Levocarnitine

Levocarnitine oral solution is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY ). …

• 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 levocarnitine 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 levocarnitine 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
• Levocarnitine 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

See DOSAGE AND ADMINISTRATION .

None known.

Reports of INR increase with the use of warfarin have been observed. It is recommended that INR levels be monitored in patients on warfarin therapy after the initiation of treatment with levocarnitine or after dose adjustments.

Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral levocarnitine. Other serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following intravenous levocarnitine administration, mostly in patients with end-stage renal disease undergoing dialysis. Discontinue use of levocarnitine and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

The following adverse reactions associated with the use of oral formulations of levocarnitine were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliability, or to establish a causal relationship to drug exposure. Gastrointestinal Reactions : Various mild gastrointestinal complaints have been reported during the long-term administration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea. …

Pregnancy Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to levocarnitine. There are, however, no adequate and well-controlled studies in pregnant women. …

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD 50 of levocarnitine in rats is 5.4 g/kg and the oral LD 50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.