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Posology: Bleeding oesophageal varices: Adults: Initially an IV injection of 2 mg 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 IV every 4 hours in patients with body weight <50 kg or if adverse effects occur. Consensus statement from the sixth Baveno Congress recommends up to 5 days.
Type 1 hepatorenal syndrome: 3 to 4 mg of 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 terlipressin treatment is advised. In other cases, terlipressin acetate 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: 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).
Elderly: 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.
Method of Administration: IV Injection.
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