Epitop Tablets (Topiramate)

• Composition :
  Each tablet contains Topiramate 25 mg/50 mg/100 mg.
• Indications :
  In the treatment of partial and generalized tonic clonic seizures.
• Pharmacodynamics :
  Topiramate blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
• Dosage and administration :
  Adults and pediatric patients≥10 year: Initially 50 mg/day in two divided doses, the dosage should be increased weekly increments of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6. Recommended dose is 400 mg/day in two divided doses.Children 2 to <10 years: Initially 25 mg/day administered nightly for the first week. The dosage should be titrated over 5-7 weeks. Daily doses in two divided doses based on weight are recommended.In adjunctive therapy in adults with partial onset seizure recommended total daily dose 200 to 400mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. Should be initiated at 25 to 50 mg/day, followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day have not been shown to improve responses in adults with partial onset seizures.
• Contraindications :
  hypersensitivity to any of the drug components
• Precautions and warnings :
  In acute myopia and secondary angle closure glaucoma,Visual field defects: consider discontinuation;metabolic acidosis consider dose reduction or discontinuation,increased risk of suicidal behavior or ideation has been reported,Hypothermia has been reported with and without hyperammonemia during Topiramate treatment with concomitant valproic acid use.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category D. Topiramate can cause fetal harm; when administered to a pregnant woman can cause cleft lip and/or palate in the fetus.Safety and effectiveness in nursingmothersand in patients below the age of 2 years have not been established.Dosage adjustment may be necessary for elderly with impaired renal function.
• Drug interactions :
  Concomitant administration of phenytoin or carbamazepine with topiramate decreased plasma concentrations of topiramate; Oral contraceptives: decreased contraceptive efficacy and increased breakthrough bleeding, especially at doses greater than 200 mg/day; Monitor lithium levels if lithium is used with high-dose.
• Adverse reactions :
  Most commonly adverse reactions are paresthesia, anorexia, weight decrease, fatigue, dizziness, somnolence, nervousness, psychomotor slowing and fever.
• Therapy Area :
  Anti-Eplileptics