Coagulants and hemostatics
= Additional active ingredients
Terlipressin acetate 1 mg, 5 H2O equivalent to 0.85 mg terlipressin/vial.
PRESENTATION AND DOSSAGE
AMPS: 5 X 1 mg
Bleeding esophageal varices; hepatorenal syndrome (HRS).
– Pregnancy. Due to its effect on the unstriated muscles, terlipressin may cause spontaneous abortions during the first three months. Furthermore, studies in pregnant rabbits have shown that malformations of the organs, also in man, cannot be excluded.
– Septic shock.
– Terlipressin should be used with caution and under close monitoring in case of the following concomitant diseases: bronchial asthma, hypertension, coronary and vascular diseases (advanced arteriosclerosis, cardiovascular disease, coronary insufficiency, arrhythmia), renal insufficiency.
– There is no experience on the use of Glypressin 1 mg in children. Therefore, Glypressin 1 mg should not be used in children.
Bronchial asthma, hypertension, coronary and vascular diseases (advanced arteriosclerosis, cardiovascular disease, coronary insufficiency, arrhythmia), renal insufficiency. Constant monitoring of blood pressure, serum sodium and potassium and fluid balance is essential.
During therapy of bleeding oesophageal varices with Glypressin 1 mg (1 mg i.v. and more), the following adverse events may occur:
– Due to the vasoconstriction effect, paleness of face and body and a slight blood pressure increase, which is more extreme in patients with high blood pressure, may occur.
– Seldom, arrhythmia, slowed-down heart beat and coronary insufficiency may occur.
– Occasionally, headache and, in single cases, local necrosis may occur.
– Due to its contracting effect, terlipressin may increase the peristaltic motion which occasionally may lead to abdominal pain, nausea, diarrhoea and spontaneous evacuation.
– In single cases, contractions of the bronchial muscles may lead to dyspnoea. • Convulsions of the uterine muscles as well as disturbed circulation of the myometrium and the endometrium may occur.
– Although terlipressin has only 3% of the antidiuretic action of the native vasopressin, single cases of hyponatraemia and hypokalaemia may occur, especially in patients with already disturbed fluid balance.
Drugs which are known to cause bradycardia (e.g. propofol, sufentanil) may induce severe bradycardia.
In bleeding oesophageal varices: Unless otherwise prescribed, initially 1-2 mg terlipressin acetate, equivalent to 1-2 vials of Glypressin 1 mg, are slowly administered intravenously in adults. The maintenance dose is 1 mg terlipressin acetate each, equivalent to 1 vial Glypressin 1 mg, after 4-6 hours. The standard value for the maximum daily dose of Glypressin is 120-150 g/kg body weight. For an adult person of 70 kg body weight, this corresponds to a dose of 8-9 vials per day, to be administered in 4-hour intervals.
In type 1 hepatorenal syndrome: 3 to 4 mg 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. In the other cases, Glypressin treatment is to be pursued until the obtaining either of a serum creatinine less than 130 mol/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.
For full details see prescribing information.
Due to its pharmacokinetic properties, overdosage is not probable. Attention is to be paid in case of patients
with known arterial hypertension
PREGNANCY & LACTATION
Due to its effect on the unstriated muscles, terlipressin may cause spontaneous abortions during the firstthree months. Furthermore, studies in pregnant rabbits have shown that malformations of the organs, also in man, cannot be excluded.
Teratogenic effect Rat: In a dosage of 10 and/or 50 g per kg body weight per day (s.c.), terlipressin had no toxic effect on the mean number of absorption points in the uterus, the mean number of living foetuses or new-born children, the mean body weight of the foetuses or new-born children and on the postnatal growth of the new-born children. No malformations were observed in any foetus or new-born child. Egg test: The embryo toxicity in hen embryos was also examined. No toxic effects of terlipressin have been observed. Guinea pigs: In an examination in pregnant guinea pigs with a dosage of 10 g per kg body weight, an insufficient uterine and placental blood circulation has been observed. Also in pharmacological examinations in humans, an insufficient blood circulation and an increased contraction of the uterus have been determined. Since insufficient uterine and placental blood circulation leads to an increase of the abortion rate, absorptions and unspecific malformations, terlipressin is contraindicated during pregnancy. For full details see prescribing information.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Ferring Pharmaceuticals Israel
License Holder: Lapidot Medical Import and Marketing Ltd.