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The drug improving cerebral blood flow dosage form Film-coated tablets Composition 30 mg of nicergoline
Cover structure: Valium, titanium dioxide (E171), polyethylene glycol 6000, iron oxide yellow (E172), silicon. pharmachologic effect Nicergoline — ergoline derivative, improves metabolic and hemodynamic processes in the brain, reduces platelet aggregation and improves hemorheological parameters of blood, increases blood flow in the upper and lower limbs, showing alpha1-adrenoceptor blocking action. Pharmacokinetics Suction
Once inside, nicergoline is rapidly and almost completely absorbed.
Eating or dosage form does not significantly affect the extent and rate of absorption of nicergoline. Pharmacokinetics nicergoline when used in doses up to 60 mg is linear and does not vary depending on the age of the patient.
Distribution and metabolism
Nicergoline active (> 90%) bound to plasma proteins, and its degree of affinity for the? -acid Glycoprotein is greater than for serum albumin. It is shown that nicergoline and its metabolites are distributed in blood cells.
Major metabolites nicergoline: 1,6-dimethyl-8beta-hydroxymethyl-10alfa metoksiergolin (MMDL, hydrolysis product) and 6-methyl-8beta-hydroxymethyl-10alfa metoksiergolin (MDL, demethylation product under the action of the isoenzyme CYP2D6).
The ratio of AUC values for MMDL MDL and by ingestion and / in the introduction of nicergoline indicates a marked metabolism in the «first pass» through the liver. After receiving 30 mg of nicergoline inside Cmax MMDL (21 ± 14 ng / ml) MDL (41 ± 14 ng / ml) were achieved after about 1 and 4 hours, respectively, and then decreased with the concentration of MDL T1 / 2 of 13-20 hours. Studies confirm lack of accumulation of other metabolites (including MMDL) in the blood.
Nicergoline is displayed in the form of metabolites, mostly urine (about 80% of the total dose) in a small amount (10-20%) — with the feces.
Pharmacokinetics in special clinical situations
In patients with severe renal failure was observed a significant reduction in the degree of removal of metabolic products in the urine as compared to patients with normal renal function Side effects Since the cardiovascular system: rarely — hypotension and dizziness (after parenteral administration), sensation of heat and flushing.
CNS: rarely — drowsiness, insomnia.
From the digestive system: rarely — mild stomach disorder. sale Properties prescription Special conditions Sermion® At therapeutic doses, usually has no effect on blood pressure, but in patients with hypertension, it can cause its gradual decrease.
After injecting Sermiona® recommended patients be in a horizontal position for several minutes after injection, especially at the beginning of treatment, due to possible occurrence of hypotension.
The drug acts slowly, so it should be taken for a long time, and the doctor should periodically (at least every 6 months) to evaluate the effect of treatment and appropriateness of its continuation.
Effects on ability to drive and use other mechanisms. Despite the fact that Sermion® improves reaction and concentration, its effect on the ability to drive and use sophisticated techniques not been specifically studied. In any case, care should be taken, given the nature of the underlying disease. testimony — Acute or chronic vascular or metabolic cerebral insufficiency (atherosclerosis, thrombosis or cerebral embolism, transient cerebral ischemic attacks);
— Acute or chronic peripheral vascular insufficiency (limbs obliterating vascular disease, Raynaud’s syndrome, other syndromes characterized by impaired peripheral circulation);
— As an adjunct in the treatment of hypertension and edema PNDS crises (parenteral administration). Contraindications — Acute bleeding;
— Acute myocardial infarction;
— Orthostatic hypotension;
— Increased sensitivity to nicergoline. Drug interactions Sermion® may exacerbate the effects of antihypertensive drugs.
Sermion® metabolized by the action of cytochrome CYP450 2D6, so we can not exclude the possibility of interaction with drugs that are metabolized with the participation of the same enzyme. Dosage Inside the drug is prescribed 5-10 mg 3 at equal intervals between doses for a long period of time. To improve absorption of the drug should be taken between meals. At / m administration drug prescribed by 2-4 2 mg dose, duration of treatment and the route of administration is determined individually depending on the severity of the disease. In some cases, it is advisable to start treatment with parenteral administration of the drug with a subsequent transition to the ingestion during the period of maintenance therapy.