LEVOCARNITINE PAEDIATRIC 30% Oral solution Ref.[6409] Active ingredients: L-carnitine

Posology

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

Method of administration

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

There have been no reports of toxicity from levocarnitine overdosage. Overdosage should be treated with supportive care.

2 years.

Discard 30 days after first opening.

Store below 25°C.

Carton box that contains an amber glass bottle with 20ml of drug product, with a plastic polypropylene and low density polyethylene child proof cap and a graduated dosage pipette, along with the patient information leaflet.

No special requirements for disposal.