通用中文 | 马沙骨化醇乳液 | 通用外文 | Maxacalcitol マキサカルシトール |
品牌中文 | 品牌外文 | Oxarol Lotion | |
其他名称 | オキサロールローション | ||
公司 | 中外制药(Chugai) | 产地 | 日本(Japan) |
含量 | 25μg | 包装 | 10瓶/盒 |
剂型给药 | 储存 | 室温 | |
适用范围 | 治疗肾透析(肾衰)患者的继发性甲状旁腺功能亢进症(SHPT) |
通用中文 | 马沙骨化醇乳液 |
通用外文 | Maxacalcitol マキサカルシトール |
品牌中文 | |
品牌外文 | Oxarol Lotion |
其他名称 | オキサロールローション |
公司 | 中外制药(Chugai) |
产地 | 日本(Japan) |
含量 | 25μg |
包装 | 10瓶/盒 |
剂型给药 | |
储存 | 室温 |
适用范围 | 治疗肾透析(肾衰)患者的继发性甲状旁腺功能亢进症(SHPT) |
简介:
部份马沙骨化醇中文资料(仅供参考)
马沙骨化醇是日本中外制药公司开发的新型第三代活性维生素D类药物。其马沙骨化醇软膏/乳液于2000年上市,商品名为Oxarol软膏/乳液,用于治疗银屑病等干癣类皮肤病。注射液于2000年上市,商品名为Oxarol,用于治疗肾透析(肾衰)患者的继发性甲状旁腺功能亢进症(SHPT)。本品剂量很小,2.5~5.0微克/支,3次/周,肾透析(肾衰)患者一年用量不到1毫克。
オキサロール軟膏25μg/g/オキサロールローション25μg/g
薬効分類名
尋常性乾癬等 角化症治療剤
商標名
Oxarol Ointment
Oxarol Lotion
一般名
マキサカルシトール(Maxacalcitol)(JAN)
慣用名
22‐oxacalcitriol
1α, 25‐dihydroxy‐22‐oxavitamin D3
化学名
(+)‐(5Z, 7E)‐(1S, 3R, 20S)‐20‐(3‐Hydroxy‐3‐methylbutyloxy)‐9, 10‐secopregna‐5, 7, 10(19)‐triene‐1, 3‐diol
構造式
分子式
C26H42O4
分子量
418.61
性 状
白色の結晶性の粉末である。
メタノールに極めて溶けやすく、エタノール(99.5)に溶けやすく、ジエチルエーテルにやや溶けやすく、水にほとんど溶けない。
包装
軟膏:10g×1
軟膏:10g×10
ローション:10g×1
ローション:10g×10
製造販売元
中外製薬株式会社
完整处方资料附件:
Psoriasis Vulgaris Treatment Ethical Drug Topical Lotion Containing Active Vitamin D3 Launch of "Oxarol® Lotion"
Chugai Pharmaceutical Co., Ltd. [Head Office, Chuo-ku, Tokyo; President, Osamu Nagayama] (hereafter, "Chugai") and Maruho Co., Ltd. [Head Office, Kita-ku, Osaka; President, Koichi Takagi] (hereafter, "Maruho") are pleased to announce the market launch of "Oxarol® Lotion" (nonproprietary name, maxacalcitol; hereafter, "Lotion"), a treatment for keratosis including psoriasis vulgaris, scheduled on June 18. The marketing approval for the product, which will be distributed by Maruho, was granted to Chugai on March 15.
As with the keratosis treatment "Oxarol® Ointment" (nonproprietary name, maxacalcitol; hereafter, "Ointment") for which marketing approval was also granted to Chugai, "Lotion" contains the active vitamin D3 derivative maxacalcitol as an active ingredient. With the modified new formulation for enhanced patient convenience, "Lotion" is easy to apply to common sites of psoriasis vulgaris including hairy areas such as head. "Lotion" containing active vitamin D3 will be a useful new topical treatment option.
1. About Maxacalcitol
Maxacalcitol, an active vitamin D3 derivative developed by Chugai, inhibits proliferation and induces differentiation of epidermal keratinocytes. Since market launch of "Ointment" containing the active ingredient maxacalcitol in October 2001, it has been widely used in patients with keratosis including psoriasis vulgaris, remarkably improving the symptoms.
2. Features of "Oxarol® Lotion"
"Lotion" is an emulsion lotion that can be easily applied to hairy areas such as head and has excellent usability. "Lotion" has shown to be highly effective and safe as with "Ointment" in the controlled clinical study in patients with psoriasis vulgaris.
Dermal transfer of "Lotion" in human skin has shown to be equivalence to that of "Ointment". "Lotion" with excellent usability and efficacy/safety comparable to "Ointment” will be a useful new topical treatment option for psoriasis vulgaris.
The most frequently observed adverse drug reactions in the clinical study were 4 events of skin irritation (4.7%), 3 events of skin exfoliation (3.5%), and 2 events each of eczema and erythema (2.3%).
[Reference]
Product Summary
[Product Name] Oxarol® Lotion
[Nonproprietary Name] Maxacalcitol
[Composition] One gram of Oxarol® Lotion contains maxacalcitol 25 μg.
[Indications] Psoriasis vulgaris, ichthyosis, palmoplantar keratosis
[Dosage and Administration] Appropriate amount of Oxarol® Lotion should be applied to the affected area twice daily. Depending on the symptom, application frequency should be decreased as necessary.
[Precaution concerning Dosage and Administration] The maximum recommended daily dose of maxacalcitol is 250 μg, or 10 g of topical maxacalcitol.
[Package] Bottle; 10 g x 1, 10 g x 10
[Manufacturer] Chugai Pharmaceutical Co., Ltd.
[Release Date] June 18, 2007
[Date of Approval] March 15, 2007