CLONAZEPAM tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Rebel Distributors

INN (International Name):

CLONAZEPAM

রচনা:

CLONAZEPAM 0.5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clonazepam is 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 is 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 CLINICAL PHARMACOLOGY , Clinical

পণ্য সারাংশ:

Clonazepam tablets 0.5 mg are available as yellow, round, single-scored tablets debossed “93” – “832” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 30, 60, 90, 100 and 120. Clonazepam tablets 1 mg are available as mottled green, round, single-scored tablets debossed “93” – “833” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 30, 60, 90, 100 and 120. Clonazepam tablets 2 mg are available as white to off-white, round, single-scored tablets debossed “93” – “834” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 60. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CLONAZEPAM - CLONAZEPAM TABLET
REBEL DISTRIBUTORS
----------
CLONAZEPAM TABLETS, USP CIV
0832
0833
0834
RX ONLY
DESCRIPTION
Each single-scored tablet, for oral administration, contains 0.5 mg, 1
mg, or 2 mg clonazepam, a
benzodiazepine. Each tablet also contains lactose monohydrate,
magnesium stearate, microcrystalline
cellulose, povidone, purified water, and corn starch. Clonazepam
tablets 0.5 mg contain Yellow D&C
No. 10 Aluminum Lake. Clonazepam tablets 1 mg contain Yellow D&C No.
10 Aluminum Lake, as well
as FD&C Blue No. 1 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 the following structural
formula:
C
H ClN O M.W. 315.72
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
15
10
3
3
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