levocarnitine
levocarnitine is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including levocarnitine, CARNITOR, Carnitor. Available dosage forms: injection, solution, powder, tablet, solution.
Drug Details
- Generic Name
- levocarnitine
- Brand Names
- levocarnitine, CARNITOR, Carnitor, Carnitor SF
- Application Number
- ANDA217430
- Sponsor
- Devatis Inc.
- NDC Codes
- 7
- Dosage Forms
- INJECTION, SOLUTION, POWDER, TABLET, SOLUTION
- Routes
- INTRAVENOUS, ORAL
- Active Ingredients
- LEVOCARNITINE
Indications and Usage
INDICATIONS AND USAGE For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
Warnings
WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine administration, mostly in patients with end stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine. If a severe hypersensitivity reaction occurs, discontinue levocarnitine treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering levocarnitine to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.