WARNINGS
Focal areas of retinal degeneration have developed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose-related. At lower doses some lesions have appeared to be reversible.
Limited data in cats and rabbits showed retinal changes in some animals with doses as low as 126 mg/kg/day (only about 3 times the recommended human dose) administered for several days to two weeks.
No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials.
However, visual abnormalities, often poorly characterized, represent the most frequently reported postmarketing adverse reaction in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground
and visual fields, is advised, before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found.

ADVERSE REACTIONS
Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur but disappear when the dosage is reduced. Giddiness and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. To avoid this response, the solution should not be injected more rapidly than 1 mL per minute.
Worldwide Postmarketing Reports: Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined.

DOSAGE AND ADMINISTRATION
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of CYKLOKAPRON intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (μmol/L)： 120 to 250 (1.36 to 2.83 mg/dL)；250 to 500 (2.83 to 5.66 mg/dL)；>500 (>5.66 mg/dL).
Tranexamic Acid I.V. Dosage：10 mg/kg BID；10 mg/kg BID；10 mg/kg every 48 hours or 5 mg/kg every 24 hours.
For intravenous infusion, CYKLOKAPRON Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions and Dextran solutions. The mixture should be prepared the same day the solution is to be used. Heparin may be added to CYKLOKAPRON Injection. CYKLOKAPRON Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.

HOW SUPPLIED
CYKLOKAPRON Injection 100 mg/mL NDC 0013-1114-10 10 x 10 mL ampules
STORAGE
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F)

【商品名称】Cyklokapron
【药品名称】氨甲环酸
【作用和用途】用于减少或预防血友病患者拔牙期间或拔牙后出血。
【主要成分】氨甲环酸
【药理作用】低剂量能抑制纤溶酶原的活化作用。高剂量还能直接抑制纤溶酶的蛋白溶解酶的活性，也能抑制胰蛋白酶、糜蛋白酶的活性。本品与纤溶酶原或纤溶酶的赖氨酸结合区有高度亲和力，故能竞争性抑制纤维蛋白的赖氨酸与纤溶酶结合，从而抑制纤维蛋白凝块的裂解，产生止血作用。
【适应证】血友病患者拔牙前后给药，可减少输注凝血因子的用量。
【不良反应】头痛、头晕、嗜睡、恶心、呕吐、腹泻等。
【禁忌证】有血栓形成倾向病人禁用。
【注意事项】①心、肝、肾功能损害者减量或慎用。②上泌尿道出血者慎用，因有引起肾小球毛细血管血栓的可能性。③不宜用于前列腺或尿道手术的止血药。④该类药物不宜用于治疗活跃的血管内凝血或纤维蛋白沉积的患者，因有加重血栓栓塞的危险，也不宜用于弥漫性血管内凝血患者。⑤若纤溶十分明显，应用时应小心监测。⑥持续应用本品者，应作视力、视野及眼底检查。

------------------------------------------------------
详细处方信息以本药内容附件PDF文件（201931316421717.pdf）的“原文Priscribing Information”为准
------------------------------------------------------