CLOBAZAM suspension

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Amneal Pharmaceuticals NY LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 oral suspension 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 ] . Availab

Каталог на резюме:

Clobazam oral suspension, 2.5 mg/mL , is a berry flavored 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. It is available as follows: Bottle containing 120 mL of suspension:                   NDC 69238-1535-2 Store oral suspension at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Amneal Pharmaceuticals NY LLC
----------
MEDICATION GUIDE
Clobazam (kloe’ ba zam)
Oral Suspension, CIV
What is the most important information I should know about clobazam
oral suspension?
•
Clobazam oral suspension 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 oral suspension with
opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including clobazam oral suspension, 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 oral suspension. 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 oral suspension
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 oral suspension
can cause physical
dependence and withdrawal reactions.
•
Do not suddenly stop taking clobazam oral suspension. Stopping
clobazam oral suspension
suddenly can cause serious and life-threatening side effects,
incl

Данни за продукта

CLOBAZAM- CLOBAZAM SUSPENSION
AMNEAL PHARMACEUTICALS NY LLC
----------
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 ORAL SUSPENSION,
EXPOSES USERS TO
RISKS OF ABUSE, MISUSE AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. BEFORE
PRESCRIBING CLOBAZAM ORAL SUSPENSION AND THROUGHOUT TREATMENT, ASSESS
EACH
PATIENT’S RISK FOR ABUSE, MISUSE AND ADDICTION (5.2).
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF CLOBAZAM ORAL
SUSPENSION 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 ORAL SUSPENSION 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