英文药名: Trental(Pentoxifylline Tablets) 中文药名: 活脑灵,己酮可可豆碱,己酮可可碱,丁咯地尔,潘通,循能泰 生产厂家：Sanofi-aventis 药品介绍 【分类】血管扩张药 【别名】活脑灵；己酮可可豆碱，己酮可可碱，丁咯地尔，己酮可可碱，潘通，循能泰 【外文名】Pentoxifylline，Trental，Pentomer，PentoxifyllineOxpentifylline 【适应症】 用于血栓闭塞性脉管炎、脑血管障碍、血管性头痛等。脑部供血不足(脑部血管硬化/栓塞、老年痴呆症)，末梢血管病、Raynaud氏病、耳蜗扰乱症、冻疮及缺氧所产生的痛症。 【用量用法】 ①口服：1次200～600mg，1日3次。静注：1次100～200mg，需缓慢。静滴：每日100～400mg，溶于250～500ml的5%葡萄糖液中，滴注90～180分钟。 ②片剂450-600mg/日，分2-3次服用，注射液50-200mg/日，静脉或肌肉注射，静滴。 【注意事项】 1.少数病人服后有胃部不适、恶心、头昏等不良反应。 2.新近心肌梗塞、严重冠状动脉硬化并有高血压者禁用。 3.孕妇不宜使用。 4.个别病人发生视力模糊，过敏性皮疹和皮肤瘙痒等，对肝脏、血象也有影响。5.肝脏疾病患者慎用。 【禁忌】急性脑溢血、严重动脉出血患者，妊娠及哺乳妇女。 【规格】 ①片剂：每片100mg。注射液：每支100mg(5ml)。 ②片剂150mgx30片。300mgx20片。注射液50mg/5mlx5支 Trental 400(pentoxifylline) 1. Name of the medicinal product TRENTAL 400. 2. Qualitative and quantitative composition Pentoxifylline 400MG. 3. Pharmaceutical form Modified release tablet. 4. Clinical particulars 4.1 Therapeutic indications Trental 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain. 4.2 Posology and method of administration The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Tablets should be taken with or immediately after meals, and swallowed whole with plenty of water. Elderly: No special dosage requirements. Children: Trental 400 is not suitable for use in children. Special Cases: In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approximately 30% to 50% may be necessary guided by individual tolerance. 4.3 Contraindications Trental 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias. 4.4 Special warnings and precautions for use At the first signs of an anaphylactic/anaphylactoid reaction, Trental 400 must be discontinued immediately, and a physician must be informed. Particular careful monitoring is required: In patients with hypotension or severe coronary artery disease, Trental 400 should be used with caution, as a transient hypotensive effect is possible and, in isolated cases, might result in a reduction in coronary artery perfusion. Particularly careful monitoring is required in patients with impaired renal function. In patients with a creatinine clearance of less than 30 ml/min it may be necessary to reduce the daily dose of Trental 400 to one or two tablets to avoid accumulation. In patients with severely impaired liver function the dosage may need to be reduced. In patients treated concomitantly with pentoxifylline and anti-vitamin K (see also section 4.5). In patients treated concomitantly with pentoxifylline and antidiabetic agents (see also section 4.5). In patients treated concomitantly with pentoxifylline and ciprofloxacin (see also section 4.5). 4.5 Interaction with other medicinal products and other forms of interaction High doses of Trental injection have been shown, in rare cases, to intensify the hypoglycaemic action of insulin and oral hypoglycaemic agents. However, no effect on insulin release has been observed with Trental following oral administration. It is recommended that patients under medication for diabetes mellitus be carefully monitored. Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed. Trental 400 may potentiate the effect of anti-hypertensive agents and the dosage of the latter may need to be reduced. Trental 400 should not be given concomitantly with ketorolac as there is increased risk of bleeding and/or prolongation of prothrombin time. Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore there may be an increase in and intensification of adverse effects of theophylline. Concomitant administration with ciprofloxacin may increase the serum concentration of pentoxifylline in some patients. Therefore, there may be an increase in and intensification of adverse reactions associated with co-administration. 4.6 Pregnancy and lactation There is no information on the use of Trental in pregnancy but no untoward effects have been found in animal studies. Trental 400 should not be administered during pregnancy. Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the possible risks and benefits must be weighed before administration of Trental 400 to breast feeding mothers. 4.7 Effects on ability to drive and use machines No effect known. 4.8 Undesirable effects These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown. System Organ Class Adverse Reaction Investigations Transaminases increased Cardiac disorders Arrhythmia, Tachycardia, Angina Pectoris Blood and lymphatic system disorders Thrombocytopenia Nervous system disorders Dizziness, headache, meningitis aseptic* Gastrointestinal disorders Gastrointestinal disorder, Epigastric discomfort, Abdominal distension, Nausea, Vomiting, Diarrhoea Skin and subcutaneous tissue disorders Pruritus, Erythema, Urticaria, Hot flush Vascular disorders Haemorrhage**, Hypotension Immune system disorders Anaphylactic reactions, Anaphylactoid reaction, Angioedema Hepatobiliary disorders Cholestasis Psychiatric disorders Agitation, Sleep disorder Respiratory disorders Bronchospasm Description of selected adverse reactions * Reports of aseptic meningitis were predominantly in patients with underlying connective tissue disorders ** A few very rare events of bleeding (e.g. skin, mucosa) have been reported in patients treated with Trental with and without anticoagulants or platelet aggregation inhibitors. The serious cases are predominantly concentrated in the gastrointestinal, genitourinary, multiple site and surgical wound areas and are associated with bleeding risk factors. A causal relationship between Trental therapy and bleeding has not been established. Thrombocytopenia has occurred in isolated cases. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 4.9 Overdose The treatment of overdosage should be symptomatic with particular attention to supporting the cardiovascular system. 5. Pharmacological properties 5.1 Pharmacodynamic properties Leukocyte properties of haemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. 5.2 Pharmacokinetic properties The half life of absorption of Trental 400 is 4-6 hours. Pentoxifylline is extensively metabolised, mainly in the liver. Sixty percent of a single dose of Trental 400 is eliminated via the kidney over 24 hours. 5.3 Preclinical safety data Nothing of clinical relevance. 6. Pharmaceutical particulars 6.1 List of excipients Hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine (E127). titanium dioxide (E171). 6.2 Incompatibilities None known. 6.3 Shelf life 36 months 6.4 Special precautions for storage Do not store above 25°C. Store in the original package. 6.5 Nature and contents of container Amber glass bottle: 100 or 250 tablets. Plastic (PE) pots: 100 or 250 tablets. Blister Pack (Alu/PVC): 10 or 90 tablets. 6.6 Special precautions for disposal and other handling None. 7. Marketing authorisation holder Aventis Pharma Limited One Onslow Street Guildford Surrey GU1 4YS UK Trading as: Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey GU1 4YS UK 8. Marketing authorisation number(s) PL 04425/0213 9. Date of first authorisation/renewal of the authorisation 15th April 2002 10. Date of revision of the text 3 October 2014