Sodium Bicarbonate Oral Liquids - October 2016
Background: Sodium bicarbonate oral solution is used to treat children aged 0-16 years with hyperacidic states related to chronic renal
disease. A 1mmol/ml product (Thamicarb) was licensed in 2016, but the labelling of this product has raised safety concerns and use of
unlicensed preparations is currently known to continue. The table on the following page summarises details of currently known products.
Recommended Action
1. Use of the licensed medicine (Thamicarb) with current labelling should be subject to a local risk assessment due to the risk of dosing
errors. The risk might be mitigated by a local “caution in use” warning to users or by overlabelling.
2. If local risk assessment concludes that the risk of dosing errors posed by Thamicarb is unacceptable, one of the available unlicensed
medicines should be used instead. The reasons for the decision should be documented.
3. The in-use shelf life is the responsibility of the end user unless the manufacturer provides guidance. The licensed medicine was
required to have a relatively short in-use shelf life (3 days for 100ml and 7 days for 500ml packs) based on a change in pH once the
bottle is opened. If an unlicensed medicine is being used, the impact of opening on shelf life needs to be carefully considered
1
*The regulatory framework for the manufacturing of medicines and that for the production of dietary supplements are different. Food law does not require
or enforce compliance with GMP. Any claims made by a manufacturer’s claim that a dietary supplement has been made to GMP standards have therefore
not been validated.
Summary of available products
Manufacturer
Product
details
Licensing
Cost
Labelling
Comments
Thame laboratories
84mg/ml
(equivalent to
1mmol/ml)
Licensed for
dyspepsia in
patients over 12
years of age.
100ml £39.80
ex VAT
Expressed as
84mg/ml
Unpreserved
‘Thamicarb’
Mandeville
medicines
100ml - 3 day
expiry
500ml - 7 day
expiry
84mg/ml
(equivalent to
1mmol/ml)
Unlicensed
medicine
Huddersfield
Pharmacy Specials
Huddersfield
Pharmacy Specials
Arjun
1mmol/ml
100ml - use
within 1 month
of first opening
0.8mmol/ml
1mmol/ml
100ml - 7 day
expiry once
opened
100ml £5.62
ex VAT
(£6.74 inc
VAT)
100ml - 7 days
once opened
Risk of dosing errors: dose for some (off-label) indications is often
prescribed in mmol but product labelled as 84mg/ml
500ml
£199.20 ex
VAT
Manufacture of this product was suspended by the MHRA earlier in
2016 but is now available once again
Expressed as
weight/volume
and mmols as
follows:
8.4% w/v
(1mmol/ml)
Unlicensed
medicine
£6.63
(no VAT
element)
Expressed as
1mmol/lml
Unlicensed
medicine
£12.81/
200ml ex VAT
Manufactured as a
dietary
supplement*
100ml £17.71
Expressed as
(0.8mmol/ml)
[1gram (12mmol)
in 15ml]
Expressed as
1mmol/ml
Also caution stated on product label:
Sodium Bicarbonate may precipitate as insoluble carbonate. Solution
must be inspected prior to use to confirm absence of precipitation
which may be seen as wisps of cloudy suspension at the base of the
bottle.
Preserved
Preserved
Preserved
2
*The regulatory framework for the manufacturing of medicines and that for the production of dietary supplements are different. Food law does not require
or enforce compliance with GMP. Any claims made by a manufacturer’s claim that a dietary supplement has been made to GMP standards have therefore
not been validated.