LEVOCARNITINE

Posology Adults and children over 12 years of age 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.

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. Method of administration For oral administration only. The Oral Solution can be drunk directly or diluted further in water or fruit juices.

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).

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’. Excipients The 1g oral solution contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218). It may cause hypersensitivity (anaphylactoid) reactions (possibly delayed). 2 mg propylene glycol in each 1ml which is equivalent to 24mg /10ml.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.

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