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TOPAMAX TABLETS
Migraine and headache
Seizure disorders
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Drug Name:

TOPAMAX TABLETS Rx

Generic Name and Formulations:
Topiramate 25mg, 50mg, 100mg, 200mg.

Company:
Janssen Pharmaceuticals, Inc.



Therapeutic Use:

Indications for TOPAMAX TABLETS:

Migraine prophylaxis. Not been studied for use in acute treatment of migraines.

Adult Dose for TOPAMAX TABLETS:

May swallow caps whole or sprinkle contents onto soft food (swallow immediately). Give in two equally divided doses. Titrate in 1-week intervals. Initially 25mg once daily in the PM, then 25mg twice daily, then 25mg in the AM and 50mg in the PM, then 50mg twice daily. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose.

Children's Dose for TOPAMAX TABLETS:

Not established.

See Also:

TOPAMAX SPRINKLE CAPS

Pharmacological Class:

Sulfamate.

Warnings/Precautions:

Discontinue if acute myopia, secondary angle-closure glaucoma occur. Consider discontinuing if visual field defects occur. Kidney stones. Maintain adequate hydration and caloric intake; avoid ketogenic diets. Measure serum bicarbonate at baseline, then periodically during therapy; consider reducing dose or discontinuing if acidosis occurs. Inborn errors of metabolism, reduced mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Monitor closely for oligohidrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Avoid abrupt cessation. Hepatic or renal impairment. Elderly. Risk of fetal toxicity. Labor & delivery. Pregnancy (Cat.D). Nursing mothers.

Interactions:

Contraindicated with metformin during metabolic acidosis condition. Avoid concomitant other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Phenytoin, carbamazepine, valproic acid, lamotrigine reduce topiramate levels. Topiramate reduces valproic acid levels. May increase phenytoin levels. May antagonize digoxin, oral contraceptives, risperidone. CNS depression potentiated with alcohol, other CNS depressants. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Monitor lithium levels with high-dose topiramate.

Adverse Reactions:

Paresthesia, anorexia, weight decrease, taste perversion, upper RTI, abdominal pain, diarrhea, hypoesthesia, nausea, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, difficulty with memory, difficulty with concentration/attention, cognitive problems, confusion, mood problems, fever, infection, flushing; kidney stones, hyperchloremic acidosis, hyperammonemia, visual field defects.

Metabolism:

Hepatic (minor).

Elimination:

Renal.

Generic Availability:

YES

How Supplied:

Tabs, caps—60

Indications for TOPAMAX TABLETS:

Initial monotherapy and adjunct in partial-onset or primary generalized tonic-clonic seizures. Adjunct in Lennox-Gastaut syndrome.

Adult Dose for TOPAMAX TABLETS:

May swallow caps whole or sprinkle contents onto soft food (swallow immediately). Give in two equally divided doses. Monotherapy: initially 50mg/day, increase at 1-week intervals by increments of 50mg/week for the 1st 4 weeks, then increase by 100mg/week for weeks 5–6 to target dose of 400mg/day. Adjunctive therapy: ≥17yrs: Initially 25–50mg/day, increase at 1-week intervals by 25–50mg/day every week (see full labeling) to target dose of 200–400mg/day (partial onset seizures or Lennox-Gastaut) or 400mg/day (primary generalized tonic-clonic seizures); usual max 1.6g/day. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose.

Children's Dose for TOPAMAX TABLETS:

May swallow caps whole or sprinkle contents onto soft food (swallow immediately). Give in two equally divided doses. Monotherapy: <2yrs: not established. 2–<10yrs: (dosing based on weight) initially 25mg/day in the PM for the 1st week, then increase to 50mg/day in the 2nd week; subsequently, may increase weekly by 25–50mg/day as tolerated. Titration to the minimum or max maintenance dose should be attempted over 5–7 weeks: see full labeling. ≥10yrs: initially 50mg/day, increase at 1-week intervals by increments of 50mg/week for the 1st 4 weeks, then increase by 100mg/week for weeks 5–6 to target dose of 400mg/day. Adjunctive therapy: <2yrs: not established. 2–16yrs: initially 1–3mg/kg (max 25mg) per day given in the PM for 1 week, increase at 1–2 week intervals by 1–3mg/kg/day to target range of 5–9mg/kg/day in 2 divided doses. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose.

See Also:

TOPAMAX SPRINKLE CAPS

Pharmacological Class:

Sulfamate.

Warnings/Precautions:

Discontinue if acute myopia, secondary angle-closure glaucoma occur. Consider discontinuing if visual field defects occur. Kidney stones. Maintain adequate hydration and caloric intake; avoid ketogenic diets. Measure serum bicarbonate at baseline, then periodically during therapy; consider reducing dose or discontinuing if acidosis occurs. Inborn errors of metabolism, reduced mitochondrial activity: increased risk of hyperammonemia; measure ammonia levels if encephalopathic symptoms occur. Monitor closely for oligohidrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Avoid abrupt cessation. Hepatic or renal impairment. Elderly. Risk of fetal toxicity. Labor & delivery. Pregnancy (Cat.D). Nursing mothers.

Interactions:

Contraindicated with metformin during metabolic acidosis condition. Avoid concomitant other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Phenytoin, carbamazepine, valproic acid, lamotrigine reduce topiramate levels. Topiramate reduces valproic acid levels. May increase phenytoin levels. May antagonize digoxin, oral contraceptives, risperidone. CNS depression potentiated with alcohol, other CNS depressants. Hyperammonemia (w/ and w/o encephalopathy) and/or hypothermia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). Monitor lithium levels with high-dose topiramate.

Adverse Reactions:

Paresthesia, anorexia, weight decrease, speech disorders, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, difficulty with memory, difficulty with concentration/attention, cognitive problems, confusion, mood problems, fever, infection, flushing, taste perversion; kidney stones, hyperchloremic acidosis, hyperammonemia, sudden unexplained death in epilepsy, visual field defects.

Metabolism:

Hepatic (minor).

Elimination:

Renal.

Generic Availability:

YES

How Supplied:

Tabs, caps—60

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