Chemical formula: C₅₂H₇₄N₁₆O₁₅S₂ Molecular mass: 1,227.372 g/mol PubChem compound: 72081
Terlipressin interacts in the following cases:
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, such as class IA and III antiarrhythmics, erythromycin, certain antihistamines and tricyclic antidepressants or medications that can cause hypokalaemia or hypomagnesemia (e.g. some diuretics).
Terlipressin increases the hypotensive effect of non-selective β-blockers on the portal vein. The reduction in heart rate and cardiac output caused by the treatment can be attributed to the inhibition of the reflexogenic activity of the heart through the vagus nerve as a result of increased blood pressure. Concomitant treatment with drugs known to induce bradycardia (e.g. propofol, sufentanil) can cause severe bradycardia.
Terlipressin has a weak antidiuretic effect (only 3% of the antidiuretic effect of native vasopressin) therefore patients with a history of disturbed electrolyte metabolism should be monitored for a possible hyponatraemia and hypokalaemia.
Terlipressin should only be used with caution and under strict monitoring of the patients in the following cases:
The use of terlipressin is not recommended during pregnancy as it has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow. Terlipressin may have harmful effects on pregnancy and foetus. Spontaneous abortion and malformation has been shown in rabbits after treatment with terlipressin.
Terlipressin should therefore only be used at vital indication on a case by case decision especially in the first trimester, when bleeding cannot be controlled with endoscopic therapy.
It is not known whether terlipressin is excreted in human breast milk. The excretion of terlipressin in milk has not been studied in animals. A risk to the suckling child cannot be excluded.
A decision on whether to discontinue breast-feeding or to discontinue/abstain from terlipressin therapy taking into account the benefit of breast-feeding to the child and the benefit of therapy for the woman.
No studies on the effect on the ability to drive and use machines have been performed.
The most common side effects reported in clinical studies (frequency 1-10%) are paleness, high blood pressure, abdominal pain, nausea, diarrhoea and headache.
The antidiuretic effects of terlipressin can cause hyponatremia if the fluid balance is not controlled.
The following frequencies are used to evaluate side effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data).
| MedDRA System Organ Class | Adverse Reaction (Preferred Term) |
|---|---|
| Metabolism and nutrition disorders | |
| common (≥1/100 to <1/10) | hyponatraemia if fluid not monitored |
| Nervous system disorders | |
| common (≥1/100 to <1/10) | headache |
| uncommon (≥1/1,000 to <1/100) | triggering of a convulsive disorder |
| very rare (<1/10,000) | stroke |
| Cardiac disorders | |
| common (≥1/100 to <1/10) | ventricular and supra-ventricular arrhythmia, bradycardia, signs of ischaemia in the ECG |
| uncommon (≥1/1,000 to <1/100) | angina pectoris, acute hypertension rise, in particular in patients already suffering from hypertension (generally, it decreases spontaneously), atrial fibrillation, ventricular extrasystoles, tachycardia, chest pain, myocardial infarction, fluid overload with pulmonary oedema, cardiac failure, Torsade de Pointes |
| very rare (<1/10,000) | myocardial ischemia |
| Vascular disorders | |
| common (≥1/100 to <1/10) | hypertension, hypotension, peripheral ischaemia, peripheral vasoconstriction, pallor |
| uncommon (≥1/1,000 to <1/100) | intestinal ischaemia, peripheral cyanosis, hot flushes |
| Respiratory, thoracic and mediastinal disorders | |
| uncommon (≥1/1,000 to <1/100) | painful breathing, bronchospasm, respiratory distress, respiratory failure, respiratory arrest |
| rare (≥1/10,000 to <1/1,000) | dyspnoea |
| Gastrointestinal disorders | |
| common (≥1/100 to <1/10) | abdominal cramps, diarrhoea, nausea |
| uncommon (≥1/1,000 to <1/100) | vomiting |
| Skin and subcutaneous tissue disorders | |
| uncommon (≥1/1,000 to <1/100) | lymphangitis, skin necrosis unrelated to the site of administration |
| Pregnancy, puerperium and perinatal conditions | |
| uncommon (≥1/1,000 to <1/100) | uterine hypertonus, uterine ischemia |
| Reproductive system and breast disorders | |
| common (>1/100 to <1/10) | abdominal cramps (in women) |
| General disorders and administration site conditions | |
| uncommon (≥1/1,000 to <1/100) | injection site necrosis |
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