Dear Healthcare Professional letter on the safe use of the medicinal product Peyona (caffeine citrate)
11.12.2013
The company Chiesi Farmacutici S.p.A., marketing authorisation holder for the medicinalproduct Peyona 20 mg/ml solution for infusion and oral solution, has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter with relevant information to healthcare professionals concerning the safe use of this medicinal product.
Summary
- The medicinal product Peyona (caffeine citrate) is authorised only for the treatment of primary apnoea of premature newborns. Treatment must be initiated under the supervision of a physician experienced in neonatal intensive care. Peyona is for use in Neonatal Intensive Care units only.
- Measurement of baseline caffeine levels, monitoring of plasma concentrations as well as dose adjustments during therapy is advisable.
- Healthcare professionals should pay special attention to dosage recommendations, contraindications, warnings and precautions for use.
Further information on dosage
- Peyona (caffeine citrate) is available as ampoules containing 20 mg/ml of caffeine citrate solution for infusion or oral administration.
- There are two authorised presentations which differ in the fill-volume: 3 ml (equivalent to 60 mg of caffeine citrate) and 1 ml (equivalent to 20 mg of caffeine citrate).
- Each ampoule is for single and immediate use only. Any unused portions remaining in the ampoule should be discarded.
- Doses specified on prescriptions should always be expressed as caffeine citrate in order to avoid medication errors, as the dose expressed as caffeine base is one-half the dose expressed as caffeine citrate (e.g. 20 mg caffeine citrate is equivalent to 10 mg caffeine base).
- A second loading dose of 10-20 mg/kg may be given in preterm infants with insufficient clinical response of the recommended loading dose after 24 hours.
- Higher maintenance doses of 10 mg/kg body weight could be considered in case of insufficient response taking into account the potential for accumulation of caffeine in premature neonates and the progressively increasing capacity to metabolise caffeine in relation to post-menstrual age (where clinically indicated, caffeine plasma levels should be monitored).
- The diagnosis of apnoea of prematurity may need to be reconsidered in patients who do not respond adequately to a second loading dose or higher maintenance dose.
Here you may view the Dear Healthcare Professional Letter.
HALMED has not received any adverse reaction report associated with the use of the medicinal product Peyona. HALMED will continue monitoring the safe use of Peyona and will promptly inform the public about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
