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DIVALPROEX is a brand name for Valproate (also known as Valproic Acid), supplied as a tablet (delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DIVALPROEX (divalproex sodium delayed-release tablets) is indicated for: Epilepsy • 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…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 10/2022 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 ................................................................
5 1 INDICATIONS ......................................................................................................... 1 Pediatrics ......................................................................................................
2 Geriatrics ...................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................ 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................
6 4 DOSAGE AND ADMINISTRATION ............................................................................ 1 Dosing Considerations ................................................................................... 2 Recommended Dose and Dosage Adjustment ..............................................
4 Administration ............................................................................................ 5 Missed Dose ................................................................................................ 12 DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) Page 3 of 85 Unclassified / Non classifié 5 OVERDOSAGE ......................................................................................................
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). , low fibrinogen), platelet counts and coagulation tests are recommended before initiating therapy and at periodic intervals. It is recommended that patients receiving DIVALPROEX 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 the 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 (particularly elevated liver enzymes and thrombocytopenia) DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) Page 22 of 85 Unclassified / Non classifié 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).
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 delayed-release tablets (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 divalproex sodium and its derivatives.
1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 10/2022 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 ................................................................
5 1 INDICATIONS ......................................................................................................... 1 Pediatrics ......................................................................................................
2 Geriatrics ...................................................................................................... 5 2 CONTRAINDICATIONS ............................................................................................ 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................
6 4 DOSAGE AND ADMINISTRATION ............................................................................ 1 Dosing Considerations ................................................................................... 2 Recommended Dose and Dosage Adjustment ..............................................
4 Administration ............................................................................................ 5 Missed Dose ................................................................................................ 12 DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) Page 3 of 85 Unclassified / Non classifié 5 OVERDOSAGE ......................................................................................................
12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................... 12 7 WARNINGS AND PRECAUTIONS ........................................................................... 1 Special Populations:.....................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These incidences usually occurred during the first 6 months of treatment with divalproex sodium. Caution should be observed when administering DIVALPROEX 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 divalproex sodium as monotherapy. Similarly, patients aged 3 to 10 years were at somewhat greater risk if they received multiple anticonvulsants than those who received only divalproex sodium.
Above the age of 2 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 divalproex sodium alone.
DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) Page 23 of 85 Unclassified / Non classifié If DIVALPROEX is to be used for the control of seizures 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 DIVALPROEX should be avoided due to the risk of liver toxicity. 3 Pediatrics). Serious or fatal hepatotoxicity may be preceded by nonspecific symptoms such as, malaise, weakness, lethargy, facial edema, anorexia, and vomiting.
In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Patients and parents should be instructed to report such symptoms. Because of the nonspecific nature of some of the early signs, hepatotoxicity should be suspected in patients who become unwell, other than through obvious cause, while taking DIVALPROEX.
4 Drug-Drug Interactions, Table 4). 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 and albumin for decreases in concentration and serum ammonia for increases in concentration. If changes occur, DIVALPROEX should be discontinued. Dosage should be titrated to and maintained at the lowest dose consistent with optimal seizure control.
The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug. The frequency of adverse hepatic effects (particularly elevated liver enzymes) […]
1 Pregnant Women .................................................................................................. 2 Breast-feeding.......................................................................................................
3 Pediatrics .............................................................................................................. 4 Geriatrics ..............................................................................................................
37 8 ADVERSE REACTIONS ........................................................................................... 1 Adverse Reaction Overview ......................................................................... 2 Clinical Trial Adverse Reactions ....................................................................
3 Less Common Clinical Trial Adverse Reactions .............................................. 5 Post-Market Adverse Reactions ................................................................... 46 9 DRUG INTERACTIONS ...........................................................................................
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 ................................................................ 63 10 CLINICAL PHARMACOLOGY .................................................................................. 1 Mechanism of Action ...................................................................................
2 Pharmacodynamics ..................................................................................... 3 Pharmacokinetics ........................................................................................ 64 11 STORAGE, STABILITY AND DISPOSAL ....................................................................
66 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 66 PART II: SCIENTIFIC INFORMATION ................................................................................. 67 13 PHARMACEUTICAL INFORMATION .......................................................................
67 14 CLINICAL TRIALS ................................................................................................... 1 Trial Design and Study Demographics .......................................................... 3 Comparative Bioavailability […]