67．潘通

出处：按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第385页（7690字）

【中文释文】：

(己酮可可碱)注射剂 100mg

〔成分〕

每支(5m1)含己酮可可碱100mg。

〔性能与作用〕

本品为血流改善剂。改善红细胞变形能力，降低纤维蛋白原浓度，抑制红细胞及血小板聚集。促进缺血组织的微循环，对中枢神经系统没有刺激作用。

药代动力学：潘通不与血浆蛋白结合，一般由肝代谢然后经肾脏消除，母体药物的消除半衰期在0．5～1．5h。严重肾功能失调时，代谢物的消除被推迟。

〔适应证〕

脑部动脉血流障碍。暂时性脑缺血发作，中风引起的后遗症。周围血管血流障碍疾病。血栓闭塞性脉管炎，眼部动脉血流障碍。内耳功能障碍疾病。

〔方法〕

药物加入相应溶液静脉点滴。配药溶液：生理盐水，5%或10%葡萄糖溶液，林格溶液或通用血浆代用品。

溶液配制后24h内用完。

静脉用药时病人应处平卧位。

〔剂量〕

初次剂量100mg已酮可可碱加入250～500ml相应的溶液，静脉点滴。输液时间应大于90～180min。最大滴速不可超于100mg／h。根据病人耐受性可增加50mg／d，每次用药量不可超过300mg。按不同病情每天可用1～2次。需加口服药时，总量不应大于1500mg／d。严重病人可缓慢静脉推注100mg／d，推注时间应在5min以上，必要时可增加到100mg，每日3次。

〔禁忌证〕

对己酮可可碱及其他甲黄嘌呤类药物过敏。

急性心肌梗塞。

大出血。

视网膜出血。

妊娠和哺乳期不宜用。

对严重冠状动脉硬化及脑动脉硬化伴高血压、心律失常、低血压和肾功能严重不良者慎用。

〔副作用〕

可出现恶心、呕吐、胃痛、腹胀。偶见眩晕、头痛。

极个别出现皮肤过敏或全身过敏反应(面潮红、心动过速、血压下降)、情绪不安、失眠、血像变化、血小板减少、皮肤及胃肠出血。

〔药物相互作用〕

增强降压药、降糖药及抗凝药的作用。

〔注意事项〕

心衰情况下，用潘通治疗前，必须先治疗心衰，在同时服用抗高血压药胰岛素或口服降糖药这些药物的剂量必须调整。

用药期间在同时用抗凝药或血小板聚集抑制剂，必须密切监测凝聚参数。出现视网膜出血、严重低血压、过敏反应者应立即停药。

驾驶车辆及机器操作者要注意。

出现眩晕及服降糖药物等应报告医师。

出现妊娠现象或在哺乳期应告知医师。

药品勿放在儿童可取处。

〔包装〕

5×5ml／盒

〔保存期〕

48个月

〔生产厂家〕

德国布劳博伊伦麦克乐制药公司

【外文释文】：

1 ampoale(5 ml)contains：

Pentoxifylline 100 mg

Properties and effects

Pentoxifyllin is a xanthine derivative that improves the flow properties of the blood due to its effect on pathologically impaired erythrocyte deformability，inhibition of thrombocyte aggregation，and reduction of the fibrinogen level．

Thus，Pentoxifyllin enhances the nutritive microcirculation in ischaemic tissues．Pentoxifyllin does not have a stimulating effect on the CNS．

Pharmacoknetics

Pentoxifyllin is not bound to plasma proteins．

Pentoxifyllin is generally metabolized by the liver and then eliminated renally．The elimination half-life of the parent substance and the metabolites is between 0．5 and 1．5 hours．

In cases of severe renal dysfunction，the elimination of metabolites is delayed．

Indications

·Peripheral arterial circulation disorders(peripheral arterial occlusive disease，Fontaine grade Ⅱ to Ⅳ；angioneuropathies)．

·Arterial circulation disorders in the region of the brain and the eye．

·Function disorders of the inner ear(sudden loss of hearing)．

Application

Intravenous infusion after addition to carrier solutions．

5%And 10%glucose solutions，normal saline，as well as Ringer’s solution and Ringer’s lactate solution may be used as carriers．

Use prepared solution for infusion within 24 hours．

If other carriers are used，compatibility must be checked prior to use．

Dosage

Initially，100 mg in 250-500 ml carrier over 90-180 minutes per application．

Thereafter，increase daily dosage by 50-300 mg per application，with a maximum drip rate of 100 mg per hour，depending on tolerance．

To be applied 1-2 times per day，depending on the severity of the circulation disorder．

Administer small initial doses，and gradually increase to optimum amounts in patients with hypotension or cardiovascular instability．

Reduce the dosage in patients with severely impaired renal function(creatinine clearanceunder 10 ml per minute)，subject to general contra-indications of infusion therapy(see contraindications)．

Additional oral administration of Pentoxifyllin is possible．Thereby，a maximum total daily dose of 1 200-1 500 mg(iv and oral)must not be exceeded．

Contra-indications

·Hypersensitivity to Pentoxifyllin or other methylxanthines

·Acute myocardial infarct

·Massive bleeding

·Retinal haemorrhage

Caution is required in patients with a predisposition for retinal haemorrhage，e．g．diabetes and hypertension．

Caution is cases of severe coronary or cerebral sclerosis with hypertension，severe cardiac arrhythmias，severe hypertension and severely impaired kidney function(creatinine clearance under 10 ml per minute)．

Please note general contra-indications for infusion therapy-congestive heart failure，pulmonary or cerebral oedema，kidney function disorders(oliguria，anuria)and hyperhydration．

Pregnancy and breast-feeding

Animal tests have shown no teratogenic effects of Pentoxifyllin．

Controlled studies of application in humans are not available．

Pentoxifyllin passes into the breast milk；therefore，it should not be administered during pregnancy and breast-feeding．

Side effects

Most commonly，headaches，dizziness and gastrointestinal disorders(nausea，vomiting，heartburn，epigastric pain，diarrhoea)occur．

In rare cases，hypersensitive reactions of the skin，flush，palpitations，tachycardia and a drop in blood pressure may occur．

Occasionally， unrest， insomnia， cardiac dysrhythmias， icterus， haematologicalchanges，thrombocytopenia，skin and mucosal bleeding and gastrointestinal bleeding have been reported．

Interactions

The blood pressure-reducing effects of antihypertensives，and the blood sugar reducing effects of insulin and oral antidiabetics may be enhanced．

When administered concurrently with anticoagulants，an enhancement of the anticoagu lant effect cannot be excluded．

Special warnings and advice

In cases of heart failure，recompensation is necessary prior to treatment with Pentoxifyllin．In cases of concurrent administration of antihypertensives，insulin or oral antidiabetics，the dosage of these substances must be adjusted．

In cases of concurrent therapy with anticoagulants or platelet aggregation inhibitors，the coagulation parameters must be monitored very carefully．

Overdose

After an overdose，hypotension，coffee-ground vomiting，unconsciousness，areflexia and tonoclonic spasms may occur，

The treatment is symptomatic．

Plasma expanders are recommended for strong drops in blood pressure，and diazepam for spasms．

Package size

5×5ml

Durability

48 months

Distribution

Prescription only，ethical．

Application Instructions

It is no longer necessary to file the ampoule．

How to use the new OPC(one-point-cut)ampoules：see illustration．

Coloured point upwards!

Allow solution in tip of ampoule to flow down by shaking．

Break off tip of ampoule with a downward movement．

Manufacturer

Merckle GmbH Blaubeuren，Germany．