RUFINAMIDE

Anticonvulsant

Brand names: Banzel

Oral

Mechanism of Action

12.1 Mechanism of Action The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown. The results of in vitro studies suggest that the principal mechanism of action of rufinamide is modulation of the activity of sodium channels and, in particular, prolongation of the inactive state of the channel. Rufinamide (≥ 1 μM) significantly slowed sodium channel recovery from inactivation after a prolonged prepulse in cultured cortical neurons, and limited sustained repetitive firing of sodium-dependent action potentials (EC 50 of 3.8 μM).

Indications

and in adults ( 1 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5
4 ) Withdraw BANZEL gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5
1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including BANZEL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication
Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Drowsiness

1-10%

Diarrhea

0.1-1%

Condition Worsened

0.1-1%

Vomiting

0.1-1%

Fatigue

0.1-1%

Falls

0.1-1%

Decreased Appetite

0.1-1%

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Compare With

14 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral