Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Argipressin AOP 20 I.U. / ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Argipressin acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Argipressin AOP contains argipressin which is similar to a naturally occurring hormone in your body. It is an 'antidiuretic' which helps to prevent excess loss of water in your urine and also narrows some blood vessels in the body. Argipressin is used to treat: diabetes insipidus. This is a rare form of diabetes causing production of large quantities of urine. Argipressin increases the amount of water absorbed back into your kidneys. bleeding from enlarged veins in the oesophagus (food pipe). 2.
What you need to know before you take it
e Argipressin AOP
Do not use Argipressin AOP: if you are allergic to argipressin or any of the other ingredients of Argipressin AOP (listed in section 6). if you suffer from a certain type of kidney disease called chronic nephritis with nitrogen retention (your doctor will advise you). if you suffer from any types of diseases or conditions of your blood vessels, especially the blood vessel of your heart. if you are intended to receive halogenated anaesthetic agents during surgical procedures. Speak to your doctor if one of these applies to you before you are given this medicine. Warnings and precautions Special precautions for use of Argipressin is mandatory, if you suffer from asthma or other allergic conditions if you suffer from migraine if you suffer from epilepsy (fits) if you suffer from high blood pressure, heart or kidney disease if you suffer from obstruction of the blood vessels of the heart (e.g. coronary artery disease). if you have undergone removal of pituitary gland (dosage will depend on urine concentration). 1
Speak to your doctor or nurse if one of these applies to you before you are given this medicine. Other medicines and Argipressin AOP Tell your doctor or pharmacist if you are using or have recently used any other medicines, even if this involves over-the-counter pharmaceuticals. This is extremely important because some medicines can strengthen or weaken the effects of others. In particular, tell your doctor if you are taking any of the following: medicine which control seizures (carbamazepine) medicine to treat diabetes (chloropropamine) medicine used in corticosteroid replacement therapy (fludrocortisone) medicines to treat depression (e.g. amitriptyline, imipramine etc.) lipid lowering agent (clofibrate) medicines containing urea (in some skin and ear preparations) antibiotics (demeclocycline) medicine used for severe low blood pressure or cardiac arrest (noradrenaline) medicine used to treat mania (lithium) medicine which prevents blood clotting (heparin). Argipressin AOP with food, drink and alcohol Argipressin may not be used in combination with alcohol. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No sufficient data is available which demonstrates the safety for use of Argipressin during pregnancy. Whether Argipressin is excreted in human milk is not known. There is no evidence for an increased risk of injury to humans. The use of Argipressin during pregnancy and during lactation is not recommended. Driving and using machines Argipressin can affect your ability to drive and use machinery safely, as you may feel dizzy after receiving your injection. Speak to your doctor for further advice. Argipressin AOP contains less than 1 mmol of sodium (23 mg) per ml, i.e. essentially sodium-free. 3.
How to take it
Argipressin AOP
Argipressin AOP will always be administered by a physician. It is most likely that you will be in hospital when you are given Argipressin. For the treatment of diabetes insipidus: the dose is usually 0.25 ml to 1 ml injected under the skin or into a muscle every four hours. For the treatment of bleeding in the oesophagus: the dose is usually 1 ml diluted in a sugar solution and slowly dripped through a needle into a vein. This will usually take about 15 minutes. Your doctor will decide on the most suitable dose and way to give it to you depending on your symptoms. If you have any further questions on the use of this product, ask your doctor or nurse. Elderly (over 65 years) The dose is the same as for adults. Use in children Not recommended in children below 18 years. If you use more Argipressin AOP than you should As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary. However, if you think that you have been given too much, tell your doctor immediately. 2
If you stop using Argipressin AOP This medication will usually be administered by a physician. If you believe that the use of the medicine was stopped too early, talk to your doctor immediately. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Argipressin can cause 'water intoxication'. Signs of this are drowsiness, being uninterested in anything (listless) and headaches. If you notice any of these signs, tell the nurse or your doctor straightaway. If it is not corrected, water intoxication can lead to fits or even coma. Other side effects sometimes seen are: Dizziness Abnormal collection of fluid in the body leading to swollen face, swelling in hands and feet and weight gain Feeling sick or being sick or 'bloating' Diarrhoea Paleness of the lips, nail beds and tongue (pallor) Wind (flatulence) Wheezing 'Nettle rash' or hives – itchy red bumps Excessive Sweating Shakiness Gangrene which causes redness, swelling, loss of sensation/severe pain and dead black areas of skin like fingers or toes (very rare). Loss of sensation in fingers and toes Heart problems with slow or irregular heart beat Pounding in the head or a headache Stomach ache In patients with disease of the heart or circulation, Argipressin may give rise to angina (chest pain). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via UK: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Argipressin AOP
Keep this medicine out of the sight and reach of children. Store in a refrigerator (2°C – 8°C). Do not freeze. Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Do not use this medicine if the solution is not clear and colourless. 3
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. 6.
Contents of the pack and other information
What Argipressin AOP contains The active substance is Argipressin. One ampoule with 1 ml solution for injection contains Argipressin, equivalent to 20 International Units (IU) of argipressin (as argipressin acetate). The other excipients are sodium chloride, glacial acetic acid to adjust the pH value, water for injection. What Argipressin AOP looks like and contents of the pack Argipressin AOP 20 IU/ml solution for injection is a clear, colourless injection solution. Each pack contains 5, 10 or 50 ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder AOP Orphan Pharmaceuticals GmbH Leopold-Ungar-Platz 2 1190 Vienna Austria Manufacturer AOP Orphan Pharmaceuticals GmbH Leopold-Ungar-Platz 2 1190 Vienna Austria Marketing authorization number PL 21344/0024 This leaflet was last revised in 10/2021
4
Frequently asked questions about Argipressin AOP 20 I.U. / ml solution for injection
How do I take Argipressin AOP 20 I.U. / ml solution for injection?
Argipressin AOP 20 I.U. / ml solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Argipressin AOP 20 I.U. / ml solution for injection?
The active substance in Argipressin AOP 20 I.U. / ml solution for injection is argipressin acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Argipressin AOP 20 I.U. / 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.
Can I get Argipressin AOP 20 I.U. / ml solution for injection without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: argipressin acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Argipressin AOP is indicated in adults for the treatment of diabetes insipidus, when this is not of nephrogenic origin, and control of bleeding from oesophageal varices.
4.2. Posology and method of administration
Posology
Adults
Diabetes Insipidus:
A dose of 0.25 ml to 1 ml (5 to 20 units) by subcutaneous or intramuscular injection every four hours.
Oesophageal Varices:
For the initial control of variceal bleeding Argipressin AOP should be given intravenously. Argipressin AOP 20 units, diluted in 100 ml dextrose 5% w/v, may be infused over a 15 minute period.
Elderly (over 65 years)
As for adults, no clinical or pharmacokinetic data specific to this age group are available. However, the drug has been successfully used at normal dosage in the elderly.
Paediatric population
Not recommended in children below 18 years.
Method of administration
Subcutaneous, intravenous or intramuscular injection.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patient with coronary artery disease, or those intended to receive halogenated anaesthetic agents.
Vascular disease (especially disease of coronary arteries), chronic nephritis (until reasonable blood nitrogen concentrations attained).
4.4. Special warnings and precautions for use
Argipressin should not be used in patients with systemic hypertension or vascular disease, especially disease of the coronary arteries, except with extreme caution. In such patients, even small doses may precipitate pain, and with larger doses, the possibility of myocardial infarction should be considered. If this drug must be used in patients with peripheral vascular disease then the skin should be observed carefully for signs of ischaemia.
Argipressin may produce water intoxication. The early signs of drowsiness, listlessness, and headaches should be recognised to prevent terminal coma and convulsions.
Adjustment of dosage in cases immediately post-hypophysectomy should be controlled on the basis of measurements of urine osmolality.
Argipressin should be used cautiously in the presence of epilepsy, migraine, asthma, heart failure, or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system.
Chronic nephritis with nitrogen retention contraindicates the use of argipressin injection until reasonable nitrogen blood levels have been attained.
4.5. Interaction with other medicinal products and other forms of interaction
The following drugs may potentiate the antidiuretic effect of argipressin when used concurrently: carbamazepine, chlorpropamine, clofibrate, fludrocortisone, urea or tricyclic antidepressants.
The following drug may decrease the antidiuretic effect of argipressin when given concurrently: demeclocycline, noradrenaline, lithium, heparin, alcohol.
Ganglion blocking agents may produce a marked increase in sensitivity to the pressor effect of argipressin.
4.6. Fertility, pregnancy and lactation
Fertility
Effects of vasopressin on fertility are unknown.
Pregnancy
No animal reproduction studies have been performed with argipressin. Oxytocic effect in third trimester has been reported. However, argipressin has been used successfully during pregnancy for the treatment of diabetes insipidus with no adverse effects on the fetus being reported. Nevertheless, as with all medicines, use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the fetus.
Breastfeeding
Argipressin has been administered to breast feeding women without apparent adverse effect on the infant.
4.7. Effects on ability to drive and use machines
Argipressin AOP has moderate influence on the ability to drive and use machines and may cause vertigo (see section 4.8).
4.8. Undesirable effects
The following undesirable effects have been observed and reported during treatment with Argipressin with the following frequency:
The undesirable effects are listed below by organ class and the following frequency convention:
Very common: (≥1/10)
Common: (≥1/100, <1/10)
Uncommon: (≥1/1,000, <1/100)
Rare: ((≥1/10,000, <1/1,000)
Very rare: (<1/10,000),
Not known – frequency cannot be estimated from the available data.
The frequency of the following side effects is not known.
Immune system disorders
• hypersensitivity
• anaphylaxis
Metabolism and nutrition disorders
• hyperhydration / water intoxication
Nervous system disorders
• headache
• vertigo
• tremor
Cardiac disorders
• chest pain due to angina
• cardiac arrest
Vascular disorders
• peripheral ischaemia
• pallor
• hypertension
Respiratory, thoracic and mediastinal disorders
• bronchospasm
Gastrointestinal disorders
• flatulence
• nausea
• vomiting
• diarrhoea
• abdominal pain
Skin and subcutaneous tissue disorders
• gangrene
• hyperhidrosis
• urticaria
Renal and urinary disorders
• fluid retention
General disorders and administration site conditions
• non-cardiac chest pain
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.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
If water intoxication occurs, no fluids should be given. In severe cases, small amounts of hypertonic saline may be administered. Urea and mannitol infusions may be helpful in cases of cerebral oedema. If a patient should experience anginal pain after administration of Argipressin AOP, amyl nitrite by inhalation or glyceryl trinitrate sublingually, may be given.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- EmpesinArgipressinum · injection / infusion
- Argipressin FarmakArgipressinum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Argipressin AOP 20 I.U. / 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.