CLONAZEPAM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Contract Pharmacy Services-PA

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 tablets 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-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 tablets 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

제품 요약:

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. NDC 67046-914-07 blisterpacks of 7 NDC 67046-914-14 blisterpacks of 14 NDC 67046-914-15 blisterpacks of 15 NDC 67046-914-20 blisterpacks of 20 NDC 67046-914-21 blisterpacks of 21 NDC 67046-914-28 blisterpacks of 28 NDC 67046-914-30 blisterpacks of 30 NDC 67046-914-60 blisterpacks of 60 Clonazepam tablets USP 2 mg are available as white to off-white, round, flat beveled, single-scored tablets debossed "834" above the scored line and "TEVA" on the unscored side. NDC 67046-920-07 blisterpacks of 7 NDC 67046-920-14 blisterpacks of 14 NDC 67046-920-15 blisterpacks of 15 NDC 67046-920-20 blisterpacks of 20 NDC 67046-920-21 blisterpacks of 21 NDC 67046-920-28 blisterpacks of 28 NDC 67046-920-30 blisterpacks of 30 NDC 67046-920-60 blisterpacks of 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. T 12/2016

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Contract Pharmacy Services-PA
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MEDICATION GUIDE
Clonazepam (klo-NAY-zeh-pam) Tablets USP CIV
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 side effects.
•
Clonazepam tablets are 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 affect 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 tablets 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 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 can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feeli

제품 특성 요약

CLONAZEPAM- CLONAZEPAM TABLET
CONTRACT PHARMACY SERVICES-PA
----------
914 CLONAZEPAM 0.5 MG
920 CLONAZEPAM 2 MG
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
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
15
10
3
3
_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 m