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新型止痛剂Ryzolt（tramadol）将在美国上市

2011-10-31 17:52:19 作者：新特药房来源：中国新特药网天津分站浏览次数：253 文字大小：【大】【中】【小】

简介：近日，FDA已通过加拿大Labopharm制药公司每日用药一次的止痛剂Ryzolt（tramadol）的销售批准。该药主要用于治疗那些需要长期治疗的中-重度慢性疼痛成人患者。 Ryzolt为中枢性止痛剂，同时具备速释及缓释双重效 ...

关键字：Ryzolt（tramadol）

近日，FDA已通过加拿大Labopharm制药公司每日用药一次的止痛剂Ryzolt（tramadol）的销售批准。该药主要用于治疗那些需要长期治疗的中-重度慢性疼痛成人患者。

Ryzolt为中枢性止痛剂，同时具备速释及缓释双重效果。Ryzolt在美国市场的销售由Labopharm在当地的合作伙伴Purdue公司负责，该公司计划于2009年第二季度推出100毫克、200毫克和300毫克三种剂量。

Labopharm公司表示，Ryzolt是第一种获准的采用该公司Contramid固体制剂缓释专利技术的口服药物。Ryzolt在美国获准对该公司来说具有里程碑意义，这意味着其产品开始进入全球最大的止痛剂市场。

加拿大Labopharm公司是一家专门采用其先进控释释药技术开发药物的制药公司，其核心技术为Contramid，为非活性物质，作为制备片剂时所用的辅料，使活性物质控制释放，其技术特点为药物装载量大，可用于药物范围广泛，适用于溶解度小、生物利用度差、可溶性及pH敏感性药物，制备成口服固体制剂，可减少给药次数，改善药物性能。

RYZOLT

Generic Name for RYZOLT

Tramadol HCl 100mg, 200mg, 300mg; ext-rel tabs.

Legal Classification:

Pharmacological Class for RYZOLT

Opioid.

Manufacturer of RYZOLT

Purdue Pharma L.P.

Indications for RYZOLT

Moderate to moderately severe chronic pain when around-the-clock treatment for an extended time is needed.

Adult dose for RYZOLT

Swallow whole. Take once daily (allow 24 hours in between doses). Not currently on tramadol: 100mg once daily; may increase every 2–3 days by 100mg/day. Usual range: 200–300mg/day. Currently on immediate-release tramadol: Switch to ext-rel at same daily dose or rounded down to nearest 100mg increment. Max 300mg/day. Withdraw gradually.

Children's dosing for RYZOLT

<16yrs: not recommended.

Contraindications for RYZOLT

Significant respiratory depression, acute or severe bronchial asthma, or hypercapnia in unmonitored settings or without resuscitative equipment.

Warnings/Precautions for RYZOLT

Do not give to opioid- dependent patients. Respiratory depression. Increased intracranial pressure. Head injury. Seizure disorders. Suicidal ideation. Acute abdomen. Hepatic or severe renal impairment (CrCl<30mL/min): not recommended. Drug abusers. Avoid abrupt cessation. Elderly (esp. >75yrs). Labor & delivery, pregnancy (Cat.C), nursing mothers: not recommended.

Interactions for RYZOLT

Concomitant other forms of tramadol. Do not take with MAOIs, alcohol, carbamazepine. Potentiated by alcohol, other CNS depressants (reduce dose). Increased risk of seizures and/or serotonin syndrome with SSRIs, SNRIs, tricyclics, cyclobenzaprine, promethazine, opioids, MAOIs, naloxone, triptans, linezolid, lithium, neuroleptics, others that lower seizure threshold. May be affected by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, amitriptyline) or CYP3A4 inhibitors (eg, ketoconazole, erythromycin) or inducers (eg, rifampin, St. John's wort). Monitor digoxin, warfarin.