DUBLIN, Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®. This is the first generic colchicine capsule approved by the U.S.

都柏林，2023年11月2日/PRNewswire/-Endo International plc（OTC:ENDPQ）今天宣布，其一家运营公司Par Pharmaceutical，Inc。已开始运送秋水仙碱0.6 mg胶囊，这是Hikma的Releasere®的通用版本。这是美国批准的第一种通用秋水仙碱胶囊。

Food and Drug Administration..

食品药品监督管理局。。

'We are pleased to offer this high-quality, affordable medication,' said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. 'As a reliable supplier of generic products, we take pride in providing choices to appropriate patients.'

“我们很高兴提供这种高质量，价格合理的药物，”Endo注射解决方案和仿制药高级副总裁兼总经理Scott Sims说作为通用产品的可靠供应商，我们为适当的患者提供选择感到自豪

Colchicine capsules are indicated for prophylaxis of gout flares in adults.

秋水仙碱胶囊适用于预防成人痛风发作。

According to IQVIA™, colchicine capsules sales were approximately $65.4 million for the 12 months ended September 30, 2023.

根据IQVIA™, 截至2023年9月30日的12个月，秋水仙碱胶囊的销售额约为6540万美元。

MITIGARE® is a registered trademark of Hikma Pharmaceuticals USA, Inc.

Releasre®是Hikma Pharmaceuticals USA，Inc。的注册商标。

IMPORTANT SAFETY INFORMATION

重要的安全信息

CONTRAINDICATIONSPatients with renal or hepatic impairment should not be given colchicine with drugs that inhibit both P-glycoprotein and CYP3A4 inhibitors. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity.Patients with both renal and hepatic impairment should not be given colchicine..

禁忌症患有肾或肝功能损害的患者不应给予秋水仙碱同时抑制P-糖蛋白和CYP3A4抑制剂的药物。将这些双重抑制剂与秋水仙碱联合用于肾或肝损伤患者已导致危及生命或致命的秋水仙碱毒性。肾功能损害和肝功能损害的患者不应给予秋水仙碱。。

WARNINGS AND PRECAUTIONSFatal Overdose: Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine should be kept out of the reach of children.Blood Dyscrasias: Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.Interactions with CYP3A4 and P-gp Inhibitors: Coadministration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.Neuromuscular Toxicity: Neuromuscular toxicity and rhabdomyolysis have been reported from chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect.

警告和注意事项：摄入秋水仙碱的成人和儿童报告了意外和故意的致命过量。秋水仙碱应该放在儿童接触不到的地方。血液恶液质：用治疗剂量的秋水仙碱报道了骨髓抑制，白细胞减少，粒细胞减少，血小板减少，全血细胞减少和再生障碍性贫血。与CYP3A4和P-gp抑制剂的相互作用：秋水仙碱与双重P-gp和CYP3A4抑制剂的共同给药导致危及生命的相互作用和死亡。神经肌肉毒性：用治疗剂量的秋水仙碱长期治疗已经报道了神经肌肉毒性和横纹肌溶解，特别是与已知引起这种效应的其他药物组合。

Patients with impaired renal function and elderly patients (even those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of colchicine..

肾功能受损患者和老年患者（即使肾功能和肝功能正常的患者）风险增加。考虑暂时中断或停用秋水仙碱。。

ADVERSE REACTIONSThe most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

不良反应最常报告的秋水仙碱不良反应是胃肠道症状，包括腹泻，恶心，呕吐和腹痛。

DRUG INTERACTIONS

药物相互作用

Coadministration of P-gp or CYP3A4 inhibitors or inhibitors of both P-gp and CYP3A4 (e.g., clarithromycin or cyclosporine) have been reported to lead to colchicine toxicity. The potential for drug-drug interactions must be considered prior to and during therapy.

据报道，P-gp或CYP3A4抑制剂或P-gp和CYP3A4抑制剂（例如克拉霉素或环孢菌素）的共同给药导致秋水仙碱毒性。在治疗前和治疗期间必须考虑药物相互作用的可能性。

Concomitant use of colchicine and inhibitors of CYP3A4 or P-gp should be avoided if possible. If coadministration of colchicine and an inhibitor of CYP3A4 or P-gp is necessary, the dose of colchicine should be reduced and the patient should be monitored carefully for colchicine toxicity

如果可能，应避免同时使用秋水仙碱和CYP3A4或P-gp抑制剂。如果需要联合使用秋水仙碱和CYP3A4或P-gp抑制剂，应减少秋水仙碱的剂量，并应仔细监测患者的秋水仙碱毒性

USE IN SPECIFIC POPULATIONS

在特定人群中使用

In the presence of renal or hepatic impairment, patients should be monitored closely and dose adjustment should be considered as necessary.

在存在肾脏或肝脏损害的情况下，应密切监测患者，并应根据需要考虑剂量调整。

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1).

怀孕：只有当潜在的益处证明对胎儿有潜在风险时才使用（8.1）。

Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3).

哺乳母亲：给予哺乳期妇女时应谨慎行事（8.3）。

Geriatric Use: The recommended dose of colchicine should be based on renal/hepatic function (8.5).

老年人使用：秋水仙碱的推荐剂量应基于肾/肝功能（8.5）。

INDICATION AND USAGEColchicine Capsules are indicated for prophylaxis of gout flares in adults.Limitations of use: The safety and effectiveness of colchicine for acute treatment of gout flares during prophylaxis has not been studied.Colchicine is not an analgesic medication and should not be used to treat pain from other causes..

适应症和用途秋水仙碱胶囊适用于预防成人痛风发作。使用限制：尚未研究秋水仙碱在预防期间急性治疗痛风发作的安全性和有效性。秋水仙碱不是镇痛药，不应用于治疗其他原因引起的疼痛。。

Click for Full Prescribing Information.

点击完整的处方信息。

About EndoEndo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward.

关于EndoEndo（OTC:ENDPQ）是一家专业制药公司，致力于通过提供高质量，增强生活的疗法帮助我们为每个人提供最佳生活。我们数十年来证明的成功来自全球充满激情的团队成员，他们合作提出治疗方案。

Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn..

总之，我们大胆地将见解转化为有利于那些需要他们的人的治疗方法。在www.endo.com了解更多信息或通过LinkedIn与我们联系。。

Cautionary Note Regarding Forward-Looking StatementsCertain information in this press release may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr.

关于前瞻性陈述的警示本新闻稿中的某些信息可被视为1995年“私人证券诉讼改革法”和任何适用的加拿大证券立法（包括但不限于Mr声明）范围内的“前瞻性陈述”。

Sims, any statements relating to product launch, shipping, quality, affordability, reliability or sales, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as 'believe,' 'expect,' 'anticipate,' 'intend,' 'estimate,' 'plan,' 'will,' 'may,' 'look forward,' 'intend,' 'guidance,' 'future,' 'potential' or similar expressions are forward-looking statements.

Sims，与产品推出，运输，质量，可负担性，可靠性或销售有关的任何声明，以及涉及预期，估计或预期未来结果或仅与历史事实无关的任何声明。包括“相信”，“期望”，“预期”，“打算”，“估计”，“计划”，“将会”，“可能”，“展望”，“打算”，“指导”，“未来”，“潜在”或类似的表达是前瞻性陈述。

All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S.

本通讯中的所有前瞻性陈述均反映了本公司截至本通讯发布之日的当前观点，其计划，意图，期望，策略和前景基于其当前可用信息及其所作假设。基于多种因素，实际结果可能与当前预期存在实质性差异和不利影响，其中包括公司应急计划和重组活动的结果；任何未决或未来诉讼，调查，诉讼或索赔的时间，影响或结果，包括阿片类药物，税收和反托拉斯相关事宜；任何实际或或或有负债；结算讨论或谈判；本公司的流动性，财务业绩，现金状况和经营状况；与第11章程序相关的风险和不确定性；根据美国第363条确认公司业务销售的时间、条款和能力。

Bankrupt.

破产。

Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S.

有关风险因素的其他信息，包括以上引用的信息，可以在公司发布的新闻稿中找到，也可以在公司与美国证券交易所委员会和加拿大证券监管机构的公开定期申请中找到，包括在公司最近的10-K表格年度报告和随后的10-Q表格季度报告或与美国的其他文件中的“风险因素”标题下的讨论。

Securities and Exchange Commission..

证券交易委员会。。

SOURCE Endo International plc

来源Endo International plc