Levocarnitine (Page 2 of 2)

Pediatric Use

See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS

Clinical Trials Experience
Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology.

Postmarketing Experience
The following adverse reactions have been reported:
Neurologic Reactions: Seizures have been reported to occur in patients, with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.
Hypersensitivity reactions: Anaphylaxis, laryngeal edema and bronchospasm (see WARNINGS).

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

Levocarnitine Injection, USP is administered intravenously.

Metabolic Disorders
The recommended dose is 50 mg/kg given as a slow 2 to 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 every 3 hours or every 4 hours, and never less than every 6 hours 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 concentration 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 concentration should be between 35 and 60 μmol/L) 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

Levocarnitine Injection, USP is compatible and stable when mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer’s in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (8 mg/mL) and stored at room temperature (25°C) for up to 24 hours in PVC plastic bags.

HOW SUPPLIED:

Levocarnitine Injection, USP is available in 1 g per 5 mL single dose vials packaged 25 vials per tray (NDC 0517-1045-25 ).

Store at or below 25°C (77°F) (See USP). Do not freeze. Store vials in carton until their use to protect from light. Discard unused portion of an opened vial, as the formulation does not contain a preservative.

REFERENCES

  1. Bohmer, T., Rydning, A. and Solberg, H.E. 1974. Carnitine levels in human serum in health and disease. Clin. Chim. Acta 57:55-61.
  2. Brooks, H., Goldberg L., Holland, R. et al. 1977. Carnitine-induced effects on cardiac and peripheral hemodynamics. J. Clin. Pharmacol. 17:561-568.
  3. Christiansen, R., Bremer, J. 1976. Active transport of butyrobetaine and carnitine into isolated liver cells. Biochim. Biophys. Acta 448:562-577.
  4. Lindstedt, S. and Lindstedt, G. 1961. Distribution and excretion of carnitine in the rat. Acta Chem. Scand. 15:701-702.
  5. Rebouche, C.J. and Engel, A.G. 1983. Carnitine metabolism and deficiency syndromes. Mayo Clin. Proc. 58:533-540.
  6. Rebouche, C.J. and Paulson, D.J. 1986. Carnitine metabolism and function in humans. Ann. Rev. Nutr. 6:41-66.
  7. Scriver, C.R., Beaudet, A.L., Sly, W.S. and Valle, D. 1989. The Metabolic Basis of Inherited Disease. New York: McGraw-Hill.
  8. Schaub, J., Van Hoof, F. and Vis, H.L. 1991. Inborn Errors of Metabolism. New York: Raven Press.
  9. Marzo, A., Arrigoni Martelli, E., Mancinelli, A., Cardace, G., Corbelletta, C., Bassani, E., and Solbiati, M. 1991. Protein binding of L-carnitine family components. Eur. J. Drug Met. Pharmacokin., Special Issue III: 364-368.
  10. Rebouche, C.J. 1991. Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism 40:1305-1310.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN1055
Rev. 10/19
MG # 16074

PRINCIPAL DISPLAY PANEL — 5 mL Container

NDC 0517-1045-25

LEVOCARNITINE INJECTION, USP

1 g/5 mL (200 mg/mL)
5 mL SINGLE DOSE VIAL

FOR IV USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 7/05

Container
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Carton

LEVOCARNITINE INJECTION, USP

1 g/5 mL (200 mg/mL)

NDC 0517-1045-25

25 x 5 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE

Rx Only

Each mL contains: Levocarnitine 200 mg, Water for Injection q.s. pH (range 6.0-6.5) adjusted with Hydrochloric Acid.
WARNING: Protect from light. Retain in carton until time of use. Discard unused portion.
Contains no preservatives.
Store at or below 25°C (77°F) (See USP). Do not freeze.
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.SHIRLEY, NY 11967

Rev. 10/04

Carton
(click image for full-size original)

Serialization Label

Serialization Label
(click image for full-size original)
LEVOCARNITINE levocarnitine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-1045
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCARNITINE (LEVOCARNITINE) LEVOCARNITINE 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-1045-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE
1 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-1045-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075861 10/08/2001
Labeler — American Regent, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 002033710 ANALYSIS (0517-1045), MANUFACTURE (0517-1045)

Revised: 06/2019 American Regent, Inc.

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