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levocarnitine
Overview
What is CARNITOR?
CARNITOR (levocarnitine) is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
The chemical name of levocarnitine is 3-carboxy-2()-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder. It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is:
Empirical Formula: CHNO
Molecular Weight: 161.20
Each CARNITOR (levocarnitine) Tablet contains 330 mg of levocarnitine and the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone.
Each 118 mL container of CARNITOR (levocarnitine) Oral Solution contains 1 g of levocarnitine/10 mL. Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified Water, Sucrose Syrup. Methylparaben NF and Propylparaben NF are added as preservatives. The pH is approximately 5.
Each 118 mL container of CARNITOR SF (levocarnitine) Sugar-Free Oral Solution contains 1 g of levocarnitine/10 mL. Also contains: Natural Cherry Flavor, D,L,-Malic Acid, Purified Water, Sodium Saccharin USP. Methylparaben NF and Propylparaben NF are added as preservatives. The pH is approximately 5.
What does CARNITOR look like?
What are the available doses of CARNITOR?
Sorry No records found.
What should I talk to my health care provider before I take CARNITOR?
Sorry No records found
How should I use CARNITOR?
CARNITOR (levocarnitine) is 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 (see ). 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.
CARNITOR (levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
CARNITOR (levocarnitine) Tablets.
Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response.
Infants and children: 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.
Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.
CARNITOR (levocarnitine) Oral Solution and CARNITOR SF (levocarnitine) Sugar-Free Oral Solution.
For oral use only. Not for parenteral use.
Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of CARNITOR (levocarnitine) Oral Solution or CARNITOR SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.
Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day CARNITOR (levocarnitine) Oral Solution or CARNITOR SF (levocarnitine) Sugar-Free Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.
CARNITOR (levocarnitine) Oral Solution or CARNITOR SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.
What interacts with CARNITOR?
Sorry No Records found
What are the warnings of CARNITOR?
Sorry No Records found
What are the precautions of CARNITOR?
Sorry No Records found
What are the side effects of CARNITOR?
Sorry No records found
What should I look out for while using CARNITOR?
None known.
What might happen if I take too much CARNITOR?
There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD of levocarnitine in rats is 5.4 g/kg and the oral LD of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.
How should I store and handle CARNITOR?
CARNITOR (levocarnitine) Tablets are supplied as 330 mg tablets embossed with “CARNITOR ST” in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.CARNITOR (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-145-08). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-148-01). Store at controlled room temperature (25°C). See USP. CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.Rx only.CARNITOR (levocarnitine) Tablets are supplied as 330 mg tablets embossed with “CARNITOR ST” in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.CARNITOR (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-145-08). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-148-01). Store at controlled room temperature (25°C). See USP. CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.Rx only.CARNITOR (levocarnitine) Tablets are supplied as 330 mg tablets embossed with “CARNITOR ST” in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.CARNITOR (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-145-08). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-148-01). Store at controlled room temperature (25°C). See USP. CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.Rx only.CARNITOR (levocarnitine) Tablets are supplied as 330 mg tablets embossed with “CARNITOR ST” in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc.CARNITOR (levocarnitine) Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-145-08). Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL. OZ.) plastic containers (NDC 54482-148-01). Store at controlled room temperature (25°C). See USP. CARNITOR SF (levocarnitine) Sugar-Free Oral Solution is manufactured for Leadiant Biosciences, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.Rx only.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
Primary systemic carnitine deficiency is characterized by low concentrations of levocarnitine in plasma, RBC, and/or tissues. It has not been possible to determine which symptoms are due to carnitine deficiency and which are due to an underlying organic acidemia, as symptoms of both abnormalities may be expected to improve with CARNITOR. The literature reports that carnitine can promote the excretion of excess organic or fatty acids in patients with defects in fatty acid metabolism and/or specific organic acidopathies that bioaccumulate acylCoA esters.
Secondary carnitine deficiency can be a consequence of inborn errors of metabolism. CARNITOR may alleviate the metabolic abnormalities of patients with inborn errors that result in accumulation of toxic organic acids. Conditions for which this effect has been demonstrated are: glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency. Autointoxication occurs in these patients due to the accumulation of acylCoA compounds that disrupt intermediary metabolism. The subsequent hydrolysis of the acylCoA compound to its free acid results in acidosis which can be life-threatening. Levocarnitine clears the acylCoA compound by formation of acylcarnitine, which is quickly excreted. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 µmol/L at one week post term and may be associated with low tissue and/or urine concentrations. Further, this condition may be associated with a plasma concentration ratio of acylcarnitine/levocarnitine greater than 0.4 or abnormally elevated concentrations of acylcarnitine in the urine. In premature infants and newborns, secondary deficiency is defined as plasma levocarnitine concentrations below age-related normal concentrations.
Non-Clinical Toxicology
None known.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.
CARNITOR (levocarnitine) Oral Solution and CARNITOR SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only.
The following adverse reactions associated with the use of oral formulations of levocarnitine were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliability, or to establish a causal relationship to drug exposure.
Gastrointestinal Reactions:
Musculoskeletal Reactions
Neurologic Reactions
Hypersensitivity Reactions
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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