Desmopressin (Desmopressine)

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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: & nbsppills
    Composition:

    1 tablet dosage 0.1 mg contains:

    active substance: Desmopressin acetate 0.1 mg, corresponding to 0.089 mg desmopressin;

    Excipients: lactose monohydrate 120 mg, potato starch 76.9 mg, povidone-K30 2 mg, magnesium stearate 1 mg.

    1 tablet with a dosage of 0.2 mg contains:

    active substance: desmopressin acetate 0.2 mg corresponding to 0.178 mg desmopressin;

    Excipients: lactose monohydrate 120 mg, potato starch 76.8 mg, povidone-K30 2 mg, magnesium stearate 1 mg.

    Description:

    Tablets 0.1 mg: round tablets of white color, with a risk on one side and engraving "D1 "on the other hand.

    Tablets 0.2 mg: round tablets of white color, with a risk on one side and engraving "D2 "on the other hand.

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

    H.01.B.A.02   Desmopressin

    Pharmacodynamics:

    Desmopressin is an analogue of the natural hormone arginine-vasopressin with a pronounced antidiuretic effect. Compared with vasopressin, it has a less pronounced effect on the smooth muscle of the vessels and internal organs, which is due to changes in the structure of the desmopressin molecule compared to the natural vasopressin molecule - deamination of 1-cysteine ​​and replacement of 8-L-arginine with D-arginine. Increases the permeability of the epithelium of the distal sections of the convoluted tubules for water and increases its reabsorption. The use of desmopressin in central diabetes insipidus leads to a decrease in the volume of urine output and a simultaneous increase in osmolality of urine and a decrease in osmolality of the blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria.

    The maximum antidiuretic effect occurs when ingestion - after 4-7 hours Antidiuretic effect with oral administration at a dose of 0.1-0.2 mg - up to 8 hours, at a dose of 0.4 mg - up to 12 hours.

    Pharmacokinetics:

    Absolute bioavailability with oral administration varies from 0.08% to 0.16%.Simultaneous intake of food can reduce the degree of absorption by 40%. Time to reach the maximum concentration in the blood plasma (Tcmax) - 2 hours. The volume of distribution (Vd) is 0.2-0.3 l / kg. Desmopressin does not penetrate the blood-brain barrier. Metabolised in the kidneys. It is excreted by the kidneys. The half-life at ingestion (T1/2) - 2-3 hours.

    Indications:

    - Central diabetes insipidus (diagnosis and treatment);

    - primary nocturnal enuresis in children older than 5 years;

    - nocturnal polyuria in adults as symptomatic therapy.

    Contraindications:

    - Dhypersensitivity to the components of the drug;

    - chronic heart failure or other conditions requiring diuretic therapy;

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

    - polydipsia (congenital or psychogenic);

    - hyponatremia;

    - syndrome of inadequate production of antidiuretic hormone;

    - lactose intolerance, congenital intolerance to galactose, deficiency of lactase Lappa or glucose-galactose malabsorption.
    Carefully:

    With renal failure, fibrosis of the bladder, with violations of water and electrolyte balance, the potential risk of increased intracranial pressure, in pregnancy and in children under 1 year.

    The drug should be administered with caution to patients with diseases of the cardiovascular system, as well as patients with bronchial asthma, epilepsy and migraine, incl. in the anamnesis (in case of need it is necessary to lower a dose of Desmopressin).

    With extreme caution apply the drug in elderly patients (over 65 years) due to a high risk of side effects (including fluid retention, hyponatremia). If the decision to treat desmopressin is taken, the concentration of sodium in the blood plasma should be determined before the drug is prescribed, 3 days after the start of the dose and at each dose increase and the patient's condition is monitored.

    Pregnancy and lactation:

    Care should be taken when applying the drug during pregnancy.

    Studies have shown that the amount of desmopressin entering the body of a newborn with breast milk from a woman taking high doses of desmopressin is significantly less than that which can affect diuresis.

    Dosing and Administration:

    Inside. The optimal dose is selected individually. The drug should be taken, some time after eating, because eating can affect the absorption of the drug and its effectiveness.

    Central diabetes insipidus: the initial dose for children and adults is 0.1 mg 1-3 times a day, then the dose is selected depending on the response - from 0.2 to 1.2 mg / day. For most patients, the optimal dose is 0.1-0.2 mg 1-3 times a day.

    Primary night enuresis: the initial dose is 0.2 mg per night, if the dose is ineffective, increase to 0.4 mg. It is necessary to monitor compliance with the restriction of fluid intake in the evening. The recommended course of continuous treatment is 3 months. The decision to continue treatment should be made on the basis of clinical data, which will be observed after the drug is discontinued within 1 week.

    Nocturnal polyuria in adults: the initial dose is 0.1 mg per night, with ineffectiveness after 1 week the dose is increased to 0.2 mg and further, with weekly increase.

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

    Side effects:

    From the central nervous system: headache, dizziness;

    From the digestive system: nausea, vomiting, dry mouth;

    Other: hyperemia sclera, hot flashes, transient tachyarrhythmia, convulsions.

    Reception desmopressina without simultaneous restriction of reception of a liquid can result or bring to fluid retention in the body, accompanied by hyponatremia, increased body mass, edema, and in severe cases - convulsions.

    Overdose:

    Symptoms: fluid retention, hypoosmolarity of plasma, hyponatremia, development of seizures and other neurological and mental symptoms.

    Treatment: withdrawal of the drug, restriction of fluid intake, in severe cases - slow intravenous infusion of concentrated saline solutions simultaneously with furosemide.

    Interaction:

    When combined indomethacin may enhance, but not increase, the duration of desmopressin.

    With the joint use of glybutide, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

    When sharing desmopressin strengthens the action of hypertensive drugs.

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

    With the simultaneous use of desmopressin with non-steroidal anti-inflammatory drugs (NSAIDs), there may be an increased risk of side effects (fluid retention, hyponatremia).

    With the simultaneous use of desmopressin with loperamide, a threefold increase in desmopressin level in the plasma is possible, which significantly increases the risk of fluid retention and the occurrence of hyponatremia. Presumably, other drugs 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:

    To avoid the development of side effects, it is mandatory to minimize the intake of liquid 1 h before and during 8 h after application of the drug in patients with primary nocturnal enuresis. Treatment without restriction of fluid intake can lead to fluid retention in the body and hyponatremia with the development of such symptoms as: headache, nausea / vomiting, weight gain and in severe cases - convulsions and coma.

    In the treatment of nocturnal enuresis, desmopressin in children and young people has been reported on the development of cerebral edema.

    Desmopressin should not be used when there are other additional reasons for fluid retention and electrolyte disorders.

    High risk of side effects in elderly patients and in patients with initially low concentration of sodium in blood plasma and polyuria from 2.8 to 3.0 liters.

    Prevention of the development of hyponatremia consists in increasing the frequency of determination of the concentration of sodium in the blood plasma, especially with simultaneous applications with drugs that cause the syndrome of inadequate secretion of antidiuretic hormone (including tricyclic antidepressants, selective inhibitors of serotonin, chlorpromazine and carbamazepine) and NSAIDs.

    In the event of acute urinary incontinence, dysuria and / or nocturia of the urinary tract infection, suspected bladder or prostate tumor, the presence of polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and diseases should be performed prior to treatment with desmopressin.

    When developing against the background of treatment of systemic infections, fever, gastroenteritis drug use should be discontinued.

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

    There is no influence on the ability to drive vehicles and manage mechanisms.

    Form release / dosage:Tablets, 0.1 mg and 0.2 mg.
    Packaging:

    By 28, 30, 90 tablets in polyethylene containers of high density (HDPE), sealed with a lid with a protective ring; 1 polyethylene container in a cardboard box with instructions for use.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children
    Shelf life:

    2.5 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000894
    Date of registration:18.10.2011
    Expiration Date:18.10.2016
    The owner of the registration certificate:AKTAVIS, LTD. AKTAVIS, LTD. Russia
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp25.03.2017
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