CLONAZEPAM tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Proficient Rx LP

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Clonazepam tablets USP 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 tablets USP 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 tablts USP 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 tablets USP was established in two 6 to 9 week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of pani

পণ্য সারাংশ:

Clonazepam tablets USP 0.5 mg are available as yellow, round, flat beveled, single-scored tablets debossed "832" above the scored line and "TEVA" on the unscored side. Packaged in bottles of 30, 60 and 90 with a child-resistant closure. 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 Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel & Manufactured In Czech Republic By: Teva Czech Industries , s.r.o. Opava-Komarov, Czech Republic  Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. Q 9/2012 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

CLONAZEPAM- CLONAZEPAM TABLET
Proficient Rx LP
----------
Medication Guide
Clonazepam (klo-NAY-zeh-pam) Tablets, USP CIV
Read this Medication Guide before you start taking clonazepam tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
Clonazepam tablets can cause serious side effects. Because stopping
clonazepam tablets suddenly can also
cause serious problems, do not stop taking clonazepam tablets without
talking to your healthcare provider
first.
What is the most important information I should know about clonazepam
tablets?
Do not stop taking clonazepam tablets without first talking to your
healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems.
Clonazepam tablets can cause serious side effects, including:
1.Clonazepam tablets can slow your thinking and motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clonazepam tablets affect you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking clonazepam
tablets until you talk to your healthcare provider. When taken with
alcohol or drugs that cause
sleepiness or dizziness, clonazepam tablets may make your sleepiness
or dizziness worse.
2.Like other antiepileptic drugs, clonazepam tablets may cause
suicidal thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How ca

পণ্য বৈশিষ্ট্য

CLONAZEPAM- CLONAZEPAM TABLET
PROFICIENT RX LP
----------
CLONAZEPAM TABLETS, USP CIV
RX ONLY
DESCRIPTION
Each single-scored tablet, for oral administration, contains 0.5 mg, 1
mg, or 2 mg
clonazepam, USP, a benzodiazepine. Each tablet also contains corn
starch, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, and
povidone.
Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake.
Clonazepam
tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as
FD&C Blue No. 1
Aluminum Lake.
Chemically, clonazepam, USP 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
15
10
3
3
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
deriva