Minirin, pills 0.2 mg, 30 pcs.

Composition

Active ingredient:

desmopressin acetate 200 mcg;

Auxiliary substances:

lactose,

potato starch,

povidone,

magnesium stearate

Pharmacological action

Minirin – vasopressin-like.

Pharmacodynamics

Desmopressin is a structural analog of arginine-vasopressin, a human pituitary hormone. The difference is in the deamination of cysteine and the substitution of L-arginine with D-arginine. This leads to a significant extension of the period of action and the complete absence of vasoconstrictor effect.

Desmopressin increases the permeability of the epithelium of the distal convoluted tubules and increases water reabsorption, which leads to a decrease in the volume of urine released, an increase in the osmolarity of urine with a simultaneous decrease in the osmolarity of blood plasma, a decrease in the frequency of urination and a decrease in nocturia (nocturnal polyuria).

Pharmacokinetics

The bioavailability of desmopressin in sublingual form at doses of 200,400 and 800 mcg is about 0.25%.

Cmax of desmopressin in blood plasma is reached within 0.5-2 hours after taking the drug and is directly proportional to the dose taken: after taking 200,400 and 800 mcg, Cmax was 14,30 and 65 pg / ml, respectively.

Desmopressin does not penetrate the BBB. Desmopressin is excreted by the kidneys, T1 / 2 is 2.8 hours.

Indications

• diabetes insipidus of central origin;
• primary nocturnal enuresis in children over 6 years of age;
• nocturia (nocturnal polyuria) as symptomatic therapy.

Use during pregnancy and lactation

No side effects on the course of pregnancy, the health of the pregnant woman, fetus and newborn were detected when taking Minirin®. However, caution should be exercised when prescribing Minirin® to pregnant women.

The dose at which desmopressin can enter the body of a newborn with breast milk from a woman taking high doses (about 300 mcg) of desmopressin can not affect the child’s diuresis. The decision to continue breastfeeding is made if the benefits to the mother outweigh the potential risk to the baby.

Contraindications

• hypersensitivity to desmopressin or other components of the drug;
• habitual or psychogenic polydipsia (with the volume of urine formation 40 ml/kg/day);
• cardiac insufficiency and other conditions requiring the appointment of diuretics;
• hyponatremia;
• renal failure of moderate severity and severe (Cl creatinine below 50 ml/min);
• syndrome of inappropriate antidiuretic hormone production;
• children up to age 6 years.

If the patient has one of these diseases, they should definitely consult their doctor before taking the drug.

With caution: renal insufficiency (creatinine clearance >50 ml / min); bladder fibrosis; impaired water-electrolyte balance; potential risk of increased intracranial pressure; pregnancy; elderly (65 years and older).

Side effects

The most common side effects are observed in cases where treatment is carried out without limiting fluid intake and fluid retention and/or hyponatremia occur, which may be asymptomatic or manifest as the following symptoms: headache, dizziness, nausea, vomiting, dry mouth, peripheral edema, weight gain; in severe cases — convulsions.

If any of the side effects listed in the instructions have worsened or any other side effects that are not listed in the instructions have appeared, you should inform your doctor.

Interaction

Tricyclic antidepressants, SSRIs, chlorpromazine and carbamazepine, which can cause the syndrome of inadequate secretion of antidiuretic hormone, may increase the antidiuretic effect of Minirin® and increase the risk of fluid retention and hyponatremia.

Concomitant use of NSAIDs also increases the risk of side effects.

Combination with loperamide can lead to a threefold increase in the concentration of desmopressin in plasma and increase the risk of side effects (fluid retention, hyponatremia). There is a possibility that other drugs that lower the tone and motility of the smooth muscles of the intestine may have a similar effect.

When Minirin® is co-administered with the above medications, regular determination of the sodium concentration in the blood plasma is necessary to prevent the development of hyponatremia.

How to take, course of administration and dosage

The optimal dose of Minirin® is selected individually. Dosage ratios between the two oral forms of the drug are as follows: tablets of 0.1; 0.2; 0.4 mg correspond to sublingual tablets of 60; 120; 240 mcg.

Minirin® should be taken some time after a meal, as food intake reduces the absorption of the drug and its effectiveness.

Diabetes insipidus of central origin. The recommended starting dose of Minirin® is 60 mcg 3 times a day. Subsequently, the dose is changed depending on the onset of the therapeutic effect. The recommended daily dose is in the range of 120-720 mcg. The optimal maintenance dose is 60-120 mcg 3 times a day sublingually.

Primary nocturnal enuresis. The recommended starting dose is 120 mcg per night. In the absence of an effect, the dose can be increased to 240 mcg. During treatment, it is necessary to limit the intake of fluids in the evening. The recommended course of continuous treatment is 3 months. The decision to continue treatment is made on the basis of clinical data that will be observed after discontinuation of the drug for 1 week.

Nocturia. The recommended starting dose is 60 mcg per night. If there is no effect for 1 week, the dose is increased to 120 mcg and then to 240 mcg, with an increase in the dose with a frequency of no more than 1 time per week.

If an adequate clinical effect is not observed after 4 weeks of treatment and dose adjustment, it is not recommended to continue taking the drug.

Overdose

Symptoms: overdose leads to an increase in the duration of action of the drug and an increased risk of fluid retention and hyponatremia. In case of overdose, you should consult a doctor.

Treatment: treatment of hyponatremia should be individual, it is mandatory to stop taking the drug and cancel the restriction on fluid intake. If there are symptoms of overdose, an infusion of isotonic or hypertonic sodium chloride solution is possible. In case of severe fluid retention (convulsions and loss of consciousness), furosemide should also be prescribed.

Special instructions

It is mandatory to limit fluid intake to a minimum 1 hour before and within 8 hours after taking the drug in patients with primary nocturnal enuresis. Failure to follow this rule can lead to the development of side effects.

Patients over 65 years of age with an initially low plasma sodium concentration and polyuria of 2.8-3 l / day have a high risk of side effects.

In cases of acute urinary incontinence, dysuria and/or nocturia, urinary tract infection, suspected bladder or prostate cancer, polydipsia and decompensated diabetes mellitus, these conditions and diseases should be diagnosed and treated prior to treatment with Minirin®.

In case of acute concomitant diseases, such as systemic infections, fever, gastroenteritis, accompanied by an imbalance of fluid and electrolytes, the drug should be discontinued.

With extreme caution, the drug is prescribed to elderly patients (65 years and older) due to the high risk of side effects (fluid retention and hyponatremia).

When prescribing Minirin® in these cases, it is necessary to determine the concentration of sodium in the blood plasma before starting the drug,3 days after the start of administration, and with each dose increase. It is necessary to monitor the patient’s condition during the entire period of taking Minirin®.

Influence on the ability to drive a car and mechanisms. Minirin® it does not directly affect the ability to drive a car or other mechanisms. However, fluid retention due to a violation of the drinking regime or an overdose of Minirin® can cause dizziness.

Composition

Tablet Form of production

Storage conditions

In a dry place, at a temperature not exceeding 25 °C and a relative humidity of up to 60%

Shelf life

2 years

Active ingredient

Desmopressin

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Enuresis

Weight

Weight: 34 gr.