Cobalamin Depot Ampoules

Description

PHARMACEUTICAL FORM
Solution for injection
THERAPEUTIC INDICATIONS
Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with Vitamin B12 deficiency. Tobacco amnblyopia and Leber’s optic atropy.
DOSAGE AND ADMINISTRATION
Route of Administration
Intramuscular injection
Dosage and Administration
The following dosage schemes are suitable for adults and children.
Addisonian pernicious anaemias and other macrocytic anaemias without neurological involvement.
Initially 250 to 1000 micrograms intramuscularly on alternate days for one or two weeks, then 250 micrograms weekly until the blood count is normal.
Maintenance: 1000 micrograms every two to three months.
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement.
Initially: 1000 micrograms on alternate days as long as improvement is occurring.
Maintenance: 1000 micrograms every two of three months.
Prophylaxis of macrocytic anaemia associated with Vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism.
1000 micrograms every two or three months.
Tobacco amblyopia and Leber’s optic atrophy.
Initially: 1000 micrograms or more daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.
Maintenance: 1000 micrograms monthly.
CONTRAINDICATIONS
– Hypersensitivity to any ingredient in the preparation.
– Pregnancy, Nusrsing mothers & pediatric use:
Do not administer injections preserved with benzyl alcohol to premature infants, neonates, infants below 13 years pregnant women or nursing mothers. Benzyl alcohol has been associated with serious adverse events & death, particularly in pediatric patients (it may cause Gasping Syndrome) Injections preservative free should be used in these populations.
WARNINGS AND PRECAUTIONS
– The dosage schemes given above are normally satisfactory, but regular examination of the blood is advisable.
– If megaloblastic anaemia fails to respond, folate metabolism should be investigated. Doses in excess of 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.
– Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period.
INTERACTIONS
Chloramphenicol-treated patients may respond poorly to Hydroxocobalamin injection.
Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives.
The above interactions are unlikely to have clinical significance.
Antimetabolites and most antibiotics invalidate B12 assays by microbiological techniques.
PREGNANCY AND LACTATION
Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.

UNDESIRABLE EFFECTS
Itching, exanthema, chills, fever, hot flushes, nausea and dizziness and exceptionally anaphylaxis.
Acniform and bulbous eruptions have been reported rarely.
OVERDOSAGE
Treatment is unlikely to be required in the case of overdosage.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Hydroxocobalamin is extensively bound to specific plasma proteins. It is absorbed from the gastro-intestinal tract, but may be irregularly absorbed when given in large therapeutic doses and absorption is impaired in patients with an absence of intrinsic factor, with a malabsorption syndrome or with disease or abnormality of the gut, or after gastrectomy.
Hydroxocabalamin is stored in the liver, excreted in the bile, and undergoes some enterohepatic recycling, part of the dose is excreted in the urine, most of it in the first 8 hours. Hydroxocobalamin diffuses across the placenta.
Pharmacokinetic properties
An Intramuscular injection of hydroxocobalamin produced higher serum levels than the same dose of cyanocobalamin and these levels are well maintained.
Pack
A carton box containing 2 amber glass ampoules each of 1 ml with a pamphlet.
Storage
Keep at a temperature not exceeding 30C.
Keep out of reach of children.