CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Clonazepam Tablets, USP are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, round, scored tablets debossed with M on one side of the tablet and C above the score and 13 below the score on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5452-0 The 1 mg tablets are light green, round, scored tablets debossed with M on one side of the tablet and C above the score and 14 below the score on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5462-0 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Cardinal Health
----------
MEDICATION GUIDE
Clonazepam Tablets, USP CIV
(kloe naz' e pam)
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 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
•
new or worse anxiety
•
trouble sleeping (insomnia)
•
acting on dangerous impulses
•
attempts to commit suicide
•
feeling agitated or restless
•
new or worse irritability
•
an extreme increase in
activity and talking
(mania)
•
new or worse depression
•
panic attacks
•
acting aggressive, being
angry, or violent
•
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.
•

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
CARDINAL HEALTH
----------
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 tablets, USP, a benzodiazepine, are available containing
0.5 mg, 1 mg or 2 mg clonazepam,
USP. The 0.5 mg tablets are yellow, round, scored tablets debossed
with M on one side of the tablet
and C above the score and 13 below the score on the other side. The 1
mg tablets are light green,
round, scored tablets debossed with M on one side of the tablet and C
above the score and 14 below the
score on the other side. The 2 mg tablets are white, round, scored
tablets debossed with M on one side
of the tablet and C above the score and 15 below the score on the
other side. Each tablet contains
anhydrous lactose, colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch (corn) and sodium lauryl sulfate. The 0.5 mg
tablets also contain D&C Yellow No.
10 Aluminum Lake and the 1 mg tablets also contain D&C Yellow No. 10
Aluminum Lake and FD&C
Blue No. 1 Aluminum 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,
molecular formula of C
H
ClN
0
and the following structural formula:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
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.
15
10
3
3
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