Caffeine Citrate 10mg/ml Inj. Sol. Ref.[4796] Active ingredients: Caffeine

The recommended doses of Caffeine Citrate 10mg/ml Solution for Injection are expressed below. Please note:

(a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base.

(b) given orally or intravenously, caffeine is clinically effective within 4 hours. If the patient fails to respond within this time, a second loading dose may be given. If there is no clinical response to the second loading dose, caffeine blood levels should be measured (see ‘special warnings and precautions for use’ section 4.4 below)

© Caffeine Citrate 10mg/ml Solution for Injection is also effective when administered orally, and this route may be used alternatively without adjusting the dose.

(d) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.

(e) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation.

* In some cases maintenance doses higher than 10mg/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)
** By intravenous infusion
*** Beginning 24 hours after the loading dose(s)

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.

Caffeine Citrate 10mg/ml Solution for Injection should not be given intramuscularly; being acidic, i.m. injection is likely to be painful. When given intravenously, it should be given as a slow infusion rather than a bolus injection; there is evidence that bolus administration may cause sudden changes in blood pressure.

Please see Section 4.4 below regarding use of the filter straws.

Hepatic and Renal Impairment

In the presence of renal impairment, a reduced daily maintenance dose of caffeine is required and the dose should be guided by blood caffeine measurements. There is increased potential for accumulation.

In very premature infants, clearance of caffeine does not depend on hepatic function. Hepatic caffeine metabolism develops progressively in the weeks following birth and for the older infant, hepatic disease may reduce maintenance caffeine dose requirements.

Adults and Children

Not applicable.

Elderly

Not applicable.

Caffeine overdose has been reported in a few cases in newborns and premature infants. There should normally be no concern with blood levels below 50micrograms/ml; based on limited data, toxicity seems to occur when levels over 100micrograms/ml are reached. Symptoms of overdosage from these reports include jitteriness, tachycardia, tachypnoea, tremor, opisthotonos, rigidity and tonic-clonic movements. In one case of overdose the patient developed compromised circulation, vomiting and seizures. Other reported effects of gross overdose include fever, agitation, hyperexcitability, hypertonia, gastric residues, distended abdomen, metabolic acidosis, hyperglycaemia and elevated urea levels.

Treatment of overdosage should include monitoring of blood levels of caffeine and supportive measures. Previous cases reported resolved satisfactorily.

In severe cases of overdose, exchange transfusion should be considered. In one case, this was found to reduce plasma caffeine levels by 40mg/L per transfusion.

Shelf life: 3 years.

No special precautions for storage.

Type I clear glass ampoule containing 1ml or 2ml in packs of 10 ampoules.

Only clear solution without particulate matter should be used. For single use only. Any unused solution should be discarded.

There was no detectable degradation of the solution when diluted 50/50 with commercial glucose 5%, glucose 4% saline 0.18%, and sodium chloride 0.9% infusions, when stored in disposable plastic syringes at room temperature for 4 hours.