英文药名：BACTRAMIN Combination Granule/Tablet(Trimethoprim/Sulfamethoxazole) 中文药名：甲氧苄啶/磺胺甲恶唑配合片/顆粒 生产厂家：中外制药 バクトラミン配合錠／バクトラミン配合顆粒 治疗类别名称 合成抗菌剂 商標名 BACTRAMIN 1. 一般名 トリメトプリム（Trimethoprim）（JAN） 略　名 TMP 化学名 2,4-Diamino-5-（3,4,5-trimethoxybenzyl）-pyrimidine 構造式 分子式 C14H18N4O3 分子量 290.32 性　状 白色结晶或结晶性粉末，不臭，味微苦。 易溶于乙酸（100），稀乙酸，稍微在甲醇或氯仿，乙醇（95）或微溶于丙酮微溶，在极微溶于水，并在乙醚中几乎不溶。 熔点 199〜203℃ 2. 一般名 スルファメトキサゾール（Sulfamethoxazole）（JAN） 略　名 SMX 化学名 4-Amino-N-（5-methylisoxazol-3-yl）benzenesulfonamide 構造式 分子式 C10H11N3O3S 分子量 253.28 性　状 白色结晶或结晶性粉末，没有气味，味道微苦。 N，N-二甲基甲酰胺以非常易溶，乙醇（95），以微溶，微溶于乙醚，在极微溶于水。溶于氢氧化钠TS。光逐渐着色。 熔点 169〜172℃ 适应病症 1.一般感染 ○磺胺甲恶唑/甲氧苄啶为肠球菌的敏感性，大肠杆菌，痢疾杆菌，伤寒杆菌，副伤寒杆菌，枸橼酸杆菌，克雷白杆菌，肠杆菌，变形杆菌，摩根Morugani，普罗维登Rettogeri，流感嗜血杆菌 ○肺炎，慢性呼吸系统疾病，膀胱炎复杂，肾盂肾炎，传染性肠炎，伤寒的继发感染，副伤寒。 2. 肺肺炎治疗，抑制发病。 ○肺Irobechi ○肺肺炎，抑制肺肺炎的发作 用法用量 1.一般感染 成人师的每日剂量4片（4克在颗粒的情况下）的2倍，并口服给药。然而，年龄，适当增加或根据状况减少。 2. 肺肺炎治疗，抑制发病 (1) 治疗中使用 成人除法每日剂量9-12片（9〜12克在颗粒的情况下）在三到四倍，并口服给药。通常情况下，孩子们被分为每日剂量15〜20毫克/公斤的甲氧苄啶，口服3-4次。然而，年龄，适当增加或根据状况减少。 （2）当在抑制发病使用 正常，（在颗粒的情况下，1〜2克）1〜2片，每天一次对成人的每日或每周三天口服给药。 通常，儿童被分成一个每日剂量为4〜为8mg/ kg的两倍甲氧苄啶，每天或周1天口服给药。 药效药理 1. 体外抗菌活性 它显示了与绿脓杆菌外大多数革兰氏阳性菌和革兰氏阴性菌的抗菌活性。革兰氏阳性菌，革兰氏阴性菌显示（大肠杆菌，克雷伯氏菌属，肠杆菌属，变形杆菌，流感嗜血杆菌，痢疾杆菌，伤寒杆菌）易感性的临床分离株。 2. 作用机序 这种药物的2成分分别抑制细菌的叶酸代谢途径的连续两个地方。换句话说，新诺明抑制与对氨基苯甲酸二氢冲突的合成，甲氧抑制还原过程从二氢叶酸向四氢叶酸。其结果是，这种药物与在允许单独作用于组件的情况相比，在抗微生物活性协同增加观察到。 包装规格 组合片剂：100片（PTP） 混合颗粒：100g（罐） 制造厂商 中外制药有限公司 注：以上中文资料仅供参考，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/6290100D1096_1_09/ BACTRAMIN Combination Granule（バクトラミン配合顆粒）  Brand name : BACTRAMIN Combination Granule 　Active ingredient: Trimethoprim  Sulfamethoxazole 　Dosage form: white to faintly yellowish white granule 　Print on wrapping: BACTRAMIN Combination Tablet（バクトラミン配合錠）  Brand name : BACTRAMIN Combination Tablet 　Active ingredient: Trimethoprim  Sulfamethoxazole 　Dosage form: white tablet, diameter: approx. 11mm, thickness: approx. 5.3mm 　Print on wrapping: バクトラミン配合錠  Effects of this medicine This medicine contains 2 kinds of active ingredients working on folate which is necessary for bacteria; one is for blocking folate biosynthesis and another is for blocking folate activation. Consequently, it has antibacterial effect synergistically. It is usually used to treat general infections such as pneumonia, secondary infection caused by chronic respiratory lesion, complicated cystitis, pyelonephritis, infectious enteritis, typhoid, or paratyphoid. It is also usually used to treat pneumocystis pneumonia and to suppress symptom onset. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, bronchial asthma, etc.) to any medicines. If you have: glucose-6-phosphate dehydrogenase deficiency, hepatic/renal disorder, folate deprivation or folate metabolism abnormality (a history of gastric resection, just after delivery, congenital folate metabolism abnormality). If you have/had blood disease. If you or any of your parents or siblings have previously experienced any allergic reactions such as bronchial asthma, rash, and hives. •If you are pregnant, breastfeeding or possibly pregnant. •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>> •General infections: In general, for adults, take 2 g at a time, twice a day. It should be adjusted according to your disease, age and symptoms. Treatment of pneumocystis pneumonia: In general, for adults, take 9 to 12 g in 3 to 4 divided doses a day. In general, for children, take 15 to 20 mg/kg of trimethoprim in 3 to 4 divided doses a day. The dosage should be adjusted according to your age and symptoms in any case. Suppression of symptom onset of pneumocystis pneumonia: In general, for adults, take 1 to 2 g at a time, once a day. In general, for children, take 2 to 4 mg/kg of trimethoprim at a time, twice a day. One gram of this medicine contains 80 mg of trimethoprim and 400 mg of sulfamethoxazole as the active ingredients. Strictly follow the instructions in any case. •If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, take a dose as soon as possible and skip the next dose. 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 •Contact your doctor immediately when you notice that you are having such symptoms as anemia, bleeding tendency (nose bleeding, etc.), continuous bleeding, persistent bruise, rash, hives, blister and itch. Possible adverse reactions to this medicine The most commonly reported adverse reactions include loss of appetite, nausea, stomach discomfort, rash, hives, erythema, bulla, pruritus and hematologic disorder (anemia, bleeding tendency). 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. •palpitation/shortness of breath when moving, going upstairs or uphill, palpitation, shortness of breath, breathlessness, nose/gum bleeding, blue spot, bleeding tendency, continuous bleeding, subcutaneous bleeding, glossitis accompanied by numbness and pain, facial pallor, toenails/fingernails/lips turning blue, easy fatigability, lassitude, headache, fever, sore throat, dizziness, lightheadedness, dizziness on standing up, ear ringing, dull headache, yellowness in the skin and/or the white of the eye, brown urine [aplastic anaemia, haemolytic anaemia, anaemia megaloblastic, methaemoglobinaemia, pancytopenia, agranulocytosis, thrombocytopenia] •gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath, breathlessness, yellowness in the skin and/or the white of the eye, dark urine, decreased consciousness, impaired mind/judgment, numbness, convulsion, decreased urinary volume, swelling [thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)] •hoarseness, swelling around the eye and lips, hives, impaired judgment, palpitation, shortness of breath, breathlessness, lassitude, impaired mind, glow, decreased consciousness, faint consciousness, lightheadedness, dizziness, cold sweat, pale face [anaphylaxis, shock] •lassitude, high fever, inflamed eyelid/eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red spot with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the genitalia, joint pain [toxic epidermal necrolysis (TEN), oculomucocutaneous syndrome (Stevens-Johnson syndrome)] •chills, lightheadedness, heavy sweating, fever, faint consciousness, impaired mind, breathlessness, itch, rash, numbness, impaired judgment [drug-induced hypersensitivity syndrome] •sudden and severe abdominal/lower-back/back pain, fever, nausea, vomiting [acute pancreatitis] •vomiting, feeling sick, abdominal pain, fever, diarrhea, bloody stool, frequent diarrhea, bloody diarrhea [serious colitis with bloody stool caused by pseudomembranous colitis, etc.] •fever, impaired judgment, decreased consciousness, flapping tremor in hands, impaired mind, yellowness in the skin and/or the white of the eye, lassitude, loss of appetite, nausea, vomiting, rash, itch [severe liver disorder] •decreased consciousness, swollen eye, decreased urinary volume, swollen body, headache, lassitude, breathlessness, easy fatigability, joint pain, fever, rash, urine with blood [renal failure acute, nephritis interstitial] •fever, headache, vomiting, inactive sensory, numbness in the limbs, weakness/muscle atrophy/pain of the limbs [meningitis aseptic, peripheral neuritis] •fever, cough, shortness of breath, breathlessness [interstitial pneumonia, PIE syndrome] •dizziness, hungry feeling, lightheadedness, cold sweat, shaky limbs, feeling of weariness, headache, palpitation [hypoglycaemic attack] •loss of strength in the limbs, paralyzed limbs, numbness in the lips/limbs, muscle weakness, feeble muscles, difficulty moving limbs, decreased consciousness, headache, nausea, vomiting, loss of appetite, convulsion [hyperkalaemia, hyponatraemia] •stiff limbs, numbness in the limbs, feeling of weariness, muscle pain, red-brown urine [rhabdomyolysis] 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 at room temperature (1-30 ℃), away from light and moisture. •Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them. Chugai Pharmaceutical Co., Ltd.Internal Revised: 10/2014 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.