Minirin Special Precautions

Tablet/Melt oral lyophilisate: In patients with urgency/urge incontinence, organic causes for increased micturition frequency or nocturia (e.g. benign prostate hyperplasia, urinary tract infection, bladder stone/tumor), polydipsia and poorly adjusted diabetes mellitus, the specific cause should be treated primarily.
At treatment of primary nocturnal enuresis and nocturia, fluid intake should be limited to the least possible during the period of 1 hour before evening dose until at least 8 hours after administration. Treatment without concomitant reduction in fluid intake may lead to water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in serious cases convulsions).
All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.
In clinical trials, higher occurrence of hyponatraemia was found in patients over 65 years. Therefore, treatment should not be initiated in the elderly, especially not in patients suffering from other conditions that may increase the likelihood of fluid or electrolyte imbalance.
Elderly patients, patients with low serum sodium levels and patients with a high 24-hour urine volumes (above 2.8 to 3 litres) have an increased risk for hyponatraemia.
Precautions to avoid hyponatraemia including careful attention to fluid restriction and more frequent monitoring of serum sodium must be taken at: concomitant treatment with drugs known to induce syndrome of inappropriate ADH secretion (SIADH), e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), chlorpromazine and carbamazepine, concomitant treatment with NSAIDs.
Precautions must be taken in patients at risk for increased intracranial pressure.
Treatment with desmopressin should be interrupted during acute illnesses characterised by fluid and/or electrolyte imbalance such as systemic infections, fever, gastroenteritis.
MINIRIN tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Solution for injection: For all indications, MINIRIN solution for injection should be used with caution in: very young and elderly patients; conditions characterized by fluid and/or electrolyte imbalance; patients at risk for increased intracranial pressure.
In addition for renal concentration capacity testing: The fluid intake must be limited to a maximum of 0,5 l to quench thirst from 1 hour before until 8 hours after administration. Renal concentration capacity testing in children below the age of 1 year should only be performed in hospital and under careful supervision.
In addition for haemostatic use: Measures to prevent fluid overload must be taken in patients requiring treatment with diuretic agents.
Special attention must be paid to the risk of water retention/hyponatremia. The fluid intake should be restricted to the least possible and the body weight should be checked regularly. Should there be a gradual increase of the body weight, decrease of serum sodium to below 130 mmol/l or plasma osmolality to below 270 mOsm/kg body weight, the fluid intake must be reduced drastically and the administration of MINIRIN interrupted.
MINIRIN does not reduce prolonged bleeding time in thrombocytopenia.
Effects on Ability to Drive and Use Machines: MINIRIN has no or negligible effect on the ability to drive vehicles and use machines.