What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Banzel (rufinamide)
Also Known as Inovelon
Prescription Required
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Product Details
Description
Banzel (rufinamide) is an add-on medication used to treat seizures in adults and pediatric patients who are at least 1 years old with Lennox-Gastaut Syndrome (LGS).
Banzel is available in 200 mg and 400 mg film-coated tablets for oral use. It also comes in a 40 mg/mL oral suspension (liquid).
Fact Table
Formula
C10H8F2N4O
License
US FDA, EU EMA,US FDA
Bioavailability
85%
Legal status
Rx-Only
Chemical Name
rufinamide
Elimination half-life
6–10 hours
Dosage (Strength)
100mg, 200mg, 400mg
Pregnancy
Consult doctor
Brands
Banzel
Protein binding
34%
PubChem CID
129228
MedlinePlus
a609001
ChEBI
Not Assigned
ATC code
N03AF03
DrugBank
Not Assigned
KEGG
D05775
Routes of administration
By mouth
Directions
Be sure to take Banzel exactly as your doctor has prescribed. Discuss any questions or concerns with your doctor or pharmacist.
Each pediatric patient's Banzel dose is based on weight.
Adults are recommended to start on 400 mg to 800 mg by mouth daily in two equally divided doses. The doctor may increase the dose every other day until the patient reaches a maximum dose of 3,200 mg a day, taken in two divided doses.
Your doctor will tell you how much Banzel you should take and how often.
Ingredients
Banzel contains rufinamide. Inactive ingredients include colloidal silicon dioxide, corn starch, crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. Hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide make up the film coating of the tablets.
Inactive ingredients in the oral suspension 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.
Contraindications
Patients with Familial Short QT syndrome should not take Banzel.
Cautions
- Before you start treatment with Banzel, tell your doctor about:
- All the medications you take.
- Your allergies.
- Your current health problems and past medical history.
- Your pregnancy or breastfeeding status.
- Banzel can increase the risk of suicidal thoughts or behaviors. Patients should be monitored for worsening depression, suicidal thoughts or behaviors, or unusual mood or behavioral changes.
- Central nervous system reactions such as sleepiness, fatigue, dizziness, walking problems, and poor muscle control can occur with Banzel use.
- Caution should be used when taking Banzel with other medications that can shorten the QT interval.
- Multi-organ hypersensitivity can occur with the use of Banzel. Signs and symptoms include fever, rash, lymphadenopathy, and/or facial swelling. Liver or kidney inflammation, blood disorders, inflamed heart muscle, and weak, painful, or achy muscles may also occur. Patients should seek medical care right away if they experience any of these effects.
- When stopping Banzel, it should be gradually stopped to reduce the risk of seizures.
Side Effects
Common Banzel medication side effects include headache, dizziness, fatigue, drowsiness, and nausea; however, other side effects may occur, so contact your doctor right away if you have bothersome or persistent side effects.
Reference:
Banzel (rufinamide). Nutley, NJ: Eisai Inc.; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 11599
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