Monograph Details
|
|
Central Nervous System
> Seizure disorders
|
|
TOPAMAX SPRINKLE CAPS |
| Manufacturer |
|
Ortho-McNeil Neurologics, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Sulfamate. |
| Generic Name |
|
Topiramate 15mg, 25mg; coated beads in caps. |
| Also |
|
• TOPAMAX TABLETS
|
| Indications |
|
Partial-onset or primary generalized tonic-clonic seizures. Adjunct in Lennox-Gastaut syndrome. |
| Children |
|
May swallow sprinkle caps whole or sprinkle contents onto soft food (swallow immediately). Give in two equally divided doses. Monotherapy: <10yrs: not recommended. ≥10yrs: initially 50 mg/day, increase at 1-week intervals by increments of 50 mg/day until daily dose is 200 mg/day then increase by 100 mg/day to target dose of 400 mg/day. Adjunctive therapy, Lennox-Gastaut: <2years: not recommended. 2–16years: Initially 1–3 mg/kg (max 25 mg) per day given in the PM for 1 week, increase at 1–2 week intervals by 1–3 mg/kg per day in 2 divided doses. Usual range: 5–9 mg/kg per day in 2 divided doses. |
| Adults |
|
May swallow caps whole or sprinkle contents onto soft food (swallow immediately). Give in two equally divided doses. Monotherapy: initially 50 mg/day, increase at 1-week intervals by increments of 50 mg/day until daily dose is 200 mg/day then increase by 100 mg/day to target dose of 400 mg/day. Adjunctive therapy, Lennox-Gastaut: ≥17years: Initially 25–50 mg/day, increase at 1-week intervals by 25–50 mg/week (see literature) to target dose of 400 mg/day; usual max 1.6 g/day. Renal impairment (CrCl <70mL/min): reduce dose by ½. Hemodialysis: may need extra dose. |
| Precautions |
|
Discontinue if acute myopia and secondary angle-closure glaucoma occur. Hepatic or renal impairment. Kidney stones. Maintain adequate hydration and caloric intake; avoid ketogenic diets. Monitor serum bicarbonate; follow up if acidosis occurs. Monitor closely for oligohidrosis and hyperthermia (esp. children). Suicidal tendencies (monitor). Avoid abrupt cessation. Labor & delivery. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
|
Avoid carbonic anhydrase inhibitors. Phenytoin, carbamazepine, valproic acid reduce topiramate levels. Topiramate reduces valproic acid levels. May increase phenytoin levels. May increase levels with lamotrigine. May antagonize digoxin, oral contraceptives, lithium, risperidone. CNS depression potentiated with alcohol, other CNS depressants. Hyperammonemia possible with valproic acid. Caution with other drugs that interfere with temperature regulation (eg, anticholinergics, carbonic anhydrase inhibitors). |
| Adverse Reactions |
|
Drowsiness, dizziness, ataxia, speech disorder, psychomotor slowing, nervousness, other mental changes, paresthesia, hypoaesthesia, visual disorders/eye pain (follow-up if occurs), fatigue, weight loss, GI upset, anorexia, URIs, kidney stones, hyperchloremic acidosis. |
| How Supplied |
|
Tabs, caps—60 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
