CLOBAZAM suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

VistaPharm, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Clobazam is 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. 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 published observatio

Περίληψη προϊόντος:

Clobazam oral suspension is a wild cherry flavored opaque white to off-white liquid supplied in a bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter. Store and dispense clobazam oral suspension in its original bottle in an upright position. Use within 90 days of first opening the bottle, then discard any remainder. NDC 66689-058-04: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension. Store oral suspension at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

VistaPharm, LLC
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MEDICATION GUIDE
Clobazam (KLOE-ba-zam)
Oral Suspension, CIV
What is the most important information I should know about clobazam
oral suspension?
•
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 oral suspension exactly as your healthcare provider
prescribed.
•
Do not share your clobazam oral suspension with other people.
•
Keep clobazam oral suspension 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 oral suspension. Stopping
clobazam suddenly can
cause serious and life-threatening side effects, including, unusual
movements, responses,
or expressions, seizures, sudden and severe mental or nervous system
changes, depression,
se

Αρχείο Π.Χ.Π.

CLOBAZAM- CLOBAZAM SUSPENSION
VISTAPHARM, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBAZAM ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CLOBAZAM ORAL
SUSPENSION.
CLOBAZAM ORAL SUSPENSION, 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 oral suspension is 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