Cyanocobalamin (Vitamin B12) - instructions for use, dose, side effects, contraindications

Vitamin B12 has a metabolic, hematopoietic effect. In the body (mainly in the liver) is converted into a coenzyme form - adenosylcobalamin or kobamid, which is an active form of vitamin B12 and is a part of numerous enzymes, including. in the reductase that restores folic acid to tetrahydrofolic. Has a high biological activity.

Cobamamide participates in the transfer of methyl and other single-carbon fragments, so it is necessary for the formation of deoxyribose and DNA, creatine, methionine-donor of the methyl groups, in the synthesis of the lipotropic factor-choline, for the conversion of methylmalonic acid to succinic, myelin-containing, for utilization propionic acid. It is necessary for normal hematopoiesis - promotes the maturation of red blood cells.

Promotes the accumulation in erythrocytes of compounds containing sulfhydryl groups, which increases their tolerance to hemolysis. Activates the blood coagulation system, in high doses causes an increase in thromboplasty activity and prothrombin activity. Reduces cholesterol in the blood.Has a beneficial effect on the function of the liver and nervous system. Increases the ability of tissues to regenerate.

Pharmacokinetics:In the blood, vitamin B12 binds to trans-balanamines I and II, which transport it to tissues. It is deposited mainly in the liver.

The connection with plasma proteins is 90%. The maximum concentration after subcutaneous and intramuscular injection 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% - through the intestine; with a decrease in kidney function - 0-7% kidney, 70-100% - through the intestine. Penetrates through the placental barrier, into breast milk.

Indications:

Conditions accompanied by vitamin B12 deficiency:

Chronic anemia, occurring with a deficiency of vitamin B12 (Addison-Birmer disease, alimentary macrocytic anemia), as part of complex therapy of anemia (including iron deficiency, posthemorrhagic, aplastic, anemia caused by toxic substances and / or drugs).

In complex therapy:

Chronic hepatitis, cirrhosis, hepatic insufficiency, alcoholism.

In neurology: polyneuritis, radiculitis, neuralgia (including trigeminal neuralgia), funicular myelosis, peripheral nervous system diseases of traumatic origin, amyotrophic lateral sclerosis, cerebral palsy, Down's disease.

In dermatology: psoriasis, photodermatosis, herpetiform dermatitis, atopic dermatitis.

With the preventive purpose - with the appointment of biguanides, PASK, ascorbic acid in high doses, abnormalities of the stomach and intestines with a violation of absorption of vitamin B12 (resection of part of the stomach, small intestine, Crohn's disease, malabsorption syndrome, sprue), enteritis, diarrhea, radiation sickness.

Contraindications:Hypersensitivity to the drug components, thromboembolism, erythremia, erythrocytosis, pregnancy (there are separate indications of possible teratogenic effects of B vitamins in high doses), lactation period.

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

Dosing and Administration:

The drug is administered subcutaneously, intramuscularly, intravenously and intralumbly.

Subcutaneously, with Addison-Birmer anemia, 100-200 μg / day every other day; with funicular myelosis, macrocytic anemia with violation of the nervous system function - 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, the maintenance dose is 100 mcg / day 2 times a month, in the presence of 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; with aplastic anemia - 100 mcg before the onset of clinical and hematologic improvement. Young children with alimentary anemia and premature babies are subcutaneously 30 μg per day every day for 15 days.

In diseases of the central and peripheral nervous system - 200-500 mcg every other day for 2 weeks. In diseases of the peripheral nervous system of traumatic genesis - 200-400 mcg every other day for 40-45 days.

With hepatitis and cirrhosis of the liver - 30-60 mcg / day or 100 mcg every other day for 25-40 days.

With radiation sickness - 60-100 mcg daily for 20-30 days. With funicular myelosis, lateral amyotrophic sclerosis - intralumbalno, 15-30 mcg with a gradual increase in the dose to 200-250 mcg for administration.

To eliminate the deficiency of vitamin B12 is administered intramuscularly or intravenously, 1 mg daily for 1-2 weeks; for prophylaxis - 1 mg once a month.

In dystrophies in young children, Down's disease and cerebral palsy - subcutaneously 15-30 mcg every other day.

Side effects:Allergic reactions, mental agitation, cardialgia, tachycardia, diarrhea, headache, dizziness. When used in high doses, hypercoagulation, violation of purine metabolism.

Interaction:

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

You can not combine with drugs that increase blood coagulability. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium drugs reduce the absorption of cyanocobalamin. Increases the risk of allergic reactions against thiamine. Increases the toxic effect in combination with folic acid. Chloramphenicol reduces the hematopoietic response of cyanocobalamin.

Special instructions:

Deficiency of vitamin B12 should be confirmed diagnostically prior to prescribing, as it can mask a 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 within 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 content of reticulocytes after a reticulocytic crisis. After reaching hematological remission, control of peripheral blood is carried out at least once in 4-6 months.

Be careful in individuals prone to thrombosis, with angina (use in smaller doses up to 0.1 mg per injection). Take a long time with pernicious anemia, the upcoming operations on the gastrointestinal tract. When applying the recommended doses during pregnancy, lactation, as well as in elderly people, there were no adverse reactions other than those listed above.

Form release / dosage:

Solution for injection 0.2 mg / ml and 0.5 mg / ml.

Packaging:

Solution for injection 0.2 mg / ml and 0.5 mg / ml per 1 ml in ampoules.

10 ampoules together with the instruction for use and scarifier ampoule or a knife for opening ampoules in a box or a pack of cardboard, with partitions or with a liner of paste paper.

Storage conditions:List B. Store in a place protected from light, out of the reach of children, at a temperature of no higher than 25 ° C.

Shelf life:2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000959

Date of registration:05.02.2009

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp01.12.2015

Illustrated instructions

Instructions

Cyanocobalamin (Vitamin B12) (Cyanocobalamin (Vitamin B12))