Product Code : T-11F
PACK : – 10 x 5 x 2ml
COMPOSITION:Each 2 ml contains:
Methylcobalamin IP 1000 mcg Pyridoxine HCl IP 100 mg Niacinamide IP 100 mg D-Panthenol IP 50 mg Benzyl Alcohol IP 1.5 % v/v (As Preservative) Water for Injection qs
Dosage Form :Ampoule
INFORMATION FOR THE USER
Methylcobalamin 1,500 mcg 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.
1. COMPOSITION:
Eachvial contains:
Methylcobalamin – 1,500 mcg
For IV/IM use only.
2. DESCRIPTION:
Methylcobalamin is a form of Vitamin B12.
3. PHARMACOLOGICAL ACTION:
Methylcobalamin is a co-enyme form of VitaminB12. t is a cofactor in the enzyme methionine synthase which functions to transfer methyl groups for the regeneration of methionine from homocysteine.
4. CLINICAL PHARMACOKINETICS:
Evidence indicates methylcobalamin is utilized more efficiently than cyanocobalamin to increase levels of one of the coenzyme forms of vitamin B12. Experiments have demonstrated similar absorption of methylcobalamin following oral administration. The quantity of cobalamin detected following a small oral dose of methylcobalamin is similar to the amount following administration of cyanocobalamin; but significantly more cobalamin accumulates in liver tissue following administration of methylcobalamin. Human urinary excretion of methylcobalamin is about one third of a similar dose of cyanocobalamin, indicating substantially greater tissue retention.
5. INDICATIONS:
Methylcobalamin injection is indicated for the treatment of:
– Bell’s palsy
– In the treatment of Cancer
– Diabetic neuropathy
– Homocysteinemia
– Heart rate variability
– Addisonian pernicious anemia
6. CONTRAINDICATIONS:
– Hypersensitivity to methylcobalamin 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.
7. WARNINGS AND PRECAUTIONS:
– The dosage schemes given are usually satisfactory, but regular examination of the blood is advisable.
– If megaloblastic anaemia fails to respond to injection, 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 and 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.
8. ADVERSE EFFECTS:
– Hypersensitivity reactions have been reported including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis.
– Other symptoms reported include fever, chills, hot flushing, dizziness, malaise, nausea, acneiform and bullous eruptions, tremor and injection site reactions including injection site pain, injection site induration and injection site necrosis.
– Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
9. DRUG INTERACTIONS:
– Chloramphenicol-treated patients may respond poorly. Serum concentrations of methylcobalamin may be lowered by oral contraceptives but this interaction is unlikely to have clinical significance.
– Antimetabolites and most antibiotics invalidate vitamin B12 assays by microbiological techniques.
10. DOSAGE:
The approved dosage is 1,500mcg to 6,000 mcg per day.
11. ADMINISTRATION:
For IV/IM use only.
Administration to be done by a registered medical practitioner/nurse in a proper sterile and hospital setting only.
12. STORAGE:
Do not store above 25°C. Store in the original package. Keep away from children. Do not expose to direct sunlight.
13. MANUFACTURED BY:
14. MARKETED BY:
Last revised on May 2019.