Nicergoline - instructions for use, dose, side effects, contraindications

Active substance - nicergoline 10 mg, auxiliary substances - potato starch, lactose sugar, aerosil (silicon dioxide colloid), magnesium stearate, magnesium carbonate, sugar (sucrose), povidone, titanium dioxide, talc, bee yellow wax.

Description:Round, biconvex tablets, coated with a coat of white or almost white. Two layers are visible on the cross-section.

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 blood flow in the upper and lower extremities, shows an alpha-1-adrenergic blocking effect.

Pharmacokinetics:

After oral administration, nicergoline quickly and almost completely absorbed. The main products of metabolism of nicergoline: 1,6-dimethyl-8ß-hydroxymethyl-10α-methoxyergoline (MMDL, hydrolysis product) and 6-methyl-8β-hydroxymethyl-10α-methoxyergoline (MDL, dimethylation product under the action of the CYP2D6 isoenzyme). The ratio of the area values of the concentration-time curve (AUC) for MMDL and MDL for ingestion and intravenous administration of nicergoline indicates a marked metabolism on the first pass. After taking 30 mg of nicergoline, the maximum concentrations of MMDL (21 ± 14 mg / ml) and MDL (41 ± 14 mg / ml) were reached after approximately 1 and 4 hours, respectively, then the concentration of MDL decreased with a half-life of 13 to 20 hours. does not have a significant effect on the degree and rate of absorption of nicergoline. Nicergoline Active (> 90%) binds to plasma proteins, and the degree of its affinity for the a-acid of the glycoprotein is greater than to serum albumin. Shown, that nicergoline and its metabolites can be distributed in blood cells. The pharmacokinetics of nicergoline with doses up to 60 mg is linear and does not vary with the age of the patient.

Nicergoline is excreted in the form of metabolites, mainly with urine (approximately 80% of the total dose), and in small amounts (10-29%) with feces. In patients with severe renal insufficiency, there is a significant decrease in the excretion rate of metabolic products with urine in comparison with patients with normal renal function.

Indications:

- Acute and chronic cerebral metabolic and vascular disorders (due to atherosclerosis, arterial hypertension, thrombosis and embolism of cerebral vessels), including transient ischemiavascular 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.

Contraindications:Recently suffered myocardial infarction, acute bleeding, severe bradycardia, disturbed orthostatic regulation, hypersensitivity to nicergoline or other components of the drug.

Carefully:Hyperuricemia or gout in the anamnesis and / or in combination with drugs that disrupt the metabolism or excretion of uric acid.

Pregnancy and lactation:

Due to the lack of special studies, during pregnancy nicergoline should be used only if there is an obvious need and under the direct supervision of a physician. At the time of taking the drug, you must stop breastfeeding, because nicergoline and the products of its metabolism penetrate into the mother's milk.

Dosing and Administration:

Inside, 5 to 10 mg three times a day at the same intervals for a long period of time (up to several months). In vascular dementia, the use of 30 mg twice a day (with every 6 months it is recommended to consult a doctor about the advisability of continuing therapy).

The dose and duration of therapy depend on the nature of the disease.In some cases, it is preferable to begin therapy with parenteral administration, and then switch to taking the drug inside for maintenance treatment.

Patients with impaired renal function (serum creatinine> 2 mg / dL) nicergoline it is recommended to use at lower therapeutic doses.

Side effects:

Decrease in blood pressure (BP), dizziness, dyspeptic phenomena, fever, allergic reactions, drowsiness 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. Side effects are usually mild or moderate.

Overdose:Symptoms: a transient, marked decrease in blood pressure. Special treatment is usually not required, the patient enough for a few minutes to take a horizontal position. In exceptional cases, with a sharp violation of the blood supply to the brain and heart, it is recommended the introduction of sympathomimetic drugs under the constant control of blood pressure.

Interaction:May enhance the effect of antihypertensive drugs. Nicergoline metabolized by cytochrome CYP450 2D6, so it is impossible to exclude the possibility of its interaction with drugs that are metabolized with the participation of the same enzyme.

Special instructions:

In therapeutic doses Nicergoline, as a rule, does not affect blood pressure, however, in patients with arterial hypertension, it can cause its gradual decline.

The drug acts gradually, so it should be taken for a long time, with the doctor periodically (at least every 6 months) to evaluate the effect of treatment and the appropriateness of its continuation.

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, care should be taken, given the nature of the underlying disease.

Form release / dosage:

Tablets, coated with a coating, 10 mg.

Packaging:

For 20, 30 tablets in cans of polymer or in polymeric bottles.

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

Each jar, vial or 1, 2, 3 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children

Shelf life:2 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000794

Date of registration:04.08.2010 / 02.02.2018

Expiration Date:Unlimited

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp23.06.2018

Illustrated instructions

Instructions

Nicergoline (Nicergoline)