Desmopressin (Desmopressin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDesmopressinDesmopressin
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    • Dosage form: & nbspnasal drops
    Composition:

    1 ml of the preparation contains: desmopressin 0.1 mg;

    Excipients: chlorobutanol 4.5 mg, sodium chloride 9 mg, hydrochloric acid diluted to pH 3.2-4.5, water purified to 1 ml.

    Description:

    A clear, colorless liquid.

    Pharmacotherapeutic group:Diabetes is a non-sugar drug treatment
    ATX: & nbsp

    H.01.B.A.02   Desmopressin

    Pharmacodynamics:

    Desmopressin - a synthetic analogue of the natural hormone of the posterior lobe of the pituitary - arginine-vasopressin (antidiuretic hormone). Structural changes in the arginine-vasopressin molecule cause a decrease in vasopressor activity and an increase in the antidiuretic effect of desmopressin in comparison with natural vasopressin.Antidiuretic effect occurs after 15-30 minutes after taking the drug. Application of 10-20 .mu.g desmopressin intranasally allows most patients antidiuretic effect lasting 8 hours. The use of desmopressin to treat patients with central diabetes insipidus leads to a significant reduction in urinary volume, resulting in a decrease in the frequency of urination.

    Pharmacokinetics:

    When intranasal administration of desmopressin absorbs 10-20%, with increasing dose, the degree of absorption decreases. Bioavailability is 3-6%. The maximum concentration in the blood is reached after 1 hour. Metabolized mainly in the liver and kidneys. Biotransformation consists in the cleavage of the disulfide bridge by the enzyme transhydrogenase. Desmopressin is excreted from the body mainly by the kidneys. The elimination half-life is 3-4 hours.

    Indications:

    - Non-diabetes mellitus of central origin;

    - acute polyuria of central genesis (due to trauma, disease or surgical intervention on the central nervous system);

    - the study of the concentration ability of the kidneys.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - state, accompanied by plasma hypoosmolarity;

    - habitual polydipsia, including psychogenic or congenital;

    - Decompensated heart failure;

    - edematous syndrome of different genesis;

    - anuria;

    - the need for diuretic therapy;

    - syndrome of inadequate secretion of antidiuretic hormone;

    - hyponatremia, including in the anamnesis;

    - renal insufficiency of moderate and severe degree (creatinine clearance (CK) less than 50 ml / min);

    - predisposition to thrombosis;

    - allergic rhinitis, nasal congestion, edema and cicatricial changes in the nasal mucosa;

    - upper respiratory tract infection;

    - impaired consciousness.

    Carefully:

    The drug should be used with caution in patients with renal insufficiency (KC more than 50 ml / min), fibrosis of the bladder, children under 5 years old and elderly (over 65 years), during pregnancy and during breastfeeding, in violation of water and electrolyte balance, potential risk of increased intracranial pressure.

    Pregnancy and lactation:

    According to known data, when using desmopressin in pregnant women with diabetes insipidus, there was no side effect on the course of pregnancy, on the state of health of the pregnant, fetus and newborn.However, the prospective benefit to the mother and the potential risk to the fetus should be correlated.

    Studies have shown that the amount of desmopressin that enters the body of a newborn with breast milk from a woman taking high doses of desmopressin is significantly less than that capable of affecting diuresis, but caution should be exercised when prescribing desmopressin to women during breastfeeding.

    Dosing and Administration:

    It is applied intranasally. The drug should be instilled with a slight tipping of the patient's head back and to the side directly into the nasal passage towards the nasal septum. The number of drops is measured with a pipette, which is part of the bottle cap with the drug. The therapeutic effect of the drug begins to appear within 30 minutes after application.

    Non-diabetes mellitus of central genesis. The dose and intervals between administration of the drug are determined by the attending physician individually for each patient, depending on the sensitivity to the drug. In addition, it should be borne in mind that only a small proportion of patients have a complete blockade of the secretion of antidiuretic hormone.

    The recommended daily intake in adults is 10-40 μg desmopressin (2-8 drops), in children 5-20 μg desmopressin (1-4 drops). The daily dose can be administered once or in 2-3 doses.

    Acute form of central polyuria. The drug is used 2 drops (about 10 μg desmopressin). Fluid intake and diuresis is evaluated in hourly intervals until a complete balance is obtained, and the onset of desmopressin effect can be expected within 30 minutes after application of the drug. During the next 3-5 hours, the compliance of the liquid that has entered the body and released is evaluated, the osmolality of plasma and urine is monitored, and the concentration of sodium in the blood is monitored.

    Concentration study of kidneys. The recommended dose is 3 drops (about 15 μg desmopressin), and for children over 1 year - from 2 to 3 drops (about 10-15 μg desmopressin).

    After using the drug, the patient should empty the bladder. For the next 4 hours after using the drug, urine samples are collected every hour for the patient to determine osmolality.

    Feature of medical use of a medicinal preparation by children

    Children under 1 year study the concentration ability of the kidneys with the drug is carried out in exceptional cases, tk.At this age, the concentrating ability of the kidneys is reduced. Studies of the concentration ability of the kidney should be performed by a children's neurologist. The use of too large doses in children aged around 1 year can be accompanied by the development of convulsions caused by irritation of the nervous system. During the time of collection of urine should be completely eliminated fluid intake.

    Features of the drug during the first admission or when it is canceled

    Not marked.

    The actions of a doctor / paramedic / patient while missing one or more doses of the drug

    The need to change the dose is not defined. In case of missing the dose, the preparation is continued, observing the regimen and not increasing the subsequent dosage.

    Side effects:

    Can be observed: headache, nausea, pain in the stomach, rhinitis, rhinitis and nosebleeds.

    In rare cases, skin manifestations of allergic reactions to the drug components are observed.

    In isolated cases - dizziness, increased blood pressure, algodismenorea, conjunctivitis, reduced tearing.

    Treatment with a drug without restriction of fluid intake may cause a delayfluid in the body, which is manifested by an increase in body weight, a decrease in the level of sodium in the blood plasma, edema and in severe cases - transient neurologic disorders, mainly generalized convulsions.

    Overdose:

    Overdose increases the risk of fluid retention and leads to seizures.

    In the case of hyponatremia, desmopressin should be immediately withdrawn and the fluid intake reduced to normalize the concentration of sodium in the serum, in severe cases, a slow intravenous infusion of 0.9% or a hypertonic sodium chloride solution. If necessary, can be appointed furosemide.

    Interaction:

    With simultaneous application desmopressin strengthens the action of hypertensive drugs.

    With simultaneous application buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

    With simultaneous application indomethacin strengthens, but does not increase the duration of action of desmopressin.

    With the simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, chlorpromazine and carbamazepine, capable of causing a syndrome of inadequate secretion of antidiuretic hormone, can enhance the antidiuretic effect of desmopressin and lead to an increased risk of fluid retention and hyponatremia.

    When using desmopressin with loperamide, a threefold increase in desmopressin concentration in plasma is possible, which significantly increases the risk of fluid retention and the occurrence of hyponatremia. Perhaps other medications that slow down peristalsis can cause a similar effect.

    With simultaneous use of desmopressin with dimethicone, a decrease in desmopressin absorption is possible.

    Special instructions:

    When studying the concentration ability of the kidneys, the patient should not take any liquid 1 hour before and within 8 hours after using the drug. In case of thirst, the intake of not more than 200 ml is permitted during the entire period of time indicated above. If you need to increase fluid intake (for example, in case of fever), discontinue therapy and consult your doctor. Restrict fluid intake during the day or disrupt the normal mode of fluid intake should not be.

    With pronounced rhinitis, absorption with intranasal application is disrupted, in this case, the use of tablet forms of the drug is recommended.

    It is necessary to control the treatment of children, adolescents, patients at risk of increased intracranial pressure.

    When used as a diagnostic drug, do not perform forced hydration (inside, parenteral).

    With the use of desmopressin intranasal in patients with diabetes insipidus of central genesis, the risk of severe hyponatraemia increases.

    Special precautions for the destruction of unused medicinal product

    Special measures are not required.

    Effect on the ability to drive transp. cf. and fur:

    At present, there is no evidence of the possible effect of desmopressin on the ability to drive vehicles and mechanisms. However, the use of the drug may lead to the development of side effects such as dizziness, headache, which can adversely affect the ability to drive vehicles and carry out potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions. It is recommended to use caution when driving vehicles and machinery.

    Form release / dosage:Nasal drops, 0.1 mg / ml.
    Packaging:

    To 5 ml in bottles of colorless glass, ukuporennyh plastic caps and droppers from polyethylene.

    1 bottle with instructions for use is placed in a pack of cardboard.

    Storage conditions:

    In a dry, dark place at a temperature of 2-8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001672
    Date of registration:13.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOFARM, AO BIOFARM, AO Georgia
    Manufacturer: & nbsp
    Information update date: & nbsp25.03.2017
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