Pitomate

Topiramate

Initial monotherapy or adjunctive therapy for management of partial-onset, primary generalized clonic-tonic seizure in patients >2 yr. Adjunctive therapy for management of seizures associated w/ Lennox-Gastaut syndrome in patients >2 yr. Prophylaxis of migraine headache in adults & adolescents ≥12 yr.

Epilepsy, monotherapy in partial-onset seizure & primary generalized tonic-clonic seizure Adult, adolescent & childn ≥10 yr 400 mg daily in 2 divided doses. Initially 25 mg daily in the evening or 25 mg bid in the 1st wk, may increase wkly by 50 mg daily up to 100 mg bid in the 4th wk of therapy. May further increase wkly by 100 mg daily up to 200 mg bid. Childn 2-10 yr Initially 25 mg once daily in the evening, may increase to 25 mg bid in wk 2. Thereafter, may increase by 25-50 mg daily at wkly intervals over 5-7 wk up to the min recommended maintenance dose & further increase by 25-50 mg daily at wkly intervals following max recommended maintenance dose. Childn weighing >38 kg 250-400 mg daily in 2 divided doses, 32-38 kg 250-350 mg daily in 2 divided doses, 23-31 kg 200-350 mg daily in 2 divided doses, 12-22 kg 200-300 mg daily in 2 divided doses, ≤11 kg 150-250 mg daily in 2 divided doses. Epilepsy, adjunctive therapy in partial-onset seizure, primary generalized tonic-clonic seizure or Lennox-Gastaut syndrome Adult & adolescent >17 yr Maintenance dose: 100-200 mg bid. Max: 400 mg daily. Initially 25 mg once daily or bid for 1 wk, may increase wkly by 25-50 mg daily. Adolescent & childn 2-17 yr Initially 25 mg once daily (based on range of 1-3 mg/kg daily in evening) for 1 wk, may increase in increments of 1-3 mg/kg daily up to 5-9 mg/kg in 2 divided doses every 1-2 wk. Migraine prophylaxis Adult & adolescent >12 yr Initially 25 mg once daily in the evening, may increase wkly by 25 mg daily up to 100 mg daily given in 2 divided doses. Elderly Initially 25 mg daily followed by incremental increases of 25 mg at wkly intervals. Renal impairment (CrCl <70 mL/min/1.73 m²) Administer 50% of dose w/ slower titration. Patients on hemodialysis Supplemental dose may be needed.

May be taken with or without food: Swallow whole, do not crush/break/chew.

Hypersensitivity.

Discontinue use immediately if any visual abnormalities eg, blurred vision, ophth pain occur. Consider discontinuation or dose reduction (by tapering dose) in patients w/ persistent or severe metabolic acidosis (consider alkali supplementation if continued). Monitor for signs/symptoms of depression, suicide tendencies & other unusual behavior changes. Hematologic abnormality; acute myopia & secondary angle closure glaucoma w/in 1 mth of initiation; oligohydrosis (decreased sweating) & anhidrosis; hyperthermia especially in young childn; hyperchloremic non-anion gap metabolic acidosis; hyperammonemia w/ or w/o encephalopathy. Increased risk of renal calculus. Not to discontinue abruptly; gradually decrease dose in wkly intervals. Ensure adequate hydration. Monitor serum bicarbonate & potential complications of chronic acidosis. Consider hyperammonemic encephalopathy & measure ammonia levels in patients who develop unexplained lethargy, or mental status changes. Wt loss (consider dietary supplement or increased food intake). Avoid concomitant use w/ alcohol or alcohol-containing product. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Young childn exposed to high ambient temp.

Ataxia, behavioral problems, confusion, depression, dizziness, drowsiness, fatigue, lack of conc, language problems, memory impairment, mood disorder, nervousness, paresthesia, psychomotor retardation, speech disturbance; decreased serum bicarbonate, hyperammonemia, wt loss; abdominal pain, anorexia, diarrhea, dysgeusia, nausea; viral infection; fever, trauma; nystagmus, visual disturbance; increased serum creatinine; sinusitis, upper resp infection.

Pharmacokinetic interactions w/ drugs metabolized by CYP2C19 including some anticonvulsants, CNS depressants & OCs. Increased levels/effects of α-/β-agonists, amitriptyline, amphetamines, blonanserin, buprenorphrine, CNS depressants, flecainide, fosphenytoin, hydrocodone, lithium, memantine, metformin, methotrimeprazine, metyrosine, mirtazapine, oxycodone, phenytoin, pramipexole, primidone, quinidine, ropinirole, rotigotine, SSRIs, suvorexant, valproate products, zolpidem. Decreased levels/effects of contraceptives (estrogens, progestins), methenamine, primidone, glyburide, digoxin, diltiazem. Increased levels/effects w/ anticholinergics, topical brimonidine, cannabis, doxylamine, dronabinol, droperidol, hydroxyzine, kava kava, loop diuretics, Mg sulfate, methotrimeprazine, minocycline, nabilone, perampanel, rufinamide, salicylates, Na oxybate, tapentadol, tetrahydrocannabinol, thiazide & thiazide-like diuretics. Decreased levels/effects w/ carbamazepine, fosphenytoin, mefloquine, mianserin, orlistat, phenytoin, valproic acid. May increase possibility of acidosis &/or kidney stones w/ ketogenic diet. Avoid concomitant use w/ ethyl alcohol, nasal azelastine, carbonic anhydrase inhibitors, orphenadrine, paraldehyde, thalidomide, ulipristal.

Anticonvulsants / Antimigraine Preparations

N03AX11 - topiramate ; Belongs to the class of other antiepileptics.

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