CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Seizure Disorders:   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 ). Panic Disorder:  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 Tri

Product summary:

Clonazepam tablets USP, 0.5 mg are available as yellow, round, flat beveled, tablets. Scored and debossed with "832" above the score on one side, debossed with "TEVA" on the other side. Packaged in bottles of 100 (NDC 0093-0832-01) with a child-resistant closure, in bottles of 500 (NDC 0093-0832-05). Clonazepam tablets USP, 1 mg are available as mottled green, round, flat beveled tablets. Debossed with "833" on one side and debossed with "TEVA" on the other side. Packaged in bottles of 100 (NDC 0093-3212-01) with a child-resistant closure, in bottles of 500 (NDC 0093-3212-05). Clonazepam tablets USP, 2 mg are available as white to off-white, round, flat beveled tablets. Debossed with "834" on one side and debossed with "TEVA" on the other side. Packaged in bottles of 100 (NDC 0093-3213-01) with a child-resistant closure, in bottles of 500 (NDC 0093-3213-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. Y 4/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Clonazepam (kloe naz’e pam) Tablets CIV
for oral use
What is the most important information I should know about clonazepam
tablets?
•
Clonazepam tablets are a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines, alcohol, or other central
nervous system
(CNS) depressants (including street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma, and
death.
emergency help right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clonazepam tablets and opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including clonazepam
tablets, which
can lead to overdose and serious side effects including coma and
death.
•
Serious side effects including coma and death have happened in people
who have abused or misused benzodiazepines, including
clonazepam tablets. These serious side effects may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty
breathing. Call your healthcare provider or go to the nearest hospital
emergency room right away if you get any of these serious side
effects.
•
You can develop an addiction even if you take clonazepam tablets as
prescribed by your healthcare provider.
•
Take clonazepam tablets exactly as your healthcare provider
prescribed.
•
Do not share your clonazepam tablets with other people.
•
Keep clonazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clonazepam tablets can
cause physical dependence and withdrawal reactions.
•
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam
tablets suddenly can cause serious and life-threateni

Summary of Product characteristics

CLONAZEPAM- CLONAZEPAM TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
CLONAZEPAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM TABLETS, EXPOSES
USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CLONAZEPAM TABLETS
AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS)_._
_ _THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM TABLETS,
MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF CLONAZEPAM TABLETS AFTER CONTINUED USE MAY PRECIPITATE
ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE
THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
CLONAZEPAM TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND
ADMINISTRATION AND WARNINGS).
DESCRIPTION
Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg
of 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