Lyophilisate oral "Minirin Melt" is applied at the following indications: not sugar diabetes of the central genesis; primary night enuresis at patients (since 5 years) after an exception of organic disorders from bodies of an urinary system:

• use within the general principles of therapy, for example, in cases of inefficiency of other non-medicament methods of treatment or appointment as pharmacotherapy;
• treatment of the state caused by night insufficiency of ADG (antidiuretic hormone);
• symptomatic treatment of a nocturia (not less than two cases of urination at night) at adults in combination with a night polyuria.

Structure

Active ingredient - desmopressin (1 lyophilisate oral contains desmopressin of acetate 68 mkg that is equivalent to desmopressin of the basis of 60 mkg).

Excipients: gelatin, Mannitolum, anhydrous citric acid.

Contraindication

• hypersensitivity to desmopressin or to other components of drug;
• a congenital or psychogenic polydipsia (with a volume of uropoiesis more than 40 ml/kg/day), a polydipsia at alcoholics;
• diagnosed or suspected heart failure;
• a state which demand treatment by diuretics;
• diagnosed hyponatremia;
• a moderate and heavy renal failure (the clearance of creatinine is lower than 50 ml/min.);
• syndrome of inadequate secretion of antidiuretic hormone;
• age of patients of 65 years if to apply desmopressin to treatment of a nocturia.

Route of administration Drug is intended to

by

for sublingual use.

to accept

"Minirin Melt" under language where medicament is dissolved without water addition. To use medicament after meal after a while, food can reduce antidiuretic effect at use of small doses of desmopressin and its duration. If the necessary clinical effect is not reached within 4 weeks as a result of adequate selection of a dose, treatment should be stopped.

treatment has to be suspended by

At emergence of symptoms of a delay of liquid and/or a hyponatremia (a headache, nausea/vomiting, increase in body weight, in hard cases - developing of spasms) before total disappearance of these symptoms. When resuming treatment it is necessary to limit liquid consumption strictly.

Nesakharny diabetes

Dose to select

individually. Usually daily dose is in limits of 120-720 mkg. The recommended initial dose for children and adults makes 60 mkg 3 times a day, sublingual. Further the dose can be changed depending on treatment response. For most of patients an optimum maintenance dose are 60-120 mkg 3 times a day.

treatment should stop and carry out by

in case of symptoms of a delay of a liquid/hyponatremia the corresponding correction of a dose.

Primary night enuresis

Recommended initial dose makes 120 mkg for the night, sublingual. In the absence of effect the dose can be increased to 240 mkg. Liquid consumption restriction is necessary. The course of treatment makes 3 months. In need of continuation of treatment it is necessary to take a break not less than one week without administration of drug.

Nocturia with a night polyuria

At patients with a nocturia for the purpose of diagnosis of a night polyuria should have data on volume and frequency of urination within two days prior to therapy. The night polyuria is a night discharge of urine which exceeds the volume of a bladder or exceeds ⅓ a daily urine. The recommended initial dose - 60 mkg for the night, sublingual. In the absence of effect within 1 week to increase a dose to 120 mkg and further to 240 mkg at increase in a dose with frequency no more than one once a week. Liquid consumption restriction is necessary at night.

Body weight of the patient should be checked within several days in an initiation of treatment and after increase in a dose.

by

If after one week of treatment with the corresponding selection of a dose does not observe satisfactory clinical effect, it is not recommended to continue administration of drug.

Pregnant

With care to appoint

Feature of use by

during pregnancy. At the same time it is recommended to trace the level of arterial blood pressure. There are limited data on use of desmopressin during pregnancy (53 pregnant women with not diabetes and 54 pregnant women with an angiohemophilia). In researches on animals the direct or indirect harmful effects of drug, as for reproductive toxicity are not revealed. Pregnant women should appoint medicament only after careful assessment of advantages and risks of treatment.

by

In researches on rats did not reveal disturbances of reproductive function of males and females of animals. There are no these influences of desmopressin on fertility at people.

Only a small amount of desmopressin gets into breast milk of women. At use in therapeutic doses of desmopressin any influence on newborns/children is not expected.

Children

to Apply

to children since 5 years to treatment of primary night enuresis.

Drivers

Drug does not influence or has insignificant impact on ability to drive the car and to work with mechanisms, it should be considered to drivers and experts whose work demands the increased vigilance.

Overdose

Overdose of medicament leads

to increase in duration of action with the increased risk of a delay of a liquid/hyponatremia.

Symptoms of overdose can arise under following conditions:

• reception of very high dose;
• use of excess liquid at the same time or soon after desmopressin use.

overdose Symptoms: increase in body weight (at the expense of a water delay), a headache, nausea, and in hard cases water intoxication with spasms which sometimes is followed by obscuring or even a loss of consciousness.

In particular, the overdose can arise at babies owing to inadequate selection of a dose of drug.

Treatment of a hyponatremia individual. The general recommendations include treatment interruption by desmopressin, restriction of the use of liquids and symptomatic treatment if necessary.

in case of overdose, depending on weight of a condition of the patient, needs to reduce a dose of medicament and to increase an interval between reception of separate doses. At suspicion of wet brain of the patient it is necessary to hospitalize immediately in intensive care unit. Spasms also demand use of intensive measures of treatment. Specific antidote of desmopressin is absent. In need of a diuresis it is possible to apply saluretic, for example, furosemide, under control of level of serumal electrolytes.

Side effects

Most serious side reactions connected with desmopressin use is the hyponatremia which can cause a headache, abdominal pain, nausea, vomiting, increase in body weight, dizziness, confusion of consciousness, a general malaise, a memory impairment, vertigo, a syncope, and in hard cases - spasms, wet brain that sometimes is followed by obscuring or even a loss of consciousness, and to whom. It, in particular, concerns small children up to one year and elderly people depending on the general condition of their health.

Storage conditions

to Store

in original packing at a temperature not above 25 °C, in the place, dry and inaccessible for children.

Expiration date - 4 years.