Glypressin Dosage/Direction for Use

Posology: Bleeding oesophageal varices: Adults: Initially an i.v. injection of 2 mg (2 x 8.5 ml) terlipressin acetate is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg (8.5 ml) terlipressin acetate i.v. every 4 hours in patients with body weight <50 kg or if adverse effects occur.
Type 1 hepatorenal syndrome: An i.v. injection 3 to 4 mg (3 x 8.5 ml to 4 x 8.5 ml) terlipressin acetate every 24 hours as 3 or 4 administrations. In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of GLYPRESSIN treatment is advised. As an alternative to bolus injection, terlipressin can be administered as a continuous intravenous (IV) infusion with a starting dose of 2 mg of terlipressin acetate/24 hours and increased to a maximum of 12 mg of terlipressin acetate/24 hours. Administration of terlipressin as continuous IV infusion may be associated with lower rates of severe adverse events than with administration by IV bolus (see Pharmacology: Pharmacodynamics under Actions).
In the other cases, GLYPRESSIN treatment is to be pursued until the obtaining either of a serum creatinine less than 130 µmol/litre or of a drop of at least 30% in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome.
The standard average duration of treatment is 10 days.
Special Populations: Elderly patients: There is no data available regarding dosage recommendation in the elderly.
Paediatric population: There is no data available regarding dosage recommendation in the paediatric population.
Type 1 hepatorenal syndrome: Renal impairment: Terlipressin should be avoided in patients with advanced renal dysfunction, i.e., baseline serum creatinine ≥442 µmol/L (5.0 mg/dL), unless the benefit is judged to outweigh the risks (see Precautions).
Hepatic impairment: Terlipressin should be avoided in patients with severe liver disease defined as Acute-on-Chronic Liver Failure (ACLF) grade 3 and/or a Model for End-stage Liver Disease (MELD) score ≥39, unless the benefit is judged to outweigh the risks (see Precautions).
Method of Administration: IV injection.
Type 1 hepatorenal syndrome: IV injection or IV infusion.