Glypressin

Terlipressin acetate.

Each vial contains terlipressin acetate 1 mg (equivalent to terlipressin 0.86 mg). It also contains mannitol 10 mg as excipient.
Each ampule with 5-mL solvent contains water for injection, sodium chloride and hydrochloric acid.

Treatment and control of bleeding esophageal varices.

Adults: Initially, 1-2 mg slowly administered via IV. Maintenance Dose: 1 mg administered after 4-6 hrs. The standard value for the maximum daily dose of terlipressin is 120-150 mcg/kg body weight.
Adults of 70 kg Body Weight: 8-9 vials/day to be administered in 4-hr intervals.

Due to the pharmacokinetic properties of terlipressin acetate, overdosage is not probable. Attention is to be paid in case of patients with known arterial hypertension (see Contraindications).

Septic shock.
Use in pregnancy: Due to its effect on the unstriated muscles, terlipressin may cause spontaneous abortions during the first 3 months. Furthermore, studies in pregnant rabbits have shown that malformations of the organs, also in man, cannot be excluded.
Use in children: There is no experience on the use of Glypressin in children. Therefore, Glypressin should not be used in children.

Terlipressin should be used with caution and under close monitoring in case of the following diseases: Bronchial asthma, hypertension; coronary and vascular diseases (advanced arteriosclerosis, cardiovascular disease, coronary insufficiency, arrhythmia) and renal insufficiency.

During therapy of bleeding esophageal varices with Glypressin, the following adverse events may occur: Due to the vasoconstricting 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 case, local necrosis may occur.
Due to its contracting effect, terlipressin may increase the peristaltic motion which occasionally may lead to abdominal pain, nausea, diarrhea and spontaneous evacuation.
In single cases, contractions of the bronchial muscles may lead to dyspnea.
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 hyponatremia and hypocalcemia may occur, especially in patients with already disturbed fluid balance.

Simultaneous administration of drugs which are known to cause bradycardia (eg, propofol, sufentanil) may induce severe bradycardia.

Store at temperatures not exceeding 25°C. Protect from direct sunlight.
Shelf-Life: 36 months.

Haemostatics

H01BA04 - terlipressin ; Belongs to the class of vasopressin and analogues. Used in posterior pituitary lobe hormone preparations.

Rx