Pronunciation:

(lee voe KAR ni teen)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Oral: Primary systemic carnitine deficiency; acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency

I.V.: Acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency; prevention and treatment of carnitine deficiency in patients with end-stage renal disease (ESRD) who are undergoing hemodialysis.

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Warnings/Precautions:

Adverse Reactions:

Cardiovascular: Hypertension (18% to 21%), peripheral edema (3% to 6%)

Central nervous system: Dizziness (10% to 18%), fever (5% to 12%), paresthesia (3% to 12%), depression (5% to 6%)

Endocrine & metabolic: Hypercalcemia (6% to 15%)

Gastrointestinal: Diarrhea (9% to 35%), abdominal pain (5% to 21%), vomiting (9% to 21%), nausea (5% to 12%)

Neuromuscular & skeletal: Weakness (9% to 12%)

Miscellaneous: Allergic reaction (2% to 6%)

Overdosage/Toxicology:

Drug Interactions:

Stability:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Metabolism: Hepatic (limited with moderate renal impairment), to trimethylamine (TMA) and trimethylamine N-oxide (TMAO)

Bioavailability: Tablet/solution: 15% to 16%

Half-life elimination: 17.4 hours

Time to peak: Tablet/solution: 3.3 hours

Excretion: Urine (4% to 9% as unchanged drug); metabolites also eliminated in urine

Dosage:

Oral:

Infants/Children: Initial: 50 mg/kg/day; titrate to 50-100 mg/kg/day in divided doses with a maximum dose of 3 g/day

Adults: 990 mg (oral tablets) 2-3 times/day or 1-3 g/day (oral solution)

I.V.:

Metabolic disorders: 50 mg/kg as a slow 2- to 3-minute I.V. bolus or by I.V. infusion

Severe metabolic crisis:

A loading dose of 50 mg/kg over 2-3 minutes followed by an equivalent dose over the following 24 hours administered as every 3 hours or every 4 hours (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 parenteral therapy accompanied by weekly and monthly monitoring

ESRD patients on hemodialysis:

Predialysis levocarnitine concentrations below normal (40-50 mol/L): 10-20 mg/kg dry body weight as a slow 2- to 3-minute bolus after each dialysis session

Dosage adjustments should be guided by predialysis trough levocarnitine concentrations and downward dose adjustments (to 5 mg/kg after dialysis) may be made as early as every 3rd or 4th week of therapy

Note: Safety and efficacy of oral carnitine have not been established in ESRD. Chronic administration of high oral doses to patients with severely compromised renal function or ESRD patients on dialysis may result in accumulation of metabolites.

Administration:

Oral: Solution may be dissolved in either drink or liquid food, and should be consumed slowly. Doses should be spaced every 3 to 4 hours throughout the day, preferably during or following meals.

I.V.: Hemodialysis patients: Injection should be administered over 2-3 minutes into the venous return line after each dialysis session.

Monitoring Parameters:

Reference Range:

Patient Education:

Oral: Take exactly as directed; do not alter dose or frequency except as directed by prescriber. Dissolve solution in any liquid and drink with or following meals. The oral solution should be consumed slowly and spaced evenly throughout the day to improve tolerance. You may experience abdominal pain, nausea, or vomiting (small, frequent meals, chewing gum, or sucking hard candy); diarrhea (yogurt, boiled milk, or buttermilk may help); or dizziness (use caution driving or engaging in hazardous activities until response to drug is known). Report acute headache, chest pain, tremors, or visual changes; muscle or skeletal weakness; skin rash; swelling of extremities; or other adverse effects. Breast-feeding precaution: Consult prescriber if breast-feeding.

Nursing Implications:

Additional Information:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

Capsule: 250 mg

Injection, solution (Carnitor®): 200 mg/mL (5 mL)

Solution, oral (Carnitor®): 100 mg/mL (118 mL) [cherry flavor]

Tablet: 500 mg

Carnitor®: 330 mg

International Brand Names: