英文药名：EBUTOL（Ethambutol Hydrochloride Tablets） 中文药名：盐酸乙胺丁醇片 生产厂家：科研制药 エブトール１２５ｍｇ錠／エブトール２５０ｍｇ錠 类别名称 制定乙胺丁醇 商標名 EBUTOL 125mg Tablets EBUTOL 250mg Tablets 一般名： エタンブトール塩酸塩 (Ethambutol Hydrochloride) 化学名： 2, 2'-(Ethylenediimino) bis［(2S )-butan-1-ol］dihydrochloride 分子式： C10H24N2O2・2HCl 分子量： 277.23 融点： 200～204℃ 旋光度： [α]20D： ＋5.5～＋6.1°(乾燥後、5g、水、50mL、200mm) 構造式： 性状： 盐酸乙胺丁醇，白色结晶或结晶性粉末，无臭，味微苦。 这是非常易溶于水，微溶于甲醇或乙醇（95），并在乙醚中几乎不溶。 溶解于水20ml的盐酸乙胺丁醇1.0克液体PH值为3.4〜4.0。 药理 1.针对结核分枝杆菌较强的抗菌活性，对结核分枝杆菌H37Rv菌株，1％小川培养基，以防止在杜伯士液体介质的生长，在2.5〜为5μg/mL） 2.异烟肼，不对其他抗结核药物链霉素等之间的交叉耐药性。 3. 抑制核酸合成结核杆菌，已经发现抑制细胞分裂 适应症 肺结核和结核等，非结核分枝杆菌疾病，包括鸟分枝杆菌复合体（MAC）病 用法用量 [肺结核和结核等] 成年人，口服给药分为每日剂量0.75〜1克1-2倍。年龄，适宜体重。与其它抗结核病药物的组合。 [非结核分枝杆菌疾病，包括MAC病] 成人，口服给药，每天一次0.5〜0.75克。年龄，体重，可以根据症状调整，每日剂量不超过1g。 包装规格 片剂：125mg （PTP）100,1,000片（瓶）1000片 片剂：250毫克 （PTP）100,500片（瓶）500片 制造厂商 科研制药有限公司 EBUTOL TABLETS（Ethambutol Hydrochloride）由日本科研生产，为二线抗结核药，可用于经其他抗结核药治疗无效的病人，常与其他抗结核药联合应用，以增强疗效，并延缓细菌耐药性的产生。 Brand name : EBUTOL 125mg Tablets 　Active ingredient: Ethambutol hydrochloride 　Dosage form: pale yellow tablet, diameter:8.2mm, thickness:4.6mm  　Print on wrapping: エブトール125mg錠, EBUTOL125mgTab, エブトール125, EBUTOL125, KC12, 125mg, エタンブトール塩酸塩 ------------------------------------ Brand name : EBUTOL 250mg Tablets 　Active ingredient: Ethambutol hydrochloride 　Dosage form: pale yellow tablet, diameter:10.2mm, thickness:6.1mm  　Print on wrapping: エブトール250mg錠, EBUTOL250mgTab, エブトール250, EBUTOL250, KC11, 250mg, エタンブトール塩酸塩 Effects of this medicine This medicine suppresses the growth of bacteria by inhibiting nucleic acid synthesis of Mycobacterium tuberculosis and non-tuberculous mycobacterium. It is usually used to treat pulmonary tuberculosis, other tuberculosis and nontuberculous mycobacteriosis including Mycobacterium avium complex (MAC). Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have optic nerve inflammation, diabetes, or alcoholism. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •For pulmonary tuberculosis and other tuberculosis: In general, for adults, take 3 to 4 tablets (0.75 to 1 g of the active ingredient) a day, in 1 to 2 divided doses. The dosage may be adjusted according to your disease, age, symptoms, or weight. It is recommended to take this medicine with other antiphthisics. For nontuberculous mycobacteriosis including MAC: In general, for adults, take 2 to 3 tablets (0.5 to 0.75 g of the active ingredient) at a time, once daily. The dosage may be adjusted according to your disease, age, symptoms, or weight, however, the maximum daily dose is 4 tablets (1 g). In both cases, strictly follow the instructions. •If you miss a dose, take a dose as soon as possible. However, if you take this medicine at a time twice a day in the morning and in the evening, take an interval of 4 to 5 hours before the next dose. If it is only 2 to 3 hours or less before the next dose, skip the missed dose and continue your regular dosing schedule. In both cases, you should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •Every morning, you should read a newspaper by one eye at a time, at a certain distance. Then, if you feel something wrong with your vision, check with your doctor immediately. Possible adverse reactions to this medicine The most commonly reported adverse reactions include vision disorder, numbness of limbs, fever, rash, itch, hallucination, anxiety and insomnia. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •reduced visual acuity, tunnel vision, color vision deficiency [vision disorder] •general malaise, loss of appetite, yellowing of the skin/white of eyes [serious liver disorder] •breathing difficulty, cold sweat, hives [shock, anaphylaxis] •fever, erythema, blister, erosion [oculomucocutaneous syndrome, toxic epidermal necrolysis, erythroderma (exfoliative dermatitis)] •nasal bleeding, gum bleeding, subcutaneous hemorrhage of limbs [thrombocytopenia] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Ask the pharmacist or medical institution how to discard them. Kaken Pharmacetical Co.,LtdInternal Revised: 4/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. http://www.info.pmda.go.jp/go/pack/6225001F1036_1_14/