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  • Bedodeka
    / Teva


    Active Ingredient
    Vitamin B12 1 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    10 X 1 mg/ml

    full basket chart 40129

    Dosage

    Pernicious Anemia, Vitamin B12 Deficiency States and Macrocytic Anemias: The usual initial dose is 250-1000 micrograms on alternate days for 1-2 weeks, followed by 250 micrograms weekly until the blood count is normal. Thereafter, the maintenance dose is 1000 micrograms monthly. If there are neurological complications, the initial dose of 1000 micrograms is recommended on alternate days while improvement is occurring.
    Maintenance: 1000 micrograms monthly.
    Schilling Test: The flushing dose is 1000 micrograms.
    For full details see prescribing information.


    Indications

    Pernicious anemia, vitamin B12 deficiency, macrocytic anemia.


    Contra-Indications

    Known hypersensitivity to vitamin B12, or to any other ingredient of the preparation. Bedodeka is not indicated for treatment of toxic amblyopias.


    Special Precautions

    An intradermal sensitivity test may be performed in patients with suspected hypersensitivity to cobalamins. It is important to accurately diagnose anemias prior to treatment, to ensure that appropriate therapy is initiated. If folic acid is used to treat pernicious anemia, for example, hematologic improvement may occur while neurologic complications continue to progress. Patients who have early Leber’s disease (hereditary optic nerve atrophy) have been found to suffer severe and swift optic atrophy when treated with vitamin B12, and its use should be avoided in these patients. Serum potassium concentrations should be monitored during early vitamin B12 therapy and potassium administered if necessary, since fatal hypokalaemia could occur upon conversion of megaloblastic anaemia to normal erythropoiesis with vitamin B12 as a result of increased erythrocyte potassium requirements. Hypokalaemia and cardiac arrest have been reported when megaloblastic anaemia is treated intensively. 2 BEDODEKA Injection, 25 5. 2011, RH Patients’ nutritional status, including folate deficiency, should be considered. Folic acid may potentiate the neurological complications of vitamin B12 deficiency, so it should not be administered to patients with pernicious anaemia. Treatment with cyanocobalamin injection may unmask polycythaemia vera, because vitamin B12 deficiency may suppress the symptoms of this condition. The increase in nucleic acid degradation produced by administration of cyanocobalamin injection to vitamin B12 deficient patients could lead to gout in susceptible patients. Cyanocobalamin injection should not be given before a diagnosis has been fully established because of the possibility of subacute degeneration of the spinal cord. Lack of therapeutic response may be due to infection, uremia, concomitant treatment with chloramphenicol or misdiagnosis.
    Use in Pregnancy: Cyanocobalamin should not be used for the treatment of megaloblastic anemia of pregnancy unless vitamin B12 deficiency has been demonstrated.
    Use in Breastfeeding: Safety of use in breastfeeding has not been established. Vitamin B12 is secreted into breast milk during lactation in concentrations that approximate the maternal blood vitamin B12 concentration. No adverse effects have been reported with intake of normal daily requirements during lactation. For pernicious anemia, an adequate dose must be used and the blood picture must be examined regularly at least every 3 months for 18 months until stabilized, and then annually. Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result. Doses of Cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. 3 BEDODEKA Injection, 25 5. 2011, RH Anaphylactic shock and death have been reported after parenteral vitamin B12 administration Before administering Bedodeka, an intradermal test dose is recommended for patients known to be sensitive to cobalamins. Diagnosis of vitamin B12 deficiency should be confirmed by laboratory investigation before institution of cyanocobalamin (vitamin B12) therapy. Do not use until diagnosis is fully established, because of the possibility of masking symptoms of subacute degeneration of the spinal cord, or of the true diagnosis of pernicious anaemia. Serum potassium must be monitored closely and potassium supplement administered if necessary, since cardiac arrhythmias secondary to hypokalemia have been reported with intensive vitamin B12 treatment. Cyanocobalamin has no effect on ability to drive and use machines.


    Side Effects

    Various reactions are occasionally reported and some allergic reactions have been reported after injection. These have included: abdominal pain, bullous eruption, depression, emotional lability, injection site reactions such as pain, myalgia, nausea, nervousness, palpitation, personality disorders, photosensitivity reaction, pruritus, maculopapular rash, syncope and thinking abnormally. Other reported adverse effects include mild transient diarrhea, peripheral vascular thrombosis, urticaria or a feeling of swelling of the whole body, anaphylaxis and death. Anaphylaxis, pulmonary oedema and congestive heart failure have all been reported during early vitamin B12 treatment, possibly as a result of an increase in blood volume induced by the drug. Accelerated optic nerve atrophy has been reported following administration of cyanocobalamin to patients with early Leber’s disease. Administration of cyanocobalamin doses greater than 10 micrograms daily, may produce a haematological response in patients with folate deficiency.


    Drug interactions

    Vitamin B12/ Chloramphenicol: Chloramphenicol and other drugs with bone marrow suppressant properties may cause a lack of therapeutic response to vitamin B12. This effect may be due to interference with erythrocyte maturation.
    Other Interactions: Colchicine, aminoglycosides, certain anticonvulsants (e.g. phenytoin, phenobarbital, primidone), para-aminosalicylic acid and/or excessive alcohol intake for longer than 2 weeks may impair the absorption of vitamin B12. Long-term ingestion of meformin and antacids may also contribute to food-cobalamin malabsorption especially in elderly patients Histamine2-receptor antagonists (e.g. cimetidine, ranitidine, nizatidine, famotidine) and proton pump inhibitors (e.g. omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) may potentially cause vitamin B12 deficiency by decreasing gastric acid cleavage of vitamin B12 from food sources. This may be important in patients with low stores of vitamin B12 or in patients taking H2-antagonists or proton pump inhibitors for extended periods of time (more than 2 years).
    Diagnostic Interference: Antimetabolites, most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays. For full details see prescribing information.


    Pregnancy and Lactation

    Use in Pregnancy: Cyanocobalamin should not be used for the treatment of megaloblastic anemia of pregnancy unless vitamin B12 deficiency has been demonstrated.
    Use in Breastfeeding: Safety of use in breastfeeding has not been established. Vitamin B12 is secreted into breast milk during lactation in concentrations that approximate the maternal blood vitamin B12 concentration. No adverse effects have been reported with intake of normal daily requirements during lactation.


    Overdose

    Since large amounts of the drug are routinely administered as a treatment, no case of acute overdose in humans has been described. Treatment is symptomatic and supportive.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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