Levocarnitine (oral)

Levocarnitine (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Levocarnitine (oral) is an amino acid supplement that is FDA approved for the treatment of primary systemic carnitine deficiency. Common adverse reactions include diarrhea, nausea, stomach cramps and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Levocarnitine tablets, USP are indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation. In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.

• Levocarnitine tablets, USP are also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Dosage

• The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levocarnitine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levocarnitine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Dosage

• 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.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levocarnitine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levocarnitine in pediatric patients.

Contraindications

• None known.

Warnings

• None.

Adverse Reactions

Clinical Trials Experience

• Various mild gastrointestinal complaints have been reported during the long-term administration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea. Mild myasthenia has been described only in uremic patients receiving D,L-carnitine. Decreasing the dosage often diminishes or eliminates drug-related patient body odor or gastrointestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration, and after any dosage increases.

• 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.

Postmarketing Experience

There is limited information regarding Levocarnitine (oral) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Levocarnitine (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

• 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. 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.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levocarnitine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Levocarnitine (oral) during labor and delivery.

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

There is no FDA guidance on the use of Levocarnitine (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Levocarnitine (oral) in geriatric settings.

Gender

There is no FDA guidance on the use of Levocarnitine (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Levocarnitine (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Levocarnitine (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Levocarnitine (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Levocarnitine (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Levocarnitine (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Levocarnitine (oral) Administration in the drug label.

Monitoring

There is limited information regarding Levocarnitine (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Levocarnitine (oral) and IV administrations.

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.

Pharmacology

There is limited information regarding Levocarnitine (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Levocarnitine (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Levocarnitine (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Levocarnitine (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

In a relative bioavailability study in 15 healthy adult male volunteers, levocarnitine tablets were found to be bio-equivalent to levocarnitine oral solution. Following 4 days of dosing with 6 tablets of levocarnitine 330 mg b.i.d. or 2 g of levocarnitine oral solution b.i.d., the maximum plasma concentration (Cmax) was about 80 μmol/L and the time to maximum plasma concentration (Tmax) occurred at 3.3 hours.

The plasma concentration profiles of levocarnitine after a slow 3 minute intravenous bolus dose of 20 mg/kg of levocarnitine were described by a two-compartment model. Following a single i.v. administration, approximately 76% of the levocarnitine dose was excreted in the urine during the 0 -24h interval. Using plasma concentrations uncorrected for endogenous levocarnitine, the mean distribution half life was 0.585 hours and the mean apparent terminal elimination half life was 17.4 hours.

The absolute bioavailability of levocarnitine from the one oral formulation of levocarnitine, calculated after correction for circulating endogenous plasma concentrations of levocarnitine, was 15.1 ± 5.3% for levocarnitine tablets.

Total body clearance of levocarnitine (Dose/AUC including endogenous baseline concentrations) was a mean of 4.00 L/h.

Levocarnitine was not bound to plasma protein or albumin when tested at any concentration or with any species including the human.

In a pharmacokinetic study where five normal adult male volunteers received an oral dose of [3H-methyl]-L-carnitine following 15 days of a high carnitine diet and additional carnitine supplement, 58 to 65% of the administered radioactive dose was recovered in the urine and feces in 5 to 11 days. Maximum concentration of [3H-methyl]-L-carnitine in serum occurred from 2.0 to 4.5 hr after drug administration. Major metabolites found were trimethylamine N-oxide, primarily in urine (8% to 49% of the administered dose) and [3H]-γ-butyrobetaine, primarily in feces (0.44% to 45% of the administered dose). Urinary excretion of levocarnitine was about 4 to 8% of the dose. Fecal excretion of total carnitine was less than 1% of the administered dose.10

After attainment of steady state following 4 days of oral administration of levocarnitine tablets (1980 mg q12h) to 15 healthy male volunteers, the mean urinary excretion of levocarnitine during a single dosing interval (12h) was about 9% of the orally administered dose (uncorrected for endogenous urinary excretion).

Nonclinical Toxicology

There is limited information regarding Levocarnitine (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Levocarnitine (oral) Clinical Studies in the drug label.

How Supplied

• Levocarnitine tablets, USP are supplied as white, round compressed tablets debossed “cor” over “160” on one side and other side is plain.

• They are supplied as follows:

• Blister pack of 10 tablets, packaged in boxes of 90 tablets (NDC 64980-130-09).

Storage

• Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature].
• KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Levocarnitine (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Levocarnitine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Levocarnitine (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Levocarnitine (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.