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Drug Description
Each tablet contains L-Carnitine inner salt 330 mgPresentation
White, round, standard biconvex tablets, approximately 13 mm diameter.Adult Dosage
For oral administration only.
Adults and children over 12 years of age
The tablets should be given in divided doses.
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 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.
Contra Indications
Hypersensitivity to any constituent of the product.
Special Precautions
While improving glucose utilisation, the administration of L-carnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.
The safety and efficacy of oral L-carnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral L-carnitine 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 L-carnitine.
Interactions
There are no known interactions.
Adverse Reactions
Various mild gastro-intestinal complaints have been reported during the long term administration of oral levocarnitine, these include transient nausea and vomiting, abdominal cramps and diarrhoea.
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.
Manufacturer
sigma-tau Pharma Limited UKDrug Availability
POM – Prescription Only MedicineUpdated
05 May 2010Advert for Healthcare Professionals Only
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