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ODAN LEVOCARNITINE is a brand name for Levocarnitine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General ODAN LEVOCARNITINE (levocarnitine oral solution) contains sucrose. Consideration should be given when used in diabetic patients and those on a low calorie diet. Carcinogenesis and Mutagenesis No human data are available. See TOXICOLOGY section.
Gastrointestinal Rapid consumption of ODAN LEVOCARNITINE may result in gastrointestinal reactions. Renal The safety and efficacy of oral levocarnitine have not been evaluated in patients with renal insufficiency. The chronic use of, or administration of high doses in excess of 1 gram per dose of the oral formulations of levocarnitine for long periods of time, are not recommended in patients with severely compromised renal function or in ESRD patients on dialysis due to the fact that major metabolites formed following oral administration (trimethylamine [TMA] and trimethylamine-N- oxide [TMAO]) will accumulate.
Increased levels of TMA in dialysis patients have been reported to be associated with possible neurophysiologic effects. Also, the inefficient removal of TMA may result in the development of “fish odor” syndrome. In ESRD patients on hemodialysis, only the intravenous form of levocarnitine is indicated for use.
8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to levocarnitine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Women:
Levocarnitine has not been studied in lactating women. Levocarnitine should only be used by nursing mothers if benefit to the mother outweighs any potential risks to the child from excess carnitine exposure. Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine.
In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to ODAN LEVOCARNITINE Product Monograph Page 5 of 21 discontinuation of nursing or of levocarnitine treatment.
Geriatrics (> 65 years of age):
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Limited data are available therefore ODAN LEVOCARNITINE should be used with caution in these patients.
Pediatrics (<18 years of age):
The evaluation of carnitine in primary and secondary carnitine deficiency included pediatric patients. Evidence from clinical studies and experience suggests that use in the pediatric population is not associated with differences in safety or efficacy.
Monitoring and Laboratory Tests Reports of International Normalised Ratio (INR):
INR levels should be monitored in patients treated concomitantly with levocarnitine and anticoagulant drugs1, 6. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.
ADVERSE REACTIONS Adverse Drug Reaction Overview 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.
Mild myasthenia has been described only in uremic patients receiving D,L-carnitine. 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. Seizures have been reported to occur in patients with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine.
In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. ODAN LEVOCARNITINE Product Monograph Page 6 of 21 The table below lists the adverse events that have been reported in two double-blind, placebo- controlled trials in patients on chronic hemodialysis.
Events occurring at ≥5% are reported without regard to causality. Table 1 % of Patients With Adverse Events Occurring at a Frequency ≥5% Regardless of Causality by Body System Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5 3 3 2 Atrial fibrillation 2 6 2 Cardiovascular disorder 6 3 5 6 5 Electrocardiogram abnormal 3 6 2 Hemorrhage 6 9 2 3 4 Hypertension 14 18 21 21 20 Hypotension 19 15 19 3 14 Palpitations 3 8 5 Tachycardia 5 6 5 9 6 Vascular disorder 2 2 6 2 Digestive Anorexia 3 3 5 6 5 Constipation 6 3 3 3 3 Diarrhea 19 9 10 35 16 Dyspepsia 10 9 6 5 ODAN LEVOCARNITINE Product Monograph Page 7 of 21 Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Gastrointestinal disorder 2 3 6 2 Melena 3 6 2 Nausea 10 9 5 12 8 Stomach atony 5 Vomiting 16 9 16 21 15 Endocrine System Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic Anemia 3 3 5 12 6 […]