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Banzel
Overview
What is Banzel?
BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1-1,2,3-triazole-4 carboxamide. It has an empirical formula of CHFNO 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 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 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 does Banzel look like?
What are the available doses of Banzel?
Film-coated Tablets: 200 mg (pink) and 400 mg (pink). Tablets are scored on both sides.
Oral Suspension: 40 mg/mL.
What should I talk to my health care provider before I take Banzel?
How should I use Banzel?
BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Pediatric patients
(
1
year
to less than 17 years)
The recommended starting daily dose of BANZEL in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than the target doses are effective.
Adults
(17 years and older)
The recommended starting daily dose of BANZEL in adults with Lennox-Gastaut Syndrome is 400 to 800 mg per day administered in two equally divided doses. The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than 3200 mg are effective.
What interacts with Banzel?
Sorry No Records found
What are the warnings of Banzel?
Sorry No Records found
What are the precautions of Banzel?
Sorry No Records found
What are the side effects of Banzel?
Sorry No records found
What should I look out for while using Banzel?
BANZEL is contraindicated in patients with Familial Short QT syndrome [
].
Serotonergic Drugs:
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What might happen if I take too much Banzel?
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Certified Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
One overdose of 7200 mg per day BANZEL was reported in an adult during the clinical trials. The overdose was associated with no major signs or symptoms, no medical intervention was required, and the patient continued in the study at the target dose.
Treatment or Management of Overdose: There is no specific antidote for overdose with BANZEL. If clinically indicated, elimination of unabsorbed drug should be attempted by induction of emesis or gastric lavage. Usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Hemodialysis: Standard hemodialysis procedures may result in limited clearance of rufinamide. Although there is no experience to date in treating overdose with hemodialysis, the procedure may be considered when indicated by the patient’s clinical state.
How should I store and handle Banzel?
Store the tablets at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). Protect from moisture. Replace cap securely after opening.Store the oral suspension at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). Replace cap securely after opening. The cap fits properly in place when the adapter is in place.Store the tablets at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). Protect from moisture. Replace cap securely after opening.Store the oral suspension at 25ºC (77ºF); excursions permitted to 15º- 30ºC (59ºF - 86ºF). Replace cap securely after opening. The cap fits properly in place when the adapter is in place.Citalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tabletsCitalopram Tablets USP, 10 mg are modified oval shaped, white, film-coated tablets, debossed “ ” on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-019-30 Bottles of 30 tabletsNDC 42806-019-01 Bottles of 100 tabletsNDC 42806-019-10 Bottles of 1000 tabletsCitalopram Tablets USP, 20 mg are modified oval shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-020-30 Bottles of 30 tabletsNDC 42806-020-01 Bottles of 100 tabletsNDC 42806-020-10 Bottles of 1000 tabletsCitalopram Tablets USP, 40 mg are capsule-shaped, white, film-coated tablets, debossed “ ” to the left of bisect and “ ” to the right of bisect on one side and plain on the other side, available in bottles of 30, 100 and 1000. NDC 42806-021-30 Bottles of 30 tabletsNDC 42806-021-01 Bottles of 100 tabletsNDC 42806-021-10 Bottles of 1000 tablets
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism(s) by which rufinamide exerts its antiepileptic effect is unknown.
The results of 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 of 3.8 μM).
Non-Clinical Toxicology
BANZEL is contraindicated in patients with Familial Short QT syndrome [ ].Array
Antiepileptic drugs (AEDs), including BANZEL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
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 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.
The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs.
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.
Anyone considering prescribing BANZEL or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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