CLONAZEPAM tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Aphena Pharma Solutions - Tennessee, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Seizure Disorders: 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 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. Panic Disorder: Clonazepam tablets, USP 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 was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR

產品總結:

Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted cdfd5711-figure-02 and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. Tablets are supplied in: Bottles of 15 (NDC 60429-524-15) Bottles of 30 (NDC 60429-524-30) Bottles of 45 (NDC 60429-524-45) Bottles of 60 (NDC 60429-524-60) Bottles of 90 (NDC 60429-524-90) Bottles of 120 (NDC 60429-524-12) Bottles of 150 (NDC 60429-524-51) 1 mg — Each yellow, round tablet imprinted cdfd5711-figure-03 and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. Tablets are supplied in: Bottles of 15 (NDC 60429-525-15) Bottles of 30 (NDC 60429-525-30) Bottles of 45 (NDC 60429-525-45) Bottles of 60 (NDC 60429-525-60) Bottles of 90 (NDC 60429-525-90) Bottles of 120 (NDC 60429-525-12) 2 mg — Each white, round tablet imprinted cdfd5711-figure-04 and 35 on one side and scored on the other side contains 2 mg of clonazepam USP. Tablets are supplied in: Bottles of 30 (NDC 60429-526-30) Bottles of 60 (NDC 60429-526-60) Bottles of 90 (NDC 60429-526-90) Store at 25°C (77°F); excursions permitted to 15° to 30C° (59° to 86°F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 USA 40-9148 Revised — April 2017

授权状态:

Abbreviated New Drug Application

资料单张

CLONAZEPAM- CLONAZEPAM TABLET
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
Clonazepam (kloe naz' e 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 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 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 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 ● attempts 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, i

产品特点

CLONAZEPAM- CLONAZEPAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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CLONAZEPAM TABLETS, USP CIV
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).
•
•
•
DESCRIPTION
Clonazepam USP, 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, USP 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.
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.
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.
_PHARMACOKINETICS