PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Pagkage Label. Principal Display Panel. NDC 85551-122-30 Levocarnitine Injection 500 mg/mL For Intravenous Administration30 mL Multi-Dose VialRx OnlySterile, Preservative-Containing SolutionEach mL contains: Levocarnitine 500 mg, Benzyl Alcohol 2%, Sterile Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Store at USP Controlled Room Temperature 20C to 25C (68F to 77F). Protect from light and freezing.Compounded by: Xseer Pharmaceuticals 1990 Westwood Blvd., Suite 300 Los Angeles, CA 90025 Phone: (888) 658-8005 Lot Exp. Date: To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.. Front label.

STORAGE AND HANDLING SECTION.

Storage and Handling. Store at USP Controlled Room Temperature, 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F to 86F).Protect from light and from deep freezing. Do not freeze.Inspect visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the solution is cloudy, discolored, or contains visible particles.This product is supplied as sterile multiple-dose vial for intravenous administration. Use aseptic technique when entering the vial. Discard unused portion in accordance with institutional procedures and applicable regulations.Keep out of reach of children.

DESCRIPTION SECTION.

Description. Levocarnitine Injection is sterile, nonpyrogenic injectable solution containing 500 mg/mL of Levocarnitine in Sterile Water for Injection. The formulation contains benzyl alcohol 2% as preservative, with pH adjusted to 5.0-6.5 using Hydrochloric Acid and/or Sodium Hydroxide.Each mL contains:Levocarnitine 500 mg Benzyl Alcohol 2% Sterile Water for Injection q.s. The solution is supplied as multiple-dose vial for intravenous administration by licensed healthcare professional.Levocarnitine is naturally occurring amino acid derivative involved in fatty acid metabolism and mitochondrial energy production. This compounded sterile preparation is intended for office or clinical use only.

COMPONENTS.

Components. Active Ingredient:Levocarnitine 500 mg/mLInactive Ingredients:Benzyl Alcohol 2% (preservative) Sterile Water for Injection pH Adjusters:Hydrochloric Acid and/or Sodium Hydroxide may be used to adjust pH to 5.0-6.5.

CONTRAINDICATIONS SECTION.

Contraindications. Levocarnitine Injection is contraindicated in:Patients with known hypersensitivity to Levocarnitine, benzyl alcohol, or any component of the formulation. Neonates, premature infants, or low birth weight infants due to the risk of benzyl alcohol toxicity (gasping syndrome). Patients with history of serious hypersensitivity reactions associated with Levocarnitine administration. Patients in whom administration of hypertonic intravenous solutions may result in clinically significant complications unless closely monitored by healthcare professional.

WARNINGS AND PRECAUTIONS SECTION.

Warnings and Precautions. For intravenous administration under the supervision of licensed healthcare professional. Monitor patients for hypersensitivity reactions, including rash, urticaria, dyspnea, hypotension, or anaphylactoid reactions. Discontinue administration if serious reactions occur. Contains benzyl alcohol 2% as preservative. Benzyl alcohol has been associated with serious adverse reactions, including fatal gasping syndrome, in neonates and premature infants. Use with caution in patients with seizure disorders, as seizures have been reported in patients receiving Levocarnitine. Use caution in patients with renal impairment or compromised renal function, as accumulation of metabolites may occur. Rapid intravenous administration may increase the risk of adverse reactions such as nausea, vomiting, abdominal discomfort, headache, flushing, or dizziness. Intravenous administration should be performed cautiously to minimize infusion-related reactions or vein irritation. Protect from light and from deep freezing. Do not use if the solution is discolored, cloudy, or contains particulate matter. Use aseptic technique when entering the multiple-dose vial. Discard unused portion according to institutional policy and applicable regulations.