Active substanceDesmopressinDesmopressin
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  • Dosage form: & nbspnasal dosing spray
    Composition:

    1 ml of the solution contains:

    active ingredient: desmopressin acetate trihydrate (in terms of desmopressin acetate) 0.10 mg;

    auxiliary ingredients: sodium chloride, sodium hydrogen phosphate heptahydrate, citric acid monohydrate, benzalkonium chloride, 50% solution, purified water.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:Treatment for diabetes insipidus
    ATX: & nbsp

    H.01.B.A.02   Desmopressin

    Pharmacodynamics:

    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 L-arginine on 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 dosing, reaches clinically significant within 1 hour and remains high for 8 hours after dosing.

    Pharmacokinetics:

    Bioavailability of desmopressin with intranasal administration is about 10%.

    After the administration of 20 μg desmopressin is detected in the plasma after 15 minutes. The maximum concentration after intranasal administration is achieved after 1 hour. Desmopressin binds to proteins in a very small degree. It is excreted in human breast milk in low concentration.

    Desmopressin, like vasopressin, is metabolized mainly in the liver and kidneys.However deamination cysteine-1 gives it a resistance to enzymatic degradation, resulting in a significantly longer half-life of desmopressin. The half-life is about 4 hours. There is no information about enterohepatic circulation and the pharmacological activity of its metabolites.

    Indications:

    - Non-diabetes mellitus of central origin;

    - diagnostic test for the concentration ability of the kidneys.

    Contraindications:

    Hypersensitivity to the components of the drug, 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, as well as allergic rhinitis, nasal congestion, edema and cicatricial changes in the nasal mucosa, upper respiratory tract infections; impaired consciousness.

    Carefully:

    With renal failure, fibrosis of the bladder, children under 1 year old, and with violations of water-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 advisable to exercise caution when prescribing treatment for breastfeeding women.

    Dosing and Administration:

    The drug is intended for intranasal administration.

    Non-diabetes mellitus of central origin. The dose is selected individually, however, according to clinical experience, the average daily dose in adults is 10-40 mcg, in children 10-20 mcg (one or two clicks on the dosing device (10-20 mcg) once or twice 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 μg; 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 (the first portion of the urine is poured). Repeated urine sampling is performed 4 hours after the first emptying of the bladder. Another urine sampling is 4 hours later (ie, only two portions of urine are collected for 8 hours to determine the 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, the normal osmolality of urine after the administration of Vasomirin is 800 mOsm / kg. In children, osmolality of urine 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. Repeated detection of a low value indicates a violation of the concentration ability of the kidneys, in which case the patient needs additional survey.

    Side effects:

    There may be: headache, abdominal pain, nausea, edema 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, swelling and, in severe cases, transient neurologic disorders, mainly generalized seizures.

    Overdose:

    Overdose increases the risk of fluid retention and leads to seizures. In the case of hyponatremia, treatment with vasomirin should immediately be 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.

    Interaction:

    Indomethacin may increase, but not increase, the duration of action of desmopressin.

    Oral hypoglycemic agents, for example, glibenclamide, can reduce the duration of desmopressin.

    Therapy in combination with drugs that cause the release of antidiuretic hormone and enhance anti-diuretic activity or disrupt the water-electrolyte balance, for example, tricyclic antidepressants, chlorpromazine, carbamazepine, clofibrate and chlorpropamide, increases the antidiuretic effect and increases the risk of fluid retention in the body.

    Tetracycline, lithium, norepinephrine weaken the antidiuretic effect.

    Desmopressin enhances the action of hypertensive drugs.

    Special instructions:

    Special care should be taken when using Vasomirin in patients at risk of intracranial hypertension; patients with a violation of water and / or electrolyte balance and patients with disorders in which the hyperhydration of the body can represent a danger, for example, a violation of kidney function, heart failure, cystic fibrosis or anesthesia.

    Before the appointment of Vasomirin, the diagnosis of psychogenic polydipsia and alcoholism should be deleted.

    The test for the concentration of kidneys in children under the age of 1 year should be performed only in a hospital.

    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 Vasomirin in case of mucosal changes such as scars, edema or other diseases, as this can lead to uneven and unreliable absorption of desmopressin.

    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 administered to children who require doses less than 10 μg of desmopressin (in the form of hydrate acetate).

    INFORMATION FOR PATIENT SPRAY VAZOMIRIN

    Nasal solution Desmopressin acetate, 10 μg / dose.

    Before using Vazomirin Spray, please read this insert carefully and follow these instructions.

    1) Carefully blow your nose.

    2) Remove the protective cap from the bottle.

    3) When using the spray for the first time, fill the pump by pressing the index and middle fingers on the white ring while keeping the bottom of the bottle with your thumb (see Figure 1). Press 4 times in a row or until the spray starts to stand out evenly. Now the spray is ready for use.

    4) Sitting or standing slightly move your head back and carefully enter the nasal applicator into one nostril (see Figure 2).

    5) Regardless of the type of spray, press the index finger and middle finger on the white ring once, while keeping the bottom of the bottle with your thumb. When you enter the required dose, hold your breath.

    6) If more than one dose is needed, repeat the 4th and 5th stages for the second nostril.

    With an additional dose every time, change the nostril.

    7) Attach the protective cap to the bottle.

    8) Store at room temperature 15-30 ° C (59-86 ° F) in a dark place.

    DO NOT KEEP THE SPRAY IN THE REFRIGERATOR.

    IMPORTANT: Always keep and keep the bottle in an upright position.

    If the spray has not been used within the last 7 days, it must be refilled. Before you enter the nasal applicator into the nostril, press several times on the white ring until the spray is evenly separated.

    CAUTION: Headache, nausea and mild abdominal cramps are symptoms of an overdose. If necessary, consult your doctor to adjust the dose. Elderly patients and children under 12 years of age are recommended to limit fluid intake after dinner because of the increased risk of its delay in the body.

    Spray Vasomirin is available in two forms: 2.5 ml (25 doses) and 5.0 ml (50 doses).

    Effect on the ability to drive transp. cf. and fur:The intake of the drug does not adversely affect the ability to drive vehicles and mechanisms.
    Form release / dosage:

    Spray nasal dosed, 10 mcg / dose.

    Packaging:

    For 2.5 ml (25 doses) and 5 ml (50 doses) in a brown glass bottle with a screwed, polypropylene lid.

    One bottle together with a dosing device and instructions for application in a cardboard box.

    Storage conditions:

    In a dry, protected from light and out of reach of children, at a temperature of 15 to 30 ° C. Do not freeze.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010922/09
    Date of registration:31.12.2009
    Expiration Date:Unlimited
    The owner of the registration certificate: Genfa Medica S.A. Genfa Medica S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspHEAD OF MEDICA SAHEAD OF MEDICA SASwitzerland
    Information update date: & nbsp11.01.2017
    Illustrated instructions
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