英文药名: Axorid(Ketoprofen/Omeprazole) 中文药名: 复合酮洛芬&奥美拉唑胶囊 生产厂家: Meda Pharma. 药品简介 英国研究人员发现，一种新型非甾体类抗炎药Axorid，在缓解疼痛的同时还能防止胃溃疡及出血，给患者带来双重功效。 这种药物名为Axorid的新药，Meda制药公司研制的新型复方制剂，主要由酮洛芬和奥美拉唑组成。Axorid已于今年年初，在英国获准用于治疗骨关节炎、风湿性关节炎和强直性脊柱炎。 胃出血是非甾体类抗炎药(NSAID)最常见的不良反应之一。每年因服用NSAID而导致肠胃出血的患者达4000例左右，其中700人死亡。 爱丁堡大学肝脏病学教授及皇家医院荣誉顾问医师皮特•海耶斯表示，将NSADI和PPI同时使用是减少用药副作用和保护胃部的惯用方法，但患者经常忘记或不愿意同时使用两种药物，因此将这两种成分基于一体可以增强患者对药物的依从度，也是一种实用有效的方法。 Axorid modified-release capsules Drug Description Each modified-release capsule contains ketoprofen 100mg or 200mg and omeprazole 20 mgExcipients: Each capsule contains propyl-p-hydroxybenzoate, methyl-p-hydroxybenzoate, and 80mg or 105 mg sucrose Presentation Modified-release capsule, hard(Modified-release capsule)The 100 mg/20 mg capsule, hard with opaque yellow cap and opaque white body, containing white to greyish-white spherical microgranulesThe 200 mg/20 mg capsule, hard with opaque white cap and body, containing white to greyish-white spherical microgranules Indications Symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential. Adult Dosage For oral use. The capsule should be swallowed whole with food once daily, with a large glass of water. Adults and adolescents over the age of 15 years: The daily dose is 100 mg/20 mg to 200 mg/20 mg depending of the severity of symptoms. The maximal daily dose is 200 mg/20 mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200 mg/20 mg daily, and higher doses are not recommended. Ketoprofen/Omeprazole is not recommended for use in children below 15 years due to a lack of data on safety and efficacy. In elderly patients, patients with renal impairment (creatinine clearance 30-50 ml/min), hepatic impairment or congestive heart failure, the starting dose is 100 mg/ 20mg. This may be increased incremently to a maximum dose of 200 mg/20 mg per day depending on the clinical response. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Contra Indications hypersensitivity to ketoprofen or to omeprazole or to any of the excipients • last trimester of pregnancy • history of asthma induced by administration of ketoprofen or similar acting substances, such as other non-steroidal anti-inflammatory agents (NSAIDs) or acetylsalicylic acid • severe hepatic failure • severe renal failure • severe heart failure • active peptic ulcer • gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding • Concomitant use with St. John's wort or atazanavir sulphate • Combination therapy with clarithromycin should not be used in patients with hepatic impairment Special Precautions Linked to Ketoprofen component The use of Axorid with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Elderly: the elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, in patients with a platelet function disorder and in the elderly. These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin. The association with omeprazole allows to decrease gastrointestinal toxicity. Nevertheless gastrointestinal haemorrhage or ulcers/perforations can occur at any time in the course of treatment. They are not necessarily preceded by premonitory signs and can occur in patients with no history of such manifestations. They have to be closely monitored. When GI bleeding occurs in patients receiving Axorid, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are more likely to exhibit allergic reactions after taking acetylsalicylic acid and/or non-steroidal anti-inflammatory agents than the general population. Administration of this product may induce an attack of asthma. Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of the patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Urine output and renal function should be closely monitored in patients with renal or hepatic impairment, in patients on diuretic treatment, following major surgery which involved hypovolaemia, and particularly in the elderly. In the elderly, as half-life of NSAIDs is longer, doses should be reduced. During long-term treatment, monitoring of blood count and hepatic and renal function is recommended. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for these reactions early in the course of the therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Axorid should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Patients with a previous history of photosensitivity or phototoxicity reactions should be carefully monitored. Ketoprofen, as any other NSAID, may mask symptoms of an underlying infectious disease. Ketoprofen component in Axorid is a prolonged-release formulation, therefore this treatment is not suitable when a quick onset of efficacy at the beginning of the treatment is required. Linked to Omeprazole component Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter. In patients with severe impaired hepatic function, liver enzyme values should be checked periodically during treatment with omeprazole. During concomitant regimens with omeprazole and other medicinal products caution should be exercised when administering additional medicinal products as interactions might occur. This is particularly important with products with a narrow therapeutic index such as warfarin --------------------------------------------------------------- 产品国家：英国 原产地英文商品名: AXORID CAP (100/20)mg/cap 10caps/bottle 原产地英文药品名: KETOPROFEN/OMEPRAZOLE 中文参考商品译名: AXORID胶囊 (100/20)毫克/胶囊 10胶囊/盒 中文参考药品译名: 酮洛芬/奥美拉唑 生产厂家中文参考译名: Meda 生产厂家英文名: Meda