英文药名: Ryanodex（dantrolene sodium injectable suspension）

中文药名: 丹曲林钠静脉注射悬液

生产厂家: Eagle Pharmaceuticals Inc
药品说明
FDA批准纳米丹曲林钠注射用混悬液治疗恶性高热
Eagle制药公司于 7月23日宣布，美国FDA批准Ryanodex®（dantrolene sodium injectable suspension，纳米丹曲林钠注射用混悬液）伴以相应的支持措施治疗恶性高热（malignant hyperthermia，MH）。MH是一种遗传性和可能致命的疾病由某些麻醉剂在基因易感个体身上触发。Ryanodex在2013年8月被FDA认定为罕用药。在未来4至6周内，FDA将通知Eagle公司是否获得7年市场独占权。
Ryanodex是30多年以来首个获准的改善MH治疗的药物。它可能成为MH治疗的新标准，因为它为麻醉医师提供一种比现有的静脉注射剂（Dantrium IV）更为便利的制剂，可由保健医师独自在1分钟内完成注射，从而能挽救生命和减少MH相关疾病发生率和死亡率。
采用创新的纳米混悬剂技术，Ryanodex以单次治疗剂量（250毫克丹曲林钠/5毫升灭菌水安瓶提供。Dantrium IV则需要将多个20毫克丹曲林钠安瓶以大量灭菌水配制，这个过程可能需要15至20分钟。
美国MH协会主席Henry Rosenberg指出：“当患者在手术过程中遇到MH时，需要立即以包括丹曲林钠等紧急处置。Ryanodex提供了MH危象迅速控制和严重并发症预防的有效手段。”
包装规格：250mg/瓶
RYANODEX®注射用混悬液 

RYANODEX®makes dantrolene sodium administration faster and easier than other alternatives.
RYANODEX®(dantrolene sodium) for injectable suspension is indicated for the1:
•Treatment of malignant hyperthermia in conjunction with appropriate supportive measures
•Prevention of malignant hyperthermia in patients at high risk
•Less than 1 minute for reconstitution and administration of a loading dose (2.5 mg/kg) in an MH crisis2,3
◦Fewer vials required to treat MH (1 vial contains 250 mg of dantrolene sodium)1,9,10
◦1 vial of RYANODEX® contains the same amount of dantrolene sodium as 12.5 vials of other approved dantrolene sodium formulations1,9,10
•Over 99% less sterile water for injection than other dantrolene sodium IV treatments1,9,10
•1 vial provides a loading dose (2.5 mg/kg) for patients up to 100 kg.1,3
◦Can be reconstituted and administered by 1 healthcare professional (eg, an anesthesia provider)
RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including:
•Discontinuing triggering anesthetic agents
•Increasing oxygen
•Managing the metabolic acidosis
•Instituting cooling when necessary
•Administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis)
The RYANODEX® MH protocol simplifies and expedites the treatment of MH, and may help reduce overall risk for a facility. See how these changes affect you.
Anesthesia Providers
•Reduce the time to administer a therapeutic dose of dantrolene sodium
•Simplify treatment process for the entire team
Pharmacy Directors
•Reduce the number of vials to be stored in each facility
•Eliminate the requirement to store large volumes of sterile water on an MH cart
•Make the reconstitution and administration of dantrolene sodium faster and more convenient
Risk Managers
•Reduce the probability of MH-treatment–related complications by shortening the time of administration for dantrolene sodium and reducing fluid volume administered in an MH crisis
Important Safety Information
Fatalities have been reported in patients who, despite initial satisfactory response, could not be weaned from dantrolene sodium after initial treatment. The administration of dantrolene sodium is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness. There have been reports of thrombophlebitis following dantrolene sodium administration. Tissue necrosis secondary to extravasation has also been reported, in addition to injection site reactions (pain, erythema, swelling), which are commonly due to extravasation. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.