For the acute and chronic treatment of patients with an inborn error of metabolism that results in secondary carnitine deficiency.

CARNITOR® Injection is administered intravenously. The recommended dose is 50mg/kg given as a slow 2-3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis followed by an equivalent dose over the following 24 hours. It should be administered q3h or q.h. and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg.

It is recommended that a plasma carnitine level be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine level should be between 35 and 60 micromoles/liter) and overall clinical condition.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Compatibility and Stability

CARNITOR® Injection is compatible and stable when mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringers in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (8.0 mg/mL) and stored at room temperature (25° C) for up to 24 hours in PVC plastic bags.

CARNITOR® (Levocarnitine) Injection, 200 mg per 1 mL, is available in 5 mL single dose ampules packaged 5 ampules per carton (NDC 54482-146-09) and in 2.5 mL single dose ampules packaged 5 ampules per carton (NDC 54482-146-10). Made in Italy.

Store ampules at room temperature (25° C / 77° F) in carton until their use to protect from light. Discard unused portion of an opened ampule, as they contain no preservative.

CARNITOR® (Levocarnitine) is also available in the following dosage forms for oral administration:

CARNITOR® (Levocarnitine) Tablets are supplied as 330 mg (unit dose), individually foil wrapped tablets embossed with CARNITOR-ST in boxes of 90 (NDC 54482-144-07). Made in Italy.

CARNITOR® (Levocarnitine) Oral Solution, 118 mL (4 fl. oz.), supplied as a red, cherry flavored solution in a multiple-dose plastic bottle. (NDC 54482-145-08).

Caution: Federal (U. S. A.) law prohibits dispensing without prescription.

References

1. Bohmer T, Rynding A, Solberg HE: Carnitine levels in human serum in health and disease. Clin Chim Acta 57:55-61, 1974.

2. Brooks H, Goldberg L, Holland R et al: Carnitine-induced effects on cardiac and peripheral hemodynam-ics. J Clin Pharmacol 17:561-578, 1977.

3. Christiansen R, Bremer J: Active transport of butyrobetaine and carnitine into isolated liver cells. Biochem Biophys Acta 448:562-577, 1977.

4. Lindstedt S, Lindstedt G: Distribution and excretion of carnitine 14002 in the rat. Acta Chim Scand 15:701 -702, 1961.

5. Rebouche CJ, Engel AG: Carnitine metabolism and deficiency syndromes. Mayo CIin Proc 58:533-540, 1983.

6. Rebouche CJ, Paulson DJ: Carnitine metabolism and function in humans. Ann Rev Nutr 6:41 -68, 1986.

7. Scriver CR, Beaudet AL, Sly WS, Valle D: The Metabolic Basis of Inherited Disease. McGraw-Hill, New York, 1989.

8. Schaub J, Van Hoof F, Vis HL: Inborn Errors of Metabolism. Raven Press, New York, 1991.

9. Marzo A, Arrigoni Martelli E, Mancinelli A, Cardace G, Corbelletta C, Bassani E, Solbiati M: Protein bind-ing of L-carnitine family components. Eur J Drug Met Pharmacokin, Special Issue Ill: 364-368, 1992.

10. Rebouche C: Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism:1305-1310, 1991.

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