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VALPROIC ACID is a brand name for Valproate (also known as Valproic Acid), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VALPROIC ACID and VALPROIC ACID ORAL SOLUTION (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…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 09/2023 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 .......................................................................
4 1 INDICATIONS .................................................................................................................... 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................................................................................................................
10 5 OVERDOSAGE ................................................................................................................. 10
). • Sucrose or Fructose Intolerance 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). 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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION 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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION 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).
1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 09/2023 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 .......................................................................
4 1 INDICATIONS .................................................................................................................... 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................................................................................................................
10 5 OVERDOSAGE ................................................................................................................. 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING..................................... 11 VALPROIC ACID (Valproic Acid Capsules) Page 3 of 75 VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution) Unclassified / Non classifié 7 WARNINGS AND PRECAUTIONS ......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION 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 VALPROIC ACID (Valproic Acid Capsules) Page 21 of 75 VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution) Unclassified / Non classifié (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 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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION 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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION 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 VALPROIC ACID / VALPROIC ACID ORAL SOLUTION.
4 Drug-Drug Interactions, Table 3). However, physicians should not rely totally on serum biochemistry […]
1 Special Populations ..................................................................................................... 1 Pregnant Women ........................................................................................................
2 Breast-feeding ............................................................................................................ 3 Pediatrics ....................................................................................................................
4 Geriatrics .................................................................................................................... 35 8 ADVERSE REACTIONS ......................................................................................................
1 Adverse Reaction Overview ........................................................................................ 5 Post-Market Adverse Reactions .................................................................................. 40 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 .............................................................................. 54 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action .................................................................................................. 2 Pharmacodynamics .....................................................................................................
3 Pharmacokinetics........................................................................................................ 54 11 STORAGE, STABILITY AND DISPOSAL ...............................................................................
56 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 57 PART II: SCIENTIFIC INFORMATION ........................................................................................
58 13 PHARMACEUTICAL INFORMATION ................................................................................. 58 14 CLINICAL TRIALS ..............................................................................................................
3 Comparative Bioavailability Studies […]