International generic name Cyanocobalamin
Drug form and composition One ampoule of 1 ml contains 100 mcg; 250 mcg; 500 mcg or 1000 mcg cyanocobalamin.
Indications For treatment of pernicious anemia; for prophylaxis and treatment of Vitamin B12 deficiency, observed in macrocytic and megaloblastic anemia, incomplete nutrition and intestinal malabsorption. In the complex therapy of: alcoholism; hemolytic anemia; chronic febrile states; fish tapeworm; in anemia after stomach resection; in gastritis accompanied with achlorhydria; in genetic diseases; hyperthyroidism; steatorrhoea, tropic sprue, regional enteritis; persisting diarrhea; after ileum resection; malabsorption syndrome with pancreas insufficiency; malignant diseases of pancreas or intestines; in renal diseases and in prolonged stress.
Dosage and administration The most frequent scheme of administration for adults in pernicious anemia is 500-1000 mcg daily for 10-20 days. The maintenance dose is 250 mcg, once monthly in the first 3-6 months, then 250 mcg each 2-3 months. The treatment with these doses continues to obtain clinical remission. As maintenance therapy it is applied intramuscularly, 100 mcg to 200 mcg once monthly in total gastrectomy and wide ileum resection. In children it is applied intramuscularly or deeply subcutaneous, 30-50 mcg daily for two or more weeks. Maintenance therapy in children: 100 mcg intramuscularly, once monthly.
Contraindications Supersensitivity to the preparation; acute thromboembolism; Osler’s disease; Leber’s disease.
Special warnings and precautions A pain in the injection spot is likely to occur. The preparation should be applied with caution and in lower doses in patients with stenocardia and to thrombogenic persons. The blood picture should be controlled regularly and in a trend to erythrocytosis and leucocytosis, the dose should be reduced or the therapy should be stopped temporary. In pregnant and nursing women it should be applied after assessment of the ratio benefit/risk of the therapy for the mother and the child.
Drug interactions The combined therapy with phenobarbital, phenythoine and aminophenazone potentiates metabolism of vitamin B12, which is risky for hypovitaminosis. The simultaneous administration with alcohol, amino-salicylates, colchicin, aminoglycosides, chloramphenicol, the resorption of vitamin B12 is inhibited significantly, and high doses of folic acid and oral contraceptives may decrease the serum concentrations of vitamin B12.
Adverse reactions In predisposed patient are observed allergic reactions; rashes; increased heart activity; pains in cardiac area; insomnia; diarrhea; pink colouration of urine.
Pharmacological mechanisms Vitamin B12 (cyanocobalamin) catalyzes protein metabolism and promotes synthesis of proteins. Affects the metabolism of carbohydrates and lipids. Stimulates erythropoesis, promoting synthesis of hemoglobin and accumulation of compounds of sulfhydryl groups in erythrocytes. Exerts a favourable effect on the function of liver and nervous system. Participates in synthesis of nucleic acids, choline, meteonine, creatinine, purines and pyramidines. B12 deficiency in organism leads to disturbance of chromosome replication of DNA in cells.
Supplied 10 or 100 ampoules of 1 ml (100 mcg; 250 mcg; 500 mcg and 1000 mcg).
Expiry 2 years |