ESMOZIN POWDER FOR SOLUTION FOR INJECTION AND INFUSION 40 MG/VIAL [SIN16074P]

Product Info

ESMOZIN POWDER FOR SOLUTION FOR INJECTION AND INFUSION 40 MG/VIAL

[SIN16074P]

Therapeutic indications

Esmozin for injection and infusion is indicated as an alternative to oral therapy when oral intake is not appropriate:

• For gastroesophageal reflux disease in patients with esophagitis and/or severe symptoms of reflux.

• For healing of gastric ulcers associated with NSAID therapy.

• For 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.

Posology and method of administration

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 oesophagitis 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 IV 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.

Method of administration

Injection
40 mg dose
The reconstituted solution should be given as an intravenous injection over a period of at least 3 minutes.

20 mg dose
Half of the reconstituted solution should be given as an intravenous injection over a period of approximately 3 minutes. Any unused solution should be discarded.

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

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

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. See “Shelf life for shelf-life of the reconstituted solution” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children and adolescents
Esmozin should not be used in children since no data is available.

Impaired renal function
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 properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Impaired hepatic function
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 Esmozin should not be exceeded (See “Pharmacokinetic properties” – 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 Esmozin for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient (See “Pharmacokinetic properties” – 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.

Contraindications

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