CLOBAZAM suspension

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Chartwell RX, LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clobazam Oral Suspension 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. 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

Proizvod sažetak:

Clobazam Oral Suspension is a blueberry flavored off-white liquid supplied in a bottle with child-resistant closure. 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 62135-527-41: 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].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

Chartwell RX, LLC
----------
GUIDE
(kloe’ ba zam)
Suspension, 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 you 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 nervous system
changes, depression, seeing or hearing things that others do not see
or hear, an extreme increase in activity or talking,
lo

Svojstava lijeka

CLOBAZAM- CLOBAZAM SUSPENSION
CHARTWELL RX, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CLOBAZAM ORAL SUSPENSION
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
Boxed Warning
2/2021
Dosage and Administration ( 2.2)
2/2021
Warnings and Precautions ( 5.2, 5.3)
2/2021
INDICATIONS AND USAGE
Clobazam 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