CLONAZEPAM tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Seizure Disorders: Clonazepam orally disintegrating tablet is 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 orally disintegrating 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. Panic Disorder: Clonazepam orally disintegrating tablet is 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 orally disintegrating tablets was established in two

Product summary:

Clonazepam orally disintegrating tablets, USP are available as follows: 0.125 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 523’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters  of 6 tablets each             NDC 62332-364-06 0.25 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 524’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 62332-365-06 0.5 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 525’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 62332-366-06 1 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 526’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 62332-367-06 2 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 527’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each             NDC 62332-368-06 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].   Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA    Revised: 11/2022

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Clonazepam (kloe NAZ e pam)
Orally Disintegrating Tablets, USP
What is the most important information I should know about clonazepam
orally disintegrating tablets?
• Clonazepam orally disintegrating tablet is 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:
o shallow or slowed breathing
o breathing stops (which may lead to the heart stopping)
o excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
clonazepam orally disintegrating
tablets with opioids affects you.
• Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clonazepam orally disintegrating tablet,
which can lead to overdose and
serious side effects including coma and death.
o Serious side effects including coma and death have happened in
people who have abused or misused
benzodiazepines, including clonazepam orally disintegrating tablets.
These serious side effects may also
include delirium, paranoia, suicidal thoughts oractions, 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.
o You can develop an addiction even if you take clonazepam orally
disintegrating tablets exactly as
prescribed by your healthcare provider.
o Take clonazepam orally disintegrating tablets exactly as your
healthcare provider prescribed.
o Do not share your clonazepam orally disintegrating tablets with
other people.
o Keep clonazepam orally disintegrating tablets in a safe place and
away from children.
• Physical dependence and withdrawal reactions. Clonazepam orally
disintegrating tablets can cause
physical dependence and withdrawal react

Summary of Product characteristics

CLONAZEPAM - CLONAZEPAM TABLET, ORALLY DISINTEGRATING
ALEMBIC PHARMACEUTICALS INC.
----------
CLONAZEPAM ORALLY DISINTEGRATING TABLETS, USP
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 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 (SEE WARNINGS AND PRECAUTIONS).
• THE USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM ORALLY
DISINTEGRATING
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 ORALLY
DISINTEGRATING TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH
PATIENT’S
RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS).
• THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM ORALLY
DISINTEGRATING 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 ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING
TABLETS OR
REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND
WARNINGS).
DESCRIPTION
Clonazepam, USP a benzodiazepine, is available as an orally
disintegrating tablet
containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP.
Each orally
disintegrating table