HOW SUPPLIED/STORAGE AND HANDLING

Store levocarnitine injection 1gm/5ml vials at controlled room temperature (25°C). Discard unused portion of an opened vial, as the formulation does not contain a preservative.

DOSAGE

Levocarnitine is available in two forms: Injection and Tablets. The recommended dosage of levocarnitine injection is administered intravenously. Although, the levocarnitine tablets are for oral administration.

• Metabolic Disorders: The recommended dose is 50 mg per kg administered as a slow 2-3 minute bolus injection or by infusion. Often a loading dose is administered in patients with severe metabolic crisis, after an equivalent dose over the following 24 hours. It should be given q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All the subsequent daily doses are prescribed to be in the range of 50 mg/kg or as therapy may require. The highest dose given has been 300 mg/kg.
• End Stage Renal Disease Patients on Hemodialysis: The standard starting dose is 10 to 20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line following each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40 to 50 µmol/L).

Levocarnitine Tablets: The recommended oral dosage of levocarnitine tablets for adult patients is 990 mg 2 or 3 times daily using the 330 mg tablets, on behalf of clinical response.
Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg daily in splited doses, with a maximum of 3 g/day. Dosage should start at 50 mg/kg daily. The exact dosage will depend on clinical response.