CLONAZEPAM tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

NuCare Pharmaceuticals,Inc.

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS : Loss of Effect ). Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. 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 CLI

leaflet_short:

Clonazepam tablets USP 2 mg are white to off white, round, flat faced, beveled edge tablets debossed with C 2 on one side and plain on the other. They are supplied as follows: NDC 68071-2310-6 BOTTLES OF 60 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad -380 009, India. 10 0533 2 682353 Issued April 2018

authorization_status:

Abbreviated New Drug Application

PIL

NuCare Pharmaceuticals,Inc.
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Medication Guide
Medication Guide
Clonazepam Tablets, USP
(kloe-NA-za-pam)
CIV
What is the most important information I should know about clonazepam
tablets?
• Clonazepam tablets is a benzodiazepine medicine. Benzodiazepines
can cause severe drowsiness, breathing
problems (respiratory depression), coma, and death when taken with
opioid medicines.
•Clonazepam tablets can make you sleepy or dizzy and can slow your
thinking and motor skills. This may get
better over time.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clonazepam tablets affects you.
•
Clonazepam tablets may cause problems with your coordination,
especially when you are walking or
picking things up.
•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 may make your sleepiness or dizziness worse.
•
Like other antiepileptic drugs, clonazepam tablets may cause suicidal
thoughts or actions in a very
small number of people, about 1 in 500.
Call your 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
•
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 can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Suicidal thoughts or act

SPC

CLONAZEPAM- CLONAZEPAM TABLET
NUCARE PHARMACEUTICALS,INC.
----------
CLONAZEPAM TABLETS, USP
CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH (SEE WARNINGS AND
PRECAUTIONS).
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED.
FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND
SEDATION.
DESCRIPTION
Clonazepam, a benzodiazepine, is available as scored tablets debossed
with “1” and “2”
containing 0.5 mg of clonazepam and unscored tablets debossed with
“C 1” on 1 mg
tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of
clonazepam. Each tablet
contains anhydrous lactose, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C
Yellow No. 6 Lake
and 1 mg- FD&C Blue No.2 Lake.
Chemically, clonazepam is 5-(2-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.
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-nitr