Instructions Neurocobal film-coated tablets 500 mcg blister No. 90
Composition
active ingredient: methylcobalamin;
1 tablet contains methylcobalamin 500 mcg;
excipients: microcrystalline cellulose, pregelatinized starch, povidone K 30, colloidal anhydrous silica, talc, stearic acid, ethylcellulose, titanium dioxide (E 171), polyethylene glycol 400, Opadry 03F565012 coating brown: hypromellose, titanium dioxide (E 171), red iron oxide (E 172), polyethylene glycol, talc.
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated with a brown film coating.
Pharmacotherapeutic group
Vitamin B12 preparations (cyanocobalamin and its analogues). ATX code B03B A05.
Pharmacological properties
Pharmacodynamics.
Methylcobalamin is one of the active forms of vitamin B12. Vitamin B12 is necessary for the synthesis of nuclear protein and myelin, cell reproduction, normal growth and normal erythropoiesis. Compared to other forms of vitamin B12, methylcobalamin is better transported to the organelles of neurons at the subcellular level and stimulates the synthesis of proteins and nucleic acids. It is thanks to this property that it is more effective in the treatment of diseases of the nervous system.
Methylcobalamin plays an important role in transmethylation processes as a coenzyme of methionine synthetase, an enzyme involved in the conversion of homocysteine to methionine in protein and DNA methylation reactions. It is known that methylcobalamin normalizes axonal transport of protein complexes and promotes axon regeneration. Methylcobalamin also promotes neuronal myelination by stimulating the synthesis of phospholipids (in particular, lecithin, the main lipid component of the myelin sheath of nerve endings). In addition, methylcobalamin restores slowed synaptic transmission and reduces the content of neurotransmitters to normal levels.
The use of therapeutic doses of methylcobalamin promotes detoxification processes in the nervous system due to an increase in the content of tetrahydrofolate. Methylcobalamin is also a coenzyme in the reaction of converting homocysteine to S-adenosylmethionine, which is a universal donor of methyl groups, which leads to the activation of transmethylation reactions.
Pharmacokinetics.
Following single oral administration of 120 mcg and 1500 mcg single doses to healthy adult male volunteers in the fasting state, peak plasma concentrations of total vitamin B12 were achieved within 3 hours for both doses and were dose-dependent. Between 40% and 90% of the total urinary B12 excreted over 24 hours was excreted within the first 8 hours. No evidence for a single dose of 1500 mcg.
Following repeated oral administration of 1500 mcg/day for 12 consecutive weeks in healthy adult male volunteers, peak serum concentrations of total vitamin B12 were determined up to 4 weeks after the last dose. Serum concentrations increased during the first 4 weeks after the start of dosing, reaching approximately 2-fold higher than baseline. Thereafter, there was a gradual increase, reaching a maximum of 2.8-fold higher than baseline at week 12 of dosing. Serum concentrations decreased after the last dose (week 12), but were still 1.8-fold higher than baseline 4 weeks after the last dose.
Indication
Peripheral neuropathy.
Contraindication
Known hypersensitivity to methylcobalamin or to other components of the drug.
Erythremia, erythrocytosis.
Neoplasms, except cases accompanied by megaloblastic anemia and vitamin B12 deficiency.
Acute thromboembolic diseases.
Angina pectoris of high functional class.
Interaction with other medicinal products and other types of interactions
Concomitant use with folic acid improves the absorption and assimilation of methylcobalamin.
Other medications containing vitamin B12 should not be prescribed simultaneously.
Chloramphenicol reduces the hematopoietic response of reticulocytes to the drug. If such a combination cannot be avoided, careful monitoring of blood counts is necessary.
Drugs that may reduce vitamin B12 absorption: aminosalicylic acid, antibiotics, colchicine, cholestyramine, H2-histamine receptor blockers, metformin, neomycin, nitrous oxide, phenytoin, phenobarbital, primidone, proton pump inhibitors, zidovudine.
When used simultaneously with thiamine, the risk of allergic reactions caused by thiamine increases.
Oral contraceptives reduce the concentration of vitamin B12 in the blood.
Application features
The drug should be used with caution in patients with allergies or a history of liver disease.
It is not recommended to use vitamin B12 with drugs that increase blood clotting. During treatment with the drug, it is necessary to monitor peripheral blood parameters. In patients with a tendency to thrombosis and patients with angina pectoris, caution should be exercised and blood clotting should be monitored during treatment.
If there is a tendency to develop leukocytosis and erythrocytosis, the dose of the drug should be reduced or treatment should be temporarily suspended.
Use during pregnancy or breastfeeding
There are no data on the use of the drug during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the negative effect of the drug on the speed of psychomotor reactions.
Method of administration and doses
The drug is intended for oral use by adults.
The recommended daily dose is 1500 mcg (3 tablets), divided into three doses.
The duration of treatment depends on the nature and course of the disease and is determined individually. In the absence of clinical effect after continuous administration of the drug for 1 month, the drug should be discontinued.
Children
The use of the drug is contraindicated in children (under 18 years of age).
Overdose
Symptoms: nausea, vomiting, dizziness, agitation, tachycardia.
Treatment: symptomatic and supportive therapy.
Adverse reactions
Gastrointestinal: anorexia, nausea, vomiting, diarrhea.
Central nervous system: anxiety, headache, dizziness, migraine, severe anxiety disorders, agitation, insomnia.
Cardiovascular system: palpitations, tachycardia, pain in the heart area.
Immune system disorders: hypersensitivity reactions, including urticaria, anaphylactic shock, anaphylactoid reactions.
Musculoskeletal system: muscle pain, joint pain.
Skin: hyperemia, itching, rash, acne.
From the blood and lymphatic system: thrombosis, hypercoagulation.
General disorders: increased sweating, general weakness, fever.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in a blister; 3 or 10 blisters in a cardboard box.
30 tablets in a blister; 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and address of its place of business
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
