Instructions for use Mexicor capsules 100 mg blister No. 20
Composition
active ingredient:
1 capsule contains ethylmethylhydroxypyridine succinate in terms of 100% substance 100 mg;
excipients: potato starch, povidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose;
capsule shell: titanium dioxide (E 171), gelatin, sunset yellow dye (E 110), quinoline yellow dye (E 104).
Dosage form
Capsules.
Main physicochemical properties:
Hard gelatin capsules No. 2, yellow in color. The contents of the capsules are granulate, which contains granules and powder of white and white with a yellowish tint.
Pharmacotherapeutic group
Cardiological drugs. Other cardiological drugs.
ATX code C01E B.
Pharmacological properties
Pharmacodynamics.
Mexicor® reduces the manifestation of oxidative stress, inhibits free radical lipid peroxidation and increases the activity of the antioxidant enzyme system. Mexicor® improves cellular energy metabolism, activates the energy-synthesizing functions of mitochondria, enhances the compensatory activation of aerobic glycolysis and reduces the degree of inhibition of oxidative processes in the Krebs cycle. The energy-synthesizing effect of the drug is associated with an increase in the delivery and consumption of succinate by cells, the implementation of the phenomenon of rapid oxidation of succinic acid by succinate dehydrogenase, as well as with the activation of the mitochondrial respiratory chain.
When dissociation of the drug Mexicor® in the cell into succinate and a 3-hydroxypyridine derivative, the latter exhibits an antioxidant effect that stabilizes cell membranes and restores the functional activity of cells. It has a modulating effect on membrane-bound enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), ion channels and receptor complexes, which contributes to the preservation of the structural and functional integrity of biomembranes, improves the transport of neurotransmitters and synaptic transmission. It affects the metabolism and blood supply of the brain, microcirculation and rheological properties of blood, reduces platelet aggregation.
Promotes the restoration of the functional state of the ischemic myocardium, the contractile function of the heart, and also reduces the manifestation of systolic and diastolic dysfunction of the left ventricle. In conditions of coronary insufficiency, it increases collateral blood supply to the ischemic myocardium and activates energy synthesis processes in the ischemic zone, thereby contributing to the preservation of cardiomyocytes and maintaining their functional activity. Restores myocardial contractility in reversible cardiac dysfunction.
In patients with stable angina, exercise contributes to increased tolerance to physical exertion and the antianginal activity of nitro drugs.
Mexicor® stabilizes the membrane structures of the vascular wall, inhibits erythrocyte aggregation, normalizes microcirculation disorders in the early stages of atherogenesis, has a hypolipidemic effect, and reduces the content of total cholesterol and low-density lipoproteins.
Mexicor® has a neuroprotective effect on the functional activity and metabolism of the ischemic brain, increases the stability of cerebral blood circulation in conditions of hypoperfusion, prevents a decrease in cerebral blood flow in the reperfusion period after ischemia. The drug promotes adaptation to ischemia, inhibiting the depletion of carbohydrate reserves, blocking the post-ischemic decrease in glucose and oxygen utilization by the brain, and prevents the progressive accumulation of lactate.
Mexicor® has nootropic properties, prevents and reduces memory impairments and learning abilities that occur in acute and chronic vascular diseases of the brain, in mild and moderate cognitive disorders of various genesis, has an antioxidant effect, and increases concentration and performance.
In patients with acute cerebrovascular accident, it reduces the manifestation of clinical symptoms of stroke and has a positive effect on the course of the rehabilitation period.
Mexicor® has a selective effect, does not cause sedation and muscle relaxation, eliminates anxiety, fear, tension, restlessness, increases the ability to adapt and emotional status.
Pharmacokinetics.
After oral administration, Mexicor® is rapidly and completely absorbed from the gastrointestinal tract. It is rapidly distributed in organs and tissues. The time to reach maximum plasma concentration (Tmax) is in the range of 0.46 to 0.5 hours. The average distribution time of the drug in the body is 4.9–5.2 hours. It is metabolized in the liver by glucuronidation.
5 metabolites have been identified: 3-hydroxypyridine phosphate – formed in the liver and with the participation of alkaline phosphatase decomposes into phosphoric acid and 3-hydroxypyridine; the second metabolite – pharmacologically active, formed in large quantities and detected in the urine 1–2 days after taking the drug; the third – excreted by the kidneys in large quantities; the fourth and fifth – glucuronide conjugates.
The elimination half-life (T1\2el) of Mexicor® is 4.7–5 hours. On average, 0.3% of the unchanged drug and 50% of the administered dose are excreted by the kidneys in the form of a glucuronide within 12 hours. Mexicor® and its glucuronide conjugates are excreted most intensively in the first 4 hours after administration. The rates of renal excretion of the unchanged drug and metabolites have significant individual variability.
Indication
Comprehensive therapy of ischemic heart disease;
complex therapy of ischemic stroke;
dyscirculatory encephalopathy;
mild and moderate cognitive disorders of various genesis.
Contraindication
Increased individual sensitivity to the drug, hepatic or renal failure, pregnancy or breastfeeding, children's age.
Interaction with other medicinal products and other types of interactions
Enhances the effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), and antiparkinsonian drugs (levodopa).
Increases the antianginal activity of nitro drugs and the hypotensive effect of angiotensin-converting enzyme (ACE) inhibitors and beta-blockers.
The combined use of Mexicor® with nibetan, propranolol and verapamil reduces the risk of developing arrhythmogenic effects.
Reduces the toxic effect of ethanol.
Application features
Use with caution in patients with diabetic retinopathy.
Special attention should be paid to prescribing Mexicor® to patients with a severe allergic history.
Since the medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take it. The medicinal product contains the colouring agent "Yellow sunset" E 110, which may cause allergic reactions. In isolated cases, especially in predisposed patients, in patients with bronchial asthma with increased sensitivity to sulphites, severe hypersensitivity reactions may develop.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
During the period of treatment with the drug, it is advisable to refrain from hazardous activities that require increased concentration of attention and speed of psychomotor reactions, taking into account the likelihood of side effects that may affect reaction speed and concentration of attention.
Method of administration and doses
Mexicor® is taken orally. Therapeutic doses and duration of treatment are determined by the doctor depending on the nosological form of the disease and the patient's sensitivity to the drug.
Treatment begins with a dose of 100 mg 3 times a day, gradually increasing the dose until a therapeutic effect is obtained.
The maximum daily dose should not exceed 800 mg, a single dose - 200 mg. It is advisable to divide the daily dose of the drug into 3 doses during the day.
The duration of the course of therapy with Mexicor® in patients with ischemic heart disease and cerebral circulation disorders is at least 1.5-2 months. Repeated courses of therapy, on the recommendation of a doctor, are preferably carried out in the spring and autumn periods.
In the complex therapy of dyscirculatory encephalopathy, mild and moderate cognitive disorders, the drug is prescribed in a dose of 100 mg 3-4 times a day. The duration of treatment is determined by the doctor depending on the course of the disease and the patient's condition.
Complete the course of therapy with Mexicor® gradually, reducing the daily dose of the drug by 100 mg per day.
Children
Controlled clinical studies on the safety of the drug in children have not been conducted, so the drug should not be used in this category of patients.
Overdose
Due to the low toxicity of the drug, overdose is unlikely. In case of accidental overdose, sleep disorders (insomnia, drowsiness) may develop.
Treatment is symptomatic.
Side effects
The drug is usually well tolerated. In rare cases, allergic reactions, dyspeptic disorders, diarrhea, nausea and dry mouth, anxiety, emotional reactivity, distal hyperhidrosis, headache, impaired coordination, increased or decreased blood pressure may occur, which quickly disappear on their own or upon discontinuation of the drug.
With prolonged use, flatulence and sleep disturbances (drowsiness or difficulty falling asleep) may occur.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister; 2 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
PrJSC "Technolog", Ukraine.
Address
04114, Kyiv, Avtozavodska St., 54/19 Lit. A, office
tel. (044) 503-78-68
Applicant
LLC "ZDRAVO", Ukraine
