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[e-drug] Oxytocin and ergometrine injection stability above 8.C

  • From: "fabian kong" <fabian.kong@development-partners-int.com>
  • Date: Fri, 11 Nov 2005 08:32:47 +0930

E-DRUG: Oxytocin and ergometrine injection stability above 8.C

[Pls see moderator comment at the end]

Dear E Druggers,

We are currently re-discussing the issue of the supply of Oxytocin and
Ergometrine to health facilities which do not have refrigerators. Currently
many health facilities have access to the drugs but under conditions of no
refrigeration. Nurses claim they have no problem in using the drugs during

The available information I have from the Novartis for Syntocinon (oxytocin)
is: "It is preferable that all refrigerated products be stored at 2 - 8 deg C. However, based on available stability data our Quality Assurance Manager has advised that Syntocinon may be stored out of the refrigerator for a maximum of one month provided the following conditions are met:
- the temperature does not exceed 25 deg C
- the product is not subject to extremes of heat
- the product is protected from light
- the batch is not at or near the end of its shelf-life (minimum of 3 months
shelf-life remaining)
- any unused ampoules after this period out of the refrigerator should be

- avoid freezing

- do not use if discoloured or precipitate present

They have no data for anything above 25 deg C, but there have been reports
that the injections didn't work.

Of course the above conditions could not be guaranteed in a tropical country.

I am wishing to ask E druggers if they have any experience in the
distribution of the above injection to facilities with no refrigerators. I
would like to fully investigate stability of the items (which I feel would
be that refrigeration is needed) before formally taking the next steps.

Thank you

Best wishes

Fabian Kong
Pharmacy Adviser
Ministry of Health, East Timor
PO BOX 374, Dili, East Timor (VIA DARWIN)
East Timor: +670 7255936
Australia: +61 423 115 203
Skype: fabiokong
MSN messenger: fabiokong@hotmail.com

KM: Below I have copied a previous E-drug posting from Hans Hogerzeil: http://www.essentialdrugs.org/edrug/archive/199808/msg00084.php

I think the most complete study on the stability of ergometrine and other
oxytocics is the review by Godfrey Walker and myself: Hogerzeil HV, Walker
GJA. Instability of (methyl)ergometrine in tropical climates: an overview.
Eur J Obs Gyn Repr Biol, 69 (1996) 25-29. It summarizes nine WHO studies in
this respect.

The findings can be summarized as follows: injections and tablets of
ergometrine and methylergometrine are very unstable in tropical climates,
but there are large differences between brands. Exposed to light, most
ergometrine ampoules lose about 20-30% of their potency per month. The
practice of keeping a few ampoules ready on a tray in the labour ward
results in a totally ineffective product and should be discouraged. Any
ampoule with a colour of the content different from water (compare the
solution with an ampoule of water against a
well-lit white background) implies that more than 10% the ingredients have
degraded, and that the ampoule should not be used.

Methylergometrine is not more stable than ergometrine; injectable oxytocin
is usually more stable than (methyl)ergometrine. Oral and buccal dosage
forms are less stable than parenteral ones.

Practical recommendations are (1) careful supplier selection and (2)
refrigerated dark storage (3) international transport by air, not sea. In
general, it is safe to try to use the injections within one year of
manufacture, irrespective of the official expiry date.

In view of better stability in tropical climates, similar costs, fewer side
effects and comparative efficacy, parenteral oxytocin, rather than
parenteral ergometrine, is the drug of choice in the prevention and
treatment of post-partum haemorrhage.

Dr Hans Hogerzeil
WHO Action Programme on Essential Drugs