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

Description:Transparent liquid from light pink to bright pink color (for a dosage of 0.2 mg / ml) or clear liquid from bright pink to bright red color (for a dosage of 0.5 mg / ml).

Pharmacotherapeutic group:Vitamin.

ATX: & nbsp

B.03.B.A.01 Cyanocobalamin

Pharmacodynamics:Cyanocobalamin (vitamin B12) in the body (mainly in the liver) is converted to methylcobalamin 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 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%. Quickly and completely absorbed after intramuscular and subcutaneous injection.The maximum concentration after intramuscular injection is achieved after 1 hour. From the liver, bile is excreted 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% - the intestine. Penetrates through the placental barrier, into breast milk.

Indications:Conditions accompanied by vitamin B12 deficiency: chronic anemia with vitamin B12 deficiency (Addison-Birmer disease, alimentary macrocytic anemia), as part of complex therapy of anemia (including iron deficiency, post-hemorrhagic, aplastic, anemia, caused by toxic substances and / or drugs).

In complex therapy:

Chronic gastritis, cirrhosis, hepatic insufficiency, alcoholism.

In neurology: polyneuritis, radiculitis, hypotrophy, neuralgia (including trigeminal neuralgia), peripheral nervous system diseases of traumatic origin.

With the preventive purpose: when administering biguanides, paraaminosalicylic acid (PASK), ascorbic acid in high doses,pathology of the stomach and intestines with a violation of the absorption of cyanocobalamin (resection of part of the stomach, small intestine, Crohn's disease, malabsorption syndrome, sprue), enteritis, diarrhea, radiation sickness.

Contraindications:Hypersensitivity to cyanocobalamin and other components of the drug, cobalt, 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 cyanocobalamin deficiency, propensity to form blood clots.

Pregnancy and lactation:Contraindicated use of the drug in pregnancy (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 intramuscularly, subcutaneously, intravenously (slowly). 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 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, with violations of the nervous system at 200-400 mcg 2-4 times a month.

In acute posthemorrhagic and iron deficiency anemia of 30 - 100 μg 2-3 times a week; with aplastic anemia - 100 mcg before the onset of clinical and hematologic improvement.

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

Young children with alimentary anemia and premature infants are prone to 30 mcg daily for 15 days. In dystrophies in young children - subcutaneously 15-30 mcg every other day.

Side effects:Allergic reactions (including skin rash, itching), extremely rarely - anaphylaxis.Nerve agitation, cardialgia, tachycardia, diarrhea, headache, dizziness. When used in high doses, hypercoagulation, violation of purine metabolism.

Overdose:

In case of an overdose: pulmonary edema, congestive heart failure, peripheral vascular thrombosis, urticaria, anaphylactic shock.

Treatment: symptomatic, withdrawal of the drug.

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). The risk of developing allergic reactions increases when combined with thiamine. Chloramphenicol reduces the hematopoietic response of cyanocobalamin. Aminoglycosides, salicylates, antiepileptic drugs, colchicine, preparations of potassium, cimetidine, metformin, oral contraceptives, ranitidine, triamterene, methotrexate reduce the absorption of cyanocobalamin.

Special instructions:Cyanocobalamin deficiency should be confirmed diagnostically prior to 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 a 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 (in smaller doses up to 0.1 mg per injection). There have been reports of cases of arrhythmia, secondary to hypokalemia in the initial period of megaloblastic anemia, and therefore, it is recommended to monitor the potassium content during this period.

Antimetabolites and most antibiotics can affect the results of the quantitative determination of cyanocobalamin using a microbiological technique.

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

Form release / dosage:

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

Packaging:

1 ml per ampoule of colorless neutral glass grade HC-1 or NS-3 or ampoules of colorless neutral glass type I with a color fracture ring or with a colored dot and notch or without a rift, color point and notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding can additionally be applied to the ampoules. 5 ampoules per circuit cell packaging made of polyvinylchloride film and aluminum foil foil or polymer film or without foil and without film. Or 5 ampoules are placed in a prefabricated form (tray) made of cardboard with cells for laying ampoules.One or two contour cellular packs or cardboard trays, together with the instruction for use and a knife ampoule or scarifier ampoule, or without a knife ampoule and scarifier ampullum placed in a cardboard package (bundle).

Storage conditions:Store in a dark place at a temperature of no higher than 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:LP-002681

Date of registration:28.10.2014

Date of cancellation:2019-10-28

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZON PHARM, LLC Russia

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Cyanocobalamin (Cyanocobalamin)