EPITECH Levetiracetam Concentrate for Infusion 500mg5ml

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

LEVETIRACETAM

Verfügbar ab:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

LEVETIRACETAM

Einheiten im Paket:

5ml x 10 Vials

Hergestellt von:

Maiva Pharma Private Limited

Fachinformation

COMPOSION:
Each mL concentrate for soluon for infusion contains.
Leveracetam Ph. Eur. 500mg
Water for injecons q.s to 5mL
DOSAGE FORM:
Soluon for Injecon
PRODUCT DESCRIPON:
Epitech is a clear colourless transparent soluon, free from foreign
parcles filled in 5mL/20mm neck USP
Type I clear Tubular glass vials.
PHARMACODYNAMICS:
The drug binds to a synapc vesicle glycoprotein, and inhibits
presynapc calcium channels reducing
neurotransmier release and acng as a neuromodulator. This is believed
to impede impulse conducon
across synapses.
PHARMACOKINECS:
Absorpon:
Leveracetam is rapidly and almost completely absorbed aer oral
administraon. Leveracetam injecon
and tablets are bioequivalent. The pharmacokinecs of leveracetam are
linear and
me-invariant, with
low intra-and inter-subject variability.
Distribuon:
Neither leveracetam nor its primary metabolite are significantly
bound to plasma proteins (< 10 %). The
volume of distribuon of leveracetam is approximately 0.5 to 0.7 l/kg,
a value close to the total body water
volume.
Metabolism:
Leveracetam is not extensively metabolized in humans. The major
metabolic pathway is the enzymac
hydrolysis of the acetamide group, which produces the carboxylic acid
metabolite, ucb L057 (24% of dose)
and is not dependent on any liver cytochrome P450 isoenzymes. Two
minor metabolites were idenfied as
the product of hydroxylaon of the 2-oxo-pyrrolidine ring (2% of dose)
and opening of the 2-oxo-pyrrolidine
ring in posion 5 (1% of dose). There is no enanomeric interconversion
of leveracetam or its major
metabolite.
Excreon:
Leveracetam is eliminated from the body primarily by the kidneys with
about 66 percent of the original
drug passed unchanged into urine. The plasma half-life of leveracetam
in adults is about 6 to 8 hours.
INDICAON:
Leveracetam Injecon is indicated as monotherapy in the treatment of
paral onset seizures with or
without secondary generalisaon and adolescents from 16 years of age
with newly diagnosed epilepsy.
Leveracetam injecon is indicated as adjuncve therapy
a)