CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quality Care Products, LLC

INN (International Name):

CLONAZEPAM

Composition:

CLONAZEPAM 0.5 mg

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. 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 characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ). Clonazepam is contraindicated in patients with the following conditions: receiving appropriate therapy). Clonazepam is a Schedule IV controlled substance. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (e.g., convulsions, psychosis, hallucinations, behavioral disorder, mood changes, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuance of clonazepam. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed (see DOSAGE AND ADMINISTRATION ). Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving clonazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence. Following the short-term treatment of patients with panic disorder in Studies 1 and 2 (see CLINICAL PHARMACOLOGY, Clinical Trials ), patients were gradually withdrawn during a 7 week downward-titration (discontinuance) period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.

Product summary:

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.  55700-564-30 55700-564-01 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. 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.  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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLONAZEPAM- CLONAZEPAM TABLET
Quality Care Products, LLC
----------
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.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clonazepam tablets affect you.
o
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:
o
thoughts about suicide or dying
o
attempt to commit suicide
o
new or worse depression
o
new or worse anxiety
o
feeling agitated or restless
o
panic attacks
o
trouble sleeping (insomnia)
o
new or worse irritability
o
acting aggressive, being angry, or violent
o
acting on dangerous impulses
o
an extreme increase in activity and talking (mania)
o
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
o
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
o
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
QUALITY CARE PRODUCTS, LLC
----------
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).
•
•
•
DESCRIPTION
Each single-scored 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:
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.
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_
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 deriva