Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to the Cenote Medical Information Department: Telephone 0330 1359 441 or Email [email protected]
Levocarnitine Paediatric 30% Oral Solution Prescribing Information
Please refer to SmPC before prescribing.
Indications: Primary and secondary carnitine deficiency in children under 12 years, infants and newborns. Available strengths: Levocarnitine 30% w/v (300mg/ml) Oral Solution Sugar Free Dosage: Children under 12 years, infants and newborns: It is advisable to monitor therapy by measuring free and acyl carnitine levels in both plasma and urine. The management of inborn errors of metabolism: The dosage required depends upon the specific inborn error of metabolism concerned and the severity of presentation at the time of treatment. However, the following can be considered as a general guide. An oral dosage of up to 200mg/kg/day in divided doses (2 to 4) is recommended for chronic use in some disorders, with lower doses sufficing in other conditions. If clinical and biochemical symptoms do not improve, the dose may be increased on a short-term basis. Higher doses of up to 400mg/kg/day may be necessary in acute metabolic decompensation or the i.v. route may be required. Haemodialysis – maintenance therapy: If significant clinical benefit has been gained by a first course of intravenous Levocarnitine then maintenance therapy can be considered using 1g per day of Levocarnitine orally. On the day of the dialysis oral Levocarnitine has to be administered at the end of the session. Maximum dose for children is 1g daily if used as a maintenance therapy for secondary deficiency in dialysis patients. Administration: For oral administration only. The Paediatric Solution can be drunk directly or diluted further in water or fruit juices. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special warnings/precautions for use: While improving glucose utilisation, the administration of levocarnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required. The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in end stage renal disease (ESRD) patients
on dialysis may result in an accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are usually excreted in the urine. This situation has not been observed following intravenous administration of levocarnitine. There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and coumarinic drugs. Interactions: There have been very rare reports of International Normalised Ratio (INR) increased in patients treated concomitantly with levocarnitine and courmarinic drugs. INR – or other appropriate test of coagulation – should be checked weekly until they become stable, and monthly thereafter, in patients taking such anticoagulants together with levocarnitine. Pregnancy/breastfeeding: Pregnancy Reproductive studies were performed in rats and rabbits. There was no evidence of a teratogenic effect in either species. In the rabbit but not in the rat there was a statistically insignificant greater number of post implantation losses at the highest dose tested (600mg/kg daily) as compared with control animals. The significance of these findings in man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency. Considering the serious consequences in a pregnant woman who has primary systemic carnitine deficiency stopping treatment, the risk to the mother of discontinuing treatment seems greater than the theoretical risk to the foetus if treatment is continued. Breast-feeding Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been studied. Effect on driving: None known. Side effects: For full list of side effects consult SmPC. Very rare: Gastrointestinal disorders: Vomiting, Nausea, Diarrhoea, Abdominal cramp. General disorders and administration site conditions: Body Odour. Investigations: International Normalised Ration Increased MA number: PL 46052/0001. Cost: £71.40 for 20ml; £142.00 for 40ml; £178.50 for 50ml. MAH: Cenoté Pharma Ltd. Elizabeth House. 13-19 London Road. Newbury, Berkshire. RG14 1JL Legal category: POM. Date reviewed: April 2024 Version number: 10106172276 v 1.0
APL1010347V1 May 2024