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Caffeine citrate
Viridian Pharma Ltd
N06BC01
Caffeine citrate
10mg/ml
Oral Solution
Oral use
Vials
POM - Prescription Only Medicine
Martindale Pharmaceuticals
Psychostimulants, agents used for ADHD and nootropics, Xanthine derivatives, Caffeine
It is indicated in neonates for the treatment of apnoea of prematurity.
Authorised
2011-09-01
IN THIS LEAFLET: 1. What Caffeine Citrate 10mg/ml Oral Solution is and what is it used for 2. Before your baby is given Caffeine Citrate 10mg/ml Oral Solution 3. How Caffeine Citrate 10mg/ml Oral Solution is used 4. Possible side effects 5. Storing Caffeine Citrate 10mg/ml Oral Solution 6. Further information 1. WHAT CAFFEINE CITRATE 10MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR • Caffeine belongs to a group of medicines known as methylxanthines • It stimulates breathing, and is used to treat apnoea of prematurity (breathing difficulties as a result of being born prematurely). 2. BEFORE YOUR BABY TAKES CAFFEINE CITRATE 10MG/ML ORAL SOLUTION YOUR BABY SHOULD NOT BE GIVEN CAFFEINE CITRATE 10MG/ML ORAL SOLUTION if there is known hypersensitivity (allergy) to any of the ingredients listed in paragraph 6 overleaf. SPECIAL CARE IS NEEDED WITH CAFFEINE CITRATE 10MG/ML ORAL SOLUTION WHEN YOUR BABY: • has liver or kidney disease • has had any unusual heart rhythms detected. Please tell the doctor looking after your baby of any of such problems. As with most medicines, Caffeine Citrate 10mg/ml Oral Solution may interact with other medicines given at the same time. A premature baby may need many medicines, and any problems with caffeine are likely to be minor, but tell the doctor about any other medication they may not know about, particularly any other medicine (for example theophylline) given to your baby to help it breathe. If you, as the mother, drank a lot of coffee, or took any other high caffeine-containing product just before your baby was born, some caffeine may still be present in your baby’s circulation. Tell the doctor about this. Medications containing phenobarbitone or phenytoin, taken by the mother herself to treat epilepsy, may also have an effect on the way the baby reacts to caffeine therapy. If you have been taking treatment for epilepsy during pregnancy, plea Aqra d-dokument sħiħ
Caffeine Citrate 10mg/ml Oral Solution Summary of Product Characteristics Updated 30Jun2015 | Martindale Pharmaceuticals Ltd 1. Name of the medicinal product Caffeine Citrate 10 mg/ml Oral Solution 2. Qualitative and quantitative composition Caffeine Citrate 10 mg/ml Each 1ml of solution contains 10 mg Caffeine citrate, equivalent to 5 mg of Caffeine. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution Appearance: clear and colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Caffeine citrate 10 mg/ml Oral Solution is indicated in neonates for the treatment of apnoea of prematurity. 4.2 Posology and method of administration Posology Neonates The recommended doses of Caffeine Citrate 10 mg/ml Oral Solution are expressed below. Please note: (a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base. (b) 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) (c) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment. (d) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation. Dose of Caffeine Citrate 10mg/ml Oral Solution Dose Expressed as Caffeine Citrate Dose Expressed as Caffeine Base Route Frequency Loading Dose See (b) above 2ml/kg 20mg/kg 10 mg/kg Oral Once Maintenance Dose 0.51ml/kg* 510mg/kg* 2.55.0mg/kg* Oral Every 24 hours** * In some cases maintenance doses higher than 10 mg/kg/day (expressed as caffeine citrate) may be req Aqra d-dokument sħiħ