Zetonna
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Uses
Levetiracetam extended-release tablet USP is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.
History
There is currently no drug history available for this drug.
Other Information
Levetiracetam extended-release tablet USP is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration.
The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
Levetiracetam extended-release tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, lactose anhydrous, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains shellac, iron oxide black and propylene glycol.
Sources
Zetonna Manufacturers
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Sunovion Pharmaceuticals Inc.
![Zetonna (Ciclesonide) Aerosol, Metered [Sunovion Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zetonna | Lupin Pharmaceuticals, Inc.
2.1 Recommended DosingLevetiracetam extended-release tablet is administered once daily.
Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day.
2.2 Dosage Adjustments in Adult Patients with Renal ImpairmentLevetiracetam extended-release tablets dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
[140-age (years)] x weight (kg)
CLcr = ---------------------------------------- x (0.85 for female patients
72 x serum creatinine (mg/dL)
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (mL/min)
CLcr (mL/min/1.73 m2) = ---------------------- x 1.73
BSA subject (m2)
Table 1: Dosage Adjustment Regimen for Adult Patients with Renal Impairment Group
Creatinine
Clearance
(mL/min/1.73m2)
Dosage
(mg)
Frequency
Normal
> 80
1000 to 3000
Every 24 hours
Mild
50 to 80
1000 to 2000
Every 24 hours
Moderate
30 to 50
500 to 1500
Every 24 hours
Severe
< 30
500 to 1000
Every 24 hours
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