Patient Leaflet Updated 14-May-2026 | Martindale Pharma, an Ethypharm Group Company
Caffeine Citrate 10mg/ml Solution for Injection
Caffeine Citrate 10mg/ml
Solution for Injection
Equivalent to Caffeine 5mg/ml
1. What Caffeine Citrate 10mg/ml Solution for Injection is and what it is used for
2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Solution for Injection
3. How Caffeine Citrate 10mg/ml Solution for Injection is used
4. Possible side effects
5. How to store Caffeine Citrate 10mg/ml Solution for Injection
6. Contents of the pack and other information
These short periods when premature babies stop breathing are due to the baby’s breathing centres not being fully developed. This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Talk to your baby’s doctor before your newborn is given Caffeine Citrate 10mg/ml Solution for Injection if your baby:
Tell your baby’s doctor if your newborn is taking, have recently taken or might take any other medicines.
If you (the mother) are breast-feeding while your infant is treated with Caffeine Citrate 10mg/ml Solution for Injection, you should not drink coffee or take any other high caffeine product as caffeine passes into breast milk.
Caffeine Citrate 10mg/ml solution for injection should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. Treatment should be initiated under supervision of a physician experienced in neonatal intensive care.
The doctor or nurse will administer Caffeine Citrate 10mg/ml Solution for Injection into a venous infusion (drip). It can also be equally effective when given by mouth, and all or some of the doses may be given this way when possible. This medicine should not be given by intramuscular injection.
The exact dose, to be determined by the doctor, depends on each baby’s needs and response to the treatment, but will usually be:
If your baby fails to respond to the starting dose (after at least 4 hours), the doctor or nurse may give one more additional starter dose, before continuing to the lower maintenance doses.
Your baby’s doctor will decide exactly how long your newborn must continue therapy with Caffeine Citrate 10mg/ml Solution for Injection. If your baby has 5 to 7 days without apnoea attacks, the doctor will stop treatment.
The doctor may decide to check the levels of caffeine in a blood sample as a precaution, or if your baby is not responding to treatment as expected.
If too much caffeine solution is accidentally given to your baby, the side effects described above may become more noticeable. In cases of very high overdosage, fits can also occur. If signs of over-dosage are noticed, please tell the baby’s doctor immediately.
Treatment with Caffeine Citrate 10mg/ ml Solution for Injection should be stopped immediately and your baby’s doctor should treat the overdose.
If you have any further questions on the use of this medicinal product, ask your baby’s doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
While under treatment with Caffeine Citrate 10 mg/ml Solution for Injection, your newborn may experience some of the following reactions:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
If your newborn gets any side effects, talk to your baby’s doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Store below 25°C. After opening the ampoule, the medicinal product should be used immediately.
Do not use this medicine after the expiry date which is stated on the label, or if there are any signs of discolouration or clouding of the solution.
The expiry date refers to the last day of that month. Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration. After opening the ampoules, the medicinal product should be used immediately.
The active ingredient is caffeine citrate 10mg/ml, equivalent to caffeine 5mg/ml.
Other ingredients are:
This leaflet was last revised in November 2025
Marketing Authorisation Number: PL 01883/0344
D06545000
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