CLOBAZAM- clobazam suspension

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Camber Pharmaceuticals, Inc.

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

Каталог на резюме:

Clobazam oral suspension is a strawberry 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.   NDC 31722-641-12: 2.5 mg/mL supplied in a amber glass bottle containing 120 mL of suspension.                                                                      Store oral suspension at 20°C to 25 o C (68°F to 77 o F) [see USP Controlled Room Temperature]. 

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CLOBAZAM - CLOBAZAM SUSPENSION
CAMBER PHARMACEUTICALS, INC.
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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