CLOBAZAM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Amneal Pharmaceuticals NY LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 tablets are 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. Healthcare providers are encouraged to recommend that pregnant women taking  clobazam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/ . Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.8) and Clinical Considerations] . Available data from pu

Produkt oppsummering:

Each clobazam tablet contains 10 mg or 20 mg of clobazam. Clobazam Tablets, 10 mg are supplied as white to off-white, oval tablets with a functional score on one side, debossed with a “C” on the left side of the score and “2” on the right side of the score and plain on other side. They are available as: Bottles of 100:                        NDC 69238-1305-1 Clobazam Tablets, 20 mg are supplied as white to off-white, oval tablets with a functional score on one side, debossed with a “C” on the left side of the score and “3” on the right side of the score and plain on other side. They are available as: Bottles of 100:                        NDC 69238-1306-1 Store tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Amneal Pharmaceuticals NY LLC
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MEDICATION GUIDE
Clobazam (kloe’ ba zam) Tablets, C-IV
What is the most important information I should know about clobazam
tablets?
•
Clobazam 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
clobazam tablets with
opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clobazam 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 clobazam 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 clobazam tablets as
prescribed by your
healthcare provider.
•
Take clobazam tablets exactly as your healthcare provider prescribed.
•
Do not share your clobazam tablets with other people.
•
Keep clobazam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Clobazam tablets can
cause physical dependence
and withdrawal reactions.
•
Do not suddenly stop taking clobazam tablets. Stopping clobazam
tablets suddenly can
cause serious and life-threatening side effects, including, unusual
movements, responses,
or expressions, seizures, sudden and severe mental or nervous sys

Preparatomtale

CLOBAZAM- CLOBAZAM TABLET
AMNEAL PHARMACEUTICALS NY LLC
----------
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
Warnings and Precautions (5.8) 1/2023
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 adjustment needed in following groups:
Geriatric patien