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

Description:Transparent liquid from slightly pink to pink for a dosage of 0.2 mg / ml, and from bright pink to bright red for a dosage of 0.5 mg / ml.

Pharmacotherapeutic group:Vitamin.

ATX: & nbsp

B.03.B.A.01 Cyanocobalamin

Pharmacodynamics:Vitamin B12 in the body (predominantly in the liver) is converted into methyl cobalamin-lamin and 5-deoxyadenosyl cobalamin. Methylcobalamin participates in the homocysteine conversion reaction in methionine and S-adenosylmethionine are key reactions of the metabolism of pyrimidine and purine bases (and, consequently, DNA and RNA). If the vitamin is deficient in this reaction, it can be replaced by methyltetra-hydrophosphonic acid, while the folicle-like metabolic reactions are disrupted. 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:

Absorption occurs throughout the small intestine, a small amount is absorbed in the large intestine. In the ileum it connects with a special internal factor and becomes inaccessible to the microorganisms of the intestine. Complex in the wall of the small intestine transmits cyanocobalamin on the receptor, which transports it into the cell (the receptor activity depends on the structure and function of the mucous membrane supported by folic acid, and also on the presence of calcium ions and pH of the medium). 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%. Stam after subcutaneous and intramuscular injection is achieved after 1h.

From the liver is excreted with bile into the intestine and again absorbed into the blood. T1 / 2 in the liver - 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, into breast milk.

Indications:

Conditions associated with 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 therapies: chronic hepatitis, cirrhosis, hepatic insufficiency, alcoholism (prolonged fever).

In Neurology: polyneuritis, radiculitis, hypotrophy, neuralgia (including trigeminal neuralgia), funicular myelosis, peripheral nerve injuries, amyotrophic lateral sclerosis, cerebral palsy, Down's disease.

In dermatology: skin diseases (psoriasis, photodermatosis, herpetiform dermatitis, atopic dermatitis).

For preventive purposes - with the appointment of biguanides, paraaminosalicylic acid (PASK), 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), malignant pancreas and intestines, radiation sickness. Stress and infection (long-term), diet, kidney pathology.

Contraindications:Hypersensitivity, 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 intramuscularly, subcutaneously, intravenously and intralumbally. Subcutaneously, with Addison-Birmer anemia, 0.1-0.2 mg / day every other day; with funicular myelosis, macrocytic anemia with impaired function of the nervous system - 0.4-0.5 mg / day in the first week - daily, then with intervals between administrations up to 5-7 days (concurrently prescribed folic acid); in the period of remission, the maintenance dose is -0.1 mg / day 2 times a month, in the presence of neurologic events - 0.2-0.4 mg 2-4 times a month.

In acute posthemorrhagic and iron deficiency anemia to 0,03 - 0,1 mg 2-3 times a week; with aplastic anemia - 0.1 mg before the onset of clinical and hematologic improvement, with anemia of alimentary nature in early childhood and anemia in premature infants - 0.03 mg for 15 days.

In diseases of the central nervous system and the peripheral nervous system, 0.2-0.5 mg every other day for 2 weeks. In injuries of the peripheral nervous system - 0.2-0.4 mg every other day for 40-45 days.

With hepatitis and cirrhosis of the liver - 0.03-0.06 mg / day or 0.1 mg every other day for 25-40 days;

With radiation sickness - 0,06-0,1 mg daily for 20-30 days. With funicular myelosis, amyotrophic lateral sclerosis - intralumbalno, 0.015-0.03 mg with a gradual increase in the dose to 0.2-0.25 mg per injection.

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 intramuscularly or intravenously.

Children of early age with alimentary anemia and premature infants - 0.03 mg per day daily for 15 days. In dystrophies in young children, Down's disease and cerebral palsy - subcutaneously 0.015-0.03 mg 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).

Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium drugs reduce absorption. Increases the development of allergic reactions caused by thiamine.

Chloramphenicol reduces the hemopoietic response.

Increases the toxic effect in combination with folic acid.

You can 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 number 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 content of reticulocytes after a reticulocytic crisis. After achieving hematological remission; control of peripheral blood, is carried out at least 1 time in 4-6 months.

Be careful in individuals prone to thrombosis, with 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.

At application in recommended doses at elderly people of by-side reactions, except for above listed, it was not noted.

Form release / dosage:

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

Packaging:

1 ml per ampoule of neutral glass.

10 ampoules are placed in boxes of cardboard. In each box, the instructions for use and the ampoule scaler are put. 5 ampoules per contour pack of PVC film.

2 contour packs together with the instruction for use and the ampoule scarifier in a pack of cardboard.

When using ampoules with a notch, dot, or kink ring, the scriber

ampoule does not invest.

Storage conditions:In the dark place at a temperature of 2 to 30 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000263

Date of registration:05.03.2010

The owner of the registration certificate:MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC MOSHIMFARM PREPARATES them. N.А.Semashko, OJSC Russia

Manufacturer: & nbsp

MOSHIMFARM PREPARATES them. NA Semashko OJSC Russia

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Cyanocobalamin (Cyanocobalamin)