Desmopressin

Oral lyophilisate "Minirin Melt" is used for the following indications: diabetes insipidus of central origin; primary nocturnal enuresis in patients (from 5 years old) after the exclusion of organic disorders from the urinary system:

• application within the framework of general principles of therapy, for example, in cases of ineffectiveness of other non-pharmacological methods of treatment or prescribing as pharmacotherapy;
• treatment of a condition caused by nighttime ADH deficiency (antidiuretic hormone);
• symptomatic treatment of nocturia (at least two cases of night urination) in adults in combination with nocturnal polyuria.

Structure

The active substance is desmopressin (1 oral lyophilisate contains 136 mcg desmopressin acetate, which is equivalent to 120 mcg desmopressin base).

Excipients: gelatin, mannitol, anhydrous citric acid.

Contraindications

• hypersensitivity to desmopressin or to other components of the drug;
• congenital or psychogenic polydipsia (with a urine volume of more than 40 ml / kg / day), polydipsia in patients with alcoholism;
• diagnosed or suspected heart failure;
• conditions that require treatment with diuretics;
• diagnosed hyponatremia;
• moderate and severe renal failure (creatinine clearance below 50 ml / min);
• syndrome of inadequate secretion of antidiuretic hormone;
• the age of patients is from 65 years, if desmopressin is used to treat nocturia.

Mode 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 is used some time after eating, food can reduce the antidiuretic effect when using small doses of desmopressin and its duration. If the desired clinical effect is not achieved within 4 weeks as a result of adequate dose selection, treatment should be discontinued.

If symptoms of fluid retention and / or hyponatremia appear (headache, nausea / vomiting, weight gain, in severe cases - the occurrence of seizures), treatment should be suspended until these symptoms disappear completely. When resuming treatment, fluid intake should be strictly limited.

Diabetes insipidus

Select a dose individually. Typically, 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.

In case of symptoms of fluid retention / hyponatremia, treatment should be discontinued and appropriate dose adjustment should be made.

Primary nocturnal enuresis

The recommended starting dose is 120 mcg at night, sublingually. In the absence of effect, the dose can be increased to 240 micrograms. It is necessary to limit fluid intake. The course of treatment is 3 months. If necessary, continue treatment should take a break of at least one week without taking the drug.

Nocturia with nocturnal polyuria

In patients with nocturia, in order to diagnose nocturnal polyuria, one should have data on the volume and frequency of urination within two days before the start of therapy. Nocturnal polyuria is an overnight discharge of urine that exceeds the volume of the bladder or exceeds ⅓ of the daily urine output. The recommended initial dose is 60 mcg at night, sublingually. If there is no effect during the 1st week, increase the dose to 120 micrograms and subsequently to 240 micrograms with an increase in dose with a frequency of not more than once a week. It is necessary to limit fluid intake at night.

The body weight of the patient should be checked for several days at the beginning of treatment and after increasing the dose.

If after one week of treatment with an appropriate dose selection there is no satisfactory clinical effect, it is not recommended to continue taking the drug.

Elderly patients

It is not recommended to start therapy in elderly patients. If it is decided to start desmopressin therapy, in such patients it is necessary to determine the level of serum sodium before starting treatment and 3 days after the start of treatment or increasing the dose, as well as at any time at the discretion of the doctor.

Application features

Pregnant women

Use with caution during pregnancy. It is recommended that you track your blood pressure. Limited data are available on the use of desmopressin during pregnancy (53 pregnant women with diabetes insipidus and 54 pregnant women with von Willebrand disease). In animal studies, no direct or indirect harmful effects of the drug have been identified with regard to reproductive toxicity. The drug should be prescribed to pregnant women only after a thorough assessment of the benefits and risks of treatment.

In studies on rats, there were no violations of the reproductive function of male and female animals. There is no evidence of the effects of desmopressin on fertility in humans.

Only a small amount of desmopressin passes into women’s breast milk. When used in therapeutic doses, desmopressin is not expected to have any effect on infants / children.

Children

Apply to children from 5 years of age for the treatment of primary nocturnal enuresis.

Drivers

The drug does not affect or has a slight effect on the ability to drive a car and work with mechanisms, this should be taken into account by drivers and specialists whose work requires increased vigilance.

Overdose

An overdose of the drug leads to an increase in the duration of action with an increased risk of fluid retention / hyponatremia.

Overdose symptoms may occur under the following conditions:

• taking a very high dose;
• the use of excess fluid at the same time or shortly after the use of desmopressin.

Symptoms of an overdose: weight gain (due to water retention), headache, nausea, and in severe cases, water intoxication with seizures, which is sometimes accompanied by dizziness or even loss of consciousness.

In particular, an overdose can occur in infants due to inappropriate selection of the dose of the drug.

Individual hyponatremia treatment. General recommendations include discontinuing desmopressin treatment, limiting fluid intake, and symptomatic treatment if necessary.

In case of an overdose, depending on the severity of the patients condition, it is necessary to reduce the dose of the drug and increase the interval between taking individual doses. If you suspect a brain edema, the patient should be immediately hospitalized in the intensive care unit. Cramps also require intensive treatment. There is no specific antidote for desmopressin. If diuresis is necessary, a saluretic, for example, furosemide, can be used, under the control of the level of serum electrolytes.

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 - cramps, cerebral edema, which is sometimes accompanied by confusion or even loss of consciousness, and to whom. This, in particular, applies to young children up to one year old and elderly people, depending on their general health.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C, in a dry place inaccessible to children.

Shelf life is 4 years.