CLONAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurobindo Pharma Limited

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 are available containing 0.5 mg, 1 mg or 2 mg of clonazepam, USP. The 0.5 mg tablets are yellow, approximately 7.93 mm, round, biconvex tablet debossed with '0.5' on one side and score on the other side. They are available as follows: Bottles of 100                              NDC 59651-722-01 Bottles of 1000                            NDC 59651-722-99 The 1 mg tablets are light green, approximately 7.93 mm, round, biconvex tablet debossed with '1' on one side and score on the other side. They are available as follows: Bottles of 100                             NDC 59651-723-01 Bottles of 1000                           NDC 59651-723-99 The 2 mg tablets are white, approximately 7.93 mm, round, biconvex tablet debossed with '2' on one side and score on the other side. They are available as follows: Bottles of 100                             NDC 59651-724-01 Bottles of 500                             NDC 59651-724-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]   Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides . Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aurobindo Pharma Limited
----------
Medication Guide
Clonazepam (kloe naz' e pam) Tablets, USP
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. Get 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 affect 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-threatening
side effects, including, unusual movements, responses, or
expressions, seizures, sudden

Summary of Product characteristics

CLONAZEPAM - CLONAZEPAM TABLET
AUROBINDO PHARMA LIMITED
----------
CLONAZEPAM TABLETS, USP CIV
0.5 MG, 1 MG AND 2 MG
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
Clonazepam tablets USP, a benzodiazepine, are available containing 0.5
mg, 1 mg or 2
mg of clonazepam, USP. The 0.5 mg tablets are yellow, approximately
7.93 mm, round,
biconvex tablet debossed with '0.5' on one side and score on the other
side. The 1 mg
tablets are light green, approximately 7.93 mm, round, biconvex tablet
debossed