Caffeine citrate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution containing caffeine citrate 10 mg/ml (equivalent to caffeine base 5 mg in 1 ml)
Drugs List
Therapeutic Indications
Uses
Apnoea of prematurity
Dosage
Exclude other causes of apnoea before initiation of treatment.
Treatment with caffeine citrate should be initiated under the supervision of a physician experienced in neonatal intensive care. Treatment should be administered only in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring.
Infants must be of sufficient respiratory maturity not to require positive pressure ventilation.
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).
Adults
Not applicable.
Elderly
Not applicable.
Children
Not applicable.
Neonates
Caffeine is clinically effective within 4 hours. If the patient fails to respond within this time, a second loading dose may be give. If there is no clinical response to the second loading dose, caffeine blood levels should be measured.
Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.
Infants must be of sufficient respiratory maturity not to require positive pressure ventilation.
Loading dose
Dose expressed as caffeine citrate: 20 mg/kg
Frequency: once
Maintenance dose
Dose expressed as caffeine citrate: 5-10 mg/kg
Frequency: every 24 hours, beginning 24 hours after the loading dose(s)
In some cases maintenance doses higher than 10 mg/kg/day (expressed as caffeine citrate) may be required to achieve maximal efficacy (eg in continuing apnoeic episodes where plasma levels indicate the dose may be safely increased).
Patients with Renal Impairment
Increased potential for accumulation. Reduce daily maintenance dose. Measure blood caffeine levels to guide dose.
Patients with Hepatic Impairment
Hepatic disease may reduce maintenance dose requirements.
In very premature infants, clearance of caffeine does not depend on hepatic function as hepatic caffeine metabolism develops in the weeks following birth.
Additional Dosage Information
Treatment should be continued until the child has reached a gestational age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously. This limit may however be revised according to clinical judgement in individual cases depending on response to treatment, the continuing presence of apnoeic episodes despite treatment, or other clinical considerations.
Contraindications
None known
Precautions and Warnings
Breastfeeding
Cardiac arrhythmias
Cardiac disorder
Gastroesophageal reflux
Hepatic impairment
Renal impairment
Seizures
Doses must always be stated as caffeine citrate
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
There may be pre-existing caffeine in the blood of neonates whose mothers may have ingested large quantities of caffeine prior to delivery, or who have previously been treated with theophylline (metabolised to caffeine). Baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate, since caffeine readily crosses the placenta into the foetal circulation.
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).
Pregnancy and Lactation
Pregnancy
Not applicable.
Lactation
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
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 enteral secretion
Increased left ventricular output
Increased sodium excretion
Increased stroke volume
Increased urination
Intestinal stasis
Irritability
Jitteriness
Necrotising enterocolitis
Reduced splanchnic blood flow
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: November 2013
Reference Sources
MHRA Drug Safety Update August 2013
Available at: https://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON300399
Last accessed: November 21, 2013
Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013.
Summary of Product Characteristics: Caffeine Citrate 10 mg/ml oral solution. Martindale Pharmaceuticals Ltd. Revised June 2013.
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