Instruction for use: Minirin

ATX Code H01BA02 Desmopressin

Active substance: Desmopressin

Pharmacological group

Hormones of the posterior lobe of the pituitary gland [Hypothalamus, pituitary, gonadotropins and their antagonists]

Composition

Tablets Sublingual 1 tab.

active substance:

Desmopressin 60 mcg\ 120 μg\ 240 μg

(In the form of desmopressin acetate - 67, 135 or 270 μg, respectively)

Auxiliary substances: gelatin - 12.5 mg; Mannitol - 10.25 mg; Citric acid - up to pH 4.8

Description of dosage form

Tablets are sublingual, 60 mcg: round, white, with the marking in the form of a single drop on one side.

Tablets are sublingual, 120 mcg: round, white, marked as two drops on one side.

Tablets are sublingual, 240 mcg: round, white, labeled as three drops on one side.

pharmachologic effect

The pharmacological action is vasopressin-like.

Pharmacodynamics

Desmopressin is a structural analogue of arginine-vasopressin, human pituitary hormone. The difference consists in the deamination of cysteine and the replacement of L-arginine with D-arginine. This leads to a significant prolongation of the period of action and a complete absence of vasoconstrictive effect.

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

Pharmacokinetics

Bioavailability of desmopressin in sublingual form at doses of 200, 400 and 800 μg is about 0.25%.

Cmax desmopressin in blood plasma is achieved within 0.5-2 h after administration of the drug and is directly proportional to the value of the accepted dose: 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 h.

Indications

Diabetes insipidus of central genesis;

Primary nocturnal enuresis in children older than 6 years;

Nocturia (nocturnal polyuria) as symptomatic therapy.

Contraindications

Hypersensitivity to desmopressin or other components of the drug;

Habitual or psychogenic polydipsia (with a volume of urination of 40 ml / kg / day);

Heart failure and other conditions requiring the appointment of diuretics;

Hyponatremia;

Renal failure of moderate severity and severe (Cl creatinine below 50 ml / min);

Syndrome of inadequate ADH production;

Children's age till 6 years.

If a patient has one of the listed diseases, he should consult a doctor before taking the drug.

With caution: renal failure (Cl creatinine> 50 mL / min); Fibrosis of the bladder; Violation of water and electrolyte balance; Potential risk of increased intracranial pressure; pregnancy; Old age (65 years and older).

pregnancy and lactation

There was no side effect on the course of pregnancy, the health of the pregnant, fetus and newborn when taking Minirin®. However, caution should be exercised when prescribing Minirin® to pregnant women.

The dose in which desmopressin can enter the body of a newborn with breast milk of a woman taking high doses (about 300 μg) of desmopressin is not capable of affecting the diuresis of the child. The decision to continue breastfeeding is taken if the benefit to the mother exceeds the potential risk for the child.

Side effects

The most common side effects are observed in cases where treatment is performed without restricting fluid intake and fluid retention and / or hyponatremia occur, which may be asymptomatic or manifest with the following symptoms: headache, dizziness, nausea, vomiting, dry mouth, peripheral edema, increase Body weight; In severe cases, convulsions.

If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions appear, you should notify the doctor.

Interaction

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

Simultaneous administration of NSAIDs also increases the risk of side effects.

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

With the simultaneous administration of Minirin® with the above drugs to prevent the development of hyponatremia, a regular determination of the concentration of sodium in the blood plasma is necessary.

Dosing and Administration

Sublingually, for resorption. Do not drink with liquid! The optimal dose of Minirin® is selected individually. The dosage ratios between the two oral forms of the drug are as follows: tablets of 0.1; 0.2; 0,4 mg correspond to tablets sublingual for 60; 120; 240 mcg.

Minirin® should be taken some time after eating, because Eating reduces the absorption of the drug and its effectiveness.

Non-diabetes mellitus of the central genesis. The recommended initial dose of Minirin® is 60 μg 3 times a day. In the following, the dose is changed depending on the onset of the therapeutic effect. The recommended daily dose is in the range of 120-720 μg. The optimal maintenance dose is 60-120 μg 3 times a day sublingually.

Primary nocturnal enuresis. The recommended initial dose is 120 μg per night. In the absence of effect, the dose may be increased to 240 μg. During treatment, it is necessary to limit fluid intake 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, which will be observed after the drug is discontinued within 1 week.

Nocturia. The recommended initial dose is 60 μg per night. If there is no effect for 1 week, the dose is increased to 120 μg and then to 240 μg, with increasing dose at a frequency of no more than 1 time per week.

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

Overdose

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

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

special instructions

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

A high risk of side effects is found in patients older than 65 with a baseline low concentration of sodium in the blood plasma and a polyuria of 2.8-3 l / day.

In cases of acute incontinence, dysuria and / or nocturia, urinary tract infection, with suspected bladder or prostate cancer, with polydipsia and decompensated diabetes mellitus, it is necessary to diagnose and treat these conditions and diseases before starting treatment with Minirin® .

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

With special care appoint the drug to elderly patients (65 years and older) due to a high risk of side effects (fluid retention and hyponatremia).

When administering Minirin® in these cases, it is necessary to determine the concentration of sodium in the blood plasma before the start of the drug, 3 days after the start of the dose and at 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 vehicles and work with machinery. Minirin® does not directly affect the ability to drive and operate machinery. However, fluid retention in case of drinking disorders or overdose of Minirin® may cause dizziness.

Form of issue

Tablets are sublingual, 60 mcg, 120 mcg and 240 mcg. In a blister of aluminum foil, 10 pcs. 1 or 3 or 10 bl. In a cardboard box.

Terms of leave from pharmacies

On prescription.

StorageConditions

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf Life

4 years.

Do not use after the expiry date printed on the package.