KEPPRA levetiracetam tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

levetiracetam (UNII: 44YRR34555) (levetiracetam - UNII:44YRR34555)

Boleh didapati daripada:

UCB Farchim S.A.

INN (Nama Antarabangsa):

levetiracetam

Komposisi:

levetiracetam 750 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

New Drug Application

Ciri produk

KEPPRA- LEVETIRACETAM TABLET
UCB FARCHIM S.A.
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KEPPRA (LEVETIRACETAM)
250 MG, 500 MG, 750 MG, AND 1000 MG TABLETS
100 MG/ML ORAL SOLUTION
DESCRIPTION
KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg
(yellow), 750 mg (orange), and
1000 mg (white) tablets and as a clear, colorless, grape-flavored
liquid (100 mg/mL) for oral
administration.
The chemical name of levetiracetam, a single enantiomer, is
(-)-(S)-α-ethyl-2-oxo-1-pyrrolidine
acetamide, its molecular formula is C H N O 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.)
KEPPRA tablets contain the labeled amount of levetiracetam. Inactive
ingredients: colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate, polyethylene
glycol 3350, polyethylene glycol
6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents
listed below:
250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
500 mg tablets: iron oxide yellow
750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron
oxide red
KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive
ingredients: ammonium
glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution,
methylparaben, potassium
acesulfame, propylparaben, purified water, sodium citrate dihydrate
and natural and artificial flavor.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism(s) by which levetiracetam exerts its
antiepileptic effect is unknown. The
antiepileptic activity of levetiracetam was assessed in a number of
animal models of epileptic s