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

Solution with a concentration of 0.2 mg / ml - a transparent liquid of pink color; solution with a concentration of 0.5 mg / ml - a clear liquid of red color.

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 cobalamid, 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, the donor of the methyl groups, in the synthesis of the lipotropic factor-choline, for the conversion of methylmalonic acid to amber, 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 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.

Daily requirement for vitamin B12: for adult men - 1-2 mg; for the elderly -1.2-1.4 mg; for women 1-2 mg (in pregnant women it is 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.

The connection with plasma proteins is 90%. The maximum concentration after subcutaneous and intramuscular injection - 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% - with calves; with a reduced renal function - 0-7% kidney, 70-100% - with a caloric mass. Penetrates through the placental barrier, 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 LC).

In complex therapy:

Chronic hepatitis, cirrhosis, hepatic insufficiency, alcoholism, sprue.

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

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:Angina pectoris, 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); in the period of remission the maintenance dose is -100 mcg / day 2 times a month, and for violations of the nervous system function of 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. With violations of 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 mcg daily for 20-30 days. With funicular myelosis, lateral amyotrophic sclerosis - introlumbalno, 15-30 mcg with a gradual increase in the dose to 200-250 mkg per injection.

To eliminate the deficiency of vitamin B12 is administered in / m or IV, 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:Allergic reactions, mental agitation, cardialgia, tachycardia, diarrhea, headache, dizziness.When used in high doses - hypercoagulation, violation of purine metabolism.

Interaction:

Pharmaceutically compatible with ascorbic acid, salts of heavy metals (inactivation cyanocobalamin) bromide thiamine, pyridoxine, riboflavin (as contained in the molecule of cyanocobalamin cobalt ion destroys al. Vitamins). You can not combine with drugs that increase blood coagulability. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium drugs reduce absorption.

Increases the risk of allergic reactions caused by thiamine.

Chloramphenicol reduces the hemopoietic response.

Increases the toxic effect in combination with folic acid.

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

Effect on the ability to drive transp. cf. and fur:

Form release / dosage:

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

Packaging:

1 ml per ampoule of glass. For 10 ampoules together with a knife for opening ampoules or a scarifier ampoule and instructions for use are put in a box of cardboard.

10 ampoules in a blister pack. 1 or 2 blister packs together with a vial for opening ampoules or a scarifier ampoule and instructions for use are put in a pack of cardboard.In case of using ampoules with a break ring or a notch and a break point, the insertion of the knife for opening ampoules is not provided.

Storage conditions:In the dark place at a temperature of 15 to 25 ° 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:П N015993 / 01

Date of registration:16.09.2009

The owner of the registration certificate:BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Manufacturer: & nbsp

BORISOVSKIY FACTORY OF MEDPREPARATES, OJSC Republic of Belarus

Information update date: & nbsp01.12.2015

Illustrated instructions

Instructions

Cyanocobalamin (Cyanocobalamin)