LEVETIRACETAM tablet film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

McKesson Contract Packaging

INN (Tên quốc tế):

LEVETIRACETAM

Thành phần:

LEVETIRACETAM 500 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg, 500 mg,
750 mg or 1000 mg 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 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, USP is a white to off-white crystalline powder with a
faint odor and a bitter taste. It is
very soluble in water (104 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 tablets contain the labeled amount of levetiracetam.
Inactive ingredients: colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate,
titanium dioxide and triacetin.
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 model in rats, another model of
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