CLONAZEPAM- clonazepam tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Teva Pharmaceuticals USA, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). 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 CLINICAL PHARMACOLOGY, Clinical Trials ). Panic disorder (DSM-V) is charact

Ringkasan produk:

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 100 (NDC 0093-0832-01) with a child-resistant closure, in bottles of 500 (NDC 0093-0832-05) and 1000 (NDC 0093-0832-10). Clonazepam tablets USP 1 mg are available as mottled green, round, flat beveled, single-scored tablets debossed "833" above the scored line and "TEVA" on the unscored side. Packaged in bottles of 100 (NDC 0093-0833-01) with a child-resistant closure, in bottles of 500 (NDC 0093-0833-05) and 1000 (NDC 0093-0833-10). 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. Packaged in bottles of 100 (NDC 0093-0834-01) with a child-resistant closure, in bottles of 500 (NDC 0093-0834-05). 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. V 10/2017

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
Clonazepam (klo-NAY-zeh-pam) Tablets USP, for oral use, CIV
What is the most important information I should know about clonazepam
tablets?
•
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
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially

Karakteristik produk

CLONAZEPAM- CLONAZEPAM TABLET
TEVA PHARMACEUTICALS USA, INC.
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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 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.
_PHARMACOKINETICS_
15
10
3
3
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 derivative. This
derivative can be a