Minirin Special Precautions

Tablet & Oral lyophilisate: Severe bladder dysfunction and outlet obstruction should be considered before starting treatment for central diabetes insipidus.
Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia.
Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis).
Precautions must be taken in patients at risk for increased intracranial pressure.
Desmopressin should be used with caution in patients with conditions characterized by fluid and/or electrolyte imbalance.
Precautions to avoid hyponatraemia including careful attention to fluid restriction and more frequent monitoring of serum sodium must be taken in case of concomitant treatment with drugs, which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonine reuptake inhibitors, chlorpromazine and carbamazepine, case of concomitant treatment with NSAIDs.
Injection: Severe bladder dysfunction and outlet obstruction should be considered before starting treatment for central diabetes insipidus.
Precautions must be taken in patients at risk for increased intracranial pressure.
Infants, elderly and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia.
Treatment with MINIRIN injection should be interrupted or carefully adjusted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis) as well as in excessive bleeding, and the fluid and electrolyte balance should be carefully monitored.
Special attention should be given when desmopressin is co-administered with other drugs affecting water and/or sodium homeostasis (see Interactions). In patients with chronic therapy with drug(s) affecting water and/or sodium homeostasis, MINIRIN injection should be administered after confirmation of normal baseline sodium.
Precautions must be taken in patients with moderate and severe renal insufficiency (creatinine clearance below 50 ml/min).
MINIRIN injection should not be used in patients with hypersensitivity to desmopressin or to any of the excipients in the product (see Adverse Reactions).
Due to post-marketing reports with MINIRIN injections of deep vein thrombosis, cerebrovascular accident and disorder (stroke), cerebral thrombosis, myocardial infarction, angina pectoris and chest pain, considerations should be taken before using MINIRIN injection in elderly patients and in patients with risk factors and history of thrombosis, thrombophilia and known cardiovascular disease.
Nasal spray: MINIRIN nasal formulations should be used only when treatment with oral formulations is inappropriate.
When MINIRIN is prescribed it is recommended to: start with the lowest dose; ensure compliance with fluid restriction instructions; increase dose progressively, with caution; ensure that children administration is under adult supervision in order to control the dose intake.
MINIRIN should be used with caution to prevent fluid overload in: the treatment of small children and elderly patients; patients with fluid and/or electrolyte imbalance; patients with risk of increased intracranial pressure.
Without simultaneous reduction in fluid intake, treatment can lead to water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in serious cases convulsions).
Elderly patients, patients with low plasma sodium levels and patients with high 24-hour urine volumes (above 2.8 to 3 litres) have an increased risk of developing hyponatraemia.
In patients with urgency/urge incontinence, organic causes for increased micturition frequency or nocturia (e.g. benign prostatic hyperplasia, urinary tract infection, bladder stones/tumours), polydipsia or poorly controlled diabetes mellitus, the specific cause of the symptoms should be dealt with primarily.
To prevent hyponatraemia, caution must be exercised and particular attention should be paid to fluid retention and frequent checks made of sodium plasma levels in the following circumstances: concomitant treatment with drugs that are known to induce inappropriate ADH secretion syndrome (SIADH), e.g. tricyclic antidepressants, SSRIs, chloropromazine and carbamazepine as well as some antidiabetics of the sulfonylurea group such as chlorpropamide; concomitant treatment with NSAID preparations.
Treatment with desmopressin should be carefully adjusted during acute illness characterized by fluid and/or electrolyte imbalance such as systemic infections, fever and gastroenteritis.
Experience from clinical use indicates a risk of severe hyponatraemia in association with the nasal formulation of desmopressin, when it is used in the treatment of central diabetes insipidus.
MINIRIN 0.1mg/ml nasal spray may cause bronchospasm due to the presence of benzalkonium chloride in this product.
At testing of renal concentration capacity: When used diagnostically, fluid intake should be restricted to a maximum of 0.5 L to satisfy thirst for 1 hour before administration until 8 hours after administration. Renal concentration capacity testing in children below 1 year of age should only be performed in hospital and under careful supervision.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: MINIRIN tablets has no or negligible influence on the ability to drive and use machines.