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ODAN-VALPROIC ACID is a brand name for Valproate (also known as Valproic Acid), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ODAN-VALPROIC ACID (valproic acid) is indicated for: • use as sole or adjunctive therapy in the treatment of simple or complex absence seizures, including petit mal, and is useful in primary generalized seizures with tonic-clonic manifestations. • use adjunctively in patients with multiple seizure types which include…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients receiving combined antiepileptic therapy require careful monitoring when another agent is started, stopped or when the dose is altered (see 9 DRUG INTERACTIONS). As the dosage of ODAN-VALPROIC ACID (valproic acid) is titrated upward, blood concentrations of phenobarbital, and/or phenytoin may be affected (see 9 DRUG INTERACTIONS).
Antiepileptic drugs (AEDs) should not be abruptly discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.
Any changes in dosage and administration, or the addition or discontinuance of concomitant drugs, should ordinarily be accompanied by close monitoring of clinical status and valproate plasma concentrations. , carbamazepine) or other drugs with valproate interactions, (see 9 DRUG INTERACTIONS), it is advisable to monitor serum valproate concentrations.
Dosing in Elderly Patients:
ODAN-VALPROIC ACID, valproic acid Product Monograph Page 7 of 58 Unclassified / Non classifié Due to a decrease in unbound clearance of valproate and possibly a greater sensitivity to somnolence in the elderly, the starting dose should be reduced.
Dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, urinary tract infection, and other adverse events. Dose reductions or discontinuation of ODAN-VALPROIC ACID should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence.
4 Geriatrics).
Dose-Related Adverse Events:
The frequency of adverse events (particularly elevated liver enzymes and thrombocytopenia) may be dose related. The probability of thrombocytopenia appears to increase significantly at total valproate concentration of ≥ 110 mcg/mL [females] or ≥ 135 mcg/mL [males] (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Dose-related Adverse Events: Thrombocytopenia).
Therefore, the benefit of improved therapeutic effect with higher doses should be weighed against the possibility of a greater incidence of adverse effects. Female children, women of childbearing potential and pregnant women with epilepsy Valproic Acid treatment must be initiated and supervised by a specialist experienced in the management of epilepsy.
). • Sucrose or Fructose Intolerance ODAN-VALPROIC ACID oral solution contains sucrose, which may be harmful to the teeth. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.
When prescribing to diabetic patients, the sucrose content should be taken into account (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). ODAN-VALPROIC ACID, valproic acid Product Monograph Page 16 of 58 Unclassified / Non classifié ODAN-VALPROIC ACID oral solution contains sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. , low fibrinogen), platelet counts and coagulation tests are recommended before initiating therapy and at periodic intervals. It is recommended that patients receiving ODAN-VALPROIC ACID be monitored for platelet count and coagulation parameters prior to planned surgery.
Clinical evidence of hemorrhage, bruising or a disorder of hemostasis/coagulation is an indication for reduction of ODAN-VALPROIC ACID dosage or withdrawal of therapy (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Dose-related Adverse Events: Thrombocytopenia).
• Dose-related Adverse Events: Thrombocytopenia The frequency of adverse effects thrombocytopenia (particularly elevated liver enzymes and thrombocytopenia) may be dose-related. In a clinical trial of divalproex sodium as monotherapy in patients with epilepsy, 34/126 patients (27%) receiving approximately 50 mg/kg/day on average, had at least one value of platelets ≤ 75 x 109/L.
Approximately half of these patients had treatment discontinued with return of platelet counts to normal. In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of ≥ 110 mcg/mL (females) or ≥ 135 mcg/mL (males).
, Use in males of reproductive potential 10/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS...................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................... 1 Pediatrics ......................................................................................................................
2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS .....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................... 5 4 DOSAGE AND ADMINISTRATION ..................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .............................................................................................................. 5 Missed Dose ...............................................................................................................
8 5 OVERDOSAGE ......................................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSI TION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS.....................................................................................
and 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Serious or Fatal Hepatotoxicity for statement regarding serious or fatal hepatic dysfunction. 1 Pediatrics Pediatrics (< 18 years of age): When ODAN-VALPROIC ACID is used in children under the age of 2 years, it should be used with extreme caution and as a sole agent.
Above the age of 2 years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. 3 Pediatrics. 2 Geriatrics Geriatrics (≥ 65 years of age): The safety and efficacy of valproic acid in elderly patients with epilepsy has not been evaluated in clinical trials.
Caution should thus be exercised in dose selection for an elderly patient, recognizing the more frequent hepatic and renal dysfunctions, and limited experience with valproic acid in this population. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics.
2 CONTRAINDICATIONS ODAN-VALPROIC ACID (valproic acid) is contraindicated in: • Patients with known hypersensitivity to the drug, any ingredient in the formulation or component of the container. For a complete listing of ingredients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
• in pregnancy unless there is no suitable alternative treatment (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Pregnant Women). Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Program (see 7 WARNINGS AND PRECAUTIONS, Pregnancy Prevention Program). In the exceptional circumstance when valproate is the only treatment option during pregnancy in epileptic women, valproic acid should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation.
During pregnancy, the daily dose of immediate release formulations should be divided into at least two single doses. Available data show an increased risk of major congenital malformations and neurodevelopmental disorders in the children of mothers treated during pregnancy with either valproate monotherapy or valproate polytherapy, compared to the population not exposed to valproate.
Male patients of reproductive potential The prescribers should discuss with the patient the need for effective contraception, including for the female partner, while using valproate and for 3 months after stopping the treatment. , allowing a new spermatogenesis without valproate exposure) is not known.
The male patient should also be informed about the need for regular (at least annual) review of treatment by a specialist experienced in the management of epilepsy. The specialist should at least annually review whether valproate is the most suitable treatment for the patient.
During this review, the specialist should ensure the male patient has acknowledged the risk and understood the precautions needed with valproate use (Annual Risk Acknowledgement Form). Educational materials are available for healthcare professionals and male patients.
A patient guide should be provided to all men of reproductive potential using valproate. 1 Recommended Dose and Dosage Adjustment ODAN-VALPROIC ACID (valproic acid) is administered orally. The recommended initial dosage is 15 ODAN-VALPROIC ACID, valproic acid Product Monograph Page 8 of 58 Unclassified / Non classifié mg/kg/day, increasing at one-week intervals by 5 to 10 mg/kg/day until seizures are controlled or side effects preclude further increases.
The maximum recommended dosage is 60 mg/kg/day. When the total daily dose exceeds 250 mg, it should be given in a divided regimen (Table 1). 9 1,250 2 1 2 Therapeutic Blood Levels: A good correlation has not been established between daily dose, total serum valproate concentration and therapeutic effect.
However, therapeutic valproate serum concentrations for most patients with epilepsy will range from 50 to 100 mcg/mL (350 to 700 micromole/L). Some patients may be controlled with lower or higher serum concentrations (see 7 […]
In addition, the findings from a crossover clinical trial conducted with divalproex sodium extended-release tablets, in 44 epilepsy patients, indicate that the frequency of treatment- emergent mild thrombocytopenia (platelet count between 100 to150 x 109/L) was significantly higher after 12 weeks of treatment with divalproex sodium extended-release tablets than after 12 weeks of treatment with divalproex sodium (7 versus 3 low counts, respectively).
The therapeutic benefit which may accompany the higher doses should therefore be weighed against the possibility of a greater incidence of adverse events. Hepatic/Biliary/Pancreatic: • Serious or Fatal Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives.
These incidences usually have occurred during the first 6 months of treatment with valproic acid. Caution should be observed when administering ODAN-VALPROIC ACID to patients with a prior history of hepatic disease. Patients on multiple anticonvulsants, children, those with congenital metabolic disorders including mitochondrial disorders such as carnitine deficiency, urea cycle disorders, POLG mutations (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Urea Cycle Disorders and Risk of Hyperammonemia, Patients at Risk of Hypocarnitinemia and, Hepatic/Biliary/Pancreatic: Patients with Mitochondrial Disease), those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk.
Experience has indicated that children under the age of 2 years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease.
The risk in this age group decreased considerably in patients receiving valproic acid as monotherapy. Similarly, patients aged 3 to 10 years were at somewhat greater risk if they received multiple anticonvulsants than those who received only valproic acid.
Above the age of 2 ODAN-VALPROIC ACID, valproic acid Product Monograph Page 17 of 58 Unclassified / Non classifié years, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patients.
No deaths have been reported in patients over 10 years of age who received valproic acid alone. If ODAN-VALPROIC ACID is to be used in children 2 years old or younger, it should be used with extreme caution and as a sole agent. In this patient population, concomitant use of salicylates and ODAN- VALPROIC ACID should be avoided due to the risk of liver toxicity.
3 Pediatrics). Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as loss of seizure control, malaise, weakness, lethargy, facial edema, anorexia, and vomiting. Patients should be monitored closely for appearance of these symptoms.
Patients and parents should be instructed to report such symptoms. Because of the non-specific nature of some of the early signs, hepatotoxicity should be suspected in patients who become unwell, other than through obvious cause, while taking ODAN-VALPROIC ACID.
4 Drug- Drug Interactions, Table 3). However, physicians should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.
In high-risk patients, it might also be useful to monitor serum fibrinogen […]
1 Pregnant Women ........................................................................................... 2 Breast-feeding ......................................................................................................... 3 Pediatrics ......................................................................................................................
4 Geriatrics ...................................................................................................................... 27 8 ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview .................................................................................. 5 Post-Market Adverse Reactions ............................................................................... 1 Serious Drug Interactions .........................................................................................
2 Drug Interactions Overview .................................................................................. 3 Drug-Behavioural Interactions ................................................................................. 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions ............................................................................................ 6 Drug-Herb Interactions.............................................................................................
7 Drug-Laboratory Test Interactions ........................................................................... 43 10 CLINICAL PHARMACOLOGY .......................................................................................... 2 Pharmacodynamics ......................................................................................................
3 Pharmacokinetics ......................................................................................................... 44 11 STORAGE, STABILITY AND DISPOSAL .................................................................................
45 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 45 PART II: SCIENTIFIC INFORMATION ...........................................................................................
46 13 PHARMACEUTICAL INFORMATION ............................................................................. 46 16 NON-CLINICAL TOXICOLOGY.......................................................................................... 46 17 SUPPORTING PRODUCT MONOGRAPHS ..........................................................................................
49 PATIENT MEDICATION INFORMATION ...................................................................................... 50 ODAN-VALPROIC ACID, valproic acid Product Monograph Page 4 of 58 Unclassified / Non classifié PART I: HEALTH […]