Glypressin Special Precautions

Blood pressure, heart rate and fluid balance should be monitored during treatment. To avoid local necrosis at the injection site, the injection must be given i.v.
Caution should be exercised in treating patients with hypertension or recognised heart disease. In patients with septic shock with a low cardiac output terlipressin should not be used.
This medicinal product contains 1.33 mmol (or 30.7 mg) of sodium per ampoule. To be taken into consideration in patients on a controlled sodium diet.
Cardiovascular Effects: Terlipressin should only be used with caution and under strict monitoring of the patients in the following cases: uncontrolled hypertension; cerebral or peripheral vascular diseases; cardiac arrhythmias; coronary artery disease or previous myocardial infarction.
Terlipressin should not be used in patients with unstable angina or recent acute myocardial infarction.
Torsade de pointes: During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including "Torsade de pointes" have been reported (see Adverse Reactions). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalaemia, hypomagnesaemia) or medications with concomitant effect on QT prolongation. Therefore, extreme caution should be exercised in the use of terlipressin in patients with a history of QT interval prolongation, electrolytic abnormalities, concomitant medications that can prolong the QT interval (see Interactions).
Ischaemic Events: To avoid local necrosis the injection must be administered intravenously.
During post-marketing experience several cases of peripheral ischemia and necrosis unrelated to the injection site have been reported. Patients with peripheral venous hypertension or morbid obesity seem to have a greater tendency to this reaction. Therefore, extreme caution should be exercised when administering terlipressin in these patients.
Respiratory Effects: Terlipressin may cause smooth muscle constriction and should be used with caution and under strict monitoring in patients with severe asthma or chronic obstructive pulmonary disease (COPD).
Laboratory Monitoring: During treatment with terlipressin, serum creatinine should be monitored at least daily as terlipressin should be used with caution in patients with renal insufficiency. Fluid balance and electrolytes should be monitored carefully as hyponatraemia, hypokalaemia, hypomagnesaemia and other electrolyte disturbances have been reported.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.
There are no data available regarding dosage recommendation in these special patient categories.
Use in the Elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.
There are no data available regarding dosage recommendation in these special patient categories.