英文药名:OPALMON Tablets(Limaprost Alfadex)
中文药名:利马前列素片(α-阿法环糊精)
生产厂家:小野制药
オパルモン錠5μg
治疗类别名称 口服前列腺素E1衍生物制剂 商標名 OPALMON 一般名 リマプロスト アルファデクス(Limaprost Alfadex) 化学名 (2E)-7-{(1R,2R,3R)-3-Hydroxy-2-[(1E,3S,5S)-3-hydroxy-5-methylnon-1-en-1-yl]-5-oxocyclopentyl}-hept-2-enoic acid-α-cyclodextrin 構造式
分子式 C22H36O5・χC36H60O30 分子量 380.52(リマプロストとして) 性状 本产品是一种白色粉末,易溶于水,略溶于甲醇,乙醇(99.5)非常微溶,并在乙酸乙酯中几乎不溶。本产品是吸湿。 适应症 1.闭塞性血栓性血管炎,改善缺血症状,如疼痛和冷感相关溃疡 2.后天性腰椎管狭窄症(SLR试验正常,患者双侧间歇性跛行)主观症状(下肢疼痛,下肢麻木)由于改善和行走的能力。 用法与用量 1.溃疡闭塞性血栓血管炎,以缺血症状,如疼痛和冷感的提高 正常成人,口服给药每天30μg的如利马前列素的三倍。 2.后天性腰椎管狭窄症(SLR试验正常,患者双侧间歇性跛行)主观症状(下肢疼痛,下肢麻木)由于改善和行走能力 正常成人,口服给药每天为15μg如利马前列素的三倍。 包装规格 片剂 5μg:100片(PTP 瓶装),210片(PTP),500片(PTP,瓶装)1050片(PTP)
制造商 小野制药有限公司
完整资料附件:http://www.info.pmda.go.jp/go/pack/3399003F1073_1_12/ OPALMON Tablets(Limaprost alfadex) Brand name : OPALMON Tablets 5mcg Active ingredient: Limaprost alfadex Dosage form: white tablet, diameter: 6.5 mm, thickness: 2.9 mm Print on wrapping: オパルモン5μg, OPALMON5μg, 5μg, ono201 Effects of this medicine This medicine relieves symptoms such as numbness, pain and cold feeling of limbs. It relieves pain/numbness of legs caused by compression of the nerve/vessels due to narrowing of the spinal canal in the lower back. It consequently improves ability to walk. It is usually used to improve ischemic symptoms such as ulcer, pain and cold feeling associated with thromboangiitis obliterans and subjective symptoms (pain/numbness of lower limbs) associated with acquired lumbar spinal canal stenosis (patients with bilateral intermittent claudication showing normal SLR). It is also used to improve ability to walk. 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 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 thromboangiitis obliterans: In general, for adults. take 2 tablets (10 mcg of Limaprost) at a time, 3 times a day. Strictly follow the instructions. For acquired lumbar spinal canal stenosis: In general, for adults. take 1 tablet (5 mcg of Limaprost) at a time, 3 times a day. Strictly follow the instructions. •If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed 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 • Possible adverse reactions to this medicine The most commonly reported adverse reactions include diarrhea, nausea/vomiting, gastric/abdominal discomfort, loss of appetite, stomachache, numbness of the tongue, headache/dull headache, drowsiness, insomnia, tachycardia, hypotension, elevated blood pressure, hot flush, rash, itch, hives, redness in the area exposed to light, bleeding and anemia. 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. •general malaise, loss of appetite, yellowing of the skin and the conjunctiva [liver dysfunction, jaundice] 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. Keep in PTP sheet and store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Ono 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.
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