Minirin

Minirin Special Precautions

desmopressin

Manufacturer:

Ferring

Distributor:

Metro Drug
Full Prescribing Info
Special Precautions
In the treatment of primary nocturnal enuresis and nocturia fluid intake shall be limited to the least possible during the period of 1 hr before and 8 hrs after administration. Treatment without concomitant reduction in fluid intake can lead to water retention and/or hyponatremia (headache, nausea/vomiting, weight gain and in serious cases, convulsions). In patients with urgency/urge incontinence, organic causes for increased micturition, frequency or nocturia [eg, benign prostate hyperplasia (BPH), urinary tract infection, bladder stones/tumors], polydipsia and poorly adjusted diabetes mellitus, the specific cause should be treated. In clinical trials, higher occurrence of hyponatremia was found in patients >65 years. Therefore, initiation of treatment in the elderly is not recommended, especially not in those patients suffering from other conditions that may increase the likelihood of fluid or electrolyte imbalance. Elderly patients with low serum sodium levels and patients with high 24-hr urine volume (above 2.8-3 L) may have an increased risk for hyponatremia. Although not investigated, other drugs slowing intestinal transport might have the same effect.
Precautions to avoid hyponatremia 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 eg, tricyclic antidepressant, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine; case of concomitant treatment with NSAIDs.
Treatment with desmopressin should be interrupted during acute intercurrent illnesses, characterized by fluid and/or electrolyte imbalance eg, systemic infections, fever and gastroenteritis.
Avoid fluid overload in the very young and elderly and conditions characterized by fluid or electrolyte imbalance.
Use in pregnancy: Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate no adverse effects of desmopressin on pregnancy or on the health of the fetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Use in lactation: Results from analyses of milk from nursing mothers receiving high-dose desmopressin (300 mcg intranasally), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
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