Levocarnine       Oral solution

L-carnitine    10gm/100ml

Usage and indications:

Levocarnine is indicated for:

In the reported cases, the clinical presentation consisted of recurrent episodes of reye-like encephalopathy, hypoketotic hypoglycemia and cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive.

  • Secondary carnitine deficiency

A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine level is below normal and that the patient does not have a primary defect in fatty acid or organic acid oxidation. In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.

Dosage and administration:

Levocarnine oral Solution for oral use only. Not for parenteral use.

Adults:

The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 ml/day of Levocarnine oral Solution.

Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit.

Dosage should start at 1 g/day, (10 ml/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Infants and children:

The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 ml/kg/day Levocarnine oral Solution.

Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit.

Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day

(30 ml/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition. Levocarnine oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.

Undesirable effects:

Various mild gastrointestinal complaints:

Transient nausea, vomiting, abdominal cramps and diarrhea have been reported during the long-term administration. 

Gastrointestinal adverse reactions might be avoided by a slow consumption of the solution or by a greater dilution.

Mild myasthenia:

It has been noticed only in uremic patients.

Seizures:

Seizures have been reported to occur in patients with or without pre-existing seizure activity.    In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.

Warnings and precautions:

Levocarnine oral solution is for oral / internal use only.

Renal impairment

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 ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine.

Pack: carton box containing a glass bottle of 100 ml solution.

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