CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-IV. 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

Product summary:

Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. Tablets are supplied in bottles of 100 (NDC 0228-3003-11) and 500 (NDC 0228-3003-50). 1 mg — Each yellow, round tablet imprinted and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. Tablets are supplied in bottles of 100 (NDC 0228-3004-11) and 500 (NDC 0228-3004-50). 2 mg — Each white, round tablet imprinted and 35 on one side and scored on the other side contains 2 mg of clonazepam USP. Tablets are supplied in bottles of 100 (NDC 0228-3005-11) and 500 (NDC 0228-3005-50). Store at 25(C (77(F); excursions permitted to 15( to 30(C (59( to 86(F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9148 Revised — June 2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLONAZEPAM - CLONAZEPAM TABLET
H.J. Harkins Company, Inc.
----------
MEDICATION GUIDE
CLONAZEPAM TABLETS, USP CIV
Rx only
Read this Medication Guide before you start taking clonazepam and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your healthcare provider about
your medical condition or treatment.
Clonazepam can cause serious side effects. Because stopping clonazepam
suddenly can also cause serious
problems, do not stop taking clonazepam without talking to your
healthcare provider first.
What is the most important information I should know about clonazepam?
Do not stop taking clonazepam without first talking to your healthcare
provider.
Stopping clonazepam suddenly can cause serious problems.
Clonazepam can cause serious side effects, including:
1. Clonazepam can slow your thinking and motor skills
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clonazepam affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clonazepam 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.
2.
Like other antiepileptic drugs, clonazepam 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, esp

Summary of Product characteristics

CLONAZEPAM - CLONAZEPAM TABLET
H.J. HARKINS COMPANY, INC.
----------
CLONAZEPAM TABLETS, USP
CIV
40-9148
Revised — June 2011
RX ONLY
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 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 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.
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