Cyanocobalamin - instructions for use, dose, side effects, contraindications

Description:Transparent liquid from light pink to bright pink, color (dosage 200 μg / ml) or clear liquid from light red to bright red color (dosage 500 μg / ml).

Pharmacotherapeutic group:Vitamin.

ATX: & nbsp

B.03.B.A.01 Cyanocobalamin

Pharmacodynamics:Vitamin B12 has a metabolic and 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 composition of reductase, restoring folic acid in tetrahydrofolic. Has a high biological activity.

Cobamamide participates in the transfer of methyl and other single carbonaceous fragments, so it is necessary for the formation of deoxyribose and DNA, creatine, methionine, the donor of the methyl groups, in the synthesis of lipotropic factor - choline, for the conversion of methylmalonic acid to amber, which is part of myelin, for the utilization of 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 increased thromboplastic activity and prothrombin activity.

Reduces cholesterol in the blood. Has a beneficial effect on functions of the liver and nervous system. Increases the ability of tissues to regeneration.

Daily requirement for vitamin B12: for adult men - 1-2 mg; for elderly people -1.2-1.4 mg; for women 1-2 mg (for pregnant women, more by 0.5 mg, in nursing - by 0.6 mg); for children - depending on the age - 0.3-1.4 mg.

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.

Relationship with proteins in plasma - 90%. The maximum concentration after subcutaneous and intramuscular injection - after 1 hour. Penetrate through the placental barrier, breast milk.

From the liver is excreted with bile into the intestine and blood is again absorbed.

The half-life in the liver is 500 days.

It is excreted by normal kidney function -7-10% by kidneys, about 50% - with calves; with a decrease in kidney function - 0-7% kidney, 70-100% with calves.

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 (incl.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, hypotrophy, neuralgia (incl.

neuralgia of the trigeminal nerve), funicular myelosis, peripheral nervous system disease of traumatic genesis, amyotrophic lateral sclerosis, cerebral palsy, Down's disease.

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

- With the preventive purpose: when administering biguanides, paraminosalicylic 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, malbosorption syndrome, sprue), enteritis, diarrhea, malignant formations of the pancreas and intestines, 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:Contraindicated use of the drug when. (there are separate indications of the possible teratogenic effects of B vitamins in high doses) and during breastfeeding.

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 impaired function of the nervous system - 400-500 mcg / day in the first week - daily, then with an interval between administrations up to 5-7 days (concomitantly prescribe folic acid); in the period of remission, the maintenance dose is 100 μg / day 2 times a month, and for violations of the nervous system functions 200-400 μg 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 hematological improvement. If there is a violation from the nervous system - 200-400 mcg 2-4 times a month.

In diseases of the central nervous system 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 μg 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 per injection.

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

Young children with alimentary anemia and premature babies are subcutaneously 30 μg per day every day for 15 days. In dystrophies in young children, Down's disease and cerebral palsy - subcutaneously, 15-30 mcg every other day.

Side effects:

With increased sensitivity to cyanocobalamin, allergic reactions, headache, dizziness, nervous excitement, pain in the heart, tachycardia, diarrhea can be observed.

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 cyanocobalamin molecule destroys other vitamins). You can not combine with drugs that increase blood coagulability. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium drugs reduce absorption.

The risk of developed allergic reactions caused by thiamine.

Chloramphenicol reduces the hemopoietic response.

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 number of reticulocytes, the concentration of iron, is determined. The number of red blood cells, hemoglobin and color index should be monitored for 1 month 1 to 2 times a week, and then 2 to 4 times a month. The remission is achieved with an increase in the number of red blood cells to 4-4.5 ppm, when the normal size of red blood cells is reached, the aniso- and poikilocytosis disappears, the reticulocyte content is normalized after the reticulocytic crisis.After achieving hematologic remission, control of peripheral blood is carried out at least once every 4 to 6 months.

Be careful in individuals prone to thrombosis, angina (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 used in recommended doses, there were no adverse reactions in the elderly except for the above.

Effect on the ability to drive transp. cf. and fur:The drug does not adversely affect the ability to drive and / or other mechanisms.

Form release / dosage:

Solution for injection 200 μg / ml or 500 μg / ml.

Packaging:

1 ml per ampoule of neutral glass.

For 10 ampoules with instructions for use and a knife for opening ampoules or a scarifier

The ampoule is placed in a box of cardboard.

By 5 or 10 ampoules per contour cell pack of polyvinyl chloride film or tape

polyethylene terephthalate and aluminum foil or paper with polyethylene coating or without foil, or without paper. For 1 or 2 contour squares with instructions for use and a knife for opening ampoules or a scarifier ampullum is placed in a pack of cardboard.

When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

Storage conditions:

In the dark place at a temperature of 10 to 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N003084 / 01

Date of registration:05.10.2009

The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia

Manufacturer: & nbsp

NOVOSIBHIMFARM, OJSC Russia

Information update date: & nbsp01.12.2015

Illustrated instructions

Instructions

Cyanocobalamin (Cyanocobalamin)