400 mg dosage of cbd oil for seizures

400 mg dosage of cbd oil for seizures

Oral anticonvulsant; weak carbonic anhydrase inhibitor
Used for partial and generalized seizures, Lennox-Gastaut, refractory seizures, and migraine prophylaxis
Close monitoring for emerging or worsening suicidal thoughts/behavior or depression recommended

Common Brand Names

Qudexy XR, Topamax, Topamax Sprinkle, Topiragen, Trokendi XR

How Supplied

Qudexy XR/Topiramate/Trokendi XR Oral Cap ER: 25mg, 50mg, 100mg, 150mg, 200mg
Topamax Sprinkle/Topiramate Oral Cap Coated Pellets: 15mg, 25mg
Topamax/Topiragen/Topiramate Oral Tab: 25mg, 50mg, 100mg, 200mg

Dosage & Indications

Initially, 50 mg/day PO administered in 2 divided doses. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6; administer total daily dose in 2 divided doses. The recommended final dose, 400 mg per day PO in 2 divided doses, is achieved during week 6. Approximately 58% of patients randomized to 400 mg per day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg per day.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 125 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 200 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 125 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 175 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 100 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 175 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 100 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 150 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 75 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 125 mg PO twice daily.

Initially, 50 mg PO once daily. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6. The recommended final dose, 400 mg PO once daily, is achieved during week 6.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 400 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 300 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 150 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 250 mg PO once daily.

Initially, 50 mg PO once daily. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6. The recommended final dose, 400 mg PO once daily, is achieved during week 6.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 400 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 300 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 150 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 250 mg PO once daily.

Initially, 25 to 50 mg/day PO; doses more than 25 mg/day should be divided and given twice daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day (divided and given twice daily); doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response; doses should be divided and given twice daily. The recommended maintenance dose is 5 to 9 mg/kg/day. A retrospective and prospective review of 41 children (mean age: 6.3 years; age range: 0.4 to 12 years) on topiramate therapy reported mean doses of adjuvant topiramate ranging from 7 to 14 mg/kg/day. Children 5 years and younger receiving a concurrent enzyme-inducing antiepileptic agent required the largest mean dose.

Limited data available; further study needed. A target dose of 3 to 25 mg/kg/day PO (divided and given every twice daily) has been safely used in infants and young children with refractory partial seizures ; however, efficacy data is lacking. Case reports have described topiramate efficacy at a dose range of 2.5 to 6 mg/kg/day PO in infants with refractory partial seizures; the maximum dose used in these reports was 7.7 mg/kg/day. However, in a double-blind, placebo-controlled, parallel-group, multicenter study of infants and young children (n = 149; mean age: 12 months; range: 1 to 24 months) topiramate was not effective as adjuvant treatment for refractory partial seizures. Patients in the study were started at a dose of 3 mg/kg/day PO (divided and given twice daily) and titrated every 3 days, as tolerated, to a target dose of 5, 15, or 25 mg/kg/day. At 25 mg/kg/day, there was no difference (p = 0.97) in median percentage reduction from baseline in daily seizure rate compared to placebo (20.4% topiramate vs. 13.1% placebo). In addition, the percentages of treatment responders in the topiramate groups (27% in the 5 mg/kg/day group, 38% in the 15 mg/kg/day group, and 44% in the 25 mg/kg/day group) were not different from placebo (36%) (p > 0.4 for all groups compared to placebo).

Limited data available. In a retrospective review, adjunctive topiramate at a dose of 3 or 10 mg/kg/day administered via nasogastric tube controlled or reduced seizure activity (including generalized tonic, partial tonic, and partial clonic) in 4 of 6 term neonates who were considered refractory to phenobarbital or phenobarbital and phenytoin therapy. Maintenance therapy was initiated at 10 mg/kg/day in 5 children and 3 mg/kg/day in 1 patient. At follow-up 5 to 11.5 months later, 5 of 6 patients were seizure free.

Initially, 25 to 50 mg/day PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response. The recommended maintenance dose is 5 to 9 mg/kg/day. Do not exceed a dose of 400 mg/day.

Initially, 25 to 50 mg/day PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response. The recommended maintenance dose is 5 to 9 mg/kg/day.

Initially, 50 mg per day PO administered in 2 divided doses. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6; administer total daily dose in 2 divided doses. The recommended final dose, 400 mg per day PO in 2 divided doses, is achieved during week 6. Approximately 58% of patients randomized to 400 mg per day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg per day.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 125 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 200 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 125 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 175 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 100 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 175 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 100 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 150 mg PO twice daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 25 mg PO twice daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 75 mg PO twice daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 125 mg PO twice daily.

Initially, 50 mg PO once daily. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6. The recommended final dose, 400 mg PO once daily, is achieved during week 6.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 400 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 300 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 150 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 250 mg PO once daily.

Initially, 50 mg PO once daily. Increase the daily dose by 50 mg once per week during weeks 2, 3, and 4. Increase the daily dose by 100 mg once per week during weeks 5 and 6. The recommended final dose, 400 mg PO once daily, is achieved during week 6.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 400 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 250 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 350 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 200 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 300 mg PO once daily.

Initially, 25 mg PO once daily in the evening. If tolerated, may increase the dosage to 50 mg PO once daily during week 2 of therapy. Thereafter, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response; attempt to titrate to the minimum maintenance dose of 150 mg PO once daily by week 5 to 7 of therapy. If seizure control is not achieved, the dosage may be further increased by 25 to 50 mg/day increments at weekly intervals. Max: 250 mg PO once daily.

Initially, 25 to 50 mg/day PO; doses more than 25 mg/day should be divided and given twice daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. During clinical trials, the optimum dose was reached at the end of 8 weeks. The recommended maintenance dose is 400 mg/day (divided and given twice daily); doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage slowly to 6 mg/kg/day PO by the end of 8 weeks; doses should be divided and given twice daily. Do not titrate by more than 1 to 3 mg/kg/day every 1 to 2 weeks. Max dose: 9 mg/kg/day. A retrospective and prospective review of 41 children (mean age: 6.3 years; age range: 0.4 to 12 years) on topiramate therapy reported mean doses of adjuvant topiramate ranging from 7 to 14 mg/kg/day. Children 5 years and younger receiving a concurrent enzyme-inducing antiepileptic agent required the largest mean dose.

Limited data available, particularly for tonic-clonic seizures; further study needed. A target dose of 3 to 25 mg/kg/day PO (divided and given every twice daily) has been safely used in infants and young children with refractory partial seizures ; however, efficacy data is lacking. Case reports have described topiramate efficacy at a dose range of 2.5 to 6 mg/kg/day PO in infants with refractory partial seizures; the maximum dose used in these reports was 7.7 mg/kg/day. However, in a double-blind, placebo-controlled, parallel-group, multicenter study of infants and young children (n = 149; mean age: 12 months; range: 1 to 24 months) topiramate was not effective as adjuvant treatment for refractory partial seizures. Patients in the study were started at a dose of 3 mg/kg/day PO (divided and given twice daily) and titrated every 3 days, as tolerated, to a target dose of 5, 15, or 25 mg/kg/day. At 25 mg/kg/day, there was no difference (p = 0.97) in median percentage reduction from baseline in daily seizure rate compared to placebo (20.4% topiramate vs. 13.1% placebo). In addition, the percentages of treatment responders in the topiramate groups (27% in the 5 mg/kg/day group, 38% in the 15 mg/kg/day group, and 44% in the 25 mg/kg/day group) were not different from placebo (36%) (p > 0.4 for all groups compared to placebo).

Limited data available. In a retrospective review, adjunctive topiramate at a dose of 3 or 10 mg/kg/day administered via nasogastric tube controlled or reduced seizure activity (including generalized tonic, partial tonic, and partial clonic) in 4 of 6 term neonates who were considered refractory to phenobarbital or phenobarbital and phenytoin therapy. Maintenance therapy was initiated at 10 mg/kg/day in 5 children and 3 mg/kg/day in 1 patient. At follow-up 5 to 11.5 months later, 5 of 6 patients were seizure free.

Initially, 25 to 50 mg/day PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. During clinical trials, the optimum dose was reached at the end of 8 weeks. The recommended maintenance dose is 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response. The recommended maintenance dose is 5 to 9 mg/kg/day. Do not exceed a dose of 400 mg/day.

Initially, 25 to 50 mg/day PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. During clinical trials, the optimum dose was reached at the end of 8 weeks. The recommended maintenance dose is 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage slowly to 6 mg/kg/day PO by the end of 8 weeks. Do not titrate by more than 1 to 3 mg/kg/day every 1 to 2 weeks. Max dose: 9 mg/kg/day.

Initially, 25 to 50 mg/day PO; doses more than 25 mg/day should be divided and given twice daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day (divided and given twice daily); doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response; doses should be divided and given twice daily. The recommended maintenance dose is 5 to 9 mg/kg/day. A retrospective and prospective review of 41 children (mean age: 6.3 years; age range: 0.4 to 12 years) on topiramate therapy reported mean doses of adjuvant topiramate ranging from 7 to 14 mg/kg/day. Children 5 years and younger receiving a concurrent enzyme-inducing antiepileptic agent required the largest mean dose.

Initially, 25 to 50 mg PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response. The recommended maintenance dose is 5 to 9 mg/kg/day. Do not exceed a dose of 400 mg/day.

Initially, 25 to 50 mg PO once daily. If tolerated, the dosage may be increased by 25 to 50 mg/day increments at weekly intervals to achieve optimal clinical response. The recommended maintenance dose is 200 to 400 mg/day; doses above 400 mg/day have not been shown to improve responses. Doses more than 1,600 mg/day have not been studied.

Initially, 1 to 3 mg/kg/day (Max: 25 mg/day) PO once daily in the evening. If tolerated, may increase the dosage by 1 to 3 mg/kg/day increments every 1 to 2 weeks to achieve optimal clinical response. The recommended maintenance dose is 5 to 9 mg/kg/day.

25 mg PO every evening for 1 week, then 25 mg PO twice daily for 1 week, then 25 mg PO every morning and 50 mg PO every evening for 1 week, and then 50 mg PO twice daily. Adjust dose and titration according to clinical outcome; use longer intervals between dose adjustments if needed.[28378] Guidelines classify topiramate as having established efficacy for migraine prophylaxis.[57981] [64551]

25 mg PO every evening for 1 week, then 25 mg PO twice daily for 1 week, then 25 mg PO every morning and 50 mg PO every evening for 1 week, and then 50 mg PO twice daily. Adjust dose and titration according to clinical outcome; use longer intervals between dose adjustments if needed. Guidelines do not make recommendations regarding migraine prophylaxis with topiramate due to insufficient evidence.

25 mg PO once daily for 1 week, then 50 mg PO once daily for 1 week, then 75 mg PO once daily for 1 week, and then 100 mg PO once daily. Adjust dose and titration according to clinical outcome; use longer intervals between dose adjustments if needed.[56847] [55675] Guidelines classify topiramate as having established efficacy for migraine prophylaxis.[57981] [64551]

25 mg PO once daily for 1 week, then 50 mg PO once daily for 1 week, then 75 mg PO once daily for 1 week, and then 100 mg PO once daily. Adjust dose and titration according to clinical outcome; use longer intervals between dose adjustments if needed.[56847] [55675] Guidelines do not make recommendations regarding migraine prophylaxis with topiramate due to insufficient evidence.[33312]

Data are limited. A suggested initial dose is 50 mg PO once daily. Then, titrate dose slowly by increments of 50 mg/week up to a target dose of 100 to 300 mg PO 3 times daily.

Based on limited clinical trials, initially 0.5 to 1 mg/kg/dose (Max: 25 mg for initial titration) PO once daily for 7 days, followed by weekly dosage increases of 0.5 to 1 mg/kg/day PO. It appears that the minimally effective target dose of topiramate as add-on therapy in children with refractory epilepsy is 3 to 6 mg/kg/day PO, given in divided doses. However, doses of up to 24 mg/kg/day PO have been used in some patients.

One pilot study has used an initial dosage of 25 mg PO once daily added to current anti-epileptic drug regimens. Dosage was increased by 25 mg PO every 2 to 3 days until spasms were controlled, or a maximum dosage of 24 mg/kg/day PO given in divided doses was achieved. The frequency of infantile spasms was reduced by half in 80% of the children treated; 45% became spasm free. Over half of the treated children were able to achieve monotherapy with topiramate after slow reduction of their other anti-epileptic medications.

Initially, 25 mg/day PO (usually given at bedtime), then titrate slowly. Max: 300 mg/day PO in divided doses has been used. Several randomized outpatient controlled trials have shown improvements in measures of alcohol use, such as the length of time to relapse or reduction in daily alcohol intake. As with other treatments, dropout rates for treatment are high, and medication should be used as a part of a comprehensive management program that includes psychosocial support and treatment. More data are needed to establish a role for topiramate in treating alcohol dependence.

In one randomized, double-blind placebo-controlled trial, adult women (n = 60) treated with topiramate (titrated to 250 mg/day PO) experienced a reduction in binge or purge episodes when compared to placebo (greater than 50% reduction, p < 0.001) during the 10-week trial. The evidence available is considered of relatively low-quality compared to data available for other treatments; experts stress the need for quality data and that side effects of treatment (e.g., paresthesias) may be problematic.

Future studies will determine if topiramate has a role for treating painful diabetic neuropathy. In clinical trials, patients received 25 mg PO once daily at bedtime for 1 week. The daily dosage was titrated by 25 mg during weeks 2 through 4; by 50 mg during weeks 5 and 6; and by 100 mg during weeks 7 and 8 up to the maximum tolerated dose, not to exceed 400 mg/day PO (e.g., 200 mg PO twice daily). Due to insufficient evidence of efficacy from this study and other available data, the American Academy of Neurology guidelines do not support or refute the use of topiramate for the treatment of painful diabetic neuropathy.

The American Psychiatric Association Practice Guidelines list topiramate as a possible treatment option, as treatment options are limited and some evidence suggests a potential benefit. Topiramate is commonly initiated at 25 mg/day to 50 mg/day PO and the daily dose increased by 25 mg/week to 50 mg/week to a range of 200 mg/day to 300 mg/day in divided doses. The optimal dose range has not been established, and study results are conflicting. One study yielded positive results, with a higher proportion of cocaine nonuse (abstinent) days and urinary cocaine free weeks observed with use of topiramate vs. placebo , while other studies have not found topiramate to be more effective than placebo. In one small placebo-controlled trial (n = 40) of patients with low cocaine withdrawal symptom severity, patients randomized to topiramate (titrated to 200 mg/day by week 8) were more likely after week 8 to be cocaine-abstinent than placebo-treated patients as measured by twice weekly qualitative urine benzoylecgonine tests (UBTs). Continuous 3-week abstinence and Clinical Global Impression scale improvements were higher for topiramate than placebo (59% vs. 26%, and 71% vs. 32%, respectively). Topiramate-treated patients showed improvement in drug use problems and employment problems as measured by Addiction Severity Index (ASI) composite scores.

According to the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines, there is level 3 evidence for use of topiramate as a third-line adjunct agent in the maintenance treatment of bipolar disorder; however, topiramate is not recommended as monotherapy for acute mania and is not recommended as monotherapy in the maintenance treatment of bipolar disorder. An effective dose range has not been established. If use of topiramate is necessary, it is advisable to initiate treatment with a low dose (e.g., 25 to 50 mg/day PO), and increase the daily dose in increments of 25 to 50 mg based on clinical response and tolerability.

Case reports suggest a starting dose of 12.5 to 25 mg PO once daily titrating to 25 to 75 mg PO twice daily as tolerated may be effective. Higher doses of 150 to 400 mg PO twice daily have also been efficacious.

†Indicates off-label use

Maximum Dosage

400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.

400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.

17 years: 400 mg/day PO for epilepsy; 100 mg/day PO for migraine prophylaxis.
13 to 16 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy; 100 mg/day PO for migraine prophylaxis.

12 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy; 100 mg/day PO for migraine prophylaxis.
10 to 11 years: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing more than 38 kg: 400 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 23 to 38 kg: 350 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 12 to 22 kg: 300 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
2 to 9 years weighing 11 kg or less: 250 mg/day PO (monotherapy) or 9 mg/kg/day PO (adjunct therapy) for epilepsy.
Younger than 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Dosing Considerations

Specific guidelines for dosage adjustments in hepatic impairment are not available; however, clearance may be reduced.

Patients with renal impairment may require a longer time than patients with normal renal function to reach steady-state with each topiramate dosage adjustment.
CrCl 70 mL/minute or more: No dosage adjustment needed.
CrCl less than 70 mL/minute: In adults, reduce the topiramate dose to one-half of the usual dose.
In pediatric patients, adjustment to the usual mg/kg dosage may be required, but should be individualized since clearance rates are higher in the pediatric population than in adults. Some experts recommend administering one-half of the usual dose for pediatric patients with a GFR 10 to 50 mL/minute/1.73 m2 and one-quarter of the usual dose for pediatric patients with a GFR less than 10 mL/minute/1.73 m2.

Intermittent hemodialysis
During the hemodialysis session, adult patients clear topiramate at a rate that is 4 to 6 times greater than an adult person with normal renal function. A supplemental dose of topiramate may be required during or post-hemodialysis in some patients. Dosage adjustments should be based on duration of dialysis period, clearance rate of the dialysis system being used, and the effective renal clearance of topiramate in the patient to be dialyzed.

Administration

For storage information, see specific product information within the How Supplied section.

Topiramate may be given orally without regard to meals.

Tablets: Because of the bitter taste, the tablets should not be broken.
Sprinkle capsules: Swallow whole. Alternatively, the contents of the capsules may be sprinkled on a small amount of soft food (e.g., applesauce, custard, ice cream, oatmeal, pudding, or yogurt) for administration. Prepare entire dose and swallow immediately after preparation. Do not chew. Drink fluids to ensure entire dose is swallowed. Do not store any sprinkle/food mixture for use at a later time. Additionally, the capsule contents may be administered via nasogastric (NG) tube; use an adequate amount of fluid to wash the full dose down the tube.
Trokendi XR extended-release capsules: Swallow whole and intact. Do not sprinkle on food, chew or crush. Because the extended release capsules must be swallowed whole and cannot be sprinkled on food, crushed or chewed, they are not recommended for children less than 6 years.
Qudexy XR extended-release capsules: May be swallowed whole or the contents of the capsule may be sprinkled on a small amount (teaspoon) of soft food. Prepare entire dose and swallow immediately after preparation. Do not chew or crush. Do not store any drug/food mixture for for use at a later time.

Storage

Qudexy XR:
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Topamax:
– Protect from moisture
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Topamax Sprinkle:
– Protect from moisture
– Store at controlled room temperature (between 68 and 77 degrees F)
Topiragen :
– Protect from moisture
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
Trokendi XR:
– Protect from light
– Protect from moisture
– Store at 77 degrees F; excursions permitted to 59-86 degrees F

Contraindications / Precautions

Topiramate is contraindicated for use in any patient hypersensitive to the drug or any of the product components. Serious and potentially fatal exfoliative dermatologic reactions have been reported in post-marketing experience with topiramate. Cross-sensitivity between antibiotic sulfonamides and nonantibiotic sulfonamides, such as topiramate, is controversial. Antibiotic sulfonamides contain an amine linked to a benzene ring (arylamine moiety), attached directly to the sulfonamide structure; this arylamine attached to the sulfonamide structure is believed to be the central pathogenesis of hypersensitivity reactions. Although topiramate is a simple sulfonamide, the sulfonamide structure is not directly connected to a ring structure, and it lacks an arylamine moiety. Some experts believe apparent cross-reactivity represents multiple concurrent and unlinked drug hypersensitivities in predisposed patients. Although cross-reactivity with sulfonamide antibiotics appears unlikely, precaution or complete avoidance of nonantibiotic sulfonamides in individuals whose previous reaction was serious and/or life-threatening or in those with multiple drug hypersensitivities may be prudent.

During pre-marketing evaluation of topiramate, 10 sudden unexplained deaths occurred among a cohort group (2,796 subject years of exposure), correlating to an incidence of 0.0035 deaths per patient year. This incidence exceeded the rate expected from a matched, healthy population; however, it was within the range of estimates for sudden unexplained deaths in patients with epilepsy who were not receiving topiramate.

In January 2008, the FDA alerted healthcare professionals of an increased risk of suicidal ideation and behavior in patients receiving anticonvulsants to treat epilepsy, psychiatric disorders, or other conditions (e.g., migraine, neuropathic pain). This alert followed an initial request by the FDA in March 2005 for manufacturers of marketed anticonvulsants to provide data from existing controlled clinical trials for analysis. Prior to this request, preliminary evidence had suggested a possible link between anticonvulsant use and suicidality. The primary analysis consisted of 199 placebo-controlled clinical studies with a total of 27,863 patients in drug treatment groups and 16,029 patients in placebo groups (>= 5 years of age). There were 4 completed suicides among patients in drug treatment groups versus none in the placebo groups. Patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation as patients receiving placebo (0.43% vs. 0.24%, respectively; RR 1.8, 95% CI: 1.2—2.7). The relative risk for suicidality was higher in patients with epilepsy compared to those with other conditions; however, the absolute risk differences were similar in trials for epilepsy and psychiatric indications. Age was not a determining factor. The increased risk of suicidal ideation and behavior was observed between 1 and 24 weeks after therapy initiation. However, a longer duration of therapy should not preclude the possibility of an association to the drug since most studies included in the analysis did not continue beyond 24 weeks. Data were analyzed from drugs with adequately designed clinical trials including carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide. However, this is considered to be a class effect. All patients beginning treatment with anticonvulsants or currently receiving such treatment should be closely monitored for emerging or worsening depression or suicidal thoughts/behavior. Patients and caregivers should be informed of the increased risk of suicidal thoughts and behaviors and should be advised to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior. Anticonvulsants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.

Abrupt discontinuation of topiramate therapy should not be undertaken. Topiramate and other antiepileptic drugs should be withdrawn gradually to minimize the potential of increased seizure frequency.

Topiramate should be used cautiously in patients with nephrolithiasis. Carbonic anhydrase inhibitors promote stone formation by reducing urinary citrate excretion and by increasing urinary pH. During clinical trials, 1.3—1.5% of topiramate-treated patients developed kidney stones. This incidence is about 2—4 times that expected in a similar, untreated population and was higher in men. The concomitant use of topiramate with other carbonic anhydrase inhibitors or in patients on a ketogenic diet may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided. Patients who are receiving topiramate, especially those who have a history of kidney stones, should be instructed to maintain adequate fluid intake in order to reduce the formation of kidney stones.

Topiramate should be used cautiously in patients with renal failure or renal impairment because the major route of elimination of unchanged drug and its metabolites is the kidney. Dosage adjustments may be required (see Dosage). Because topiramate clearance is affected by both glomerular filtration rate and renal tubular reabsorption, there may be some patients with renal disease who do not need dosage adjustments based on creatinine clearance alone. In addition, patients receiving hemodialysis may need dose adjustments in relation to their dialysis sessions (see Dosage). Topiramate has been associated with metabolic acidosis in both adults and pediatrics (see Adverse Reactions) and patients with renal disease may be at greater risk for this complication. Other conditions that may predispose patients to acidosis [i.e., diarrhea, ketogenic diet, severe pulmonary disease (chronic obstructive pulmonary disease (COPD), emphysema, status asthmaticus), surgery, status epilepticus or administration with other bicarbonate-lowering drugs] may have an additive risk for this complication. Measurement of baseline and periodic serum bicarbonate is recommended during topiramate therapy. If metabolic acidosis occurs, consider reducing the dose or tapering the patient off of topiramate. Alkali treatment (i.e., oral sodium bicarbonate) should be considered if it is decided that the patient continue topiramate despite metabolic acidosis. Patients undergoing surgery that are being treated with topiramate should have a careful history taken preoperatively. Baseline blood chemistries should be measured before surgery to screen for asymptomatic metabolic acidosis.

Topiramate should be used with extreme caution in patients with hepatic disease, including cirrhosis. The clearance of topiramate may be decreased in hepatically impaired patients, although the mechanism is not well understood. There have been post-marketing reports of hepatic failure resulting in death.

Safety and effectiveness of topiramate in neonates, infants and children below the age of 2 years have not been established. Although not FDA approved in this population, a controlled trial in infants and children less than 2 years of age demonstrated that the degree of metabolic acidosis caused by topiramate was notably greater in this population than that observed in trials of older children and adults, and the incidence was greater with higher doses. Related complications (i.e., growth inhibition, osteomalacia) may occur in pediatric patients with chronic metabolic acidosis. Some data in infants and toddlers with intractable partial seizures receiving topiramate showed reductions from baseline in Z SCORES for length, weight, and head circumference compared to age and sex-matched normative data; however, it should be noted that these patients with epilepsy are likely to have different growth rates than healthy infants. Reductions in Z SCORES for length and weight were correlated with the degree of acidosis. Pediatric patients receiving topiramate should be screened for asymptomatic metabolic acidosis prior to surgery. In clinical studies, the incidences of cognitive/neuropsychiatric adverse events in pediatric patients were generally lower than previously observed in adults.

Topiramate commonly causes somnolence, fatigue, dizziness and difficulty with concentration, particularly in the first month of therapy. Patients should be advised to use caution when driving or operating machinery, or performing other tasks that require mental alertness until they are aware of whether topiramate adversely affects their mental and/or motor performance. Clinicians should be aware that cognitive and neuropsychiatric events are among the most common adverse reactions seen with topiramate use. Confusion, psychomotor slowing, difficulties with memory or speech, depression, fatigue and somnolence are examples of the kind of cognitive and neuropsychiatric dose-related adverse events that can occur. Rapid dose titration and higher initial doses were associated with higher incidences of these events. Many of these events contributed to withdrawal from treatment in clinical trials. While cognitive and neuropsychiatric events do not appear to occur as frequently in the pediatric population, difficulty with concentration or attention was reported as the most common reason for discontinuation in pediatric patients in the monotherapy clinical trials (400 mg/day group).

Use topiramate cautiously in patients with a history of glaucoma and/or ocular disease. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and pediatric patients receiving topiramate. Symptoms typically occur within 1 month of topiramate initiation and include acute onset visual disturbance and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), increased intraocular pressure, mydriasis, and supraciliary effusion with anterior displacement of the lens and iris, with secondary closed-angle glaucoma. Visual field defects independent of elevated intraocular pressure have also been reported with topiramate. Patients experiencing ocular disturbances should seek immediate medical attention. Consideration should be given to discontinuing topiramate in an effort to reverse ocular symptoms. Other measures in conjunction with discontinuation of topiramate may be helpful. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss.

Oligohidrosis and hyperthermia have been reported in post-marketing experience with topiramate; heat stroke may occur. All patients, especially children, should be instructed to limit exposure to ambient temperature increase (i.e., elevated environmental temperature) or other temperature extremes that might aggravate temperature regulation. To help prevent oligohidrosis and hyperthermia in patients treated with topiramate, proper hydration is suggested before and during strenuous activity or exposure to warm temperatures. Use caution when topiramate is prescribed with other drugs that predispose patients to heat-related disorders, such as drugs with anticholinergic activity, carbonic anhydrase inhibitors, and zonisamide. Since topiramate exhibits carbonic anhydrase inhibitor activity, use with other carbonic anhydrase inhibitors is not recommended.

Hyperammonemia with and without encephalopathy has been reported with topiramate use and may be dose-related. Females, children under the age of 3 years, and those with inborn errors of metabolism, reduced hepatic mitochondrial activity (mitochondrial disease), or generalized tonic-clonic seizures may be at increased risk. Although hyperammonemia with and without encephalopathy has occurred with topiramate monotherapy, it appears to be more common with adjuvant valproate therapy. Concomitant administration of topiramate and valproate may exacerbate existing metabolic deficits or unmask deficiencies in susceptible persons, and has been associated with hyperammonemia in patients who have tolerated either drug alone. Monitor serum ammonia concentrations in patients who develop unexplained lethargy, vomiting, changes in mental status, or hypothermia. Patients who develop unexplained symptoms of hyperammonemia encephalopathy while receiving antiepileptic therapy should discontinue the afflicting drug and receive prompt treatment for hyperammonemia. In most cases, signs and symptoms abate with discontinuation of either topiramate or valproate.

In clinical trials, 3% of patients receiving topiramate were over 60 years of age. No age-related difference in effectiveness, adverse effects, or pharmacokinetics were seen in geriatric versus younger adults. However, the possibility of age-associated renal functional abnormalities should be considered. Because geriatric patients are at increased risk for renal insufficiency, an estimated GFR measurement should be obtained prior to dosing. According to the Beers Criteria, anticonvulsants are considered potentially inappropriate medications (PIMs) in geriatric patients with a history of falls or fractures and should be avoided in these patient populations, except for treating seizure and mood disorders, since anticonvulsants can produce ataxia, impaired psychomotor function, syncope, and additional falls. If topiramate must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures and implement strategies to reduce fall risk.[63923] The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities; the use of any anticonvulsant for any condition should be based on confirmation of the condition and its potential cause(s). Determine effectiveness and tolerability by evaluating symptoms, and use these as the basis for dosage adjustment for most patients. Therapeutic drug monitoring is not required or available for most anticonvulsants. Serum medication concentrations (when available) may assist in identifying toxicity. Monitor the treated patient for drug efficacy and side effects. Anticonvulsants can cause a variety of side effects; some adverse reactions can increase the risk of falls. When an anticonvulsant is being used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity as outlined in the OBRA guidelines.[60742]

In patients at high risk for renal insufficiency (e.g., older patients, or those with diabetes mellitus, hypertension, or autoimmune disease), an estimated GFR measurement should be obtained prior to dosing.

Topiramate should be used with caution in patients with thrombocytopenia or an increased risk of bleeding. In a pooled analysis of placebo-controlled trials, bleeding was more frequently reported for topiramate (4.5% adults and 4.4% pediatrics) than for placebo (3% adults and 2.3% pediatrics); serious bleeding events occurred in 0.3% vs. 0.2% of adult patients and 0.4% vs. 0% of pediatric patients for those treated with topiramate and placebo, respectively. Adverse events reported ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhage. In those with serious events, risk factors for bleeding were often present, or patients were taking other drugs that cause thrombocytopenia or affect platelet function or coagulation. Patients should be instructed to promptly report any bleeding-related events to their practitioner.

Topiramate can cause fetal harm when administered to a pregnant woman. Consider the benefits and risks of topiramate in women of childbearing potential, particularly when it is being considered for conditions not usually associated with permanent injury or death. Counsel women of childbearing potential regarding the potential risk to the fetus from topiramate exposure, and consider alternative therapeutic options in women who are planning a pregnancy. Data from pregnancy registries indicate infants exposed to topiramate during pregnancy have an increased risk for cleft lip and/or cleft palate and for being small for gestational age (SGA), defined as a birth weight below the tenth percentile. SGA has been seen at all doses and appears to be dose-dependent. SGA occurs more frequently in infants of women who received higher topiramate doses or continued topiramate use until later in pregnancy (i.e., third trimester). According to registry data, the prevalence of SGA was 18% to 25% in topiramate-exposed infants compared to 7% in infants exposed to a reference antiepileptic agent (AED) and 5% to 9% in those without antiepileptic drug (AED) exposure.[55675] The prevalence of oral clefts was 1.2% compared to 0.39% to 0.46% in infants exposed to another AED. The relative risk of oral clefts in topiramate-exposed pregnancies was 9.6 (95% CI 4 to 23) compared to untreated women.[28378] [55675] Oral clefts develop in the first trimester before many women know that they are pregnant.[43569] Pregnancy registry data also suggest a possible association between the use of topiramate during pregnancy and congenital malformations such as craniofacial defects, hypospadias, and anomalies of various body systems. Registry data and findings from other studies suggest that combination therapy with AEDs may increase the risk of teratogenic effects compared to monotherapy with an AED. Topiramate can cause metabolic acidosis which, when occurring during pregnancy, has been associated with decreased fetal growth, decreased fetal oxygenation, fetal death, and may impact the ability of the fetus to tolerate labor. Monitor women taking topiramate during pregnancy for metabolic acidosis and treat as in the nonpregnant state. Monitor newborns of mothers treated with topiramate for metabolic acidosis after birth. Limited data indicate topiramate may be associated with pre-term labor and premature delivery.[28378] [55675] Encourage topiramate-treated patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Patients must call 1-888-233-2334 to enroll in the registry. More information can be found at http://www.aedpregnancyregistry.org/.[55675]

Topiramate is excreted in human breast milk. Diarrhea and somnolence have been observed in breast-fed infants whose mothers received topiramate. The effects of topiramate on milk production are unknown. Consider the developmental and health benefits from breast-feeding along with the mother’s clinical need for topiramate and any potential adverse effects on the breast-fed infant from topiramate or the underlying maternal condition.[55675] Data from 5 breast-feeding infants has shown topiramate plasma concentrations of 10% to 20% of the maternal plasma concentration.[28378] Based on breast milk concentrations from 3 women taking 150 to 200 mg topiramate daily, it was estimated that a breast-fed infant (assuming a milk intake of 150 mL/kg/day) would receive approximately 0.1 to 0.7 mg/kg/day or 3% to 23% of the maternal weight-adjusted dose.[46385]

Topiramate is associated with reproductive risk. Discuss contraception requirements with the patient. Women of childbearing age who are not planning a pregnancy should use effective contraception because of the fetal risks of oral clefts and being small for gestational age.

Adverse Reactions

visual impairment / Early / 1.0-3.0
hearing loss / Delayed / 1.0-2.0
seizures / Delayed / 1.0-1.0
thrombosis / Delayed / 0.1-1.0
pulmonary embolism / Delayed / 0.1-1.0
oliguria / Early / 0.1-1.0
bradycardia / Rapid / 0-1.0
AV block / Early / 0.1-1.0
pancytopenia / Delayed / 0-0.1
acute cerebellar syndrome / Early / 1.0
bronchospasm / Rapid / 1.0
suicidal ideation / Delayed / Incidence not known
ocular hypertension / Delayed / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
pemphigus / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
pancreatitis / Delayed / Incidence not known

hyperammonemia / Delayed / 0-26.0
memory impairment / Delayed / 0-11.0
nystagmus / Delayed / 10.0-11.0
depression / Delayed / 0-9.0
hyperthyroidism / Delayed / 0-8.0
hypophosphatemia / Delayed / 0-6.0
bleeding / Early / 0.2-4.5
involuntary movements / Delayed / 0-4.0
ataxia / Delayed / 3.0-4.0
confusion / Early / 0-4.0
blurred vision / Early / 2.0-4.0
urinary incontinence / Early / 1.0-4.0
gastritis / Delayed / 0-3.0
anemia / Delayed / 1.0-3.0
dyspnea / Early / 1.0-3.0
cystitis / Delayed / 1.0-3.0
nephrolithiasis / Delayed / 0-3.0
vaginal bleeding / Delayed / 0-3.0
ejaculation dysfunction / Delayed / 0-3.0
hypertonia / Delayed / 0-3.0
aphasia / Delayed / 2.0-2.0
dysarthria / Delayed / 0-2.0
leukopenia / Delayed / 1.0-2.0
secondary malignancy / Delayed / 0-2.0
hematuria / Delayed / 0-2.0
hot flashes / Early / 1.0-2.0
edema / Delayed / 1.0-2.0
hypertension / Early / 0-2.0
dysphonia / Delayed / 0.1-1.0
hyperesthesia / Delayed / 0.1-1.0
EEG changes / Delayed / 0.1-1.0
peripheral neuropathy / Delayed / 0.1-1.0
scotomata / Delayed / 0.1-1.0
delirium / Early / 0.1-1.0
euphoria / Early / 0.1-1.0
esophagitis / Delayed / 0.1-1.0
dysphagia / Delayed / 0-1.0
melena / Delayed / 0.1-1.0
glossitis / Early / 0-1.0
stomatitis / Delayed / 0.1-1.0
fecal incontinence / Early / 0-1.0
gingival hyperplasia / Delayed / 0-1.0
hemorrhoids / Delayed / 0.1-1.0
thrombocytosis / Delayed / 0.1-1.0
eosinophilia / Delayed / 0.1-1.0
thrombocytopenia / Delayed / 0-1.0
hematoma / Early / 0-1.0
lymphadenopathy / Delayed / 0.1-1.0
lymphopenia / Delayed / 0.1-1.0
photophobia / Early / 0.1-1.0
urinary retention / Early / 0.1-1.0
orthostatic hypotension / Delayed / 0.1-1.0
peripheral vasodilation / Rapid / 0.1-1.0
hypotension / Rapid / 0.1-1.0
angina / Early / 0.1-1.0
dyskinesia / Delayed / 0.1-1.0
dystonic reaction / Delayed / 0.1-1.0
hyperglycemia / Delayed / 0.1-1.0
diabetes mellitus / Delayed / 0.1-1.0
hypocalcemia / Delayed / 0.1-1.0
dehydration / Delayed / 0.1-1.0
hyperlipidemia / Delayed / 0.1-1.0
hypoglycemia / Early / 1.0-1.0
phlebitis / Rapid / 0.1-1.0
mania / Early / 0-0.1
lymphocytosis / Delayed / 0-0.1
polycythemia / Delayed / 0-0.1
iritis / Delayed / 0-0.1
hypernatremia / Delayed / 0-0.1
hyponatremia / Delayed / 0-0.1
migraine / Early / 1.0
psychosis / Early / 1.0
hallucinations / Early / 1.0
constipation / Delayed / 1.0
conjunctivitis / Delayed / 1.0
candidiasis / Delayed / 1.0
impotence (erectile dysfunction) / Delayed / 1.0
chest pain (unspecified) / Early / 1.0
encephalopathy / Delayed / Incidence not known
myopia / Delayed / Incidence not known
hyperemia / Delayed / Incidence not known
bullous rash / Early / Incidence not known
hyperthermia / Delayed / Incidence not known

paresthesias / Delayed / 2.0-51.0
fatigue / Early / 7.0-19.0
weight loss / Delayed / 6.0-17.0
drowsiness / Early / 2.0-15.0
dysgeusia / Early / 2.0-15.0
abdominal pain / Early / 6.0-15.0
anorexia / Delayed / 4.0-15.0
infection / Delayed / 1.0-15.0
dizziness / Early / 0-14.0
nausea / Early / 0-14.0
fever / Early / 1.0-12.0
sinusitis / Delayed / 1.0-10.0
insomnia / Early / 0-9.0
diarrhea / Early / 2.0-9.0
hypoesthesia / Delayed / 4.0-8.0
anxiety / Delayed / 0-8.0
psychomotor impairment / Early / 0-8.0
emotional lability / Early / 0-8.0
purpura / Delayed / 0-8.0
epistaxis / Delayed / 0-8.0
laryngitis / Delayed / 0-8.0
cough / Delayed / 2.0-7.0
hypersalivation / Early / 0-6.0
pharyngitis / Delayed / 2.0-6.0
asthenia / Delayed / 0-6.0
hyperkinesis / Delayed / 5.0-5.0
dyspepsia / Early / 3.0-5.0
xerostomia / Early / 1.0-5.0
rhinitis / Early / 1.0-5.0
xerosis / Delayed / 0-5.0
flushing / Rapid / 0-5.0
rash / Early / 1.0-4.0
alopecia / Delayed / 1.0-4.0
pruritus / Rapid / 1.0-4.0
vertigo / Early / 0-3.0
libido decrease / Delayed / 0-3.0
vomiting / Early / 0-3.0
increased urinary frequency / Early / 0-3.0
acne vulgaris / Delayed / 2.0-3.0
hyporeflexia / Delayed / 0-2.0
irritability / Delayed / 2.0-2.0
agitation / Early / 1.0-2.0
hypertrichosis / Delayed / 2.0-2.0
menorrhagia / Delayed / 1.0-2.0
amenorrhea / Delayed / 2.0-2.0
leukorrhea / Delayed / 2.0-2.0
polydipsia / Early / 1.0-2.0
tinnitus / Delayed / 0-2.0
ptosis / Delayed / 0.1-1.0
paranoia / Early / 0.1-1.0
appetite stimulation / Delayed / 0-1.0
weight gain / Delayed / 0-1.0
flatulence / Early / 0-1.0
gingivitis / Delayed / 0-1.0
lacrimation / Early / 1.0-1.0
xerophthalmia / Early / 0.1-1.0
pallor / Early / 0-1.0
polyuria / Early / 0.1-1.0
nocturia / Early / 0-1.0
seborrhea / Delayed / 1.0-1.0
drug-induced body odor / Delayed / 0-1.0
photosensitivity / Delayed / 0.1-1.0
skin discoloration / Delayed / 1.0-1.0
urticaria / Rapid / 0.1-1.0
hyperhidrosis / Delayed / 0-1.0
breast discharge / Delayed / 0.1-1.0
parosmia / Delayed / 0.1-1.0
libido increase / Delayed / 0-0.1
mydriasis / Early / 0-0.1
melasma / Delayed / 0-0.1
tremor / Early / 1.0
headache / Early / 1.0
gastroesophageal reflux / Delayed / 1.0
ocular pain / Early / 1.0
menstrual irregularity / Delayed / 1.0
syncope / Early / 1.0
hypothermia / Delayed / Incidence not known
ecchymosis / Delayed / Incidence not known
diplopia / Early / Incidence not known
oligohidrosis / Delayed / Incidence not known

400 mg dosage of cbd oil for seizures

Hemp CBD and CBD oil are currently used for treating epilepsy.

Prescription CBD oil

The British company GW industries obtained FDA approval in 2018 as a drug to treat two types of childhood epilepsies. The drug EPIDIOLEX is being described as Pharmaceutical grade CDB oil. The cost for a single patient is predicted at about 32,000 dollars a year or about 2700 dollars a month. GW Industries obtained FDA approval after clinical trials of 571 patients. Of these Dravet syndrome and Lennox-Gastaut Syndrome were trialed and both had a substantial reduction in seizures.

In their trials, EPIDIOLEX, was added to the patients current treatment and for a 20 kg, or 50 pound child, the daily dose would be 400 mg.

The results showed that for half the patients, Epidiolex reduced seizure frequency by 50%, and over 6% of the patients became seizure free.

Epidiolex is 98% CBD oil.

The credit for discovery of CBD for seizures goes to Charlotte Figi and her family. In this now famous case, Charlotte was helped with a CBD oil that is now produced under the name Charlotte’s Web.

Charlotte’s Web is sold at their website and a non profit group has supported payments to over 1300 patients. They report a similar number to Epidiolex of 50% reduction in seizures for 50% of patients and report 10% are seizure free.

Recommendations

Hemp CBD oil is certainly worth a try for a patient with epilepsy. It can have remarkable results with few side effects. But it is likely to help only half the people who try it. But 10% of the people who try it might become seizure free.

Introduced in the Netherlands in 2014, Bedrolite� is the brand name for the cultivar Cannabis sativa L. �Rensina�. a CBD product, with less than 1% THC and 9% CBD. The virtual absence of THC means it does not have psychoactive properties. Bedrolite� is the preferred choice of patients with severe, intractable (untreatable) forms of epilepsy in the Netherlands.

Growing Live Plant Hemp CBD

Peggy Bradley is treating her epilepsy with fresh hemp CBD leaf, and not the CBD oil. This amounts to picking two or three leaves from a live hemp CBD plant.

Anti-seizure Tea

Recipe
Two to three hemp CBD fresh leaf
Three springs stevia
Moringa oleifera 3 fresh leaf
1 pat of butter

Place the ingredients in a teacup and microwave for 20 seconds to melt butter. The CBDA is soluble in fats.
Then soymilk and water and microwave for one minute. Let steep for five minutes and drink.

Peggy uses at least two cups of tea a day.

The hemp CBD that is used for this has an analysis of 4.8% CBDA in the wet weight. The CBDA in the cup is about 20 mg and so two cups a day is about 40 mg. According to the GW research, an effective dose is between 12 to 123 mg a day.

Use of cannabinoids in the treatment of epilepsy This is a patent claim listed by GW Industries showing CBDA is more bioavailable and more effective than CBD in treating some forms of epilepsy. Part of the statements are

Claim [0005] Intractable or treatment-resistant epilepsy was defined in 2009 by the International League Against Epilepsy (ILAE) as “failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom” (Kwan et al. , 2009).

Claim [0045] As the cannabinoid CBDA is more bioavailable than its neutral form CBD, it is likely that a far lower dose of CBDA will be required in comparison with CBD when treating the same indication. For example providing a human with a dose of 20 mg/kg of CBD to treat epilepsy may be effective, whereas the dose of CBDA required may be a log fold lower.

Claim [0089] Notably, in three of the four parameters measured CBDA produced significant anticonvulsant effects and were statistically more effective than CBD at an equivalent dose.

Claim [0090] For example, Panel A of Figure 2 describes the effect of CBDA and CBD on the seizure severity. The median score for the maximum seizure severity that the animals experienced with 100mg/kg CBDA was 3 (Table 6 – fully developed bilateral forelimb clonus, with righting reflex preserved) and the median for 100 mg/kg CBD was 5 (Table 6 – fully developed tonic-clonic seizure, with righting reflex lost). This shows that CBDA was able to prevent the animals from suffering from more severe types of seizure than CBD was.

[00137] CBDA has anticonvulsant effects in a mammalian model of epilepsy and is effective in treating generalised seizures, more particularly, tonic-clonic seizures. Indeed, this compound appears more effective than CBD in many of the parameters tested.

[00138] CBDA is significantly more potent than CBD upon growth of D. discoideum; and CBDA acts more quickly and is more bioavailable than CBD.

[00139] These findings are of great significance as they demonstrate that CBDA offers an alternative anti-convulsant to CBD. The finding that CBDA is more potent and more bioavailable than CBD means that a smaller daily dose of the active ingredient may be used in the treatment of epilepsy. Doses of less than 400mg and possibly doses of as little as from 1 mg – 100mg, might be used to treat human subjects. In this regard, a typical adult patient might weigh 60kg and thus, a daily dose for such a patient might be from 0.016mg/kg to 1.6mg/kg.

Moringa in treating epilepsy

Moringa oleifera, a tropical tree or bush, is an ancient treatment for epilepsy.

Now being used in several trials, the results look very promising.

Moringa and Epilepsy treatment summary from NIH.

IS IT LEGAL

The 2018 USA Farm Bill removed hemp from a schedule 1 product. This paves the way for making hemp a legal product in the states. However, state law may still make hemp illegal and so you need to check with your state and perhaps your local area.