Erosive reflux esophagitis

Active Ingredient: Esomeprazole

Indication for Esomeprazole

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

For this indication, competent medicine agencies globally authorize below treatments:

40 mg once daily

For:

Dosage regimens

Intravenous, 40 milligrams esomeprazole, once daily.

Detailed description

Patients who cannot take oral medication may be treated parenterally with 20–40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily.

Dosage considerations

Injection

40 mg dose: Should be given as an intravenous injection over a period of at least 3 minutes.

Infusion

40 mg dose: The reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.

40 mg once daily for 4 weeks

For:

Dosage regimens

Oral, 40 milligrams esomeprazole, once daily, over the duration of 4 weeks.

Detailed description

40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

For patients 1-11 years old 10 or 20 mg once daily based on body weigth and for patients 12-18 years old 40 mg once daily

For:

Dosage regimens

Regimen A, in the case that patient age in years is ≥ 1 and patient age in years is ≤ 11 and patient weight is < 20 kg :

Intravenous, 10 milligrams esomeprazole, once daily.

Regimen B, in the case that patient age in years is ≥ 1 and patient age in years is ≤ 11 and patient weight is ≥ 20 kg :

Intravenous, between 10 milligrams esomeprazole and 20 milligrams esomeprazole, once daily.

Regimen C, in the case that patient age in years is ≥ 12 :

Intravenous, 40 milligrams esomeprazole, once daily.

Detailed description

Children and adolescents aged 1-18 years

Gastric antisecretory treatment when the oral route is not possible

Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD (see doses in table below).

Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible.

Recommended intravenous doses of esomeprazole:

Age groupTreatment of erosive reflux esophagitis
1-11 YearsWeight <20 kg: 10 mg once daily
Weight ≥20 kg: 10 mg or 20 mg once daily
12-18 Years40 mg once daily

For patients weighting ≥10 - <20 kg 10 mg once daily and for patients weighting ≥20 kg 10 mg or 20 mg once daily, for 8 weeks

For:

Dosage regimens

Regimen A, in the case that patient weight is ≥ 10 kg and patient weight is < 20 kg :

Oral, 10 milligrams esomeprazole, once daily, over the duration of 8 weeks.

Regimen B, in the case that patient weight is ≥ 20 kg :

Oral, between 10 milligrams esomeprazole and 20 milligrams esomeprazole, once daily, over the duration of 8 weeks.

Detailed description

Children 1–11 years with a bodyweight of ≥10 kg

Treatment of endoscopically proven erosive reflux esophagitis:

  • Weight ≥10 - <20 kg: 10 mg once daily for 8 weeks.
  • Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks.

Active ingredient

Esomeprazole

Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+K+-ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

Read more about Esomeprazole

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