CARNITOR 330 mg/1
levocarnitine · TABLET · Leadiant Biosciences, Inc.
Carnitor is an oral tablet containing levocarnitine, a carnitine analog used to treat carnitine deficiency. It works by helping your body produce energy in cells and may be prescribed for certain medical conditions where carnitine levels are low.
Key Facts
- Brand Name
- CARNITOR
- Generic Name
- levocarnitine
- NDC Code (Product)
54482-144- Manufacturer
- Leadiant Biosciences, Inc.
- Strength
- 330 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA018948
- Drug Class
- Carnitine Analog [EPC]
- Marketing Start
- 12/27/1985
Recall History
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 CLINICAL PHARMACOLOGY ). 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 tole…
Warnings
WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral CARNITOR ® . Other serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following intravenous levocarnitine administration, mostly in patients with end stage renal disease undergoing dialysis. Discontinue use of CARNITOR ® and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
Contraindications
CONTRAINDICATIONS None known.
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.
Adverse Reactions
ADVERSE REACTIONS 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 : 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. Gastrointestinal adverse reactions with CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution dissolved in liquids might be avoided by a slow consumption of the solution or by a greater dilution. 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. Musculoskeletal Reactions : Mild myasthenia has been described only in uremic patients receiving D,L-…
Frequently Asked Questions
What is CARNITOR used for?
Carnitor is an oral tablet containing levocarnitine, a carnitine analog used to treat carnitine deficiency. It works by helping your body produce energy in cells and may be prescribed for certain medical conditions where carnitine levels are low.
Is CARNITOR a controlled substance?
CARNITOR is not classified as a controlled substance by the DEA.
What is the generic name for CARNITOR?
The generic name for CARNITOR is levocarnitine. There are 11 other brand versions of levocarnitine.
What is the NDC code for CARNITOR 330 mg/1?
The NDC (National Drug Code) for CARNITOR 330 mg/1 is 54482-144, listed by Leadiant Biosciences, Inc..