Oral lyophilisate "Minirin Melt" is used for the following indications: diabetes insipidus of central genesis; Primary nocturnal enuresis in patients (from 5 years of age) after exclusion of organic disorders of the urinary system:
use within the framework of general principles of therapy, for example, in cases of ineffectiveness of other non-drug treatments or as a pharmacotherapy; treatment of a condition caused by nocturnal ADH (antidiuretic hormone) deficiency; symptomatic treatment of nocturia (at least two urinations at night) in adults in combination with nocturnal polyuria.
Composition
The active substance is desmopressin (1 oral lyophilisate contains 68 mcg of desmopressin acetate, which is equivalent to 60 mcg of desmopressin base).
Excipients: gelatin, mannitol, anhydrous citric acid.
Contraindication
Hypersensitivity to desmopressin or to other components of the drug; congenital or psychogenic polydipsia (with urine output of more than 40 ml/kg/day), polydipsia in patients with alcoholism; Established or suspected heart failure; conditions requiring treatment with diuretics; diagnosed hyponatremia; moderate and severe renal failure (creatinine clearance below 50 ml/min); syndrome of inappropriate antidiuretic hormone secretion; age of patients over 65 years if desmopressin is used to treat nocturia.
Method of application
The drug is intended for sublingual use.
"Minirin Melt" should be taken under the tongue, where the drug dissolves without adding water. The drug should be used some time after a meal, as food can reduce the antidiuretic effect of small doses of desmopressin and its duration. If the desired clinical effect is not achieved within 4 weeks as a result of adequate dose adjustment, treatment should be discontinued.
If symptoms of fluid retention and/or hyponatremia appear (headache, nausea/vomiting, weight gain, in severe cases - seizures), treatment should be discontinued until these symptoms have completely disappeared. When treatment is resumed, fluid intake should be carefully restricted.
Diabetes insipidus
The dose should be selected individually. Usually the daily dose is in the range of 120-720 mcg. The recommended initial dose for children and adults is 60 mcg 3 times a day, sublingually. In the future, the dose can be changed depending on the response to treatment. For most patients, the optimal maintenance dose is 60-120 mcg 3 times a day.
If symptoms of fluid retention/hyponatremia occur, treatment should be discontinued and the dose adjusted accordingly.
Primary nocturnal enuresis
The recommended initial dose is 120 mcg at night, sublingually. In the absence of effect, the dose can be increased to 240 mcg. It is necessary to limit fluid intake. The course of treatment is 3 months. If it is necessary to continue treatment, a break of at least one week should be taken without taking the drug.
Nocturia with nocturnal polyuria
In patients with nocturia, in order to diagnose nocturnal polyuria, data on the volume and frequency of urination for two days before the start of therapy should be available. Nocturnal polyuria is nocturnal urine output that exceeds the volume of the bladder or exceeds ⅓ of the daily diuresis. The recommended initial dose is 60 mcg at night, sublingually. If there is no effect during the 1st week, the dose should be increased to 120 mcg and then to 240 mcg with dose increases no more than once a week. It is necessary to limit fluid intake at night.
The patient's body weight should be checked for several days at the beginning of treatment and after increasing the dose.
If after one week of treatment with appropriate dose selection there is no satisfactory clinical effect, continuing to take the drug is not recommended.
Application features
Pregnant women
Use with caution during pregnancy. Monitoring of blood pressure is recommended. There are limited data on the use of desmopressin during pregnancy (53 pregnant women with diabetes insipidus and 54 pregnant women with von Willebrand disease). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The drug should be administered to pregnant women only after careful assessment of the benefits and risks of treatment.
Studies in rats have not revealed any impairment of male or female reproductive function. There is no data on the effect of desmopressin on fertility in humans.
Only small amounts of desmopressin are excreted in human milk. No effects on the newborn/infant are expected when desmopressin is administered at therapeutic doses.
Children
Use in children from 5 years of age for the treatment of primary nocturnal enuresis.
Drivers
The drug has no or negligible effect on the ability to drive and use machines; this should be taken into account by drivers and specialists whose work requires increased alertness.
Overdose
Overdose of the drug leads to an increase in the duration of action with an increased risk of fluid retention/hyponatremia.
Symptoms of overdose: weight gain (due to water retention), headache, nausea, and in severe cases, water intoxication with convulsions, sometimes accompanied by blackouts or even loss of consciousness.
In particular, overdose can occur in infants due to improper selection of the dose of the drug.
Treatment of hyponatremia is individualized. General recommendations include interruption of desmopressin treatment, fluid restriction, and symptomatic treatment as needed.
In case of overdose, depending on the severity of the patient's condition, it is necessary to reduce the dose of the drug and increase the interval between taking individual doses. If cerebral edema is suspected, the patient should be immediately hospitalized in the intensive care unit. Convulsions also require intensive treatment. There is no specific antidote to desmopressin. If diuresis is necessary, a saluretic, such as furosemide, can be used, under the control of serum electrolyte levels.
Side effects
The most serious adverse reactions associated with the use of desmopressin are hyponatremia, which can cause headache, abdominal pain, nausea, vomiting, weight gain, dizziness, confusion, general malaise, memory impairment, vertigo, fainting, and in severe cases - seizures, cerebral edema, sometimes accompanied by clouding or even loss of consciousness, and coma. This is particularly true for young children under one year of age and the elderly, depending on their general health.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, in a dry place out of the reach of children.
Shelf life - 4 years.
