ARGIPRESSIN Solution for injection Ref.[7860] Active ingredients: Vasopressin

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.

Pregnancy

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.

Breast-feeding

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: hypersensitivity, anaphylaxis

Metabolism and nutrition disorders: hyperhydration/ water intoxication

Nervous system disorders: headache, vertigo, tremor

Cardiac disorder: 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. Website: www.mhra.gov.uk/yellowcard.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.