CARNITAB

LEVOCARNITINE

The supplemental Levocarnitine use is widely established in the management of cardiac ischemia and peripheral arterial disease. It is generally indicated for cardio protection. It lowers triglyceride levels and increases levels of HDL cholesterol. It is used with benefits in those with primary and secondary carnitine deficiency syndromes. There is also evidence of its use in liver, kidney and immune disorders or in diabetes and Alzheimer's disease. There is little evidence that supplemental Levocarnitine boosts energy, increases athletic performance or inhibits obesity. The indications of Levocarnitine may be summarized as follows: Heart Diseases Congestive Heart Failure Kidney Disease Chronic Fatigue Syndrome High Cholesterol Intermittent Claudication Dementia and memory impairment Down Syndrome Male infertility Hyperthyroidism

Drugs for muscular energy metabolism

Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production in the form of Adenosine Tri phosphate or ATP. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.

Tablet- Adults: The recommended oral dosage for adults is 990 mg, two or three times a day using the 330 mg tablets, depending on clinical response. Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition. Syrup- Adults: 10 to 30 ml/day. Dosage should start at 10 ml/day in divided doses, and be increased slowly while assessing tolerance and therapeutic response. Infants and children: 50 to 100 mg/kg/day which is equivalent to 0.5 ml/kg/day. 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. 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.

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.

There is no known disease or syndrome in which Levocarnitine administration is contraindicated. It is contraindicated in patients with hypersensitivity to any of its components.

Generally Levocarnitine is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur

Levocarnitine is categorized by the USFDA as Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Supplemental Levocarnitine should be used by pregnant women only if clearly indicated and only under medical supervision. It is not known whether Levocarnitine is excreted in human milk. Supplemental Levocarnitine is not advised for nursing mothers. Those with seizure disorders should only use Levocarnitine under medical advisement and supervision.

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD50 of levocarnitine in rats is 5.4 g/kg and the oral LD50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

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

Tablet: Store in a cool & dry place, protected from light & moisture. Solution: Store in a cool & dry place, protected from light.