Topmate 25

Topiramate is a medicine used to treat epilepsy (seizures) and to prevent migraines. It is also used in the treatment of Lennox-Gastaut syndrome (a rare, but severe form of epilepsy that starts in early childhood). Topiramate controls seizures by decreasing the abnormal and excessive activity of the nerve cells in the brain. It may be taken with or without food, preferably at the same time, each day. If you have missed a dose, take it as soon as you remember it and finish the full course of treatment even if you feel better. Stopping the medication suddenly without talking to your doctor may cause increased frequency of seizures. Your doctor may advise regular monitoring of serum bicarbonate levels while you are taking this medicine. Some of the common side effects of this medicine include nausea, taste change, fatigue, diarrhea, weight loss, loss of appetite, and memory impairment. It may also cause vision problems like myopia or glaucoma, so it is important to get your eyesight checked before you start the treatment and regularly thereafter. You may experience dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you. Please consult your doctor if these side effects bother you or do not go away. Topiramate is an antiepileptic medication. It controls seizures or fits by decreasing the abnormal and excessive activity of the nerve cells in the brain.

• Epilepsy/Seizures • Prevention of migraine • Lennox–Gastaut syndrome

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.

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 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 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 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 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).

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.

If you miss a dose of Topiramate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

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

[UNSAFE] Topiramate may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. Take your medication regularly as directed by your doctor as missing doses can trigger seizures. Do not change the brand of your medicine and make sure that you have sufficient amount of medicine present with you. Some healthy tips to prevent seizures: It may cause dizziness and sleepiness. Do not drive or do anything that requires mental focus until you know how it affects you. Keep yourself hydrated by drinking plenty of fluids throughout the day while taking Topiramate. This can reduce the risk of kidney stones. Monitor your weight during treatment with this medicine as it can cause weight gain. Talk to your doctor if you notice sudden mood changes or develop suicidal thoughts. Do not stop taking the medication suddenly without talking to your doctor as it may increase the seizure frequency.

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

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.

[UNSAFE] It is unsafe to consume alcohol with Topiramate.

[CONSULT YOUR DOCTOR] Topiramate is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

[CONSULT YOUR DOCTOR] Topiramate is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[CAUTION] Topiramate should be used with caution in patients with kidney disease. Dose adjustment of Topiramate may be needed. Please consult your doctor. [CAUTION] Topiramate should be used with caution in patients with liver disease. Dose adjustment of Topiramate may be needed. Please consult your doctor.

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