L-Carnitine (Levocarnitine) Injection
500 mg/ml
Size: 30 mlLevocarnitine is a naturally occurring endogenous compound essential for mammalian energy metabolism [1][2]. It plays a critical role in cellular bioenergetics by facilitating the transport of long-chain fatty acids into the mitochondria, where they undergo β-oxidation to generate adenosine triphosphate (ATP) [1][2].
Sterile Levocarnitine Injection is formulated to support healthcare providers with a sterile parenteral solution for intravenous administration in clinical settings. In formal clinical practice, Intravenous Levocarnitine is indicated for the acute and chronic treatment of primary systemic carnitine deficiency and for the treatment of secondary carnitine deficiency in patients with end-stage renal disease undergoing hemodialysis [3]. This makes it a critical intervention for targeted carnitine deficiency treatment.
More About This Product
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• Concentration: 500 mg/mL
• Volume: 30 mL Multi-Dose Vial
• Route of Administration: Intravenous (IV) Use.
L-Carnitine Injection is formulated as a sterile parenteral solution. For metabolic disorders associated with carnitine deficiency, dosing is individualized according to the underlying condition, clinical response, and laboratory assessment. Initial intravenous dosing commonly begins at 50 mg/kg/day; patients undergoing hemodialysis may require alternative dosing strategies based on plasma carnitine concentrations and clinical status [3]. Adherence to strict aseptic technique is required during vial puncture and administration.
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Levocarnitine exerts distinct and critical biochemical metabolic functions:
Fatty Acid Transport & Oxidation: Levocarnitine acts as a mandatory carrier molecule that shuttles long-chain fatty acids across the impermeable inner mitochondrial membrane. This process is the rate-limiting step for mitochondrial β-oxidation and subsequent ATP production from fat [1][2].
Toxic Acyl-Group Clearance: Levocarnitine binds to potentially toxic intracellular acyl-CoA metabolites, forming acylcarnitines that can cross cell membranes and be safely excreted in the urine. This mechanism regulates the intracellular acetyl-CoA/CoA ratio, allowing continued efficient cellular metabolism [2][3].
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Contraindications: Known hypersensitivity to levocarnitine or any component of the formulation. This multi-dose formulation contains benzyl alcohol (2%) and is contraindicated in neonates and low-birth-weight infants due to the risk of benzyl alcohol toxicity ("gasping syndrome") [3].
Precautions: Clinicians should exercise caution in patients with a history of seizure disorders. Seizures have been reported to occur in patients with or without pre-existing seizure activity receiving intravenous levocarnitine; in patients with a history of seizures, an increase in seizure frequency or severity has been observed [3].
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The following medications may influence therapeutic response or physiological stability:
Anticoagulants (e.g., Warfarin): Concurrent administration of levocarnitine and warfarin may lead to an increased International Normalized Ratio (INR). Patients receiving anticoagulant therapy should undergo periodic monitoring of coagulation parameters, particularly INR, during initiation or dose adjustment of levocarnitine therapy [3].
Carnitine-Depleting Agents: Chronic administration of certain medications, such as valproic acid or pivalate-conjugated antibiotics, can induce secondary carnitine deficiency, thereby increasing the clinical requirement for levocarnitine supplementation [2].
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Parenteral administration is generally well-tolerated. Reported adverse reactions following administration may include [3]:
Gastrointestinal: Nausea, vomiting, diarrhea, abdominal cramps.
Neurological: Headache; dizziness; rare occurrences of seizures.
Systemic/Dermatological: Body odor (often described as a "fishy" odor, resulting from the formation of the metabolite trimethylamine); transient flushing.
Hypersensitivity: Rare cases of anaphylaxis, bronchospasm, and laryngeal edema have been reported.
Local/Injection Site: Mild injection site reactions.
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Renal Impairment: ESRD carnitine deficiency commonly occurs in patients with end-stage renal disease due to reduced endogenous synthesis and losses during hemodialysis. Intravenous Levocarnitine may be utilized to restore and maintain physiologic carnitine concentrations in appropriate patients undergoing hemodialysis [3].
Pregnancy: Reproduction studies have been performed in rats and rabbits at doses highly exceeding the human dose and have revealed no evidence of impaired fertility or fetal harm. However, adequate and well-controlled studies in pregnant women have not been conducted. Levocarnitine should be administered during pregnancy only when clearly clinically indicated [3].
Lactation: Levocarnitine supplementation in nursing mothers has not been specifically studied. Since levocarnitine is a normal component of human milk, the decision to administer to a nursing individual should carefully weigh the potential benefits against any potential risks [3].
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Store at USP Controlled Room Temperature 20°C to 25°C (68°F to 77°F), with permitted excursions between 15°C and 30°C (59°F and 86°F). Protect from light and freezing [3]. Store in the original carton until time of use. Safely discard any unused portion after the designated beyond-use date (BUD) in accordance with standard facility protocols for medical waste. Do not flush unused medications [3].
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[1] Rebouche CJ. Kinetics, pharmacokinetics, and regulation of L-carnitine and acetyl-L-carnitine metabolism. Ann N Y Acad Sci. 2004; 1033:30-41.
[2] StatPearls. L-Carnitine (Levocarnitine). Treasure Island (FL): StatPearls Publishing.
[3] U.S. Food and Drug Administration (FDA). Levocarnitine Injection Professional Prescribing Information. DailyMed.
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This information is intended for healthcare professionals. Refer to the full prescribing information for complete safety and prescribing details.
