CLOBAZAM tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Breckenridge Pharmaceutical, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 Tablets, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women taking Clobazam Tablets 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] . Availa

Ապրանքի ամփոփագիր:

Each clobazam 5 mg tablet contains 5 mg of clobazam and is a white to off-white, oval tablet debossed on one side with a "C" and "5" and plain on the other side. Each clobazam 10 mg tablet contains 10 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and debossed "C" and "1" on the other side. Each clobazam 20 mg tablet contains 20 mg of clobazam and is a white to off-white, oval tablet with a functional score on one side and debossed "C" and "2" on the other side. NDC 51991-958-33: 5 mg tablet, Bottles of 30 NDC 51991-900-01: 10 mg scored tablet, Bottles of 100 NDC 51991-901-01: 20 mg scored tablet, Bottles of 100 Store tablets at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

CLOBAZAM- CLOBAZAM TABLET
Breckenridge Pharmaceutical, Inc.
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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

Ապրանքի հատկությունները

CLOBAZAM- CLOBAZAM TABLET
BRECKENRIDGE PHARMACEUTICAL, 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 TABLETS, EXPOSES USERS
TO RISKS OF
ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH.
BEFORE
PRESCRIBING CLOBAZAM TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH
PATIENT'S RISK
FOR ABUSE, MISUSE, AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CLOBAZAM 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 CLOBAZAM TABLETS 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 foll