Levocarnitine

Indicated for the treatment of primary and secondary carnitine deficiency in adults, children, infants and neonates. Secondary carnitine deficiency in haemodialysis patients. Secondary carnitine deficiency should be suspected in long-term haemodialysis patients who have the following conditions: 1.

Severe and persistent muscle cramps and/or hypotensive episodes during dialysis. 2. Lack of energy causing a significant negative effect on the quality of life. 3. Skeletal muscle weakness and/or myopathy. 4. Cardiomyopathy. 5. Anaemia of uraemia unresponsive to or requiring large doses of erythropoietin.

6. Muscle mass loss caused by malnutrition.

AND CLINICAL USE ............................................................................. 3 WARNINGS AND PRECAUTIONS ..................................................................................... 10 DOSAGE AND ADMINISTRATION .............................................................................

11 STORAGE AND STABILITY ......................................................................................... 15 CLINICAL TRIALS ..............................................................................................................

20 ODAN LEVOCARNITINE Product Monograph Page 3 of 21 ODAN LEVOCARNITINE Levocarnitine Oral Solution, USP 100 mg/mL PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral Solution 1 g / 10 mL (100 mg / mL) Wild Cherry Flavor, D,L-Malic Acid, Methylparaben, Propylparaben, Purified Water, Sucrose Syrup INDICATIONS AND CLINICAL USE ODAN LEVOCARNITINE (levocarnitine oral solution) is indicated for:  Treatment of primary systemic carnitine deficiency Acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms.

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.