L-Carnitine inner salt 1 g

White, round, standard convex tablets, approximately 22.3 mm diameter.

Indicated for the treatment of primary and secondary carnitine deficiency in adults and children over 12 years of age.

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.

Hypersensitivity to any constituent of the product.

There is limited experience of use in patients with primary and secondary systemic carnitine deficiency suffering from renal failure.

The chewable tablets contain sucrose. This must be considered when treating diabetics or patients who are following diets to reduce calorie intake.

There are no known interactions.

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.

sigma-tau Pharma Limited UK

POM – Prescription Only Medicine