部份中文糠酸莫米松资料(仅供参考) 类别名称 计量过敏性鼻炎的治疗剤 适应症 本品适用于治疗成人、青少年和3至11岁儿童季节性或常年性鼻炎,对于曾有中至重度季节性过敏性鼻炎症状的患者,主张在花粉季节开始前2-4周用本品作预防性治疗。 用法用量 季节过敏性或常年性鼻炎: 通常先手揿喷雾器6-7次作为启动,直至看到均匀的喷雾,然后鼻腔给药,每喷喷出糠酸莫米松混悬液100mg,内含糠酸莫米松一水合物,相当于糠酸莫米松50μg,如果喷雾器停用14日以上,则在以后应用时应重新启动。 在每次用药前充分振摇容器。 1)成人(包括老年患者)和青年:用于预防和治疗的常用推荐量为每侧鼻孔2喷(每喷为50μg)一日1 次(总量为200μg),症状被控制后,剂量可减至每侧鼻孔1喷(总量100μg),即能维持疗效。 如果症状未被有效控制,可增剂量至每侧鼻孔4喷(总量400μg),在症状控制后减小剂量。在首次给药后12小时即能产生明显的临床效果。 2)3至11岁儿童:常用推荐量为每侧鼻孔1喷(每喷为50μg),一日1次(总量为100μg)。 不良反应 季节过敏性或常年性鼻炎: 1.在临床研究中报道与本品有关的局部不良反应(成人及青少年患者)包括鼻出血如明显出血、带血粘液和血斑(8%),咽炎(4%),鼻灼热感(2%)及鼻部刺激感(2%),这些不良反应常见于使用皮质激素类鼻喷雾剂时。鼻出血一般具有自限性,同时程度较轻,与安慰剂(5%)相比发生率较高,但与阳性对照的皮质激(15%)相比发生率接近或较低,其他反应均与安慰剂相当。 2.在小儿患者中,不良反应如头疼(3%),鼻出血(6%),鼻部刺激感(2%)及流涕(2%)均与安慰剂相当。鼻腔吸入糠酸莫米松一水合物很少发生即刻过敏反应,极少有过敏和血管性水肿的报道。 禁 忌 对本品中任何成份(活性成份:糠酸莫米松一水合物;非活性成份:纤维素、甘油、柠檬酸钠二水合物、柠檬酸水化物、聚山梨酯80、苯扎氯铵、苯乙醇、纯水)过敏者禁用。 注意事项 1.对于涉及鼻粘膜的局部感染,在未经处理时不应使用本品。 2.由于皮质激素具有抑制伤口的作用,因而对于新近接受鼻部手术或受外伤的患者,在伤口愈合前不应使用鼻腔用皮质激素。 3.使用本品治疗12个月后未见鼻粘膜萎缩,同时糠酸莫米松可使鼻粘膜恢复至正常组织学表现。与任何一种药物长期使用一样,对于使用本品达数月或更长时间的患者,应定期检查鼻粘膜,如果鼻咽部发生局部真菌感染,则应停止本品或需给予适当处理。持续存在鼻咽部刺激可能是停用本品的一项指征。 4.对于活动性或静止性呼吸道结核感染,未经处理的真菌、细菌、全身性病毒感染或眼单纯疱疹的患者慎用本品。 5.长期使用本品后未见下丘脑垂体肾上腺皮质(HPA)轴受到抑制,但对于原先长期使用全身作用皮质激素而换用本品的患者,需仔细注意。这些患者可因停止使用全身用皮质激素而造成肾上腺功能不全,需经数月后下丘脑垂体肾上腺皮质轴功能才得以恢复。如果这些患者出现肾上腺功能不全的症状和体征时,应恢复使用全身用皮质激素,并给予其它治疗和采取适宜措施。 6.在全身用皮质激素换用本品时,某些患者尽管鼻部症状有所缓解,但可发生全身用药时皮质激素的停药症状如关节(和/或)肌肉痛,乏力及抑郁,这时需鼓励患者继续使用本品。此外,全身用激素转为鼻腔局部应用时亦可暴露出原先存在的过敏性疾病,如过敏性结膜炎和湿疹,这些病症在全身用药时受到抑制。 7.接受皮质激素治疗的患者,免疫功能可能受到抑制,故应警惕面临某些感染(如水痘、麻疹)的危险,如果发生这种情况,必须得到医生指导。 8.在鼻腔内气雾吸入皮质激素后,罕见报道鼻中隔穿孔或颅内压升高的病例。 儿童用药 尚不明确。 老年患者用药 尚不明确。 孕妇及哺乳期妇女用药 对于孕妇尚未进行足够或良好的对照研究。给患者鼻腔吸入临床最大推荐量时,血浆中未能检出莫米松,因而可以预期,胎儿接触药物的可能性可忽略不计,同时产生生殖毒性的可能性很小。如同其他鼻腔用皮质激素制剂,对于孕妇,乳母或育龄妇女,只有在用药后对母体、胎儿或婴儿的益处超过可能产生的危害时才使用本品。 药物相互作用 本品与氯雷他定合用,对氯雷他定及其主要代谢物的血浆浓度未见明显影响,未能检出糠酸莫米松的血浆浓度,两药合用的耐受情况良好。 药物过量 由于本品的全身生物利用度可忽略不计,因而发生药物过量时除观察外不需任何治疗,恢复后可重新使用适宜剂量的药物。
ナゾネックス点鼻液50μg56噴霧用/ナゾネックス点鼻液50μg112噴霧用
商標名 NASONEX Nasal 50μg 56sprays NASONEX Nasal 50μg 112sprays 一般名 モメタゾンフランカルボン酸エステル水和物(JAN) Mometasone Furoate Hydrate(JAN) 化学名 (+)-9,21-Dichloro-11β,17α-dihydroxy-16α-methyl-1,4-pregnadiene-3,20-dione 17-(2-furoate) monohydrate 構造式
分子式 C27H30Cl2O6・H2O 分子量 539.44 性状 本品は白色の粉末である。本品はN,N-ジメチルアセトアミドに溶けやすく,ジオキサンにやや溶けやすく,メタノール,エタノール(99.5)又はアセトニトリルに溶けにくく,水にほとんど溶けない。 融点 約220℃(分解) 取扱い上の注意 1. 患者には添付の携帯袋及び使用説明書を渡し,使用方法を指導すること。 2. 本剤の使用前に容器を上下によく振ること。 3. 本剤の初回使用時のみ空打ちを行い(10回程度),液が完全に霧状になることを確認し使用すること。 4. 噴霧口を針やピンなどで突かないこと。 包装规格 ナゾネックス点鼻液50μg 56噴霧用:10g×5,10g×10
ナゾネックス点鼻液50μg 112噴霧用:18g×5,18g×10
生产商:MSD有限公司 完整资料附件:http://www.info.pmda.go.jp/go/pack/1329710Q1027_1_08/ Nasonex Nasal(Mometasone furoate hydrate) Nasonex Nasal 50 mcg 56 sprays(ナゾネックス点鼻液50μg56噴霧用) Brand name : Nasonex Nasal 50 mcg 56 sprays Active ingredient: Mometasone furoate hydrate Dosage form: white opaque suspension for nasal spray Print on wrapping: -------------------------------------------- Nasonex Nasal 50 mcg 112 sprays(ナゾネックス点鼻液50μg112噴霧用) Brand name : Nasonex Nasal 50 mcg 112 sprays Active ingredient: Mometasone furoate hydrate Dosage form: white opaque suspension for nasal spray Print on wrapping: --------------------------------------------- Effects of this medicine This medicine is synthetic corticosteroids and has antiallergic, and antiinflammatory effects. It consequently improves nasal symptoms (sneezing, runny nose, nasal congestion, and itch in the nostril) by directly acting on nasal mucosa and suppressing inflammation. It is usually used in the treatment of allergic rhinitis. However, it takes a few days to get sufficient effect. 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 a patient with infections, systemic mycosis, tuberculous diseases, ocular herpes simplex, or repetitive nasal bleeding (repeated nasal bleeding). •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 adults: in general, spray twice (200 mcg of the active ingredient) into each nostril, at a time, once daily. Strictly follow the instructions of your doctor and pharmacist. For children under the age of 12: in general, spray once (100 mcg of the active ingredient) into each nostril, at a time, once daily. Strictly follow the instructions of your doctor and pharmacist. For children aged 12 years or over: in general, spray twice (200 mcg of the active ingredient) into each nostril, at a time, once daily. Strictly follow the instructions of your doctor and pharmacist. •Put the medicine into the bag supplied with the medicine, and read thoroughly instruction for users "Nasonex-no-tsukaikata (How to use Nasonex)" before using it (the instruction is available only in Japanese). •Never pick the point of the bottle with a needle etc. It causes damage to the spray-hole at the point and the bottle gets unavailable to spray. •If you miss a dose, use a dose as soon as possible when you remember that you missed a dose. However, if it is almost time for the next dose, use a dose and skip the next dose. You should never use two doses at one time. •If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop using 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 nasal symptoms (irritation, itch, dryness, pain, redness), laryngopharyngeal symptoms (irritation, pain, discomfort, dryness), etc. 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. •breathing difficulty, angioedema (swelling around the eye and mouth), urticaria [anaphylactoid symptoms] 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 the medicine out of the reach of children. Store it away from direct sunlight, heat and moisture. •Do not store the remainder and discard it.
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