Active substanceNicergolineNicergoline
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  • Dosage form: & nbsplyophilizate for the preparation of a solution for intramuscular injection
    Composition:

    Active substance: nicergoline - 4 mg

    Excipients: tartaric acid - 1.04 mg; lactose monohydrate (sugar milk) - 30 mg

    Description:Porous mass or white powder odorless.
    Pharmacotherapeutic group:Alpha-blocker
    ATX: & nbsp

    C.04.A.E.   Alkaloids of ergot

    Pharmacodynamics:

    Nicergoline - a derivative of ergoline, improves metabolic and hemodynamic processes in the brain, reduces platelet aggregation and improves hemorheological blood counts,increases the velocity of blood flow in the upper and lower extremities, shows an alpha-1-adrenergic blocking effect. In patients with hypertension, a gradual moderate pressure decrease can occur.

    Pharmacokinetics:The main products of the metabolism of nicergoline: 1,6-dimethyl-8ß-hydroxymethyl-10α-methoxyergoline (MMDL, product of hydrolysis) and 6-methyl-8ß-hydroxymethyl-10α-methoxyergoline (MDL, demethylated product CYP2D6). Nicergoline actively (> 90%) binds to plasma proteins, and the degree of its affinity for alpha-1-acid glycoprotein is greater than for serum albumin. Shown, that nicergoline and its metabolites can be distributed in blood cells. The pharmacokinetics of nicergoline is linear and does not vary with age of the patient. Nicergoline is excreted in the form of metabolites, mainly through the kidneys (approximately 80% of the total dose), and in a small amount (10-20%) through the intestine. In patients with severe renal insufficiency, there was a significant decrease in the excretion rate of metabolic products with urine compared with patients with normal renal function.
    Indications:

    Acute and chronic cerebral metabolic and vascular disorders(due to atherosclerosis, arterial hypertension, thrombosis or embolism of cerebral vessels, including transient ischemic attack, vascular dementia and headache caused by vasospasm).

    Acute and chronic peripheral metabolic and vascular disorders (organic and functional arteriopathies of the extremities, Raynaud's disease, syndromes caused by impaired peripheral blood flow).

    As an additional tool in the treatment of hypertensive crises.

    Contraindications:

    Recently suffered myocardial infarction, bleeding, severe bradycardia, orthostatic hypotension, hypersensitivity to nicergoline or other components of the drug, galactose intolerance, lactose deficiency or glucose-galactose malabsorption, pregnancy, breastfeeding, children under 18 years of age (due to lack of data).

    Carefully:Hyperuricemia or gout in a history in combination with drugs that disrupt the metabolism or excretion of uric acid!
    Dosing and Administration:

    Intramuscularly, previously dissolved in the attached solution of sodium chloride 0.9%, 2-4 mg 2 times a day.

    The dose and duration of therapy depend on the nature of the disease.

    Patients with impaired renal function (serum creatinine> 2 mg / dl) are recommended to use at lower therapeutic doses.

    Side effects:

    Marked reduction in blood pressure, dizziness, diarrhea disorders (nausea, diarrhea, abdominal pain), sensation of heat, allergic reaction, sleepiness or insomnia. It is possible to increase the concentration of uric acid in the blood, and this effect does not depend on the dose and duration of therapy.

    Overdose:

    Symptoms: increased severity of side effects, except for allergic reactions.

    Treatment: symptomatic therapy.
    Interaction:

    Strengthens the effect of antihypertensive drugs. Nicergoline metabolized by cytochrome CYP2D6; Therefore, it is impossible to exclude the possibility of its interaction, with drugs that are metabolized with the participation of the same enzyme.

    Special instructions:After the introduction of Nicergoline, it is recommended that patients be in a horizontal position for severalminutes after the injection, especially at the beginning of treatment, due to possible orthostatic hypotension.
    Effect on the ability to drive transp. cf. and fur:Although nicergoline improves the reaction and concentration of attention, its impact on the ability to drive and use sophisticated technology has not been specifically studied. In any case, during the treatment period, one should refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Lyophilizate for the preparation of solution for intramuscular injection 4 mg.

    Packaging:

    The drug, with an active substance content of 4 mg, is placed in ampoules from neutral glass.

    For 5 ml of sodium chloride of the solvent for the preparation of medicinal forms for injection 0.9% in ampoules of neutral glass.

    The ampoules can be marked with a dot or a break ring.

    5 ampoules with the preparation and 5 ampoules with the solvent are placed in contour cell packs of a polyvinyl chloride film.

    One out-of-the-box cell packaging with the preparation and one circuit pack with the solvent together with the ampoule scarifierceramic or ampoule, abrasive and instructions for use are placed in a pack of cardboard.

    When using ampoules with a dot or a ring of fracture, the scarifier is not inserted.
    Storage conditions:

    Store in a dark place at a temperature of 2 to 10 ° C. Keep out of the reach of children.

    Shelf life:

    4 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N000693 / 02
    Date of registration:24.12.2008
    The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.06.2018
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