Uropres (drops)

General characteristics. Structure:

Active ingredient: desmopressin;

1 ml of solution contains acetate desmopressin in terms of desmopressin 100% substance of 0,1 mg;

excipients: sodium chloride, glycine, a betaine a hydrochloride, a benzalkoniya chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. Desmopressin – a structural analog of natural hormone arginine-vasopressin. Drug increases permeability of an epithelium of distal departments of gyrose tubules for water and raises its reabsorption. Reduces the volume of the emitted urine, and at the same time increases its osmolarity and reduces osmolarity of a blood plasma. It leads to decrease in frequency of urinations and reduction of a nocturia. Antidiuretic action after intranasal introduction of 10-20 mkg of desmopressin lasts 8-12 hours.

Pharmacokinetics. Bioavailability of drug after intranasal introduction makes from 3 to 5%. Noticeable concentration of active agent in a blood plasma comes in 15-30 minutes after use, the maximum of concentration is reached in 1 hour and depends on the entered dose. The volume of distribution makes 0,2-0,3 l/kg. Desmopressin does not get through a blood-brain barrier. The elimination half-life after intranasal introduction on average makes 2-3 hours. The insignificant amount of desmopressin is metabolized in a liver.

Pharmaceutical characteristics.

Main physical and chemical properties: transparent colourless liquid. When stirring forms a foam layer which disappears in 30 min.

Indications to use:

Treatment of not diabetes mellitus;
conducting testing for concentration ability of kidneys.

Route of administration and doses:

 1 drop contains 5 mkg of medicinal substance.

Not diabetes mellitus.

The dose is selected individually, however an optimum dose for adults are 10-20 mkg (2-4 drops) 1-2 times a day. For children the dose makes 10 mkg (2 drops) 1-2 times a day. In case of symptoms of a delay of a liquid/hyponatremia, treatment needs to be stopped and to modify a dose.

Test for definition of concentration ability of kidneys.

For assessment of concentration ability of kidneys use the following doses: for adults makes 40 mkg (8 drops), for children till 1 year - 10 mkg (2 drops), 1 years – 20 mkg (4 drops) are more senior.

After drug use Uropres, the amount of the urine collected within the first hour is not considered. Within the next 8 hours collect 2 portions of urine for osmolarity measurement. It is necessary to control liquid reception.

Features of use:

Uropres, drops nasal are appointed only to those patients to whom oral administration of desmopressin in the tableted form is contraindicated. Benzalkoniya chloride which contains in drug as additional substance can cause a bronchospasm. It is not necessary to apply Uropres, drops nasal at the changed mucous membrane: hems, swelled or other disturbances, because of possible difficulty of absorption of drug.

The test for concentration ability of kidneys at children aged till 1 year is carried out only in a hospital and with the subsequent observation.

At test for concentration ability of kidneys the volume of liquid has to be limited to 0,5 l, especially in 1 hour prior to reception and within 8 hours after drug use.

Treatment without simultaneous restriction of reception of liquid can lead to a liquid delay in an organism and/or a hyponatremia (a headache, nausea, vomiting, increase in body weight, in hard cases of a spasm).

At patients of advanced age with the low level of sodium in plasma, with a high volume of daily urine (from 2,8 to 3 l) the risk of emergence of a hyponatremia is increased.

Treatment by desmopressin has to be stopped in case of an acute intercurrent disease which is characterized by disturbance of water and electrolytic balance (system infections, heat, a gastroenteritis).

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Drug does not influence ability to drive the car and to work with other mechanisms.

Side effects:

Treatment without simultaneous restriction of reception of liquid can lead to a liquid delay in an organism and/or a hyponatremia.

There can be following symptoms:

from cardiovascular system: slight increase of arterial pressure, inflows;

from a nervous system: headache, spasms;

from respiratory system: rhinitis, nasal bleeding, dryness in a throat;

from a digestive tract: nausea/vomiting, abdominal pain;

from an urinary system: vulva pain, dysuria;

others: increase in sweating.

Allergic reactions, increase in body weight are also possible.

Emotional frustration at children are seldom or never possible.

Interaction with other medicines:

Substances which effect stimulates an exit of antidiuretic hormone such as tricyclic antidepressants selective serotonin reuptake inhibitors, Chlorpromazinum and carbamazepine can strengthen antidiuretic effect and increase risk of a delay of liquid. Non-steroidal anti-inflammatory drugs can cause a delay a liquid/hyponatremia.

Contraindications:

Inborn or psychogenic polydipsia;
heart failure or other states which demand purpose of diuretics;
the moderated or expressed renal failure (the clearance of creatinine is lower than 50 ml/min.);
hypersensitivity to desmopressin or other components of drug.

Overdose:

The overdose of drug leads to a delay of liquid and a hyponatremia.

Treatment. Treatment of a hyponatremia individual. At an asymptomatic hyponatremia cancel drug and limit liquid reception.

In case of the symptoms connected with a hyponatremia it is necessary to execute intravenous administration of isotonic or hypertonic salt solution of sodium chloride; in hard cases of a delay of liquid in an organism, shown spasms and/or a loss of consciousness, it is necessary to apply therapy by diuretic drugs (furosemide).

Use during pregnancy and feeding by a breast.

With care appoint at pregnancy. Use for pregnant women is possible only in that case when the expected advantage for mother exceeds potential risk for a fruit. In need of use of drug during a lactation feeding by a breast is stopped.

Children.

At children aged till 1 year drug is used in the conditions of a hospital with the subsequent observation.

Storage conditions:

Period of validity. 2 years. A period of storage after opening of a bottle - 50 days. Not to use drug after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature from 2 ºС to 8 ºС.

Issue conditions:

According to the recipe

Packaging:

On 2,5 ml or 5 ml in the bottle enclosed in a pack.