E-DRUG: Extemporaneous compounding of d4T (2)
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Hi all
The posting by Prof Nyazema doesn't adequately contextualise the reason
for this practice. The South African ARV tender 2010-2012 includes 15mg
stavudine capsules, split 70:30 between Pharmacare Ltd (at ZAR 12.4602
for 60) and Aurobindo Pharma Pty Ltd (at ZAR 12.40 for 60).
However, the reason for issuing stavudine (d4T) capsules for
"extemporaneous compounding" (a bit of a misnomer, as each dose is
prepared immediately before administration by dispersing the contents of
a capsule in a fixed volume of liquid, and then administering a
pre-determined aliquot) is to avoid the need for refrigeration of the
oral liquid formulation - 1mg/ml oral solution, 200ml bottle, supplied
as powder for reconstitution with water (ZAR19.36 per 200ml from
Aurobindo Pharma Pty Ltd in the new tender).
The 2010 ART guidelines for children (Guidelines for the Management of
HIV in Children 2nd Edition 2010 -
http://www.doh.gov.za/docs/factsheets/guidelines/paediatric.pdf)
contain the following first line regimens :
* < 3 years or < 10 kg - Abacavir, Lamivudine, Lopinavir/ritonavir
* Over 3 years and > 10 kg - Abacavir, Lamivudine, Efavirenz
However, this caveat is expressed: "The new ART guidelines aim to
decrease the use of Stavudine, and children will no longer be initiated
on Stavudine. However children who are currently stable on regimens that
contain Stavudine should continue to take it. A high index of suspicion
should be maintained for possible lipodystrophy. Children who develop
lipodystrophy or others toxicity to Stavudine and are virologically
suppressed should have a single drug substitution to Abacavir."
Here's the reason for using capsules: "Stavudine solution requires
refrigeration. If no fridge is available, Stavudine capsules may
be opened and dissolved, and the required amount administered to the
child. The rest can be discarded."
And: "Switch to tablets or capsules from syrups or solutions as soon as
possible."
For some children, using the liquid formulation required large volumes,
which are expensive, difficult to transport, easily broken, and required
access to a fridge. In such circumstances, using the capsules was a
practical alternative. Over time, however, the need for this option will
disappear as safer regimens are used.
[US$ 1 is approximately ZAR 7]
regards
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Consultant Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net