Terlipressin ever 1 mg/5 ml (IV Injection)

Indications

• Short term management of bleeding oesophageal varices
• Emergency treatment of type 1 hepatorenal syndrome

Dosage & Administration

• Initial i.v. injection of 2 mg terlipressin acetate every 4 hours
• Maximum treatment duration of 48 hours
• Dosage adjustment based on body weight
• Administration of 3-4 mg terlipressin acetate every 24 hours for type 1 hepatorenal syndrome
• Standard average duration of treatment is 10 days

Interaction

• Increased hypotensive effect with non-selective beta-blockers
• Lower heart rate and cardiac output with concomitant bradycardiac effect medications
• Caution with medications that can prolong the QT interval or cause hypokalaemia/hypomagnesemia

Contraindications

• Hypersensitivity to the active substance or excipients
• Contraindicated in pregnancy

Side Effects

• Paleness
• Increased blood pressure
• Abdominal pain
• Nausea
• Diarrhoea
• Headache

Pregnancy & Lactation

• Contraindicated during pregnancy
• Potential harmful effects on pregnancy and foetus
• Unknown excretion in human breast milk
• Consideration for breast-feeding decision

Precautions & Warnings

• Regular monitoring of blood pressure, ECG, heart rate, serum levels of sodium and potassium
• Caution in patients with cardiac, pulmonary and vascular disease, septic shock, and injection site reaction
• Risks of Torsade de pointes and septic shock
• Caution in pediatric and elderly patients
• Sodium content in the medicinal product

Use in Special Populations

• No data available for dosage recommendation in elderly and pediatric population

Overdose Effects

• Risk of severe circulatory adverse effects with dose-dependent elevation of blood pressure
• Control of elevated blood pressure with 150 mcg clonidine i.v.
• Treatment of bradycardia with atropine

Therapeutic Class

• Other preparations

Storage Conditions

• Refrigerate at 2-8°C
• Store ampoules in the outer carton to protect from light

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