LABEL: CLONAZEPAM- clonazepam tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

DRUG LABEL INFORMATION

Updated December 4, 2013

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  • DESCRIPTION
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    Clonazepam USP is a benzodiazepine and is chemically designated as 5-(2-chlorophenyl)- 1,3-dihydro-7-nitro- 2H -1,4-benzodiazepine-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.

    chemical structure

    Each tablet for oral administration, contains 0.5 mg, 1 mg, or 2 mg of clonazepam. In addition each tablet contains the following inactive ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Pregelatinized Starch, Magnesium Stearate, D&C Yellow No. 10 Aluminum Lake (0.5 mg only), FD&C Blue No.1 Aluminum Lake (1 mg only).

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  • CLINICAL PHARMACOLOGY
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    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.

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