Cyanocobalaminus bufus - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Vitamin B12.In the body (mainly in the liver) is converted to methylcobalamin and 5-deoxyadenosylcobalamin. Methylcobalamin participates in the homocysteine conversion reaction in methionine and S-adenosylmethionine-key reactions of the metabolism of pyrimidine and purine bases (and, hence, DNA and RNA). If the vitamin is deficient in this reaction, it can be replaced by methyltetrahydrofolic acid, with folic acid reactions of metabolism being disturbed. 5-deoxyadenosylcobalamin serves as a cofactor in the isomerization of L-methylmalonyl-CoA in succinyl-CoA, an important carbohydrate and lipid metabolism reaction. Deficiency of vitamin B12 leads to a violation of the proliferation of rapidly dividing cells of hematopoietic tissue and epithelium, as well as to the violation of the formation of the myelin sheath of neurons.

Pharmacokinetics:In blood cyanocobalamin binds to the trans-balanamines I and II, which transport it into tissues. It is deposited mainly in the liver. The connection with plasma proteins is 90%. The maximum concentration after subcutaneous and intramuscular administration is achieved after 1 hour. From the liver is excreted with bile into the intestine and again absorbed into the blood. Half-life is 500 days.It is excreted at normal kidney function - 7-10% by kidneys, about 50% - by the intestine; with reduced renal function - 0-7% kidney, 70-100% - intestine. Penetrates through the placental barrier, into breast milk.

Indications:

Conditions accompanied by a deficiency of vitamin B12: B12-deficiency anemia; in the complex therapy of anemia (including iron deficiency, posthemorrhagic, aplastic, anemia, caused by toxic substances and / or drugs).

In complex therapy in neurology: neuralgia (including trigeminal neuralgia), polyneuropathy (including alcoholic). With the preventive purpose: with the appointment of biguanides, paraaminosalicylic acid, ascorbic acid in high doses, abnormalities of the stomach and intestines with impaired absorption of vitamin B12 (resection of part of the stomach, small intestine, Crohn's disease, celiac disease, malabsorption syndrome, sprue), radiation sickness.

Contraindications:Hypersensitivity, thromboembolism, erythremia, erythrocytosis, pregnancy, lactation.

Carefully:Angina pectoris, benign and malignant neoplasms, accompanied by megaloblastic anemia and vitamin B12 deficiency, propensity to form blood clots.

Pregnancy and lactation:

The drug is not recommended for use during pregnancy and during breastfeeding, because B vitamins in high doses have a teratogenic effect.

Dosing and Administration:

Subcutaneously, intravenously, intramuscularly.

Subcutaneously, with B12-deficiency anemia - 100-200 mcg / day every other day; with B12-deficiency anemia with addition of a dysfunction of the nervous system - 400-500 mcg / day in the first week - daily, then with intervals between administrations up to 5-7 days (concomitantly prescribe folic acid); during the remission, a maintenance dose of 100 mcg / day 2 times a month, with neurologic symptoms - 200-400 mcg 2-4 times a month.

In acute posthemorrhagic and iron deficiency anemia - 30-100 mcg 2-3 times a week; at aplastic anemia, anemia caused by toxic substances and / or drugs - 100 μg before the onset of clinical and hematological improvement. With violations from the nervous system - 200-400 mcg 2-4 times a month. In neurology: neuralgia (including trigeminal neuralgia), polyneuropathy (including alcoholic) - 200-500 mcg every other day for 2 weeks.

With a prophylactic goal - 60-100 mcg daily for 20-30 days.To eliminate the deficiency of vitamin B12 is administered intramuscularly or intravenously, 1 mg daily for 1-2 weeks.

Children of early age with alimentary anemia and premature infants - mildly, 30 mcg daily for 15 days.

Side effects:Allergic reactions, mental agitation, cardialgia, tachycardia, diarrhea, headache, dizziness, hypercoagulation, violation of purine metabolism.

Overdose:Data on overdose are absent.

Interaction:

Pharmaceutically incompatible with ascorbic acid, heavy metal salts (inactivation of cyanocobalamin), thiamine, pyridoxine, riboflavin (because the cobalt ion contained in the cyanocobalamin molecule destroys other vitamins).

The risk of developing allergic reactions increases when combined with thiamine.

Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of cyanocobalamin.

Chloramphenicol reduces the hematopoietic response of cyanocobalamin. Do not combine with drugs that increase blood coagulability.

Special instructions:Deficiency of vitamin B12 should be confirmed diagnostically before prescribing, as it can mask the deficiency of folic acid. During the period of treatment, it is necessary to monitor the parameters of peripheral blood: on the 5th-8th day of treatment, the content of reticulocytes, the concentration of iron is determined. The number of erythrocytes, hemoglobin and color index should be monitored for 1 month 1-2 times a week, and then - 2-4 times a month. Remission is achieved with an increase in the number of red blood cells to 4-4.5 million / μl, when normal erythrocyte sizes reach, aniso- and poikilocytosis disappear, normalizing the number of reticulocytes after a reticulocytic crisis. After reaching hematologic remission, peripheral blood monitoring is performed at least once every 4-6 months. Be careful in individuals prone to thrombosis, with angina (in smaller doses, up to 100 μg per injection). When used in recommended doses, there were no adverse reactions in the elderly except for the above. n / μl, upon reaching

Effect on the ability to drive transp. cf. and fur:The adverse effect of the drug on the ability to drive vehicles andoccupations by other activities requiring concentration of attention and speed of psychomotor reactions were not reported. However, given that the drug may cause dizziness, care should be taken when implementing these activities.

Form release / dosage:

Solution for injection 0.2 mg / ml.

Packaging:

1 ml per ampoule polymer. For polymer ampoules, labels are glued or the label text is applied directly to the ampoule by a polymer method of drop-jet printing.

For 10, 100 ampoules of polymer with instructions for use are placed in a pack of cardboard.

Storage conditions:In the dark place at a temperature of no higher than 15 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002749

Date of registration:10.12.2014

Date of cancellation:2019-12-10

The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia

Manufacturer: & nbsp

UPDATE, PFC CJSC Russia

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Cyanocobalamin bufus (Cyanocobalamin bufus)