Gastroesophageal reflux disease (GERD)

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

Symptomatic treatment of gastroesophageal reflux disease (GERD).

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

20 mg once daily

For:

Dosage regimens

Oral, 20 milligrams esomeprazole, once daily.

Detailed description

20 mg once daily in patients without esophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. An on demand regimen taking 20 mg once daily, when needed, can be used.

20 mg once daily

For:

Dosage regimens

Intravenous, 20 milligrams esomeprazole, once daily.

Detailed description

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

Dosage considerations

Injection

20 mg dose: Should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.

Infusion

20 mg dose: Should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.

10 mg once daily for up to 8 weeks

For:

Dosage regimens

In the case that patient weight is ≥ 10 kg :

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

Detailed description

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

Symptomatic treatment of gastroesophageal reflux disease (GERD): 10 mg once daily for up to 8 weeks.

Children below the age of 1 year

The experience of treatment with esomeprazole in infants <1 year is limited and treatment is therefore not recommended.

For patients 1-11 years old 10 mg once daily and for patients 12-12 years old 20 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 :

Intravenous, 10 milligrams esomeprazole, once daily.

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

Intravenous, 20 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 groupSymptomatic treatment of GERD
1-11 Years10 mg once daily
12-18 Years20 mg once daily

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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