英文药名：Sympazan(clobazam Oral Film)

中文药名：氯巴占口腔膜剂

生产厂家：Aquestive Therapeutics公司
药品介绍
难治性癫痫新药Sympazan在美国上市，成首个氯巴占口腔膜剂
2018年12月3日，美国FDA已批准Sympazan（clobazam，氯巴占）口腔膜，用于2岁及以上患者治疗Lennox-Gastaut综合征（LGS）相关的癫痫发作。该公司已计划于近期将Sympazan推向市场。此次批准，使Sympazan成为首个也是唯一一个获FDA批准治疗LGS相关癫痫发作的口腔膜剂。之前，氯巴占已以品牌名Onfi上市，并可提供口服片剂和口服混悬液2种剂型。
LGS是一种严重且难以治疗的癫痫类型，始于儿童早期，以多种类型的癫痫发作和智力残疾为特征。LGS患者由于身体限制、行为或认知影响，常常难以吞服药丸及大体积混悬液，这可能导致给药剂量的不确定和不一致，增加护理负担，特别是对治疗可能具有抵触情绪的患者。

Sympazan(Cobazam Oral Film)
SYMPAZAN(clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs for use in 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.
SYMPAZAN CIV
Generic Name and Formulations:
Clobazam 5mg, 10mg, 20mg; oral films; raspberry-type flavor.
Company:
Aquestive Therapeutics
Indications for SYMPAZAN:
Adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS).
Adults and Children:
<2yrs: not established. Allow each film to dissolve completely before administering the next film; do not give with liquids. Individualize. ≥2yrs: Give in divided doses twice daily (except for 5mg dose). ≤30kg: initially 5mg, then increase to 10mg on Day 7, then increase to 20mg on Day 14. >30kg: initially 10mg, then increase to 20mg on Day 7, then increase to 40mg on Day 14. Do not increase dose sooner than weekly. Elderly, CYP2C19 poor metabolizers, mild-to-moderate hepatic impairment (Child-Pugh score 5–9): initially 5mg/day; titrate according to weight (as shown above) but to half the dose, an additional titration to max dose (20mg/day or 40mg/day, depending on weight) may be started at Day 21.
Boxed Warning:
Risks from concomitant use with opioids.
Warnings/Precautions:
Increased risk of drug-related mortality from concomitant use with opioids. Monitor for somnolence or sedation. Monitor for signs/symptoms of serious skin reactions (eg, SJS, TEN), esp. during the first 8 weeks of initiation or when re-introducing therapy; discontinue at the first sign of rash unless it's not drug-related. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Avoid abrupt cessation; taper by decreasing total daily dose by 5–10mg/day on a weekly basis. Drug abusers. Severe renal or hepatic impairment or ESRD. Elderly. Neonates/infants: monitor for symptoms of withdrawal. Pregnancy. Labor & delivery, nursing mothers: monitor.
Pharmacological Class:
Benzodiazepine.
Interactions:
Increased risk of profound sedation, respiratory depression, coma, and death with opioids; reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. May increase risk of sedation/somnolence with concomitant other CNS depressants, alcohol. May be potentiated by CYP2C19 inhibitors (eg, fluconazole, fluvoxamine, ticlopidine, omeprazole); may need dose adjustment. May diminish effect of hormonal contraceptives (use non-hormonal forms). May need to adjust dose of drugs metabolized by CYP2D6.
Adverse Reactions:
Constipation, somnolence, sedation, pyrexia, lethargy, drooling; withdrawal symptoms, physical/psychological dependence.
Note:
To register pregnant patients in the North American Antiepileptic Drug (NAAED) Pregnancy Registry, call (888) 233-2334.
Generic Availability:
NO
How Supplied:
Oral films—60
https://www.sympazanhcp.com/
https://www.sympazanhcp.com/pdfs/pi.pdf