LEVETIRACETAM solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Dostępny od:

McKesson Corporation

INN (International Nazwa):

LEVETIRACETAM

Skład:

LEVETIRACETAM 100 mg in 1 mL

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LEVETIRACETAM- LEVETIRACETAM SOLUTION
MCKESSON CORPORATION
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LEVETIRACETAM ORAL SOLUTION
100 MG/ML
RX ONLY
DESCRIPTION
Levetiracetam is an antiepileptic drug available 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.)
Levetiracetam 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 seizures.
Levetiracetam did not inhibit single seizures induced by maximal
stimulation with electrical current or
different chemoconvulsants and showed only minimal activity in
submaximal stimulation and in threshold
tests. Protection was observed, however, against secondarily
generalized activity from focal seizures
induced by pilocarpine and kainic acid, two chemoconvulsants that
induce seizures that mimic some
features of human complex partial seizures with secondary
generalization. Levetiracetam also displayed
inhibitory properties in the kindling