CLONAZEPAM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Direct_Rx

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Seizure Disorders: 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). Panic Disorder: 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 CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder (DSM-V) is charact

Resumen del producto:

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 100 Bottles of 500 Clonazepam tablets USP 1 mg are blue, round, flat faced, beveled edge, debossed with “C 1” on one side and plain on the other. They are supplied as follows: Bottles of 100 Bottles of 500 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: Bottles of 100 Bottles of 500 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

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

CLONAZEPAM- CLONAZEPAM TABLET
Direct_Rx
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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 actions can be caused by things other than
medicines. If you have su

Ficha técnica

CLONAZEPAM- CLONAZEPAM TABLET
DIRECT_RX
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CLONAZEPAM
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.
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:
[Clonazepam Structural Formula]
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-nitro group to
the 4-amino derivative. This
derivat