Cicomin-Altfarm (Suppositories) Instructions for Use

Marketing Authorization Holder

Altpharm LLC (Russia)

ATC Code

B03BA01 (Cyanocobalamin)

Active Substance

Cyanocobalamin (Rec.INN registered by WHO)

Dosage Form

Cicomin-Altfarm

Rectal suppositories 500 mcg: 10 pcs.

Dosage Form, Packaging, and Composition

5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

B vitamin

Pharmacotherapeutic Group

Vitamins

Pharmacological Action

Vitamin B₁₂ belongs to the group of water-soluble vitamins. It has high biological activity. It is necessary for normal hematopoiesis (promotes the maturation of erythrocytes).

It participates in the processes of transmethylation, hydrogen transfer, formation of methionine, nucleic acids, choline, and creatine. It promotes the accumulation of compounds containing sulfhydryl groups in erythrocytes.

It has a beneficial effect on the function of the liver and nervous system. It participates in the synthesis of the myelin sheath, stimulates hematopoiesis, reduces pain associated with peripheral nervous system damage, and stimulates nucleic acid metabolism through the activation of folic acid.

It activates the blood coagulation system; in high doses, it causes an increase in the activity of thromboplastin and prothrombin.

Pharmacokinetics

After oral administration, it is absorbed from the gastrointestinal tract. It is metabolized in tissues, converting into the coenzyme form – adenosylcobalamin, which is the active form of cyanocobalamin.

It is excreted in bile and urine.

Indications

Anemias due to B₁₂-deficiency states; as part of combination therapy for iron deficiency and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver diseases (hepatitis, cirrhosis); funicular myelosis; polyneuritis; radiculitis; neuralgia; amyotrophic lateral sclerosis; cerebral palsy; Down syndrome; peripheral nerve injuries; skin diseases (psoriasis, photodermatoses, dermatitis herpetiformis, neurodermatitis); for the prevention and treatment of vitamin B₁₂ deficiency symptoms (including when using biguanides, PAS, vitamin C in high doses); radiation sickness.

ICD codes

Dosage Regimen

It is administered orally, subcutaneously, intramuscularly, intravenously, and intralumbally. The dosage regimen is set individually, depending on the indications, clinical situation, patient’s age, and the dosage form used.

For anemias associated with vitamin B₁₂ deficiency, 100-200 mcg is administered every other day. For anemia with signs of funicular myelosis and for macrocytic anemias with nervous system diseases – 400-500 mcg daily for the first 7 days, then once every 5-7 days.

During remission in the absence of signs of funicular myelosis, the maintenance dose is 100 mcg twice a month; in the presence of neurological symptoms – 200-400 mcg 2-4 times a month.

For acute posthemorrhagic and iron deficiency anemia – 30-100 mcg 2-3 times a week. For aplastic anemias (especially in children) – 100 mcg until clinical improvement. For nutritional anemia in young children and premature infants – 30 mcg/day for 15 days.

For diseases of the central and peripheral nervous system, neurological diseases with pain syndrome, it is administered in increasing doses – 200-500 mcg; upon improvement of the condition – 100 mcg/day. The course of treatment is 2 weeks. For traumatic lesions of the peripheral nervous system – 200-400 mcg every other day for 40-45 days.

For hepatitis and liver cirrhosis – 30-60 mcg/day or 100 mcg every other day for 25-40 days.

For dystrophies in young children, Down syndrome, and cerebral palsy – 15-30 mcg every other day.

For funicular myelosis, amyotrophic lateral sclerosis, it can be injected into the spinal canal at 15-30 mcg, gradually increasing the dose to 200-250 mcg.

For radiation sickness, diabetic neuropathy, sprue – 60-100 mcg daily for 20-30 days.

For vitamin B₁₂ deficiency for prevention – intramuscularly or intravenously 1 mg once a month; for treatment – intramuscularly or intravenously 1 mg daily for 1-2 weeks, maintenance dose 1-2 mg intramuscularly or intravenously – from once a week to once a month. The duration of treatment is set individually.

Adverse Reactions

Possible allergic reactions, mental agitation, cardialgia, tachycardia, diarrhea, headache, dizziness; when used in high doses – hypercoagulation, purine metabolism disorder.

Contraindications

Hypersensitivity to cyanocobalamin; thromboembolism, erythremia, erythrocytosis; pregnancy, breastfeeding period.

With caution

Angina pectoris, benign and malignant neoplasms accompanied by megaloblastic anemia and cyanocobalamin deficiency, tendency to thrombosis.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Can be used in children according to indications, in recommended doses and regimens. It is necessary to strictly follow the instructions for medical use of cyanocobalamin preparations in children.

Special Precautions

During treatment with cyanocobalamin, peripheral blood picture and coagulation parameters should be regularly monitored.

Cyanocobalamin deficiency must be diagnostically confirmed before its prescription, as it may mask folic acid deficiency.

Antimetabolites and most antibiotics may affect the results of the quantitative determination of cyanocobalamin using microbiological methods.

Drug Interactions

With simultaneous use with oral hormonal contraceptives, a decrease in the plasma concentration of cyanocobalamin is possible.

With simultaneous use with anticonvulsants, the absorption of cyanocobalamin from the intestine is reduced.

With parenteral use, chloramphenicol may reduce the hematopoietic effect of cyanocobalamin in anemia.

With simultaneous use, aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations, cimetidine, metformin, oral contraceptives, ranitidine, triamterene, methotrexate reduce the absorption of cyanocobalamin from the intestine.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.