The increase in the incidence of bladder tumors in males and females receiving 300 mg/kg/day was primarily due to the increased occurrence of a smooth muscle tumor considered histomorphologically unique to mice.
If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. [28378] Guidelines classify topiramate as having established efficacy for migraine prophylaxis.
The fraction bound decreased as blood concentration increased.Carbamazepine and phenytoin do not alter the binding of topiramate. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.If you miss a dose of this medicine, take it as soon as possible. If your dose is different, do not change it unless your doctor tells you to do so.The amount of medicine that you take depends on the strength of the medicine. Doses include 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. 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 (e.g., patients who received higher doses may have more severe underlying disease) In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years.
Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached.
This dataset contained data from 1217 subjects including 258 pediatric patients age 2 to <16 years (95 pediatric patients <10 years of age).Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.Table 4 shows absolute and relative risk by indication for all evaluated AEDs.The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.Rapid titration rate and higher initial dose were associated with higher incidences of cognitive-related dysfunction.In adult epilepsy adjunctive controlled trials, which used rapid titration (100–200 mg/day weekly increments), and target TOPAMAXIn the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAXIn the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAXPsychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAXIn pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults.
If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. [28378] Guidelines classify topiramate as having established efficacy for migraine prophylaxis.
The fraction bound decreased as blood concentration increased.Carbamazepine and phenytoin do not alter the binding of topiramate. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.If you miss a dose of this medicine, take it as soon as possible. If your dose is different, do not change it unless your doctor tells you to do so.The amount of medicine that you take depends on the strength of the medicine. Doses include 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. 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 (e.g., patients who received higher doses may have more severe underlying disease) In this open-label, uncontrolled study, the mortality was 37 deaths/1000 patient years.
Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. In the sixth study (Study 7), the 25 or 50 mg/day initial doses of topiramate were followed by respective weekly increments of 25 or 50 mg/day until the target dose of 200 mg/day was reached.
This dataset contained data from 1217 subjects including 258 pediatric patients age 2 to <16 years (95 pediatric patients <10 years of age).Pediatric patients on adjunctive treatment exhibited a higher oral clearance (L/h) of topiramate compared to patients on monotherapy, presumably because of increased clearance from concomitant enzyme-inducing antiepileptic drugs. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.Table 4 shows absolute and relative risk by indication for all evaluated AEDs.The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.Rapid titration rate and higher initial dose were associated with higher incidences of cognitive-related dysfunction.In adult epilepsy adjunctive controlled trials, which used rapid titration (100–200 mg/day weekly increments), and target TOPAMAXIn the monotherapy epilepsy controlled trial, the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAXIn the 6-month controlled trials for the preventive treatment of migraine, which used a slower titration regimen (25 mg/day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for TOPAMAXPsychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations Somnolence and fatigue were the adverse reactions most frequently reported during clinical trials of TOPAMAXIn pediatric epilepsy trials (adjunctive and monotherapy), the incidence of cognitive/neuropsychiatric adverse reactions was generally lower than that observed in adults.