CLOBAZAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U)

Available from:

Lannett Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobazam Tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions [see Warnings and Precautions (5.6 )]. Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as clobazam, during pregnancy. Physicians are advised to recommend that pregnant patients taking clobazam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate and well-controlled studies of clobazam in pregnant women. Available data suggest that the class of benzo

Product summary:

Each clobazam tablet contains 10 mg or 20 mg of clobazam. Clobazam Tablets, 10 mg are white to off-white, oval tablets, with a functional score debossed with “1”, score, “0” on one side and “LCI” on the other side. NDC 0527-1681-01, bottles of 100 Clobazam Tablets, 20 mg are white to off-white, oval tablets, with a functional score debossed with “2”, score, “0” on one side and “LCI” on the other side. NDC 0527-1682-01, bottles of 100 Store tablets at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOBAZAM- CLOBAZAM TABLET
Lannett Company, Inc.
----------
Dispense with Medication Guide available at:
www.lannett.com/med-guide/clobazam-tablets
MEDICATION GUIDE
Clobazam (kloe’ ba zam)
Tablets, CIV
What is the most important information I should know about clobazam?
•
Clobazam 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:
•
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
clobazam with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clobazam, 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 clobazam. 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 clobazam as prescribed
by your healthcare
provider.
•
Take clobazam exactly as your healthcare provider prescribed.
•
Do not share your clobazam with other people.
•
Keep clobazam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clobazam can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking clobazam. Stopping clobazam suddenly can
cause serious and life-
threatening side effects, including, unusual movements, responses, or
expressions, seizures,
sudden and severe mental or ne

Summary of Product characteristics

CLOBAZAM- CLOBAZAM TABLET
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBAZAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBAZAM
TABLETS.
CLOBAZAM TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2011
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 (5.1, 7.1). THE USE OF BENZODIAZEPINES, INCLUDING CLOBAZAM, EXPOSES USERS TO
RISKS OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
CLOBAZAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR
ABUSE, MISUSE,
AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CLOBAZAM 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
CLOBAZAM OR REDUCE THE DOSAGE (2.2, 5.3).
RECENT MAJOR CHANGES
Boxed Warning 2/2021
Dosage and Administration (2.2) 2/2021
Warnings and Precautions (5.2, 5.3) 2/2021
INDICATIONS AND USAGE
Clobazam Tablets are a benzodiazepine indicated for adjunctive
treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
DOSAGE AND ADMINISTRATION
For doses above 5 mg/day administer in two divided doses (2.1)
Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as
tolerated up to 20 mg daily (2.1)
Patients >30 kg body weight: Initiate at 10 mg daily and titrate as
tolerated up to 40 mg daily (2.1)
Dosage adju