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Hydroxocobalamin Injection BP 1mg/ml

Last Updated on eMC 12-Mar-2015 View changes  | Concordia International - formerly AMCo Contact details

1. Name of the medicinal product

Hydroxocobalamin 1mg/ml Solution for Injection

2. Qualitative and quantitative composition

Active Substance


Reference Standard

Hydroxocobalamin Acetate equivalent to

1.04 mg

Ph Eur


1.00 mg

An overage of 7.5% has been incorporated

3. Pharmaceutical form

Solution for Injection

4. Clinical particulars
4.1 Therapeutic indications

Addisonian pernicious anaemia. Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency. Tobacco amblyopia and Leber's optic atrophy

4.2 Posology and method of 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 daily by intramuscular injection for two weeks then twice weekly as long as improvement is occurring.

Maintenance: 1000 micrograms every one to three months as required.

4.3 Contraindications

Hypersensitivity to Hydroxocobalamin or to any of the ingredient in this preparation.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

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 Vitamin B12 assays by microbiological techniques.

4.6 Pregnancy and lactation

Hydroxocobalamin injection should not be used for the treatment of megaloblastic anaemia of pregnancy.

4.7 Effects on ability to drive and use machines

None Known.

4.8 Undesirable effects

The following effects have been reported and are listed below by body system:

Disorders of the immune system:

Frequency Not Known:

Itching, exanthema


Allergic hypersensitivity reactions, Acniform and bulbous eruptions

Very rare:


Gastro intestinal disorders:

Frequency Not Known:


General disorders:

Frequency Not Known:

Fever, dizziness, Injection site disorders, hot flushes, chills

Neurological disorders:

Frequency Not Known:


Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:

4.9 Overdose

Treatment is unlikely to be required in the case of overdosage.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Vitamin B12

ATC classification: B03B A03

An intramuscular injection of hydroxocobalamin produces higher serum levels than the same dose of cyanocobalamin and these levels are well maintained.

5.2 Pharmacokinetic properties

Vitamin B12 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, and undergoes enterohepatic recycling; part of a dose is excreted in the urine, most of it in the first 8 hours.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical particulars
6.1 List of excipients

Glacial acetic acid Ph Eur

Sodium chloride Ph Eur

Water for injection Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf life

The proposed shelf life is 24 months.

6.4 Special precautions for storage

Store at or below 25°C. Protect from light.

6.5 Nature and contents of container

Type I glass ampoules in cardboard box.

5 ampoules per pack.

6.6 Special precautions for disposal and other handling


7. Marketing authorisation holder

Mercury Pharmaceuticals Ltd,

Capital House,

85 King William Street,

London EC4N 7BL, UK

8. Marketing authorisation number(s)

PL 12762/0008

9. Date of first authorisation/renewal of the authorisation

18 August 1997

10. Date of revision of the text


Company contact details

Concordia International - formerly AMCo

Company image

Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK


+44 (0)208 588 9200

Medical Information e-mail
Medical Information Fax

+44 (0)20 8588 9200


+44 (0)208 588 9131

Medical Information Direct Line

08700 70 30 33

Customer Care direct line

+44 (0)208 588 9273

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

hydroxocobalamin acetate

Legal categories

POM - Prescription Only Medicine

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