LEVETIRACETAM tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Levetiracetam (UNII: 44YRR34555) (Levetiracetam - UNII:44YRR34555)

Available from:

ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)

INN (International Name):

Levetiracetam

Composition:

250 mg

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND
PHARMACEUTICALS LTD.)
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LEVETIRACETAM TABLETS
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg (yellow),
500 mg (orange), and 750 mg (blue)
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 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, corn starch, croscarmellose sodium, magnesium stearate,
povidone and additional agents listed
below:
250 mg tablets: Opadry Yellow (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000, iron oxide yellow and FD&C Blue #2/indigo carmine
aluminum lake).
500 mg tablets: Opadry Orange (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000, iron oxide red, FD&C Yellow #6/sunset yellow FCF aluminum
lake and FD&C Blue
#2/indigo carmine aluminum lake).
750 mg tablets: Opadry Blue (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000 and FD&C Blue #2/indigo carmine aluminum lake).
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 inhibi