Uses of Epimet 25 Tablet: - Epilepsy/Seizures - Prevention of migraine - Lennox–Gastaut syndrome Epilepsy, Migraine prophylaxis, Seizures associated w/ Lennox-gastaut syndrome Contraindicated in persons showing hypersensitivity to any component of this preparation.

Adjunct anti-epileptic drugs

Topiramate is a sulfamate-substituted monosaccharide, related to fructose. Topiramate is quickly absorbed after oral use. Topiramate enhances GABA-activated chloride channels. In addition, topiramate inhibits excitatory neurotransmission, through actions on kainate and AMPA receptors. Topiramate has a specific effect on GluR5 kainate receptors. It is also an inhibitor of carbonic anhydrase, particularly subtypes II and IV, but this action is weak and unlikely to be related to its anticonvulsant actions, but may account for the bad taste and the development of renal stones seen during treatment. Its possible effect as a mood stabilizer seems to occur before anticonvulsant qualities at lower dosages.

How to use Topiramate: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Topiramate may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Partial-Onset or Primary Generalized Tonic-Clonic Seizures Monotherapy Adult: 25 mg PO q12hr initially; may increase by 50 mg/day at weekly intervals to 200 mg PO q12hr. Adjunctive therapy 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr. Lennox-Gastaut Syndrome Indicated as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr Migraine Headache Indicated for prophylaxis of migraine headache Titrate over 4 wk to achieve a dose of 50 mg PO BID Week 1: 25 mg PO at night Week 2: 25 mg PO BID Week 3: 25 mg PO in the morning and 50 mg at night Week 4: 50 mg PO BID Hepatic impairment: Dosage adjustment may be needed. Child Dose: Oral Partial-Onset or Primary Generalized Tonic-Clonic Seizures Monotherapy <2 years: Safety and efficacy not established 2 to <10 years: 25 mg PO at night for 1 week; titrate dose over 5-7 weeks to target daily maintenance dose (weight based) and divide into q12hr dosing schedule Weight-based dosing Up to 11 kg: 150 mg/day minimum; 250 mg/day maximum 12-22 kg: 200 mg/day minimum; 300 mg/day maximum 23-31 kg: 200 mg/day minimum; 350 mg/day maximum 32-38 kg: 250 mg/day minimum; 350 mg/day maximum >38 kg: 250 mg/day minimum; 400 mg/day maximum >10 years 25 mg PO q12hr initially Titrate by increments of 50 mg/week up to 200 mg q12hr Adjunctive therapy <2 years: Safety and efficacy not established 2-16 years: 25 mg PO qHS(once at night) initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg/day PO divided q12hr at 1-2 week intervals to 5-9 mg/kg/day divided q12hr >17 years: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr for generalized tonic/clonic seizures Lennox-Gastaut Syndrome Adjunctive therapy <2 years: Safety and efficacy not established 2-16 years: 25 mg PO qHS initially for first week (based on 1-3 mg/kg/day); increase dose by 1-3 mg/kg/day PO divided q12hr at 1-2 week intervals to 5-9 mg/kg/day divided q12hr >17 years: 25-50 mg/day PO initially; increase by 25-50 mg/day at weekly intervals to 100-200 mg q12hr for partial onset seizures and 200 mg q12hr for generalized tonic/clonic seizures Migraine Headache Indicated for prophylaxis of migraine headache <12 years: Safety and efficacy not established Guide dose/titration rate by clinical outcome; if needed, use longer intervals between dose adjustments >12 years Titrate over 4 wk to achieve a dose of 50 mg PO BID Week 1: 25 mg PO qHS(once at night) Week 2: 25 mg PO BID Week 3: 25 mg PO in the morning and 50 mg HS Week 4: 50 mg PO BID Renal Dose: Renal impairment: Moderate to severe: Doses should be halved. Haemodialysis: supplemental dose equal to about ½ of the daily dose should be given in divided doses (at the start and finish of haemodialysis).

Coadmin with antiepileptic drugs e.g. phenytoin, carbamazepine, phenobarbital decreases plasma concentration of topiramate. Possible increase in phenytoin levels. Increased risk of renal stone formation with carbonic anhydrase inhibitors e.g. acetazolamide. Increased risk of CNS depression with CNS depressants and alcohol. Increased risk of hyperammonaemia and encephalopathy with valproic acid. Increased risk of contraceptive failure in women taking combined oral contraceptives.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

Common - Abdominal pain - Diarrhea - Dizziness - Fatigue - Fever - Loss of appetite - Memory impairment - Nausea - Nervousness - Numbness - Psychomotor impairment - Sleepiness - Speech disorder - Taste change - Upper respiratory tract infection - Visual impairment - Weight loss >10% Decrease in serum bicarbonate (7-67%),Dizziness (4-29%),Fatigue (9-16%),Ataxia (6-16%),Nervousness (9-18%),Paresthesia (1-11%),Psychomotor slowing (3-13%),Abnormal vision (2-13%),Anorexia (4-24%),Confusion (4-11%),Decreased memory (2-12%),Nausea (6-10%),Speech disorder (2-13%),Injury (14%) 1-10% Abdominal pain (6-10%),Weight loss (4-9%),Diplopia (1-10%),Mood problems (<6%),Pharyngitis (6%),Tremor (3-9%),Abnormal gait (3-8%),Apathy (1%),Asthenia (1-5%),Dry mouth (2%),Menorrhagia (1-2%),Skin disorder (2-3%),Taste change (2%),Edema (2%),Hypertension (1-2%),Syncope (1%),Bradycardia (1%),Pallor (1%) <1% Angina,Erythema,Hepatic failure,Hyperthermia,Hypokalemia,Neuropathy,Toxic epidermal necrolysis

Topiramate is pregnancy category C. So it may be given only if clearly needed and after the assessment of risk benefit ratio. It is not known whether Topiramate is excreted through breast milk. So caution should be taken if it is prescribed to a breast feeding mother.

Precaution: Renal or hepatic impairment, pregnancy, lactation. May impair ability to drive or operate machinery. Maintain adequate hydration to reduce the risk of renal calculi especially in predisposed patients. Measure serum bicarbonate at baseline and periodically during treatment. Avoid abrupt withdrawal; decrease dose by 100 mg daily at wkly intervals. Seek immediate medical attention if blurred vision or eye pain. Monitor closely for decreased sweating and increased body temperature, especially in hot weather. Ensure proper hydration before and during activities or exposure to warm temperatures. Lactation: Excreted in milk; use caution

Topiramate overdose can result in severe metabolic acidosis. In acute topiramate 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. Haemodialysis has been shown to be an effective means of removing topiramate from the body. The patient should be well hydrated.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Adjunct anti-epileptic drugs

Topiramate is a sulfamate-substituted monosaccharide with precise mechanism of action unknown. It may be due to various mechanisms e.g. blocking of voltage-dependent sodium channels; augmenting the activity of ?-aminobutyric acid (GABA) at GABA-A receptor; antagonising AMPA/kainate glutamate receptors; inhibiting carbonic anhydrase.

Topiramate should not be used during pregnancy unless, in the opinion of the physician, the potential benefit outweighs the potential risk to the foetus. Topiramate should not be used during breastfeeding.