CLONAZEPAM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)

Tilgjengelig fra:

McKesson Contract Packaging

INN (International Name):

CLONAZEPAM

Sammensetning:

CLONAZEPAM 0.5 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLONAZEPAM- CLONAZEPAM TABLET
MCKESSON CONTRACT PACKAGING
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CLONAZEPAM TABLETS, USP
CIV
RX ONLY
DESCRIPTION
Clonazepam, USP a benzodiazepine, is available for oral administration
as scored tablets containing 0.5
mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains
the following inactive
ingredients: corn starch, lactose monohydrate, magnesium stearate, and
microcrystalline cellulose. The
0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet
also contains D&C Yellow
#10HT aluminum lake.
Chemically, clonazepam is
5-(_o_-Chlorophenyl)-1,3-dihydro-7-nitro-2_H_-1,4-benzodiazepin-2-one.
It is a
light yellow crystalline powder. It has a molecular weight of 315.72
and the following structural
formula:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS: The precise mechanism by which clonazepam exerts its
antiseizure and antipanic
effects is unknown, although it is believed to be related to its
ability to enhance the activity of gamma
aminobutyric acid (GABA), the major inhibitory neurotransmitter in the
central nervous system.
Convulsions produced in rodents by pentylenetetrazol or, to a lesser
extent, electrical stimulation are
antagonized, as are convulsions produced by photic stimulation in
susceptible baboons. A taming effect
in aggressive primates, muscle weakness and hypnosis are also
produced. In humans, clonazepam is
capable of suppressing the spike and wave discharge in absence
seizures (petit mal) and decreasing the
frequency, amplitude, duration and spread of discharge in minor motor
seizures.
PHARMACOKINETICS: Clonazepam is rapidly and completely absorbed after
oral administration. The
absolute bioavailability of clonazepam is about 90%. Maximum plasma
concentrations of clonazepam
are reached within 1 to 4 hours after oral administration. Clonazepam
is approximately 85% bound to
plasma proteins. Clonazepam is highly metabolized, with less than 2%
unchanged clonazepam being
excreted in the urine. Biotransformation occurs mainly by reduction of
the 7-nitro group to the 4-amino
de