ESCOPRO POWDER FOR SOLUTION FOR INJECTION/INFUSION 40MG/VIAL [SIN17003P]

Product Info

ESCOPRO POWDER FOR SOLUTION FOR INJECTION/INFUSION 40MG/VIAL

[SIN17003P]

INDICATIONS
Escopro powder for solution for injection/ infusion is indicated in adults for:

• Gastric antisecretory treatment when the oral route is not possible, such as:
  

  • gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux.

  • healing of gastric ulcers associated with NSAID therapy

  • prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. Patients are considered to be at risk due to their age (≥60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months.

• Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.

DOSAGE AND ADMINISTRATION
ADULTS
Gastric antisecretory treatment when the oral route is not possible
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. Patients treated symptomatically for reflux disease should be treated with 20 mg once daily.

For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily.
For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily.

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

Prevention of rebleeding of gastric and duodenal ulcers
Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days (72 hours).

The parenteral treatment period should be followed by oral acid suppression therapy.

80 mg bolus dose
The reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.

8 mg/h dose
The reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours (calculated rate of infusion of 8 mg/h).

SPECIAL POPULATIONS
Renal impairment
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution (see “Pharmacokinetic” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
GERD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg Escopro should not be exceeded (see “Pharmacokinetic” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Bleeding ulcers
Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg Escopor for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient (see “Pharmacokinetic” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Elderly
Dose adjustment is not required in the elderly.

Children And Adolescents
Escopro should not be used in children since no data is available.

CONTRAINDICATIONS
Hypersensitivity to the active substance esomeprazole or to other substituted benzimidazoles or to any of the excipients of this medicinal product.