Terlipressin (Vascular)

Verbatim section 4.2: 'In acute variceal bleeding: Adults: Initially an i.v. injection of 2 mg Glypressin 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 i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.' Method of administration: 'Intravenous injection use'. maxDose IS DELIBERATELY EMPTY: the only 'maximum' in the whole posology is a TREATMENT DURATION (48 hours), not a dose ceiling, and the SPC states no maximum dose. Nothing here may be used to cap a calculated dose. THIS IS NOT THE HEPATORENAL SYNDROME REGIMEN. The dose above is for acute variceal bleeding only. The UK SPC in this bundle contains no hepatorenal-syndrome posology and no continuous-infusion regimen at all, so neither is published. For contrast, and as US labelling for a DIFFERENT product (TERLIVAZ) and a DIFFERENT indication: the US hepatorenal-syndrome regimen is 'TERLIVAZ 0.85 mg (1 vial) intravenously every 6 hours' on Days 1 to 3 by slow intravenous bolus injection over 2 minutes, with a Day-4 adjustment against baseline serum creatinine - continue 0.85 mg every 6 hours if creatinine has decreased by at least 30% from baseline, increase to 1.7 mg (2 vials) every 6 hours if it has decreased by less than 30%, and discontinue if creatinine is at or above baseline; 'Continue TERLIVAZ until 24 hours after two consecutive SCr <= 1.5 mg/dL values at least 2 hours apart or a maximum of 14 days.' Reconstitution: 'Reconstitute each vial with 5 mL of 0.9% Sodium Chloride Injection to prepare a 0.85 mg/5 mL solution.' That regimen is roughly a third of the daily amount of the variceal regimen above - do not transfer either regimen to the other indication. SPECIAL POPULATIONS (section 4.4, verbatim): 'Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups. There is no data available regarding dosage recommendation in these special patient categories.' SEPTIC SHOCK (section 4.4, verbatim): 'In patients with septic shock with a low cardiac output Glypressin should not be used.' TORSADE DE POINTES (section 4.4): QT prolongation and ventricular arrhythmias including torsade de pointes have been reported, mostly in patients with predisposing factors such as basal QT prolongation, electrolyte abnormalities (hypokalaemia, hypomagnesemia) or concomitant QT-prolonging medication - 'extreme caution should be exercised' in such patients.

NO PAEDIATRIC DOSE EXISTS IN THIS BUNDLE and none is drafted. Verbatim section 4.2: 'Paediatric population: There is no relevant use of Glypressin in paediatric population.' Section 4.4: 'Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups. There is no data available regarding dosage recommendation in these special patient categories.' US label section 8.4: 'Safety and effectiveness of TERLIVAZ have not been established in pediatric patients.' dosePerKg is null deliberately - no per-kilogram figure appears anywhere in either fetched label, so no weight calculator may run on this page. Verify any under-18 use against a children's formulary and specialist advice.