Topamac Tablets (Generic Topiramate Tablets)

1. Topamac Tablets (Generic Topiramate Tablets) © The Swiss Pharmacy

2. Topamac Tablets (Generic Topiramate Tablets) Topamac (Generic Topiramate Tablets) is is a medicine used to treat epilepsy. It used as monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic- clonic seizures. It is also used as adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic- clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate tablets are also used in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment. © The Swiss Pharmacy

3. Topamac Tablets (Generic Topiramate Tablets) Topamac Tablets are manufactured by Janssen Cilag Pharmaceuticals (Johnson and Johnson Private Limited, India) in the strength of 25 mg, 50 mg and 100 mg. © The Swiss Pharmacy

4. Topamac Tablets (Generic Topiramate Tablets) Chemical Structure © The Swiss Pharmacy

5. Topamac Tablets (Generic Topiramate Tablets) The active ingredient contained in Topamac tablets is Topiramate. Each film-coated Topamac tablet contains 25 mg, 50 mg or 100 mg of Topiramate. © The Swiss Pharmacy

6. Topamac Tablets (Generic Topiramate Tablets) Uses of Topamac 25 mg, 50 mg and 100 mg Tablets: Topamac (Generic Topiramate Tablets Generic Topiramate Tablets) is used alone or together with other medicines to help treat certain types of seizures (eg, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome). This medicine will not cure epilepsy and will only work to control seizures for as long as you continue to take it. It is also used to help prevent migraine headaches. Monotherapy Epilepsy: Monotherapy Epilepsy: Topamac (Generic Topiramate tablets) are used as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

7. Topamac Tablets (Generic Topiramate Tablets) Uses of Topamac 25 mg, 50 mg and 100 mg Tablets: Adjunctive Therapy Epilepsy: Adjunctive Therapy Epilepsy: Topiramate tablets are used as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. Migraine: Migraine: Topamac is used in adults for the prophylaxis of migraine headache. The usefulness of Topamac in the acute treatment of migraine headache has not been studied. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

8. Topamac Tablets (Generic Topiramate Tablets) Recommended Adult Dosage For most patients, the starting dose of Topamac Tablets (Generic Topiramate Tablets) for the treatment of Epilepsy as monotherapy for adults and pediatric patients 10 years and above is 50 mg/day in two divided doses. The dosage should be increased weekly by increments of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6. The recommended dose 400 mg/day in two divided doses Topamac Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

9. Topamac Tablets (Generic Topiramate Tablets) Recommended Adult Dosage The recommended dose for treatment of Epilepsy as adjunctive therapy for adults with partial onset seizures or LGS is 25 to 50 mg/day. The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. The recommended dose is 200 to 400 mg/day in two divided doses. The recommended dose for treatment of Epilepsy as adjunctive therapy for adults with primary generalized tonic clonic seizures 25 to 50 mg/day. The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. The recommended dose is 400 mg/day in two divided doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

10. Topamac Tablets (Generic Topiramate Tablets) Recommended Adult Dosage Topamac tablets dose for prophylaxis of Migraine in adults and adolescents 12 years of age and older is 25 mg/day administered nightly for the first week. The dosage should be increased weekly by increments of 25 mg. Dose and titration should be guided by clinical outcome. The recommended dose is 100 mg/day administered in two divided doses. Migraine: Migraine: The recommended Topamac tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

11. Topamac Tablets (Generic Topiramate Tablets) Contraindications ➔Topamac is contraindicated in patients with a known hypersensitivity to Topiramate or any component of the tablet. ➔Migraine prophylaxis in pregnancy and in women of childbearing potential if not using a highly effective method of contraception. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

12. Topamac Tablets (Generic Topiramate Tablets) Storage Instructions Topamac Tablets (Generic Topiramate Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. © The Swiss Pharmacy

13. Topamac Tablets (Generic Topiramate Tablets) Warnings Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of Topamac as rapidly as possible. Visual field defects: These have been reported independent of elevated intraocular pressure. Consider discontinuation of Topamac. Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients. Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended. Consider dose reduction or discontinuation of Topamac if clinically appropriate. Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

14. Topamac Tablets (Generic Topiramate Tablets) Warnings Cognitive/neuropsychiatric: Topamac may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy and migraine populations Fetal Toxicity: Topamac use during pregnancy can cause cleft lip and/or palate. Withdrawal of AEDs: Withdrawal of Topamac should be done gradually Hyperammonemia and encephalopathy associated with or without concomitant valproic acid use: Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyper ammonemia. Measure ammonia if encephalopathic symptoms occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

15. Topamac Tablets (Generic Topiramate Tablets) Warnings Kidney stones: Use with other carbonic anhydrase inhibitors, other drugs causing metabolic acidosis, or in patients on a ketogenic diet should be avoided. Hypothermia has been reported with and without hyperammonemia during Topiramate tablets treatment with concomitant valproic acid use. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

16. Topamac Tablets (Generic Topiramate Tablets) Possible Side Effects Most common Topiramate (Topamac Tablets) side effects with an incidence rate of greater than or equal to 10% and more frequent than placebo at recommended dosing in adult and pediatric controlled, epilepsy clinical trials were paresthesia, anorexia, weight decrease, speech disorder related speech problem, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

17. Topamac Tablets (Generic Topiramate Tablets) Possible Side Effects The following Topiramate (Topamac Tablets) side effects occurred in 5% or more frequent than placebo at recommended dosing in adult and adolescent controlled, migraine clinical trials were paresthesia, anorexia, weight decrease, difficulty with memory, taste perversion, upper respiratory tract infection, abdominal pain, diarrhea, hypoesthesia, and nausea URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

18. Topamac Tablets (Generic Topiramate Tablets) Topamac Tablets Overdosage Overdoses of Topiramate (Topamac tablets) have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. The clinical consequences were not severe in most cases, but deaths have been reported after poly-drug overdoses involving Topiramate (Topamac tablets). Topiramate overdose has resulted in severe metabolic acidosis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

19. Topamac Tablets (Generic Topiramate Tablets) Treatment of Topamac Tablets Overdosage In acute Topiramate (Topamac tablets) overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to adsorb Topiramate in vitro. Treatment should be appropriately supportive. Hemodialysis is an effective means of removing Topiramate from the body. A patient who ingested a dose between 96 and 110g Topiramate was admitted to a hospital with a coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

20. Topamac Tablets (Generic Topiramate Tablets) Topamac Tablets During Pregnancy Topiramate (Topamac tablets) has been classified by the US FDA as Pregnancy Category D. Topiramate (Topamac tablets) can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals were administered Topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. Topiramate (Topamac tablets) should be used during pregnancy only if the potential benefit outweighs the potential risk. If this medication is used during pregnancy, or if the patient becomes pregnant while taking this medicine, the patient should be apprised of the potential hazard to a fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy

21. Topamac Tablets (Generic Topiramate Tablets) Topamac Tablets Topamac Tablets (Generic Topiramate Tablets) are manufactured by Janssen Cilag Pharmaceuticals (Johnson and Johnson Private Limited, India). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html https://www.theswisspharmacy.com/product_info.php?info=p9615_Generic-Topamax-Pills.html © The Swiss Pharmacy