Levocarnitine
Levocarnitine Oral · Solution · Oral, Intravenous
Uses
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
Dosage and administration
Levocarnitine injection 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 q3h or q4h, 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 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. ESRD Patients on Hemodialysis The recommended starting dose is 10 mg/kg to 20 mg/kg dry body weight as a slow 2 to 3 minute bolus injection into the venous return line after each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40 µmol/L to 50 µmol/L). Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g., to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy. 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 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.
Contraindications
None known.
Warnings
Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine injection administration, mostly in patients with end stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine injection. If a severe hypersensitivity reaction occurs, discontinue levocarnitine injection treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering levocarnitine injection to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
Precautions
General 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. Drug Interactions 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity tests performed in Salmonella typhimurium , Saccharomyces cerevisiae , and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic. No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine. 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 injection. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied. Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment. Pediatric use See DOSAGE AND ADMINISTRATION .
Side effects
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. The table below lists the adverse events that have been reported in two double-blind, placebo- controlled trials in patients on chronic hemodialysis. Events occurring at ≥5% are reported without regard to causality. Adverse Events with a Frequency ≥5% Regardless of Causality by Body System Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5 3 3 2 Atrial fibrillation 2 6 2 Cardiovascular disorder 6 3 5 6 5 Electrocardiogram abnormal 3 6 2 Hemorrhage 6 9 2 3 4 Hypertension 14 18 21 21 20 Hypotension 19 15 19 3 14 Palpitations 3 8 5 Tachycardia 5 6 5 9 6 Vascular disorder 2 2 6 2 Digestive Anorexia 3 3 5 6 5 Constipation 6 3 3 3 3 Diarrhea 19 9 10 35 16 Dyspepsia 10 9 6 5 Gastrointestinal disorder 2 3 6 2 Melena 3 6 2 Nausea 10 9 5 12 8 Stomach atony 5 Vomiting 16 9 16 21 15 Endocrine System Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic Anemia 3 3 5 12 6 Metabolic/Nutritional Hypercalcemia 3 15 8 6 9 Hyperkalemia 6 6 6 6 6 Hypervolemia 17 3 3 12 5 Peripheral edema 3 6 5 3 5 Weight decrease 3 3 8 3 5 Weight increase 2 3 6 2 Musculo-Skeletal Leg cramps 13 8 4 Myalgia 6 Nervous Anxiety 5 2 1 Depression 3 6 5 6 5 Dizziness 11 18 10 15 13 Drug dependence 2 6 2 Hypertonia 5 3 1 Insomnia 6 3 6 4 Paresthesia 3 3 3 12 5 Vertigo 6 2 Respiratory Bronchitis 5 3 3 Cough increase 16 10 18 9 Dyspnea 19 3 11 3 7 Pharyngitis 33 24 27 15 23 Respiratory disorder 5 Rhinitis 10 6 11 6 9 Sinusitis 5 2 3 2 Skin And Appendages Pruritus 13 8 3 5 Rash 3 5 3 3 Special Senses Amblyopia 2 6 3 Eye disorder 3 6 3 3 Taste perversion 2 9 3 Urogenital Urinary tract infect 6 3 3 2 Kidney failure 5 6 6 6 6 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 ). To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Drug Interactions 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.
Pregnancy
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 injection. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pediatric use
Pediatric use See DOSAGE AND ADMINISTRATION .
Overdosage
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.
Description
Levocarnitine, USP is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is ( R )-3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder. It is freely soluble in water, hot alcohol, and practically insoluble in acetone, ether and benzene. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is: Empirical Formula: C 7 H 15 NO 3 Molecular Weight: 161.20 g/mol Levocarnitine injection, USP is a clear, colorless sterile solution containing 1 g of levocarnitine, USP per 5 mL vial and water for injection. The pH is adjusted to 6.0 to 6.5 with hydrochloric acid or sodium hydroxide. description-1.jpg
How supplied
Levocarnitine injection USP, 200 mg/mL is supplied as single-dose vial available in following strength and pack size: Strength Packaging Configuration NDC Number 1 gm/5 mL (200 mg/mL) 10 x 5 mL single-dose vials per carton 36000-368-10 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Discard any unused portion of an opened vial, as the formulation does not contain a preservative. Rx only. 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. Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Rev. 2026-02-27 1400008639 Baxter is a registered trademark of Baxter International Inc.
Label text from the FDA structured product label by Baxter Healthcare Corporation (revised Jul 2, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Levocarnitine in 12 products
Levocarnitine NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0517-1045 | Levocarnitine 200 mg/mL Injection, Solution | American Regent, Inc. | ANDA |
| 0517-1075 | Levocarnitine 200 mg/mL Injection, Solution | American Regent, Inc. | ANDA |
| 70954-139 | Levocarnitine 1 g/10mL Solution | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-140 | Levocarnitine 1 g/10mL Solution | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-492 | Levocarnitine 330 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 36000-368 | Levocarnitine 1 g/5mL Injection, Solution | Baxter Healthcare Corporation | ANDA |
| 73043-034 | Levocarnitine 1 g/5mL Injection, Solution | Devatis Inc. | ANDA |
| 0143-9852 | Levocarnitine 1 g/5mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 16571-762 | Levocarnitine 330 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 64980-503 | Levocarnitine 1 g/10mL Solution | Rising Pharma Holdings, Inc. | ANDA |
| 71656-016 | Levocarnitine 1 g/10mL Solution | Saptalis Pharmaceuticals, LLC | ANDA |
| 52817-830 | Levocarnitine 1 g/10mL Solution | TRUPHARMA, LLC | ANDA |
Levocarnitine recalls
- D-0494-2026 May 6, 2026 · Class III · Ongoing
Labeling: Missing Label
Frequently asked questions
What is Levocarnitine used for?
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
What are the side effects of Levocarnitine?
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. The table below lists the adverse events that have been reported in two double-blind, placebo- controlled trials in patients on… See the full label for the complete list.
Who makes Levocarnitine?
Levocarnitine is listed by 8 labelers in the FDA NDC directory, including American Regent, Inc., ANI Pharmaceuticals, Inc., Baxter Healthcare Corporation, Devatis Inc..
Has Levocarnitine been recalled?
The FDA enforcement database lists 1 recall for Levocarnitine, most recently D-0494-2026 (class iii): Labeling: Missing Label