Composition, form of production and packaging
Spray nasal dosed 1 dose
Desmopressin 10 Ојg
* Nonproprietary international name recommended by WHO - desmopressin.
25 doses - bottles of dark glass (1) with a dispensing device - packs of cardboard.
50 doses - bottles of dark glass (1) with a dispenser - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Desmopressin is a synthetic analogue of the natural antidiuretic hormone arginine-vasopressin.
Structural changes in the arginine-vasopressin molecule (deamination of cysteine ​​at position 1 and substitution of L-arginine for D-arginine at position 8) cause a decrease in vasopressor activity and an increase in the antidiuretic effect of desmopressin. The drug increases the permeability of the epithelium of the distal sections of the convoluted tubules of the kidneys for water and increases its reabsorption. The use of desmopressin leads to a decrease in the volume of excreted urine and a simultaneous increase in the osmolarity of the urine and a decrease in the osmolarity of the blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria.
Antidiuretic activity manifests itself 15-30 minutes after the dose, reaches clinically significant within 1 hour and remains high for 8 hours after the dose.
PHARMACOKINETICS
Bioavailability of desmopressin with intranasal administration is about 10%.
After administration of 20 Ојg, desmopressin is detected in plasma after 15 minutes. C max after intranasal administration is achieved after 1 h. Desmopressin binds to proteins to a very small extent. It is excreted in human breast milk in low concentration.
Desmopressin, like vasopressin, is metabolized mainly in the liver and kidneys. However, deamination of cysteine-1 gives it resistance to enzymatic decay, which is expressed in a much longer T 1/2 of desmopressin. T 1/2 is about 4 hours. There is no information about enterohepatic circulation and the pharmacological activity of its metabolites.
INDICATIONS
- diabetes insipidus of central genesis;
- primary nocturnal enuresis in children 5 years and older;
- diagnostic test for the concentration ability of the kidneys.
DOSING MODE
The drug is intended for intranasal administration.
Primary night enuresis
The initial dose for children (starting from 5 years) and for adults (up to age 65 years) who have primary nocturnal enuresis but with normal renal concentra- tion is 20 Ојg - one push of a dosing device (10 Ојg) in each nasal passage at night before bedtime.
If necessary, the dose should be increased to 40 mcg - two clicks on the dosing device (20 mcg) in each nasal passage.
The decision to continue treatment is taken after 3 months of continuous therapy on the basis of clinical data that will be observed after the drug is discontinued within one week.
In the case of treatment of enuresis, fluid intake should be limited to a minimum - only to quench thirst for 1 hour before and within 8 hours after the administration of the drug.
Non-diabetes mellitus of central origin
The dose is selected individually, however, as the clinical experience shows, the average daily intake in adults is 10-40 mcg, in children 10-20 mcg (one or two clicks on the dosing device (10-20 mcg) 1 or 2 times a day. This daily dose can be given once or it can be divided into 2-3 doses.
Test for the concentration ability of the kidneys
To determine the concentration ability of the kidneys, the following average doses are used: for adults , 40 Ојg; children older than 1 year - 10-20 mcg, children under the age of 1 year -10 mcg.
Immediately after the administration of the drug, the patient must empty the bladder and during the test and 4 hours after the end of the application (only 8 hours), 2 portions of urine are taken to measure its osmolality. During the test, it is necessary to limit the intake of liquid (the volume of fluid that entered the body 1 hour before the test and within 8 hours after it should not exceed 0.5 liters).
For most patients, a normal urinary osmolality after the administration of Vasomirin is 800 mOsm / kg. In children, a urine concentration of 600 mOsm / kg should be achieved within 5 hours after the administration of the drug. If the osmolality index is found to be lower than this value, then the study should be repeated. Re-detection of a low value indicates a violation of the concentration ability of the kidneys, in which case the patient needs additional examination.
SIDE EFFECT
There may be: headache, abdominal pain, nausea, swelling of the nasal mucosa, rhinitis and nosebleeds. In rare cases, there are allergic reactions to the components of the drug in the form of skin manifestations.
In isolated cases - dizziness, increased blood pressure, algodismenorea, conjunctivitis, reduced tearing.
Treatment with desmopressin without a simultaneous decrease in fluid intake may be accompanied by fluid retention in the body, accompanied by hyponatremia, weight gain, edema and, in severe cases, transient neurologic disorders, mainly generalized seizures.
CONTRAINDICATIONS
anuria;
- edematous syndrome of various genesis;
- Syndrome of inadequate secretion of antidiuretic hormone;
- hypoosmolarity of plasma;
- Decompensated heart failure (including in the anamnesis);
- the need for diuretic therapy;
- hyponatremia;
- habitual polydipsia (congenital or psychogenic);
- predisposition to thrombosis;
- Allergic rhinitis;
- nasal congestion;
- edema and cicatricial changes in the nasal mucosa;
- infections of the upper respiratory tract;
- impaired consciousness;
- Hypersensitivity to the components of the drug.
Caution should be applied to the drug with renal failure, fibrosis of the bladder, children under 1 year old, with violations of water and electrolyte balance, the potential risk of increased intracranial pressure, during pregnancy.
PREGNANCY AND LACTATION
Vazomirin should be administered with caution to pregnant patients, despite the very low activity of desmopressin in stimulating labor. The harmful effect of desmopressin on the fetus is not revealed.
The amount of desmopressin that can be transferred to a newborn with mother's milk is significantly less than that necessary to affect diuresis. However, it is recommended to exercise caution in prescribing treatment for breastfeeding women.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in anuria. Caution should be used in cases of kidney failure.
APPLICATION FOR CHILDREN
Caution should be applied to children under 1 year.
APPLICATION IN ELDERLY PATIENTS
Caution should be applied to elderly patients.
SPECIAL INSTRUCTIONS
Care should be taken with regard to patients at risk of intracranial hypertension; patients with disturbed water and / or electrolyte balance and patients with disorders in which the hyperhydration of the body can be dangerous, for example, renal dysfunction, heart failure, cystic fibrosis or anesthesia.
Before the appointment of Vasomirin should be excluded from the diagnosis of psychogenic polydipsia and alcoholism.
The test for the concentration of kidneys in children under the age of 1 year should be performed only in a hospital.
Patients receiving treatment for primary nocturnal enuresis should be warned about the need to avoid excessive fluid intake and about the need to stop taking Vasomirin in case of vomiting and / or diarrhea until they restore normal fluid balance in the body.
To prevent fluid retention, care should be taken after conducting diagnostic tests to identify diabetes insipidus or to investigate the concentration ability of the kidneys. Do not force the injection of the fluid, either orally or parenterally, and patients should take as much fluid as they need to quench their thirst.
Do not use Vasomyrin in mucosal changes such as scars, edema or other diseases, as this can lead to uneven and unreliable absorption.
In patients with nasal disorders, including catarrhal diseases, there is a risk of unstable and / or reduced efficacy of the drug. This can also be observed in patients engaged in this type of activity, in which the drug can be removed from the nasal cavity before it is sucked, for example, when swimming.
The drug Vasomirin should not be given to children who require doses less than 10 Ојg of desmopressin (in the form of hydrate acetate).
Impact on the ability to drive and work with machinery
The intake of the drug does not adversely affect the ability to drive and other mechanisms.
OVERDOSE
Overdose increases the risk of fluid retention and leads to seizures.
In the case of hyponatremia, treatment with vasomirin should be immediately abolished and limit fluid intake to normalize the sodium level in the serum, in severe cases - slow intravenous infusion of concentrated saline solutions simultaneously with furosemide.
DRUG INTERACTION
Indomethacin may increase, but not increase, the duration of action of desmopressin.
Oral hypoglycemic agents, for example, glibenclamide, can reduce the duration of action of desmopressin.
Therapy, in combination with drugs that cause the release of antidiuretic hormone and increase antidiuretic activity or disrupt the water-electrolyte balance, for example, tricyclic antidepressants (chlorpromazine and carbamazepine), clofibrate and chlorpropamide, increases the antidiuretic effect and increases the risk of fluid retention in the body.
Glybutide, tetracycline, lithium, norepinephrine weaken the antidiuretic effect. Desmopressin enhances the action of hypertensive drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light and out of reach of children at a temperature of 15 В° to 30 В° C. Do not freeze. Shelf life - 2 years.
