POM: Prescription only medicine
This information is intended for use by health professionals
Argipressin 20 International Units /ml Solution for Injection
20 international units argipressin (vasopressin) per ml.).
For the full list of excipients, see section 6.1.
Solution for injection
Clear, sterile solution.
For use in diabetes insipidus, when this is not of nephrogenic origin and control of bleeding from oesophageal varices.
A dose of 0.25ml to 1ml (5 to 20 units) by subcutaneous or intramuscular injection every four hours.
For the initial control of variceal bleeding Argipressin should be given intravenously. Argipressin, 20 units diluted in 100ml 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.
Not recommended in children below 18 years.
Method of administration
Subcutaneous, intravenous or intramuscular injection.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Anaphylaxis to the active substance or to the excipients listed in section 6.1.
Patient with coronary artery disease or those intended to receive halogenated anaesthetic agents.
Chronic nephritis with nitrogen retention contraindicates the use of Argipressin 20 International Units /ml injection until reasonable nitrogen blood levels have been attained.
Vascular disease (especially disease of coronary arteries), chronic nephritis (until reasonable blood nitrogen concentrations attained).
This drug 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.
Regular monitoring of blood urea nitrogen (BUN) levels is required in patients with chronic nephritis to ensure an adequate level is maintained (see section 4.3).
The following drugs may potentiate the antidiuretic effect of vasopressin when used concurrently: carbamazepine, chlorpropamide, clofibrate, fludrocortisone, urea or tricyclic antidepressants.
The following drug may decrease the antidiuretic effect of vasopressin when given concurrently: demeclocycline, noradrenaline, lithium, heparin, alcohol.
Ganglion blocking agents may produce a marked increase in sensitivity to the pressor effect of vasopressin.
No animal reproduction studies on Argipressin are available.
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 foetus 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 foetus.
Argipressin has been administered to breast-feeding women without apparent adverse effect on the infant.
Argipressin can have an influence on driving as it may cause vertigo (see section 4.8).
The following undesirable effects have been observed and reported during treatment with Argipressin with the following frequency:
Not known – cannot be estimated from the available data.
Immune system disorders
Metabolism and nutrition disorders
• hyperhydration/ water intoxication
Nervous system disorders
• chest pain due to angina
• cardiac arrest
• peripheral ischaemia
Respiratory, thoracic and mediastinal disorders
• abdominal pain
Skin and subcutaneous tissue disorders
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.
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, amyl nitrite by inhalation or glyceryl trinitrate sublingually, may be given.
Pharmacotherapeutic group: Vasopressin and analogues
ATC code: H01BA01
Mechanism of action
The antidiuretic action of Argipressin is ascribed to increase in reabsorption of water by the renal tubules. Argipressin can cause contraction of smooth muscle of the gastrointestinal tract, gall bladder, urinary bladder and all parts of the vascular bed, especially the capillaries, small arterioles and venules with less effect on the smooth musculature of the large veins. The direct effect on the contractile elements is neither antagonised by adrenergic blocking agents nor prevented by vascular denervation.
Following subcutaneous or intramuscular administration of Argipressin injection, the duration of antidiuretic activity is variable, but effects are usually maintained for 2-8 hours.
The majority of the dose of Argipressin is metabolised and rapidly destroyed in the liver and kidneys. Argipressin has a plasma half-life of about 10 to 20 minutes.
Approximately 5% of a subcutaneous dose of Argipressin is excreted unchanged in the urine four hours after dosing.
Preclinical safety data does not add anything of further significance to the prescriber.
Glacial acetic acid, water for injection
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Store in a refrigerator (2°C and 8°C). Do not freeze.
Keep the ampoules in the outer carton in order to protect from light.
Clear OPC/blue glass ampoules with white and blue rings above the OPC.
The white and blue rings are for product identification and should not be taken as break rings. The ampoules should be open cut at the OPC
Available in packs of 10 x1ml ampoules.
For single use only.
If only part used, discard the remaining solution.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Mercury Pharmaceuticals Ltd
85 King William Street,
London EC4N 7BL,
30th November 2004
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
+44 (0)208 588 9131
08700 70 30 33
+44 (0)208 588 9273