Banzel (Rufinamide Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Banzel

Seizure (Epilepsy) »

Introduction

Few experiences match the drama of a convulsive seizure. A person having a severe seizure may cry out, fall to the floor unconscious, twitch or move uncontrollably, drool, or even lose bladder control. Within minutes, the attack is over, and the person regains consciousness but is exhausted and dazed. This is the image most people have when they hear the word epilepsy. However, this type of seizure -- a generalized tonic-clonic seizure -- is only one kind of epilepsy. There are many other kinds, each with a different set of symptoms.

Epilepsy was one of the first brain disorders to be described. It was mentioned in ancient Babylon more than 3,000 years ago. The strange behavior caused by some seizures has contributed through the ages to many superstitions and prejudices. The word epilepsy is derived from the Greek word for "attack." People once thought that those with epilepsy were being visited by demons or gods. However, in 400 B.C., the early...

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Banzel

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BANZEL®
(rufinamide) Tablet, Film Coated for Oral Use

BANZEL®
(rufinamide) Oral Suspension

DRUG DESCRIPTION

BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H1,2,3-triazole-4 carboxamide. It has an empirical formula of C₁₀H₈F₂N₄O and a molecular weight of 238.2. The drug substance is a white, crystalline, odorless and slightly bitter tasting neutral powder. Rufinamide is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile.

BANZEL® (rufinamide) Structural Formula Illustration

BANZEL (rufinamide tablets) is available for oral administration in film-coated tablets, scored on both sides, containing 200 and 400 mg of rufinamide. Inactive ingredients are colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. The film coating contains hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

BANZEL (rufinamide tablets) is also available for oral administration as a liquid containing rufinamide at a concentration of 40 mg/mL. Inactive ingredients include microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethylcellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, noncrystallizing sorbitol solution 70%, and an orange flavor.

What are the possible side effects of rufinamide (Banzel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, panic, or if you feel hyperactive, talkative, restless, agitated, aggressive, angry, impulsive, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any...

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What are the precautions when taking rufinamide tablets (Banzel)?

Before taking rufinamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: family history of a certain heart problem (QT shortening in the EKG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe kidney disease (including dialysis), liver disease, mental/mood disorders (such as depression, thoughts of suicide).

This drug may make you dizzy or drowsy or cause blurred/double vision....

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Last reviewed on RxList: 4/22/2011
This monograph has been modified to include the generic and brand name in many instances.