TOPIRAMATE 25MG TAB; topiramate, anticonvulsants|antimigraine agents .
ACTIVE-INGREDIENT OF TOPIRAMATE 25MG TAB
Each film coated tablet contains 25 mg topiramate.
INDICATION OF TOPIRAMATE 25MG TAB
Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalized seizures, and primary generalized tonic-clonic seizures. Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalized seizures, and primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment.
DOSAGE OF TOPIRAMATE 25MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
General: It is recommended that therapy be initiated at a low dose followed by gradual titration to an effective dose. Dose and titration rate should be guided by clinical response. Topiramate film-coated tablet is available in film-coated tablets formulation. It is recommended that film-coated tablets not be broken. It is not necessary to monitor topiramate plasma concentrations to optimize therapy with Topiramate film-coated tablet. On rare occasions, the addition of topiramate tp phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of pheytoin and carbamazepine to adjunctive therapy with Topiramate film-coated tablet may require adjustment of the dose of Topiramate film-coated tablet. Topiramate film-coated tablet can be talken without regard to meals. In patients with or without a history of seizures or epilepsy, antiepileptic drugs including topiramate should be gradually withdrawn to minimize the potential for seizures or increased seizures frequency. In clinical trials, daily dosage were decreased in weekly intervals by 50 – 100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis. In paediatric clinical trials, topiramate was gradually withdrewn over a 2-8 week period. Monotherapy Epilepsy: General ; When concomitant antiepileptic drugs (AEDs) are withdrawn to acheive monotherapy with topiramate, consideration should be given to the effects this may have on seizure control. Unless safety concerns require an abrupt withdrawal of the concomitant AED , a gradual discontinuation at the rate of approximately one-third of the concomitant AED dose every 2 weeks is recommended. When enzyme inducing medicinal products are withdrawn, topiramate levels will increase. A decrease in Topiramate film-coated tablet (topiramate) dosage may be required if clinically indicated. Adults : Dose and titration should be guided by clinical response. Titration should begin at 25 mg nightly for 1 week. The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses. If the patient is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used. The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day to 200 mg/day in 2 divided doses. The maximum recommended daily dose is 500 mg/day in two divided doses. Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day. These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease. Paediatric populations (children over 6 years of age): Dose and titration rate in children should be guided by clinical outcome. Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week. The dosage should then be increased at 1 to 2 week intervals by increments of 0.5 to 1 mg/kg/day, administered in two divided doses. If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used. The recommended initial target dose range for topiramate monotherapy in children over 6 years of age is 100 mg/day depending on clinical response, ( this is about 2.0 mg/kg/day in children 6-16 years). Adjunctive therapy epilepsy ( partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome): Adults: Therapy should begin at 25 – 50 mg nightly for one week. Use of lower initial doses has been reported, but has not been studied systemically. Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25 – 50 mg/day and taken in two divided doses. Some patients may achieve efficacy with once-a-day dosing. In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose. The usual daily dose is 200-400 mg in two divided doses. These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease. Paediatric populations (children aged 2 years and above): The recommended total daily dose of Topiramate film-coated tablet (topiramate) as adjunctive therapy is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. Th dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Daily doses up to 30 mg/kg/day have been studied and were generally well tolerated. Migraine: Adults: The recommended total daily dose of topiramate for prophylaxis of migraine headache is 100 mg/day administered in two divided doses. Titration should begin at 25 mg nightly for 1 week. Th dosage should then be increased in increments of 25 mg/day administered at 1-week intervals. If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used. Some patients may experience a benefit at a total daily dose of 50 mg/day. Patients have received a total daily dose up to 200 mg/day. This dose may be benefit in some patients; neverthless, caution is advised due to an increase incidence of side effects. Paediatric population: Toprimate film-coated tablet (topiramate) is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy. General dosing recommendations for Topiramate film-coated tablet in special patient populations: Renal impairment: In patients with impaired renal function (CLcr ≤ 70 Ml / min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased. Subjects with known renal impairment may require a longer time to reach steady-state at each dose . Half of the usual starting and maintenance dose is recommended. In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplement dose of Topiramate film-coated tablet equal to approximately one-half the daily dose should be administered on haemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis preocedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used. Hepatic impairment: In patients with moderate to severe hepatic impairment topiramate should be administered with caution as the clearance of topiramate is decreased. Elderly: No dose adjustment is required in the elderly populations providing renal function is intact.
OVER-DOSAGE OF TOPIRAMATE 25MG TAB
Signs and symptoms: Overdoses of topiramate have been reported. Signs and symptoms included: convulsions, drowsiness, speech disturbances, blurred vision, diplopia, impaired mentation, lethargy, abnormal co-ordination, stupor, hypotension, abdominal pain agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses with multiple medicinal products including topiramate. Topiramate overdose can result in severe metabolic acidosis. Treatment: In acute topiramate overdose, if the ingestion is recent, the stomach should be empetied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorp topiramate in vitro. Treatment should be appropriately supportive and the patient should be well hydrated. Haemodialysis has been shown to be an effective means of removing topiramate from the body.
CONTRA-INDICATION OF TOPIRAMATE 25MG TAB
Hypersensitivity to topiramate or to any of the excipients. Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective method of contraception.
STORAGE OF TOPIRAMATE 25MG TAB
Store at temperature not exceeding 30 °C in dry place.
PACK OF TOPIRAMATE 25MG TAB
Carton box contains 1, 2 or 3 (Al/Al) blisters; each blister contains 10 film coated tablet and insert leaflet.
TOPIRAMATE 25MG TAB MANUFACTURED BY
Sabaa International Company for pharmaceutical and chemical industries S.A.E.