Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
CLOBAZAM (UNII: 2MRO291B4U) (CLOBAZAM - UNII:2MRO291B4U)
NorthStar RxLLC
ORAL
PRESCRIPTION DRUG
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
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 16714-087-01: 2.5 mg/mL supplied in a amber glass 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].
Abbreviated New Drug Application
CLOBAZAM - CLOBAZAM SUSPENSION NORTHSTAR RXLLC ---------- 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 fol Прочетете целия документ