caffeine citrate
Gencebok · ATC code N06BC01
Also known as: Kafein sitrat · Brand names: Gencebok, Coffekapton, Coffeinum N, Percoffedrinol N Aristo, Sk-Dragees Bonnies, Kafesit, Kafsiton, Peyona, Sitafein
- Key facts
- Active substance
- caffeine citrate
- ATC code
- N06BC01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Gencebok 10 mg/ml solution for infusion
- Marketing authorisation holder
- Gennisium Pharma
- Information as of
- 2026-10-28
Key facts
Caffeine citrate (Gencebok, solution for infusion) is a methylxanthine respiratory stimulant used to treat primary apnoea in premature newborns.
What it is used for
- Treatment of primary apnoea of premature newborns.
Dosing
- Previously untreated infants: loading dose of 20 mg caffeine citrate per kg body weight by slow intravenous infusion over 30 minutes.
- After 24 hours: maintenance dose of 5 mg/kg body weight every 24 hours, by intravenous infusion over 10 minutes or orally (e.g. nasogastric tube).
- The dose expressed as caffeine base is one-half the dose expressed as caffeine citrate.
- With insufficient response: a second loading dose of 10-20 mg/kg maximum after 24 hours, or higher maintenance doses of 10 mg/kg may be considered; monitor plasma levels where indicated.
- In at-risk situations (very premature infants, hepatic or renal impairment, seizure disorders, cardiac disease, interacting medicines) adjust dosing by plasma levels; reduced maintenance dose in renal impairment.
- Only in a neonatal intensive care unit.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Apnoea of prematurity is a diagnosis of exclusion; rule out or treat other causes first.
- Measure baseline caffeine levels after prior theophylline treatment or high maternal caffeine intake before delivery.
- Caution in seizures, cardiovascular disease and renal or hepatic impairment.
- Monitor carefully for necrotising enterocolitis; caution in gastro-oesophageal reflux.
- Continue monitoring for approximately one week after stopping because apnoea may recur.
Side effects
- Dose-related CNS stimulation (convulsion, irritability, restlessness, jitteriness), cardiac effects (tachycardia, arrhythmia, hypertension) and hyperglycaemia.
- Common: hyperglycaemia; uncommon: convulsion; rare: hypersensitivity reaction.
- Not known: sepsis, hypoglycaemia, failure to thrive, feeding intolerance, brain injury, deafness.
Interactions
- Do not use concurrently with theophylline (inter-conversion in preterm infants).
- Metabolised by CYP1A2; possible interactions with CYP1A2 substrates, inhibitors or inducers.
Pregnancy and breastfeeding
- Caffeine is excreted into breast milk; breast-feeding mothers of treated infants should avoid caffeine-containing foods, beverages and medicines.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- GencebokGennisium Pharma · EMEA/H/C/005435
Source: European Medicines Agency (EMA), product information
Austria
- CoffekaptonStrallhofer Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- Coffeinum NCooper Consumer Health Deutschland Gmbh · 1 register entry
- Percoffedrinol N AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Sk-Dragees BonniesInverma Johannes Lange Gmbh + Cokg · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- KafesitBERKO İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
- KafsitonONFARMA İLAÇ SAN. LTD. ŞTİ. · 1 register entry
- PeyonaCHIESI İLAÇ TİC. A.Ş. · 1 register entry
- SitafeinVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 10 more European countries
- Belgium
- Cafeine Sterop
- France
- Citrate De Cafeine Cooper, Percutafeine
- Hungary
- Coffeini Fono Viii. Naturland
- Iceland
- Gencebok, Peyona
- Italy
- Caffeina Citrato Monico
- Liechtenstein
- Gencebok, Peyona
- Malta
- Caffeine Citrate Monico
- Norway
- Gencebok, Peyona
- Spain
- Durvitan
- Sweden
- Koffein Viatris
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Gencebok – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/gencebok-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.