Caffeine citrate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of caffeine citrate.
Drugs List
Therapeutic Indications
Uses
Apnoea of prematurity
Dosage
The MHRA has recommended that 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 base).
Neonates
Loading dose
20 mg/kg by slow intravenous infusion over 30 minutes. An interval of 24 hours should pass before maintenance dose.
Those with insufficient response can receive a second loading dose 24 hours after the first loading dose.
Second loading dose: 10 to 20 mg/kg by slow intravenous infusion.
Maintenance dose
5 mg/kg by slow intravenous infusion over 10 minutes every 24 hours.
A higher maintenance dose can be considered in cases of insufficient response.
Higher maintenance dose: 10 mg/kg by slow intravenous infusion over 10 minutes every 24 hours.
Additional Dosage Information
If there is no clinical response to the second loading dose or maintenance dose of 10mg/kg/day, caffeine blood levels should be measured before further doses are given. Failure to respond could be an indication of another cause of apnoea. In cases of therapeutic failure, blood samples should be taken before the next dose and 2 to 4 hours after previous dose when monitoring for suspected toxicity. Plasma levels should not normally exceed 50 micrograms/ml (optimally 10 to 30 micrograms/ml).
If the patient has recurrent apnoea, caffeine citrate administration can be restarted with either a maintenance dose or a half loading lose, depending upon the time interval from stopping caffeine citrate to recurrence of apnoea.
Administration
For intravenous infusion by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device only.
Caffeine citrate can be either used without dilution or diluted in sterile solutions for infusion such as glucose 50mg/ml (5%), or sodium chloride 9mg/ml (0.9%) or calcium gluconate 100mg/ml (10%) immediately after withdrawal from the ampoule.
Maintenance dose may be administered orally as an alternative to injection (no dosage adjustment), such as through a nasogastric tube every 24 hours.
Contraindications
None known
Precautions and Warnings
Breastfeeding
Cardiac arrhythmias
Cardiac disorder
Gastroesophageal reflux
Hepatic impairment
Renal impairment
Seizures
Avoid caffeine while breastfeeding: May affect infant's baseline levels
Caffeine intake prior to birth may affect infant's baseline levels
Doses must always be stated as caffeine citrate
Treatment to be initiated and supervised by a specialist
Administration carried out in centres with intensive care facilities
Discard any unused portion
For single use only
Monitor fluid and electrolyte status
Monitor plasma concentrations of this drug
Monitor plasma levels and adapt dose in patients with hepatic impairment
Monitor plasma levels and adapt dose in patients with renal impairment
May aggravate gastro-oesophageal reflux
Baseline plasma caffeine concentrations should be measured prior to initiation of the treatment with caffeine citrate in cases where there may be pre-existing caffeine in the blood of neonates whose mothers may have ingested large quantities of caffeine prior to delivery, or neonates who have previously been treated with theophylline (metabolised to caffeine).
Prior to treatment, exclude other causes of apnoea such as central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea.
Monitor patient for 1 week after treatment due to the risk of apnoea recurrence after cessation of caffeine citrate. The prolonged half-life of caffeine and the potential for accumulation requires patients to be monitored.
Discontinue treatment if the patient has not experienced significant apnoeic attack for 5 to 7 days.
Treatment should continue until the child has reached a gestational age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously. Treatment may continue beyond this point, based on clinical judgement in individual cases, considering factors such as response to treatment and presence of apnoeic episodes.
Dose adjustment may be needed for at risk patients such as very premature infants (less than 28 weeks gestational age and/or body weight below 1kg), infants whose mothers consume caffeine while providing breast milk, infants with renal and/or hepatic impairment, seizure disorder, clinically significant cardiac disorders, and patients on treatments that can interfere with caffeine metabolism.
Pregnancy and Lactation
Pregnancy
Not indicated in patients of child bearing age, relevant data is not available.
Lactation
Not indicated in patients of child bearing age, relevant data is not available.
Breastfeeding mothers of neonates treated with caffeine citrate should not ingest caffeine-containing foods and beverages or medicinal products containing caffeine, since caffeine is excreted into breastmilk.
Side Effects
Arrhythmias
Brain injury
Convulsions
Deafness
Decrease in blood thyroxine values
Decrease in haemoglobin
Gastric aspiration
Gastroesophageal reflux
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Increased calcium excretion
Increased left ventricular output
Increased sodium excretion
Increased stroke volume
Increased urination
Inflammation (injection site)
Irritability
Jitteriness
Necrotising enterocolitis
Phlebitis (injection site)
Regurgitation
Restlessness
Sepsis
Suppressed erythropoietin synthesis
Tachycardia
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2013
Reference Sources
Summary of Product Characteristics: Caffeine Citrate 10 mg/ml solution for injection. Viridian Pharma Ltd. Revised February 2008.
Summary of Product Characteristics: Gencebok 10 mg/ml solution for infusion. Gennisium Pharma. Revised January 2021.
Summary of Product Characteristics: Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution. Chiesi Ltd. Revised January 2012.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 December 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.