CLONAZEPAM tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Contract Pharmacy Services-PA

INN (Internationale Bezeichnung):

CLONAZEPAM

Zusammensetzung:

CLONAZEPAM 0.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLlNICAL PHARM

Produktbesonderheiten:

Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-915-30). 1 mg — Each yellow, round tablet imprinted and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-917-30). 2 mg — Each white, round tablet imprinted and 35 on one side and scored on the other side contains 2 mg of clonazepam USP. Tablets are supplied in blisters of 30 (NDC 67046-919-30). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-8804 Revised — June 2009 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--07/2010--NJW

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CLONAZEPAM- CLONAZEPAM TABLET
CONTRACT PHARMACY SERVICES-PA
----------
CLONAZEPAM TABLETS, USP CIV
40-8804
REVISED — JUNE 2009
RX ONLY
DESCRIPTION
Clonazepam 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 insoluble in water, sparingly soluble
in acetone and chloroform and
slightly soluble in alcohol. 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
cl