Minirin

General characteristics. Structure:

Active agent: desmopressin acetate of 100 mkg

Excipients: lactose, potato starch, povidone, magnesium stearate.
 
Active agent: desmopressin acetate of 200 mkg

Excipients: lactose, potato starch, povidone, magnesium stearate.

Pharmacological properties:

Vasopressin analog. Anti-diuretic.

Desmopressin - a structural analog of natural hormone arginine-vasopressin. Desmopressin is received as a result of changes in a vasopressin molecule structure - deamination of 1 cysteine and substitution of 8-L-arginine with 8-D-arginine. Structural changes in a combination with considerably the increased antidiuretic ability lead to less expressed action on smooth muscles of vessels and internals in comparison with vasopressin that causes lack of undesirable spastic side effects.
Drug increases permeability of an epithelium of distal departments of gyrose tubules for water and raises its reabsorption.
Minirin's use at the central not diabetes mellitus leads to reduction of volume of the emitted urine and simultaneous increase in osmolality of urine and decrease in osmolality of a blood plasma. It leads to decrease in frequency of an urination and reduction of a night polyuria.
In most cases reception of 0.1-0.2 mg of desmopressin provides antidiuretic effect during 8-12 h.

Pharmacokinetics. Absorption and distribution. The concomitant use of food can lower extent of absorption from a GIT by 40%. Cmax in plasma is reached during 2 h Vd makes 0.2-0.3 l/kg.

Bioavailability of desmopressin fluctuates from 0.08% to 0.16% and differs in high variability. Desmopressin does not get through GEB.

Removal. It is removed with urine. T1/2 at intake of 2-3 h.

Indications to use:

— central not diabetes mellitus;
— primary night enuresis at children is more senior than 5 years;
— a night polyuria at adults (as symptomatic therapy).

Route of administration and doses:

The optimum dose of Minirin should be selected individually. Drug should be accepted after food as meal can influence absorption of drug and its efficiency.

At the central not diabetes mellitus the recommended initial dose for children and adults makes 100 mkg of 1-3 times/days. In the subsequent the dose is changed depending on reaction to treatment. Usually day dose is in limits of 0.2-1.2 mg. For most of patients an optimum maintenance dose are 100-200 mkg of 1-3 times/days.

At primary night enuresis the recommended initial dose makes 200 mkg for the night. In the absence of effect the dose can be increased to 400 mkg. Control of liquid reception restriction observance is necessary in the evening. The recommended course of continuous treatment makes 3 months. The decision on continuation of treatment should be made on the basis of clinical data which will be observed after drug withdrawal within 1 week.

At a night polyuria at adults the recommended initial dose makes 100 mkg for the night. In the absence of effect within 1 week the dose is increased to 200 mkg and in the subsequent to 400 mkg at increase in a dose with frequency no more than 1 once a week. It is necessary to remember danger of a delay of liquid in an organism.

If after 4 weeks of treatment and correction of a dose of adequate clinical effect it is not observed, it is not recommended to continue drug use.

Features of use:

In order to avoid development of side effects it is necessary to limit without fail to a minimum reception of liquid for 1 h before use and during 8 h after use of drug for patients with primary night enuresis.

Clinical trials showed that most often the hyponatremia arises at patients of advanced age (65 years are more senior).

Минирин® it is not necessary to apply when there are other additional reasons for a delay of liquid and electrolytic frustration. High risk of development of side effects in patients of advanced age with initially low levels of sodium in a blood plasma and a polyuria from 2.8 to 3 l.

Prevention of development of a hyponatremia consists in increase in frequency of definition of sodium in a blood plasma, especially at simultaneous use with the drugs causing a syndrome of inadequate secretion of antidiuretic hormone (including tricyclic antidepressants, the selection inhibitors of serotonin, Chlorpromazinum and carbamazepine) and NPVS.

At emergence of an acute incontience of urine, a dysuria and/or nocturia, an infection of urinary tract, suspicion of a tumor of a bladder or a prostate, existence of a polydipsia and dekompensirovanny diabetes mellitus diagnosis and treatment of the specified states and diseases should be carried out prior to treatment by Minirin.

At development against the background of treatment of system infections, fever, a gastroenteritis it is necessary to stop use of drug.

Influence on ability to driving of motor transport and to control of mechanisms
Influence on ability to driving of motor transport and to control of mechanisms is absent.

Side effects:

The most often side effects are observed in cases when treatment is carried out without restriction of reception of liquid and there are a delay of liquid and/or a hyponatremia which can be asymptomatic or be shown by following symptoms.
From TsNS and peripheral nervous system: headache, dizziness; in hard cases - spasms.
From the alimentary system: nausea, vomiting, dryness in a mouth.
Others: peripheral hypostases, increase in body weight.

Interaction with other medicines:

At simultaneous use indometacin can strengthen, but not increase duration of action of Minirin.

At simultaneous use глибутид, tetracycline, lithium, Norepinephrinum weaken antidiuretic action of Minirin.

At simultaneous use desmopressin strengthens action of hypertensive means.

At simultaneous use the tricyclic antidepressants, the selection inhibitors of serotonin, Chlorpromazinum and carbamazepine capable to cause a syndrome of inadequate secretion of antidiuretic hormone can strengthen antidiuretic effect of Minirin and lead to increase in risk of a delay of liquid and a hyponatremia.

At simultaneous use of Minirin with NPVS increase in risk of emergence of side effects is possible.

At simultaneous use of Minirin with loperamide perhaps triple increase in level of desmopressin in plasma that significantly increases risk of a delay of liquid and emergence of a hyponatremia. Presumably other medicines which are slowing down a peristaltics can cause similar effect.

At simultaneous use of Minirin with dimetikony desmopressin absorption reduction is possible.

Contraindications:

— usual or psychogenic polydipsia;
— the heart failure and other states demanding purpose of diuretic drugs;
— hyponatremia;
— renal failure of average and heavy degree (KK <50 ml/min.);
— syndrome of inadequate products of antidiuretic hormone;
— hypersensitivity to desmopressin or other components of drug.

With care it is necessary to use drug at a renal failure, bladder fibrosis, at disturbances of water and electrolytic balance, potential risk of increase in intracranial pressure, at pregnancy and at children aged till 1 year.
With extra care use drug at patients of advanced age (65 years) in connection with high risk of development of side effects (including a liquid delay, a hyponatremia are more senior). If the decision on treatment by Minirin is made: before purpose of drug, in 3 days after the beginning of reception and at each increase in a dose it is necessary to determine sodium level in a blood plasma and to control a condition of the patient.

Use of the drug MINIRIN® at pregnancy and feeding by a breast
Results of use of Minirin for 53 pregnant women with not diabetes mellitus testify to lack of side effect on the course of pregnancy, on the state of health of the pregnant woman, a fruit and the newborn.
However it is necessary to be careful at use of drug at pregnancy.
As showed researches, amount of the desmopressin getting to the newborn's organism with breast milk of the woman accepting high doses of desmopressin it is much less than that which is capable to affect a diuresis.

Use at renal failures
Use of drug at a renal failure of average and heavy degree is contraindicated (KK <50 ml/min.).
With care it is necessary to use drug at a renal failure, bladder fibrosis.

Use for elderly patients
Clinical trials showed that most often the hyponatremia arises at patients of advanced age (65 years are more senior).

Overdose:

Symptoms: the overdose leads to increase in duration of effect of drug and increase in risk of emergence of a delay of liquid (including spasms, a loss of consciousness) and hyponatremias.

Treatment: at a hyponatremia - drug phase-out, cancellation of restriction on liquid reception, is possible performing infusion of isotonic or hypertonic salt solution of sodium of chloride. At the expressed liquid delay - it is necessary to attach furosemide to above-mentioned therapy.

At overdose it is necessary to see a doctor.

Storage conditions:

Drug should be stored in unavailable to children, the dry place at a temperature not above 25 °C; it is not necessary to delete the drying-up capsule from a cover.

Issue conditions:

According to the recipe

Packaging:

Tablets of 100 mkg: 30 pieces.

Tablets of 200 mkg: 30 pieces.