Caffeine for apnoea of prematurity
- Medicines and Healthcare products Regulatory Agency
- 7 August 2013
- Therapeutic area:
- Anaesthesia and intensive care, Obstetrics, gynaecology and fertility, and Paediatrics and neonatology
All products to be named and prescribed as caffeine citrate.
Article date: August 2013
Caffeine (citrate) is authorised for treatment of apnoea of premature newborns and may be given orally or intravenously. In order to minimise the risk of prescribing or dosing errors, the Commission on Human Medicines has advised that all products be named consistently and prescribed as caffeine citrate.
In line with this advice, the naming of products available from Viridian Pharma is being changed to:
- caffeine citrate 10 mg/mL solution for injection (previously called caffeine 5 mg/mL solution for injection)
- caffeine citrate 10 mg/mL oral solution (previously called caffeine 5 mg/mL oral solution)
There is no change to the formulation of these products. The new packaging of Viridian Pharma products displaying the new name may not be immediately available (expected to be available from October 2013). However, all packaging (current and new) has dual labelling, which clearly states the strengths of both caffeine and caffeine citrate.
Prescribing of caffeine citrate products
Doses specified when prescribing should always be expressed as caffeine citrate because of a risk of confusion and potential for dosing errors (2 mg caffeine citrate is equivalent to 1 mg caffeine). It is also important to note that marketed products are available in different strengths: Peyona (caffeine citrate 20 mg/mL) is double that of products from Viridian Pharma (caffeine citrate 10 mg/mL).
Advice for healthcare professionals:
- always state dose in terms of caffeine citrate when prescribing
- take care when prescribing and dispensing because marketed products are available in different strengths: Peyona is twice the strength of products from Viridian Pharma
- caffeine citrate is for use in neonatal intensive care units only, and treatment must be initiated under the supervision of a physician experienced in neonatal intensive care
- measurement of baseline caffeine levels, monitoring of plasma caffeine concentrations, and dose adjustments during treatment are advisable—particularly in neonates with:
- insufficient response
- signs of toxicity
- possible pre-existing caffeine in the blood
- those with increased risk of elevated plasma concentrations
Please remember to report suspected adverse reactions with caffeine citrate through the Yellow Card Scheme online at http://www.mhra.gov.uk/yellowcard
For further information, refer to the summary of product characteristics or technical prescribing information for the product.
Article citation: Drug Safety Update vol 7 issue 1, August 2013: A2.
Published: 7 August 2013