pms-Topiramate

pms-Topiramate Dosage/Direction for Use

topiramate

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Dosage/Direction for Use
General: In patients with or without a history of seizures or epilepsy, pms-TOPIRAMATE (topiramate) should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency (see General under Precautions).
In clinical trials in adult patients with epilepsy, dosages were decreased by 50 - 100 mg/day at weekly intervals. In clinical trials of children, topiramate was gradually withdrawn over a two- to eight-week period.
In clinical trials in adult patients receiving topiramate for migraine prophylaxis, dosages were decreased by 25 - 50 mg/day at weekly intervals (see General under Precautions).
In situations where rapid withdrawal of pms-TOPIRAMATE is medically required, appropriate monitoring is recommended (see General under Precautions).
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 pms-TOPIRAMATE to prevent seizures therefore outweighs the risk of malformations to the fetus. However, taking pms-TOPIRAMATE to prevent migraine attacks does not outweigh this risk. Consequently, pms-TOPIRAMATE is contraindicated in pregnancy and in women of child-bearing potential who are not using an effective method of contraception (see Contraindications).
Recommended Dose and Dosage Adjustment: pms-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.
The recommended titration rate for topiramate monotherapy to 100 mg/day is: See Table 7.

Click on icon to see table/diagram/image

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. Only 14 pediatric patients have received 500 mg/day topiramate in controlled clinical trials (see Epilepsy: Clinical Trial Adverse Drug Reactions - Tables 10a and 10b under Adverse Reactions).
Adjunctive Therapy: Adults (Age 17 years and older): It is recommended that pms-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. Some patients may benefit from lower initial doses, e.g., 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 pms-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. 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, pms-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 pms-TOPIRAMATE is medically required, appropriate monitoring is recommended.
Migraine Prophylaxis: Adults: The usual total daily dose of pms-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. No extra benefit has been demonstrated from the administration of doses higher than 100 mg/day and the incidence of some adverse events increases with increasing dose (see Migraine Prophylaxis: Clinical Trial Adverse Drug Reactions - Table 15 under Adverse Reactions).
The recommended titration rate for topiramate for migraine prophylaxis to 100 mg/day is: See Table 8.

Click on icon to see table/diagram/image

Drug Discontinuation: In patients without a history of seizures or epilepsy, pms-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 pms-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 established.
Patients with Renal Impairment: In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Renal Insufficiency under Actions; Renal: Adjustment of Dose in Renal Failure under Precautions).
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 anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of pms-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 topiramate in the patient being dialyzed (see Renal: Adjustment of Dose in Renal Failure under Precautions).
Patients with Hepatic Disease: In hepatically impaired patients, topiramate plasma concentrations are increased approximately 30%. This moderate increase is not considered to warrant adjustment of the pms-TOPIRAMATE dosing regimen. Initiate topiramate therapy with the same dose and regimen as for patients with normal hepatic function. The dose titration in these patients should be guided by clinical outcome, i.e., seizure control, and avoidance of adverse effects. Such patients will require a longer time to reach steady-state at each dose (see Pharmacology: Pharmacokinetics: Special Populations and Conditions: Hepatic Insufficiency under Actions).
Geriatrics: See Use in the Elderly under Precautions.
Missed Dose: The missed dose should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. Instead, the next scheduled dose should be taken. Doses should not be doubled.
Administration: Tablets should not be broken.
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