Levocarnitine 1 g/5mL
Levocarnitine · INJECTION · Hikma Pharmaceuticals USA Inc.
Levocarnitine is a injection containing levocarnitine at 1 g/5mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Levocarnitine
- Generic Name
- Levocarnitine
- NDC Code (Product)
0143-9852- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 1 g/5mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA075567
- Drug Class
- Carnitine Analog [EPC]
- Marketing Start
- 06/01/2023
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Medistat RX L.L.C.
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
John W Hollis Inc
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Pharm D Solutions, LLC
Lack of Assurance of Sterility
John W Hollis Inc
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Well Care Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
John W Hollis Inc
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
American Regent, Inc.
Labeling: Missing Label
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Levocarnitine oral solution 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. Levocarnitine oral solution is also indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 levocarnitine 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 levocarnitine 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 conce…
Warnings
WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral levocarnitine. 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 levocarnitine 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 levocarnitine 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-carnitine. Neurologic Reactions : Seizures have been reported to occur i…
Frequently Asked Questions
What is Levocarnitine used for?
Levocarnitine contains Levocarnitine. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Levocarnitine a controlled substance?
Levocarnitine is not classified as a controlled substance by the DEA.
What is the generic name for Levocarnitine?
The generic name for Levocarnitine is Levocarnitine. There are 4 other brand versions of Levocarnitine.
What is the NDC code for Levocarnitine 1 g/5mL?
The NDC (National Drug Code) for Levocarnitine 1 g/5mL is 0143-9852, listed by Hikma Pharmaceuticals USA Inc..