years and/or with history of gastric ulcers are considered to be at risk for developing gastric ulcers.
-Controlled studies do not extend beyond 6 months

Use: Reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers.

Usual Adult Dose for Zollinger-Ellison Syndrome

Esomeprazole Magnesium:
-40 mg orally twice a day

Esomeprazole Strontium:
-49.3 mg orally twice a day

Comment: Doses up to 240 mg daily have been used.

Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome

Usual Adult Dose for Pathological Hypersecretory Conditions

Esomeprazole Magnesium:
-40 mg orally twice a day

Esomeprazole Strontium:
-49.3 mg orally twice a day

Comment: Doses up to 240 mg daily have been used.

Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome

Usual Adult Dose for Duodenal Ulcer Prophylaxis

Esomeprazole Sodium:
-Initial dose: 80 mg IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)

Comments:
-Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
-Intravenous therapy should be followed by oral acid-suppressive therapy.

Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy

Usual Adult Dose for Gastric Ulcer Prophylaxis

Esomeprazole Sodium:
-Initial dose: 80 mg IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)

Comments:
-Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
-Intravenous therapy should be followed by oral acid-suppressive therapy.

Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Esomeprazole Magnesium:
Less than 1 year:
-Data not available

1 to 11 years:
-10 mg once a day for up to 8 weeks
-Comment: Doses over 1 mg/kg/day have not been studied.

12 to 17 years:
-20 mg once a day for 4 weeks

Esomeprazole Sodium:
GERD with Erosive Esophagitis:
Less than 1 month:
-Not recommended.

1 month to less than 1 year:
-0.5 mg/kg IV infused over 10 to 30 minutes

1 to 17 years:
-Less than 55 kg: 10 mg IV infused over 10 to 30 minutes
-55 kg or more: 20 mg IV infused over 10 to 30 minutes

Esomeprazole Strontium: Not recommended.

Uses: Short term treatment of symptomatic GERD; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route

Usual Pediatric Dose for Erosive Esophagitis

Esomeprazole Magnesium:
Healing:
Less than 1 year:
-Data not available

1 to 11 years:
-Less than 20 kg: 10 mg once a day for 8 weeks
-20 kg or more: 10 mg or 20 mg once a day for 8 weeks

12 to 17 years:
-20 or 40 mg once a day for 4 to 8 weeks

Comment: Doses over 1 mg/kg/day have not been studied.

Erosive Esophagitis due to acid-mediated GERD:
Less than 1 month:
-Data not available

1 month to less than 1 year old:
-3 kg to 5 kg: 2.5 mg once a day
-Greater than 5 kg to 7.5 kg: 5 mg once a day
-Greater than 7.5 kg to 12 kg: 10 mg once a day
Duration of therapy: For up to 6 weeks

Comment: Doses over 1.33 mg/kg/day have not been studied.

1 year and older:
-Data not available

Uses: Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; short term treatment of erosive esophagitis due to acid-mediated GERD in infants

Renal Dose Adjustments

Esomeprazole Magnesium and Sodium:
-No adjustment recommended.

Esomeprazole Strontium:
-Mild to moderate renal dysfunction: No adjustment recommended.
-Severe renal dysfunction: Not recommended.

Liver Dose Adjustments

Esomeprazole Magnesium:
-Mild to moderate hepatic insufficiency (Child-Pugh class A and B): No adjustment recommended.
-Severe hepatic insufficiency (Child-Pugh class C): Maximum daily dose should not exceed 20 mg.

Esomeprazole Sodium:
For patients with bleeding gastric or duodenal ulcers and liver impairment:
Initial dose: 80 mg IV infusion
Maintenance dose:
-Mild to moderate hepatic insufficiency (Child-Pugh class A and B): Maximum of 6 mg/hr continuous IV infusion should not be exceeded.
-Severe hepatic insufficiency (Child-Pugh class C): Maximum of 4 mg/hr continuous IV infusion should not be exceeded.

Esomeprazole Strontium:
-Mild to moderate hepatic insufficiency (Child-Pugh class A and B): No adjustment recommended.
-Severe hepatic insufficiency (Child-Pugh class C): Maximum daily dose should not exceed 24.65 mg.

Dose Adjustments

-The dosage in patients with pathological hypersecretory conditions varies with the individual patient.
-Dosage regimens should be adjusted to individual patient needs.

Precautions

Safety and efficacy have not been established in patients younger than 1 month old.

Consult WARNINGS section for additional precautions.

Dialysis

Esomeprazole is highly protein bound and it is not expected to be removed by dialysis.

Other Comments

Administration advice:
Oral Capsules:
-This drug should be taken at least one hour before meals.
-Capsules should not be chewed or crushed.
-Delayed-release capsule can be opened and mixed with 1 tablespoon of applesauce and swallowed immediately. Any unused mixture should be discarded. Mixing with other foods has not been evaluated and is not recommended. Do not store for future use.
-Triple therapy: Refer to amoxicillin and clarithromycin prescribing information for contraindications, warnings, and dosing in elderly and renally impaired patients.

Intravenous:
-The intravenous injection of esomeprazole should be administered over at least 3 minutes. The intravenous infusion should be administered over 10 to 30 minutes.
-Treatment with esomeprazole injection is intended for short-term treatment (up to 10 days).

Storage requirements:
-Keep the delayed-release capsules in a tightly closed container.
Storage requirements:
-The reconstituted IV solution should be stored at room temperature up to 30C (86F) and administered within 12 hours after reconstitution. (Administer within 6 hours if 5% dextrose injection is used after reconstitution). No refrigeration is required.

Reconstitution/preparation techniques:
Delayed-release capsule:
-For patients with a nasogastric tube (NG), the delayed-release capsule can be opened, emptied into a 60 mL catheter tipped syringe, and mixed with 50 mL of water. Shake for 15 seconds, check for granules remaining in the tip, deliver contents through the NG tube, and flush the NG tube with water. Use mixture immediately after preparing. Rinse syringe with water after each use.

Oral suspension:
-Oral administration: Empty contents of 2.5 mg or 5 mg packet into 5 mL of water. Use 15 mL of water for the 10 mg, 20 mg and 40 mg packets. Stir, let thicken for 2 to 3 minutes, stir again, and drink within 30 minutes. Mix any remaining medicine with more water, stir, and drink.
-Nasogastric (NG) or gastric tube: Add 5 mL water to a catheter tipped syringe and add contents of a 2.5 mg or 5 mg packet. Use 10 mL water for the 10 mg, 20 mg and 40 mg packets. Shake the syringe and let thicken for 2 to 3 minutes. Shake syringe prior to injecting through the NG or gastric tube using a French size 6 or larger. Use mixture within 30 minutes. Refill the syringe with equal amount of water originally used, shake, and flush any remaining contents from NG or gastric tube.

General:
-Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
-Antacids can be used during treatment.

Patient advice:
-Patients should communicate if they are taking, or begin taking, other medications, because this drug can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes.
-Immediately report and seek care for diarrhea that does not improve.

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