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CAFFEINE CITRATE is a brand name for Caffeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of apnoea of prematurity.
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Posology 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. 4 below) (c) 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.
0mg/kg* Intravenous** (over 10 min) or oral Every 24 hours*** * 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) Dosage, adjustments and monitoring Plasma concentrations of caffeine may need to be monitored periodically throughout treatment in cases of incomplete clinical response or signs of toxicity.
5) - infants whose mothers consume caffeine while providing breast milk for feeding. 4) - infants who have previously been treated with theophylline, which is metabolized to caffeine. 2). Blood samples for monitoring should be taken just before the next dose in the case of therapeutic failure and 2 to 4 hours after the previous dose when suspecting toxicity.
Although a therapeutic plasma concentration range of caffeine has not been determined in the literature, caffeine levels in studies associated with clinical benefit ranged from 8 to 30 mg/l and no safety concerns have normally been raised with plasma levels below 50 mg/l.
Duration of treatment The optimal duration of treatment has not been established. In a recent large multicentre study on preterm newborn infants a median treatment period of 37 days was reported. Treatment should be continued until the child has reached a gestational age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously.
Caffeine has been reported to cause a number of adverse effects in premature neonates. Effects described include CNS stimulation such as irritability, restlessness and jitteriness and cardiac effects such as tachycardia, hypertension and increased stroke volume.
These effects are dose related and may necessitate dose reduction and measurement of plasma levels. They are generally, although not exclusively, associated with serum caffeine concentrations ≥50micrograms/ml. On the available evidence, caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out.
Caffeine treatment may increase gastro-oesophageal reflux, induce intestinal stasis and increase enteral secretion and gastric aspirations. Caffeine treatment may also reduce splanchnic blood flow. These factors may increase the risk of necrotising enterocolitis, although the prevention of systemic hypoxia may offset this theoretical increased risk.
No significantly increased incidence of necrotising enterocolitis has been reported in clinical trials. Caffeine may suppress erythropoietin synthesis and hence reduce haemoglobin concentration with prolonged treatment. Other adverse effects associated with caffeine are effects on blood glucose levels such as hypoglycemia and hyperglycemia, and renal effects including increased urine flow rate, increased sodium and calcium excretion.
Available evidence does not indicate any adverse long-term effects of neonatal caffeine therapy on neurodevelopmental outcome, failure to thrive, or on the cardiovascular, gastrointestinal or endocrine systems. However, the possibility of long-term adverse effects cannot be ruled out.
A withdrawal syndrome after discontinuation of caffeine treatment has not been reported in this age group.
Apnoea Apnoea of prematurity is a diagnosis of exclusion. , central nervous system disorders, primary lung disease, anaemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnoea) should be ruled out or properly treated prior to initiation of treatment with caffeine citrate.
It is advisable to monitor plasma levels of caffeine periodically. However, at the recommended doses, frequent (more than weekly) monitoring of plasma levels is not normally necessary unless there are concerns regarding lack of efficacy or possible toxicity.
In premature neonates, caffeine has a prolonged half-life. 2). If there is inadequate clinical response to the first loading dose, a second dose may be given, but if there is continued inadequate response, the plasma levels should be confirmed before further doses are given, as the failure to respond could be an indication of another cause of apnoea.
Plasma levels should not normally exceed 50micrograms/ml (optimally 10-30micrograms/ml). 2). 2). Theophylline In newborns previously treated with theophylline, baseline plasma caffeine concentrations should be measured prior to initiation of treatment with caffeine citrate because preterm infants metabolise theophylline to caffeine.
Seizures Caffeine is a central nervous system stimulant and seizures have been reported in cases of caffeine overdose. Extreme caution must be exercised if caffeine citrate is used in newborns with seizure disorders. Cardiovascular reactions Caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies.
Therefore, caffeine citrate should be used with caution in newborns with known cardiovascular disease. There is evidence that caffeine causes tachyarrhythmias in susceptible individuals. In newborns this is usually a simple sinus tachycardia.
If there have been any unusual rhythm disturbances on a cardiotocograph (CTG) trace before the baby is born, caffeine citrate should be administered with caution. Renal and hepatic impairment Caffeine citrate should be administered with caution in preterm newborn infants with impaired renal or hepatic function.
Caffeine Citrate 10mg/ml Solution for Injection is contraindicated in patients who have demonstrated hypersensitivity to any of its components. .
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. It is recommended that caffeine citrate administration should be stopped when the patient has 5-7 days without a significant apnoeic attack.
If the patient has recurrent apnoea, caffeine citrate administration can be restarted with either a maintenance dose or a half loading dose, depending upon the time interval from stopping caffeine citrate to recurrence of apnoea. Because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment.
As there is a risk for recurrence of apnoeas after cessation of caffeine citrate treatment monitoring of the patient should be continued for approximately one week. Hepatic and renal impairment There is limited experience in patients with renal and hepatic impairment.
8). 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.
2). m. injection is likely to be painful. When given […]
2). Doses should be adjusted by monitoring of caffeine plasma concentrations to avoid toxicity in this population. Necrotising enterocolitis Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants.
There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis. However, a causal relationship between caffeine or other methylxanthine use and necrotising enterocolitis has not been established.
8). Caffeine citrate should be used with caution in infants suffering gastro-oesophageal reflux, as the treatment may exacerbate this condition. Caffeine citrate causes a generalised increase in metabolism, which may result in higher energy and nutrition requirements during therapy.
The diuresis and electrolyte loss induced by caffeine citrate may necessitate correction of fluid and electrolyte disturbances. 04mg sodium per 1ml of the solution. To be taken into consideration by patients on a controlled sodium diet.