MINIRIN

Active material: Desmopressin
When ATH: H01BA02
CCF: Vasopressin analog. Antidiarrheal
ICD-10 codes (testimony): E23.2, F98.0, R35
When CSF: 15.06.03
Manufacturer: FERRING AB (Sweden)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills white, Oval, convex, with Valium on one side and the inscription “0.1” – another.

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

30 PC. – plastic bottles (1) – cardboard boxes.

Pills white, round, convex, with Valium on one side and the inscription “0.2” – another.

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

30 PC. – plastic bottles (1) – cardboard boxes.

* international non-proprietary name, recommended by the WHO – dezmopressin.

Pharmacological action

Vasopressin analog. Antidiarrheal.

Desmopressin – a structural analog of the natural hormone Arginine vasopressin. Desmopressin is obtained from changes in the structure of the molecule vasopressin – dezaminirovanie 1-cysteine ​​and zameshtenie 8-L-arginine-8-D-arginine. Structural changes, combined with a significantly enhanced ability antidiuretic lead to a less pronounced effect on smooth muscle of blood vessels and internal organs compared to vasopressin, hence the absence of undesirable side effects of spastic.

The drug increases the permeability of the epithelium of the distal convoluted tubule of departments for water and increases its reabsorption.

Application minirin^® when the central diabetes insipidus leads to a decrease in urine output and simultaneous increase and decrease in urine osmolality of blood plasma osmolality. This leads to a reduction in the frequency of urination and nocturia reduction.

In most cases, the reception 0.1-0.2 mg desmopressin provides an antidiuretic effect for 8-12 no.

Pharmacokinetics

Absorption and distribution

Simultaneous food intake may reduce the extent of absorption from the gastrointestinal tract on 40%. C_max plasma achieved for 2 no. V_d is 0.2-0.3 l / kg.

Bioavailability of desmopressin varies from 0.08% to 0.16% and is characterized by high variability. Desmopressin does not cross the blood-brain barrier.

Deduction

Excreted in the urine. T_1/2 ingestion 2-3 no.

Testimony

- Central diabetes insipidus;

- Primary nocturnal enuresis in children older 5 years;

- Nocturia in adults (as symptomatic therapy).

Dosage regimen

The optimal dose minirin^® should be selected individually. The drug should be taken after meals, as meal can affect absorption of the drug and its efficacy.

At central diabetes insipidus The recommended starting dose for children and Adult is 0.1 mg 1-3 times / day. Subsequently the dose varies depending on the response to treatment. Typically, the daily dose is in the range 0.2-1.2 mg. For most patients the optimal maintenance dose is 0.1-0.2 mg 1-3 times / day.

At primary nocturnal enuresis The recommended starting dose is 0.2 mg at night. In the absence of the effect of the dose can be increased to 0.4 mg. Requires monitoring compliance with fluid restriction in the evenings. The recommended course of treatment is continuous 3 of the month. The decision to continue therapy should be based on clinical data, which will occur after discontinuation for 1 of the week.

At nocturia in adults The recommended starting dose is 0.1 mg at night. If no effect for 1 week increase the dose to 0.2 mg and subsequently to 0.4 mg with increasing dose rate not exceeding 1 times a week. Should be mindful of the dangers of fluid retention in the body.

If the 4 weeks of treatment and dose adjustment adequate clinical effect is not observed, continue the use of the drug is not recommended.

Side effect

The most common side effects observed in cases, when the treatment is carried out without limiting fluid intake, and there are fluid retention and / or hyponatremia, which may be asymptomatic or manifest itself following symptoms.

From the central and peripheral nervous system: headache, dizziness; in severe cases – convulsions.

From the digestive system: nausea, vomiting, dry mouth.

Other: peripheral edema, weight gain.

Contraindications

- Habitual or psychogenic polydipsia;

- Heart failure and other conditions, requiring the appointment of diuretics;

- Giponatriemiya;

- Kidney failure moderate and severe (CC<50 ml / min);

- Syndrome of inappropriate antidiuretic hormone production;

- Hypersensitivity to desmopressin or other ingredients.

FROM caution use in patients with renal insufficiency, fibrosis bladder, for violations of water-electrolyte balance, the potential risk of increased intracranial pressure, in pregnancy and in children under the age of 1 year.

FROM caution drug use in elderly patients (senior 65 years) due to the high risk of side effects (incl. fluid retention, giponatriemiya). If the decision about treatment minirin^® received: before prescribing the drug, through 3 day after the beginning of reception, and for each increase in the dose should be determined level of sodium in the blood plasma, and monitor the patient.

Pregnancy and lactation

The results of applying minirin^® in 53 pregnant women with diabetes insipidus indicate the absence of side effects on pregnancy, the health of the pregnant woman, fetus and newborn.

However, caution should be exercised when using the drug during pregnancy.

As research, the amount of desmopressin, enter the body of the newborn through breast milk of women, receiving high doses of desmopressin, considerably less than, which is able to affect diuresis.

Cautions

To avoid side effects should be mandatory to limit fluid intake to a minimum of 1 h before use and for 8 h after treatment in patients with primary nocturnal enuresis.

Clinical studies have shown, that hyponatremia occurs most frequently in elderly patients (senior 65 years).

Minirin^® should not be used, when there are other additional reasons for delaying the fluid and electrolyte disorders. High risk of adverse events in elderly patients with initially low levels of sodium in the blood plasma and polyuria from 2.8 to 3.0 l.

Prevention of hyponatremia is to increase the frequency of determining plasma sodium, especially while the use of drugs, causing a syndrome of inappropriate secretion of antidiuretic hormone (incl. tricyclic antidepressants, Selective inhibitors of serotonin, chlorpromazine and carbamazepine) and NSAIDs.

In the event of acute urinary incontinence, dysuria and / or nocturia, urinary tract infection, suspected bladder tumor or prostate, Available polydipsia and decompensated diabetes diagnosis and treatment of these conditions and diseases should be carried out prior to treatment minirin^®.

With the development during the treatment of systemic infections, fever, gastroenteritis use of the drug should be discontinued.

Effects on ability to drive vehicles and management mechanisms

Effects on ability to drive vehicles and management mechanisms absent.

Overdose

Symptoms: overdose leads to the increased duration of action of the drug and increase the risk of fluid retention (incl. convulsions, loss of consciousness) and hyponatremia.

Treatment: when hyponatremia – discontinuation of the drug, abolition of restrictions on fluid intake, may conduct infusion of isotonic or hypertonic sodium chloride solution. In severe fluid retention – to the above treatment should be added furosemide.

In case of overdose contact your doctor.

Drug Interactions

With simultaneous use of indomethacin may exacerbate, but does not increase the duration of minirin^®.

In an application glibutida, tetracycline, lithium, norepinephrine weaken antidiuretic action minirin^®.

With simultaneous use of desmopressin, increases the effect of hypertensive agents.

With simultaneous use of tricyclic antidepressants, Selective inhibitors of serotonin, chlorpromazine and carbamazepine, can cause a syndrome of inappropriate secretion of antidiuretic hormone, can enhance the antidiuretic effect minirin^® and increase the risk of fluid retention and hyponatremia.

In an application minirin^® NSAIDs may increase the risk of side effects.

In an application minirin^® with loperamide may threefold increase in plasma levels of desmopressin, which significantly increases the risk of fluid retention and hyponatremia. Presumably other drugs, slowing peristalsis, can cause a similar effect.

In an application minirin^® with dimethicone may decrease the absorption of desmopressin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dry place at temperatures no higher than 25 ° C; should not be removed from a drying capsule lid. Shelf life – 2 year.