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Oral vitamin B12 – what are the prescribing considerations and what formulations are available?

29 June 2020This Medicines Q&A outlines what oral vitamin B12 (cyanocobalamin) preparations are available and associated prescribing considerations. Hydroxocobalamin 1mg administered intramuscularly (IM) is the preferred method…
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Medicine Compliance Aid Stability

CytaconGoldshield/Mercury

Goldshield/Mercury
Cytacon
Tablets 50 micrograms
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from moisture
Store in airtight containers, protect from light, hygroscopic.
29 March 2015

Lactation Safety Information

Vitamin B12

Vitamin B12
Yes
Hydroxocobalamin
31 July 2020

New Medicines

OrobalinVitamin B12 defiency

Information

Orobalin
New formulation

Development and Regulatory status

Launched
None
None
November 2020
Nov 20Launched in the UK. Pack size of 30 film-coated tablets = £9.99 [4,5].
Jun 20Orobalin 1mg tablets (a prescription-only medicine) are due to be launched in the UK in July 2020. They will be available in a pack of 30 tablets; price still to be agreed with the Department of Health [3].
Oct 18Approved by the MHRA for haematological, neurological and other symptoms secondary to vitamin B12 deficiency. Malabsorption of vitamin B12, such as due to the absence of intrinsic factor (pernicious anaemia), stomach resection or disease of the small intestine. It is also indicated during para-aminosalicylic acid therapy, which can cause impaired B12 resorption [2].

Category

Oral vitamin B12 in a 1mg film-coated tablet formulation.
The incidence of pernicious anaemia in the UK population is estimated to lie between 1-5/100,000 per annum. The disease occurs in all races. The peak age is 60, although it is starting to be recognised in younger age groups [1].
Vitamin B12 defiency
Oral

Trial or other data

Aug 20Orobalin was approved by the MHRA as it was shown to be bioequivalent to Betolvex 1mg film-coated tablets (Actavis Group, Iceland) [2].

Evidence based evaluations