Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Terlipressin acetate 0.12 mg/ml solution for injection is a synthetic pituitary hormone.
Terlipressin acetate 0.12 mg/ml solution for injection is used for treatment of bleeding from dilated veins in the food pipe leading to your stomach (bleeding oesophageal varices).
You should not be given Terlipressin acetate 0.12 mg/ml solution for injection • if you are allergic to terlipressin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions This medicine will be given to you if you have severe or life-threatening bleeding in your food pipe (oesophagus). It is used under continuous monitoring of your heart and blood circulation.
If you are able to, tell your doctor if you suffer from the conditions shown below:
• if you are suffering from a severe infection known as septic shock
• if you suffer from bronchial asthma or other conditions that affect your breathing
• if you suffer from acute coronary syndrome (ACS describes symptoms related to poor blood flow to the heart muscle leading to a heart attack. This results in chest pain, or angina pectoris.)
• if you suffer from uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (e.g. angina), have previously had a heart attack (myocardial infarction), or you have hardening of your arteries (arteriosclerosis)
• if you suffer from irregular heartbeats (cardiac arrhythmias)
• if you have poor blood circulation to your brain (e.g. you have had a stroke) or to your limbs (peripheral vascular disease)
• if you suffer from impaired kidney function (renal insufficiency)
• if you suffer from disturbances in the level of salt (electrolytes) in your blood
• if you are suffering from reduced amount of fluid in your circulation or have already lost a large amount of blood
• if you are over the age of 70 years
• if you are pregnant.
Children and adolescents Terlipressin acetate 0.12 mg/ml solution for injection is not recommended for use in children and adolescents due to insufficient experience.
Other medicines and Terlipressin acetate 0.12 mg/ml solution for injection Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Please inform your doctor immediately if you use the following medicines:
• drugs that have an effect on your heart rate (e.g. beta-blockers or propofol)
• drugs that can trigger irregular beating of the heart (arrhythmia) such as the following: • anti-arrhythmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
• an antibiotic called erythromycin
• antihistamines (mainly used to treat allergies but also found in certain cough and cold remedies)
• medicines used to treat depression called tricyclic antidepressants
• medicines that may alter the level of salt or electrolytes in your blood, particularly diuretics (used to treat high blood pressure and heart failure).
Pregnancy and breast-feeding Terlipressin acetate 0.12 mg/ml solution for injection should only be used during pregnancy if it is vital to treat your condition. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
It is not known if Terlipressin acetate 0.12 mg/ml solution for injection is present in breast milk. Therefore the possible effects on your baby are unknown. You should discuss the potential risk to your baby with your doctor.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. However, if you feel unwell after receiving the injection, do not drive or operate machinery.
Terlipressin acetate 0.12 mg/ml solution for injection contains sodium This medicinal product contains 15.7 mmol (or 361 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
This medicine will always be administered to you by your doctor. Please ask your doctor for further information regarding its use.
How much Terlipressin acetate 0.12 mg/ml solution for injection is given Adults
Initially 1-2 mg terlipressin acetate (equivalent to 8.5-17 ml of injection solution) is given by injection into your vein. Your dose will depend on your body weight.
After the initial injection, your dose may be reduced to 1 mg terlipressin acetate (equivalent to 8.5 ml of solution), every 4 to 6 hours.
The maximum dose you can receive each day is approximately 120 micrograms/kg body weight.
Elderly
If you are over 70 years of age speak with your doctor before you receive Terlipressin acetate 0.12 mg/ml solution for injection.
How Terlipressin acetate 0.12 mg/ml solution for injection is given Terlipressin acetate 0.12 mg/ml solution for injection should be slowly injected intravenously.
How often you will be given Terlipressin acetate 0.12 mg/ml solution for injection The use is limited to 2 – 3 days, depending on the course of your condition.
If you are given more Terlipressin acetate 0.12 mg/ml solution for injection than you should be You must not have more Terlipressin acetate 0.12 mg/ml solution for injection than the recommended dose. If you are given too much then you may have a rapid increase in your blood pressure, especially if you already suffer with high blood pressure. If this happens then you need another medicine called an alpha blocker (e.g. clonidine) to control your blood pressure.
If you experience lightheadedness, dizziness, or feeling faint, tell your doctor as these could be signs of a low heart rate. This can be treated with a medicine called atropine.
If you forget to use Terlipressin acetate 0.12 mg/ml solution for injection You will be given Terlipressin acetate 0.12 mg/ml solution for injection in hospital under the supervision of your doctor.
If you stop using Terlipressin acetate 0.12 mg/ml solution for injection If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or signs you should pay attention to, and measures to be taken if you are affected In very rare cases severe side effects are possible when you are given terlipressin. If you are affected by one of the following side effects, please tell your doctor immediately if you are able to. Your doctor should not give you any more terlipressin.
Severe shortness of breath due to an asthma attack, severe difficulty with or stopping breathing, severe pain in the chest (angina), severe and persistent irregular heartbeats, locally dead skin (necrosis), convulsions (seizure), kidney failure.
Other possible side effects Common (may affect up to 1 in 10 people)
• headache
• too slow heart rate
• signs of insufficient blood circulation in the heart vessels shown in the ECG
• high blood pressure
• low blood pressure
• insufficient blood circulation in arms, legs and skin, pale skin
• abdominal cramps
• diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• too little sodium in the blood (hyponatraemia) if not monitored
• dead skin (necrosis) not related to the injection site
• rapid increase in blood pressure
• too fast heart rate (palpitations)
• swelling of the tissues in the body or fluid on the lungs
• chest pain
• heart attack
• excess fluid on the lungs
• heart failure (Torsade de Pointes)
• insufficient blood flow to the intestines
• uterine cramps
• decreased blood flow to the uterus
• bluish colouration of the skin or lips
• hot flushes
• temporary nausea (feeling sick)
• temporary vomiting
• inflammation of the lymph vessels (fine red streaks under your skin extending from the affected area to the armpit or groin and by fever, chills, headache, and muscle pain).
Rare (may affect up to 1 in 1,000 people)
• shortness of breath.
Very rare (may affect up to 1 in 10,000 people)
• too much sugar in the blood (hyperglycaemia)
• stroke.
Not known (frequency cannot be estimated from the available data)
• uterine cramps (cramps in the womb)
• decreased blood flow to the uterus.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the ampoule after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator at 2-8˚C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Terlipressin acetate 0.12 mg/ml solution for injection contains • The active substance is terlipressin (as acetate). Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml solution for injection, corresponding to 0.85 mg terlipressin. This is equivalent to 0.12 mg terlipressin acetate per ml, corresponding to 0.1 mg terlipressin per ml.
• The other ingredients are sodium acetate trihydrate, sodium chloride, acetic acid, glacial (for pH adjustment) and water for injection.
What Terlipressin acetate 0.12 mg/ml solution for injection looks like and contents of the pack Terlipressin acetate 0.12 mg/ml solution for injection is a clear, colourless solution for injection without visible particles.
Terlipressin acetate 0.12 mg/ml solution for injection is packed into one carton with 5 ampoules.
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Terlipressinacetat SUN
Germany: Terlipressin SUN 0,1 mg/ml Injektionslösung
Finland: Terlipressin SUN 1 mg injektioneste, liuos
France: Terlipressine SUN 0,12 mg/ml, solution injectable
Italy: Terlipressina SUN 0,1 mg/ml soluzione iniettabile
The Netherlands: Terlipressine SUN 0,1 mg/ml, oplossing voor injectie
Norway: Terlipressin SUN 1 mg injeksjonsvæske, oppløsning
Spain: Terlipresina SUN 1 mg solución inyectable EFG
Sweden: Terlipressin SUN 1 mg injektionsvätska, lösning
United Kingdom: Terlipressin acetate 0.12 mg/ml solution for injection
This leaflet was last revised in June 2021.
5221270
Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Address
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
Telephone
+44 (0) 208 848 8688
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+44 (0) 208 848 5052
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http://www.sunpharma.com
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[email protected]
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Terlipressin acetate 0.12 mg/ml solution for injection comes as injection containing 0.12mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Terlipressin acetate 0.12 mg/ml solution for injection is terlipressin acetate.
Medicines with the same active substance, strength and form include: Terlipressin Acetate 0.12 mg/ml solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Terlipressin acetate 0.12 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Terlipressin is indicated in the treatment of bleeding oesophageal varices.
The administration of terlipressin serves the emergency care for acute bleeding oesophageal varices until endoscopic therapy is available. Afterwards the administration of terlipressin for the treatment of oesophageal varices is usually an adjuvant therapy to the endoscopic haemostasis. Adults The recommended initial dose is 1 to 2 mg terlipressin acetate # (equivalent to 8.5 to 17 ml of solution), administered by intravenous injection over a period of time. Depending on the patient's body weight the dose can be adjusted as follows: - weight less than 50 kg: 1 mg terlipressin acetate (8.5 ml) - weight 50 kg to 70 kg: 1.5 mg terlipressin acetate (12.75 ml) - weight exceeding 70 kg: 2 mg terlipressin acetate (17 ml). After the initial injection, the dose can be reduced to 1 mg terlipressin acetate every 4 to 6 hours. The approximate value for the maximum daily dose of Terlipressin acetate SUN 0.12 mg/ml solution for injection is 120 μg terlipressin acetate per kg body weight. The therapy is to be limited to 2 – 3 days in adaptation to the course of the disease. # 1 to 2 mg terlipressin acetate corresponding to 0.85 to 1.7 mg terlipressin. Elderly Terlipressin should only be used with caution in patients over 70 years (see section 4.4). Paediatric population Terlipressin is not recommended in children and adolescents due to insufficient experience on safety and efficacy (see section 4.4). Renal insufficiency Terlipressin should only be used with caution in patients with chronic renal failure (see section 4.4). Hepatic insufficiency A dose adjustment is not required in patients with liver failure. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Terlipressin should only be used with caution and under strict monitoring of the patients in the following cases: - septic shock - bronchial asthma, respiratory deficiencies - uncontrolled hypertension - cerebral or peripheral vascular diseases - cardiac arrhythmias - acute coronary syndrome, coronary deficiencies or previous myocardial infarction - chronic renal insufficiency - elderly patients> 70 years as experience is limited in this group - pregnancy (see section 4.6). Also hypovolaemic patients often react with an increased vasoconstriction and atypical cardiac reactions. Due to the weak antidiuretic effect of terlipressin (only 3% of the antidiuretic effect of native vasopressin) especially patients with already disturbed electrolyte metabolism should be monitored for a possible hyponatraemia and hypokalaemia. In principle the use of the product should be confined to specialist supervision in units with facilities for regular monitoring of the cardiovascular system, haematology and electrolytes. In emergency situations which require an immediate treatment before sending the patient to a hospital symptoms of hypovolaemia have to be considered. Terlipressin has no effect on arterial bleeding. To avoid local necrosis at the injection site, the injection must be administered intravenously. Skin Necrosis During post-marketing experience several cases of cutaneous ischemia and necrosis unrelated to the injection site (see section 4.8) 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. 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 section 4.8). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) 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 anormalities, 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) (see section 4.5). Particular caution should be exercised in the treatment of children, adolescents and elderly patients, as experience is limited and there is no data available regarding dosage recommendation in these special patient categories. This medicinal product contains 15.7 mmol (or 361 mg) of sodium in its single maximum dose. To be taken into consideration by patients on a controlled sodium diet. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
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 can trigger ventricular arrhythmias including "Torsade de pointes" (see sections 4.4 and 4.8). Therefore, extreme caution should be exercised in the use of terlipressin in patients with concomitant medications that can prolong the QT interval, such as class IA and III antiarrhythmics, erythromycin, certain antihistamines and tricyclic antidepressants or medications that may cause hypokalaemia or hypomagnesemia (e.g. some diuretics). <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy
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 (see section 5.3).
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.
Breastfeeding
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 continue/discontinue breast-feeding or to continue/discontinue therapy with terlipressin should be made taking into account the benefit of breast-feeding to the child and the benefit of terlipressin therapy to the woman.
No studies on the effects on the ability to drive and use machines have been performed.
The assessment of undesirable effects is based on the following frequencies: 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 (cannot be estimated from the available data). Treatment of bleeding oesophageal varices with terlipressin (1 mg intravenously and more) may be accompanied by the following adverse reactions: Metabolism and nutrition disorders Uncommon: hyponatraemia if fluid not monitored Very rare: hyperglycaemia Nervous system disorders Common: headache Uncommon: triggering of a convulsive disorder Very rare: stroke Cardiac disorders Common: ventricular and supra-ventricular arrhythmia, bradycardia, signs of ischaemia in the ECG Uncommon: 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: myocardial ischemia Vascular disorders Common: hypertension, hypotension, peripheral ischaemia, peripheral vasoconstriction, facial pallor Uncommon: intestinal ischaemia, peripheral cyanosis, hot flushes Respiratory, thoracic and mediastinal disorders Uncommon: pain in the chest, bronchospasm, respiratory distress, respiratory failure Rare: dyspnoea Gastrointestinal disorders Common: transient abdominal cramps, transient diarrhoea Uncommon: transient nausea, transient vomiting Skin and subcutaneous tissue disorders Common: paleness Uncommon: lymphangitis, skin necrosis unrelated to the site of administration Reproductive system and breast disorders Common: abdominal cramps (in women) Pregnancy, puerperium and perinatal conditions Uncommon: uterine hypertonus, uterine ischemia Not known: uterine constriction, decreased uterine blood flow General disorders and administration site conditions Uncommon: local cutaneous necrosis. During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including "Torsade de pointes" have been reported (see sections 4.4 and 4.5). During post-marketing experience, several cases of cutaneous ischemia and necrosis unrelated to the injection site have been reported (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
The recommended dose should not be exceeded in any case, since the risk of severe circulatory adverse effects is dose-dependent.
An acute hypertensive crisis, especially in patients with recognized hypertension can be controlled with a vasodilator-type alpha-blocker, e.g. 150 microgram clonidine intravenously.
Bradycardia requiring treatment should be treated with atropine.
Ask anything about Terlipressin acetate 0.12 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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