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PRO-TOPIRAMATE is a brand name for Topiramate, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EPILEPSY PRO-TOPIRAMATE (topiramate) is indicated: as monotherapy for the management of patients (adults and children six years and older) with newly diagnosed epilepsy. as adjunctive therapy for the management of patients (adults and children two years and older) with epilepsy who are not satisfactorily…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients with renal impairment Patients undergoing hemodialysis Patients with hepatic disease Prophylactic treatment of migraine: In pregnancy, the occurrence of seizures presents a significant risk for the mother and child.
Prescribing PRO-TOPIRAMATE to prevent seizures therefore outweighs the risk of malformations to the fetus. However, taking PRO- TOPIRAMATE to prevent migraine attacks does not outweigh this risk. Consequently, PRO- TOPIRAMATE is contraindicated in pregnancy and in women of child-bearing potential who are not using a highly effective method of contraception (see 2 CONTRAINDICATIONS).
2 Recommended Dose and Dosage Adjustment PRO-TOPIRAMATE (topiramate) Tablets can be taken without regard to meals. EPILEPSY Monotherapy Adults and Children (Age 6 years and older) The recommended initial target dose for topiramate monotherapy in adults and children six years of age and older is 100 mg/day and the maximum recommended dose is 400 mg/day, administered in two divided doses, as needed and tolerated.
Table 1:
Recommended titration rate for topiramate monotherapy to 100 mg/day Week 1 Weeks 2 – 3 Weeks 3 – 4 Morning Dose None 25 mg 50 mg Evening Dose 25 mg 25 mg 50 mg If doses above 100 mg/day are required, the dose may be increased at weekly intervals in increments of 50 mg/day to a maximum of 400 mg/day.
Dose and titration rate should be guided by clinical outcome. Some patients may benefit from a slower titration schedule. Daily doses above 400 mg have not been adequately studied. 1 Clinical Trial Adverse Reactions – Pediatrics, Table 9).
PRO-TOPIRAMATE (topiramate) Page 6 of 84 Adjunctive Therapy Adults (Age 17 years and older) It is recommended that PRO-TOPIRAMATE as adjunctive therapy be initiated at 50 mg/day, followed by titration as needed and tolerated to an effective dose.
At weekly intervals, the dose may be increased by 50 mg/day and taken in two divided doses. , 25 mg and/or a slower titration schedule. Some patients may achieve efficacy with once-a-day dosing. The recommended total daily maintenance dose is 200 to 400 mg/day in two divided doses.
Doses above 400 mg/day have not been shown to improve responses and have been associated with a greater incidence of adverse events. The maximum recommended dose is 800 mg/day. Daily doses above 1,600 mg have not been studied. Children (Ages 2 – 16 years) It is recommended that PRO-TOPIRAMATE as adjunctive therapy be initiated at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week followed by titration as needed and tolerated to an effective dose.
). Open-Label Epilepsy Trial In an open-label, adjunctive therapy, epilepsy trial, increasing impairment of adaptive behaviour was documented in behavioural testing over time in children under two years of age. There was a suggestion that this effect was dose-related.
However, because of the absence of an appropriate control group, it is not known if this decrement in function was treatment- related or reflects the patient’s underlying disease. For example, patients who received higher doses may have more severe underlying disease.
In this open-label, uncontrolled study, the mortality was 37 deaths/1,000 patient years. It is not possible to know whether this mortality rate is related to topiramate treatment, because the background mortality rate for a similar, significantly refractory, young pediatric population under two years with partial epilepsy is not known.
Safety and efficacy of topiramate for the monotherapy treatment of partial onset seizures or any other type of epilepsy in patients under two years of age have not been established. PRO-TOPIRAMATE (topiramate) Page 27 of 84 MIGRAINE PROPHYLAXIS Although not indicated for migraine prophylaxis in patients under 18 years of age (see 1 INDICATIONS), in a double-blind, placebo-controlled trial of migraine prophylaxis in patients 12 to 16 years, topiramate treatment produced a dose-related increased shift in serum creatinine from normal at baseline to an increased value at the end of 4 months.
The incidence of these abnormal shifts was 4% for placebo, 4% for 50 mg, and 18% for 100 mg.
Weight Loss in Pediatrics (> 2 years of age):
Topiramate administration is associated with weight loss in some children that generally occurs early in therapy. Of those pediatric subjects treated in clinical trials for at least a year who experienced weight loss, 96% showed a resumption of weight gain within the period tested.
1 Pregnant Women 12/2023 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 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, COMPOSITION AND PACKAGING ....................................... 9 7 WARNINGS AND PRECAUTIONS .......................................................................................
PRO-TOPIRAMATE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
1 Pregnant Women).
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The dosage should then be increased at one- or two-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses). Some patients may benefit from lower initial doses and/or a slower titration schedule. The recommended total daily maintenance dose is approximately 5 to 9 mg/kg/day in two divided doses.
Drug Discontinuation In patients with a history of seizures or epilepsy, PRO-TOPIRAMATE should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In clinical trials, daily dosages were decreased in weekly intervals by 50 to 100 mg in adults with epilepsy.
In clinical trials of children, topiramate was gradually withdrawn over a two- to eight-week period. In situations where rapid withdrawal of PRO-TOPIRAMATE is medically required, appropriate monitoring is recommended. MIGRAINE PROPHYLAXIS Adults The usual total daily dose of PRO-TOPIRAMATE as treatment for prophylaxis of migraine headache is 100 mg/day administered in two divided doses.
Dose and titration rate should be guided by clinical outcome. If required, longer intervals between dose adjustments can be used. 2 Clinical Trial Adverse Reactions, Table 8).
PRO-TOPIRAMATE (topiramate) Page 7 of 84 Table 2:
Recommended Titration Rate for Topiramate for Migraine Prophylaxis to 100 mg/day Morning Dose Evening Dose Week 1 None 25 mg Week 2 25 mg 25 mg Week 3 25 mg 50 mg Week 4 50 mg 50 mg Drug Discontinuation In patients without a history of seizures or epilepsy, PRO-TOPIRAMATE should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
In clinical trials, daily dosages were decreased in weekly intervals by 25 – 50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis. In situations where rapid withdrawal of PRO-TOPIRAMATE is medically required, appropriate monitoring is recommended.
Pediatrics The safety and efficacy of topiramate in the management or prevention of migraine in pediatrics have not been studied. Health Canada has not authorized an indication for pediatric use. 73 m2), one-half of the usual adult dose is recommended.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). Patients Undergoing Hemodialysis Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an antiseizure effect.
To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of PRO-TOPIRAMATE may be required. The supplemental dose should take into account 1) the duration of dialysis, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of […]
1). 0). Weight decreases, usually associated with anorexia or appetite changes, were reported as adverse events for 9% of patients treated with topiramate. The long-term effects of reduced weight gain in pediatric patients are not known.
4 Geriatrics There is limited information in patients over 65 years of age. The possibility of age-associated renal function abnormalities should be considered when using PRO-TOPIRAMATE. 3 Pharmacokinetics, Special Populations and Conditions).
1 Adverse Reaction Overview The majority of the most common adverse events in clinical trials were mild to moderate in severity and dose-related. These dose-related adverse events typically began in the titration phase and often persisted into the maintenance phase, but infrequently began in the maintenance phase.
Rapid titration rate and higher initial dose were associated with higher incidences of adverse events leading to discontinuation. EPILEPSY Monotherapy Adults The most commonly observed adverse events associated with the use of topiramate at dosages of 100 to 400 mg/day in controlled trials in adults with newly diagnosed epilepsy were: paresthesia, fatigue, headache, somnolence, dizziness, upper respiratory tract infection, anorexia, weight decrease, depression, and nausea (see Table 4).
PRO-TOPIRAMATE (topiramate) Page 28 of 84 Approximately 19% of the 886 adult patients who received topiramate as monotherapy in controlled clinical trials for patients with newly diagnosed epilepsy discontinued therapy due to adverse events.
6%). Pediatrics The most commonly observed adverse events associated with the use of topiramate at dosages of 100 to 400 mg/day in controlled trials in children with newly diagnosed epilepsy were: upper respiratory tract infection, headache, anorexia, difficulty with concentration/attention, weight decrease, somnolence, paresthesia, fever, and fatigue (see Table 9).
Approximately 10% of the 245 pediatric patients who received topiramate as monotherapy in controlled clinical trials for patients with newly diagnosed epilepsy discontinued therapy due to adverse events. 0%). No pediatric patients withdrew due to psychomotor slowing.
Adjunctive Therapy Adults The most commonly observed adverse events associated with the adjunctive use of topiramate at dosages of 200 to 400 mg/day in controlled trials in adults that were seen at greater frequency in patients treated with topiramate and did not appear to be dose-related within this dosage range were: somnolence, dizziness, ataxia, speech disorders and related speech problems, psychomotor slowing, nystagmus, and paresthesia (see Table 5).
8% of subjects (n = 69) receiving placebo. The percentage of subjects discontinuing due to adverse events appeared to increase at dosages above 400 mg/day. Overall, approximately 17% of all subjects (n = 527) who received topiramate in the double- blind trials discontinued due to adverse events, compared to 4% of the subjects (n = 216) receiving placebo.
The most common dose-related adverse events at dosages of 200 to 1,000 mg/day were: nervousness, difficulty with concentration or attention, confusion, depression, anorexia, language problems, and mood problems (see Table 6). […]
1 Special Populations ..................................................................................................... 1 Pregnant Women ........................................................................................................
2 Breast-feeding ............................................................................................................. 3 Pediatrics.....................................................................................................................
4 Geriatrics ..................................................................................................................... 27 8 ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ..................................................................................
1 Clinical Trial Adverse Reactions – Pediatrics............................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................... 5 Post-Market Adverse Reactions..................................................................................
43 9 DRUG INTERACTIONS ..................................................................................................... 2 Drug Interactions Overview ........................................................................................
4 Drug-Drug Interactions ............................................................................................... 5 Drug-Food Interactions ...............................................................................................
6 Drug-Herb Interactions ............................................................................................... 7 Drug-Laboratory Test Interactions..............................................................................
57 10 CLINICAL PHARMACOLOGY ............................................................................................ 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics ........................................................................................................
59 11 STORAGE, STABILITY AND DISPOSAL .............................................................................. 62 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................
62 PART II: SCIENTIFIC INFORMATION ...................................................................................... 64 13 PHARMACEUTICAL INFORMATION .................................................................................
64 14 CLINICAL TRIALS ............................................................................................................. 1 Clinical Trials by Indication..........................................................................................
2 Comparative Bioavailability Studies ........................................................................... 71 15 MICROBIOLOGY .............................................................................................................
72 16 NON-CLINICAL […]