CARNITOR

For slow intravenous administration over 2-3 minutes Adults, Children, infants and neonates 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. In acute decompensation, dosages of up to 100 mg/kg/day in 3-4 divided doses are recommended. Higher doses have been used although an increase in adverse events, primarily diarrhoea, may occur.

Secondary carnitine deficiency in haemodialysis patients It is strongly recommended that, before initiating therapy with Carnitor, plasma carnitine is measured. 4 and/or when free carnitine concentrations are lower than 20 μmol/litre.

A dose of 20mg per kg should be administered as an intravenous bolus at the end of each dialysis session (assuming three sessions per week). The duration of intravenous treatment should be at least three months, which is the time usually required to restore normal muscle levels of free carnitine.

The overall response should be assessed by monitoring plasma acyl to free carnitine levels and by evaluating the patient's symptoms. When carnitine supplementation has been stopped there will be a progressive decline in carnitine levels.

The need for a repeat course of therapy can be assessed by plasma carnitine assays at regular intervals and by monitoring the patient's symptoms. Haemodialysis - maintenance therapy If significant clinical benefit has been gained by the first course of intravenous Carnitor then maintenance therapy can be considered using 1 g per day of Carnitor orally.

On the day of the dialysis, oral Carnitor has to be administered at the end of the session. Elderly No changes in posology are necessary in elderly patients. 4).

Adverse reactions from any source are listed in the table below by MedRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

In addition the corresponding frequency category for each adverse drug reaction is based on the following conventions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).

4). 5 ‘Interactions’. Decreasing the dosage often diminishes or eliminates drug related patient body odour or gastro-intestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increase.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

8 ‘Undesirable Effects’. INR – or other appropriate tests of coagulation – should be checked weekly until they become stable, and monthly thereafter, in patients taking such anticoagulants together with L
carnitine. There have been reports of seizures in patients with previous seizure activity, however it is not clear if Levocarnitine increases the incidence and/or severity of seizure attacks.

In instances where levocarnitine is a suspected cause of seizures, consideration should be given to withdrawing treatment with levocarnitine. High doses and long-term administration of Levocarnitine have been associated with diarrhoea.

1.