Drugs List

Therapeutic Indications

Uses

Bleeding oesophageal varices: short term treatment
Emergency treatment of hepatorenal syndrome type 1

Bleeding oesophageal varices: short term treatment.

Emergency treatment of hepatorenal syndrome (type 1), characterised by spontaneous acute renal failure in patients with severe cirrhosis and ascites.

Unlicensed Uses

Acute massive haemorrhage of the GIT in children (adjunctive treatment)
Bleeding oesophageal varices in children (adjunctive treatment)

Administration

Administer by intravenous injection over a duration of 1 minute to avoid local necrosis at the injection site.

Some formulations require reconstitution before injection. Reconstituted products should be injected immediately following reconstitution.

For single use only, discard any unused solution.

Contraindications

Children under 12 years
Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Children aged 12 to 18 years
Disorders aggravated by fluid retention
Family history of long QT syndrome
Obesity
Patients over 70 years
Septic shock
Asthma
Atherosclerosis
Electrolyte imbalance
Epileptic disorder
History of cardiac arrhythmias
History of myocardial infarction
History of torsade de pointes
Hypovolaemia
Renal impairment
Respiratory impairment
Uncontrolled hypertension
Vascular disorder

Correct electrolyte disorders before treatment
Not all presentations are licensed for all indications
Treatment to be initiated and supervised by a specialist
Monitor blood pressure continuously
Chronic nephritis: ensure reasonable blood nitrogen levels before therapy
Monitor serum electrolytes before and during treatment
Perform ECG before and during treatment
Monitor cardiovascular function
Monitor fluid balance
Monitor periodically for signs of hypokalaemia
Monitor plasma sodium in patients at risk of hyponatraemia
Monitor serum electrolytes
Hepatorenal syndrome: Increased risk of respiratory failure and sepsis
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias

Pregnancy and Lactation

Pregnancy

The use of terlipressin is contraindicated during pregnancy
It has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow.

Schaefer (2007) advises that the use of terlipressin during pregnancy is not grounds for termination or invasive diagnostic procedures.

Spontaneous abortion and malformation has been shown in rabbits after treatment with terlipressin.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

There are no data available on the use of terlipressin during pregnancy.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal cramps
Angina pectoris
Arterial pressure may increase
Atrial fibrillation
Blanching
Bradycardia
Bronchospasm
Convulsions
Cyanosis
Decreased uterine blood flow
Diarrhoea - transient
Dyspnoea
Fluid retention
Headache
Hot flushes
Hyperglycaemia
Hypertension
Hyponatraemia
Hypotension
Ischaemia
Left ventricular failure
Lymphangitis
Myocardial infarction
Myocardial ischaemia
Nausea
Necrosis (injection site)
Painful breathing
Peripheral ischaemia
Peripheral vasoconstriction
Prolongation of QT interval
Respiratory arrest
Skin necrosis
Stroke
Supraventricular arrhythmias
Tachycardia
Torsades de pointes
Uterine constriction
Ventricular arrhythmias
Ventricular extrasystoles
Vomiting

Presentation

Parenteral formulations of terlipressin.

Drugs List

Therapeutic Indications

Uses

Bleeding oesophageal varices: short term treatment
Emergency treatment of hepatorenal syndrome type 1

Bleeding oesophageal varices: short term treatment.

Emergency treatment of hepatorenal syndrome (type 1), characterised by spontaneous acute renal failure in patients with severe cirrhosis and ascites.

Unlicensed Uses

Acute massive haemorrhage of the GIT in children (adjunctive treatment)
Bleeding oesophageal varices in children (adjunctive treatment)

Dosage

Adults

Children

Administration

Administer by intravenous injection over a duration of 1 minute to avoid local necrosis at the injection site.

Some formulations require reconstitution before injection. Reconstituted products should be injected immediately following reconstitution.

For single use only, discard any unused solution.

Contraindications

Children under 12 years
Breastfeeding
Long QT syndrome
Pregnancy
Torsade de pointes

Precautions and Warnings

Children aged 12 to 18 years
Disorders aggravated by fluid retention
Family history of long QT syndrome
Obesity
Patients over 70 years
Septic shock
Asthma
Atherosclerosis
Electrolyte imbalance
Epileptic disorder
History of cardiac arrhythmias
History of myocardial infarction
History of torsade de pointes
Hypovolaemia
Renal impairment
Respiratory impairment
Uncontrolled hypertension
Vascular disorder

Correct electrolyte disorders before treatment
Not all presentations are licensed for all indications
Treatment to be initiated and supervised by a specialist
Monitor blood pressure continuously
Chronic nephritis: ensure reasonable blood nitrogen levels before therapy
Monitor serum electrolytes before and during treatment
Perform ECG before and during treatment
Monitor cardiovascular function
Monitor fluid balance
Monitor periodically for signs of hypokalaemia
Monitor plasma sodium in patients at risk of hyponatraemia
Monitor serum electrolytes
Hepatorenal syndrome: Increased risk of respiratory failure and sepsis
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias

Pregnancy and Lactation

Pregnancy

The use of terlipressin is contraindicated during pregnancy
It has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow.

Schaefer (2007) advises that the use of terlipressin during pregnancy is not grounds for termination or invasive diagnostic procedures.

Spontaneous abortion and malformation has been shown in rabbits after treatment with terlipressin.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

There are no data available on the use of terlipressin during pregnancy.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal cramps
Angina pectoris
Arterial pressure may increase
Atrial fibrillation
Blanching
Bradycardia
Bronchospasm
Convulsions
Cyanosis
Decreased uterine blood flow
Diarrhoea - transient
Dyspnoea
Fluid retention
Headache
Hot flushes
Hyperglycaemia
Hypertension
Hyponatraemia
Hypotension
Ischaemia
Left ventricular failure
Lymphangitis
Myocardial infarction
Myocardial ischaemia
Nausea
Necrosis (injection site)
Painful breathing
Peripheral ischaemia
Peripheral vasoconstriction
Prolongation of QT interval
Respiratory arrest
Skin necrosis
Stroke
Supraventricular arrhythmias
Tachycardia
Torsades de pointes
Uterine constriction
Ventricular arrhythmias
Ventricular extrasystoles
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Variquel 1mg powder and solvent for solution for injection. Sinclair IS Pharma. December 2012.

Summary of Product Characteristics: Variquel 0.2 mg/ml solution for injection. Alliance Pharmaceuticals. July 2021.

Summary of Product Characteristics: Glypressin 0.12mg/ml solution for injection. Ferring Pharmaceuticals Ltd. Revised August 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017