Product Code : T-09B
Group : INJECTION
Pack : 30ml Vial Pack
T-09B:
INFORMATION FOR THE USER
Cyanocobalamin Injection
Read all of this information carefully before you start taking this medicine because it contains important information for you.
Keep this information. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.
COMPOSITION:
Each ml ampoule contains:
Cyanocobalamin IP – 500mcg
For IM use only.
DESCRIPTION:
Cyanocobalamin is the manufactured form of Vitamin B12.
PHARMACOLOGICAL ACTION:
Cobalamin is a water soluble vitamin involved in the metabolism of every cell in the body. It is a cofactor in DNA synthesis and in both fatty acid and amino acid metabolism. It is particularly important in the normal functioning of the nervous system via its role in the synthesis of myelin and in the maturation of developing red blood cells in the bone marrow.
CLINICAL PHARMACOKINETICS:
It is absorbed from the GIT, but may be irregularly absorbed when given in large therapeutic doses. Absorption is impaired in patients with an absence of intrinsic factor, with a malabsorption syndrome or with a disease/abnormality of the gut, or after gastrectomy. After injection a large proportion is excreted in the urine within 24 hrs; the body retains only 55% of a 100mcg dose & 15% of a 1000mcg dose. It is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. It is stored in the liver, excreted in the bile & undergoes extensive enterohepatic recycling; part of an administered dose is excreted in the urine, most of it in the first 8 hrs; urinary excretion, however, accounts for only a small fraction in the reduction of total body stores acquired by dietary means. It diffuses across the placenta & also appears in breast milk.
INDICATIONS:
Cyanocobalamin injection is indicated for the treatment of:
Addisonian pernicious anaemia
Prophylaxis & treatment of other macrocytic anaemias associated with vitamin B12 deficiency
CONTRAINDICATIONS:
Hypersensitivity to cyanocobalamin or any other constituents
Should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated
Not indicated for treatment of toxic amblyopias
WARNINGS AND PRECAUTIONS:
The dosage schemes given are usually satisfactory, but regular examination of the blood is advisable. If megaloblastic anaemia fails to respond, folate metabolism should be investigated. Doses in excess of 10mcg daily may produce an incomplete haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
The haematological & neurological state should be monitored regularly to ensure adequacy of therapy.
Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period.
Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrence of reactive thrombocytosis.
ADVERSE EFFECTS:
Common side effects include: Hypersensitivity reactions have been reported including skin reactions (e.g. rash, itching) & exceptionally anaphylaxis. Other symptoms reported include fever, chills, hot flushing, dizziness, malaise, nausea, acneiform & bullous eruptions, tremor & injection site reactions including injection site pain, injection site induration & injection site necrosis. Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
DRUG INTERACTIONS:
Chloramphenicol-treated patients may respond poorly
Serum conc. of cyanocobalamin may be lowered by oral contraceptives
Antimetabolites & most antibiotics invalidate vitamin B12 assays by microbiological techniques
DOSAGE:
Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:Initially 250-1000mcg IM on alternate days for 1-2 weeks, then 250mcg weekly until the blood count is normal. Maintenance: 1000mcg monthly.
Addisonian pernicious anaemia and other macrocytic anaemias with neurological complications: Initially 1000mcg IM on alternate days as long as improvement is occurring. Maintenance 1000mcg monthly.
Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes & strict vegetarianism: 250mcg-1000mcg monthly.
ADMINISTRATION:
For IM use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile and hospital setting only.
STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
MANUFACTURED BY:
MARKETED BY:
Last revised on August 2020.