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  药店国别: 美国药房
产地国家: 美国
所属类别: 皮肤科药物->皮肤炎症
处方药:处方药
包装规格: 50克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
施泰福
生产厂家英文名:
STIEFEL LABS INC
该药品相关信息网址1:
www.drugs.com/extina.html
该药品相关信息网址2:
www.rxlist.com/extina-drug.htm
该药品相关信息网址3:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=42023
原产地英文商品名:
EXTINA 2% FOAM 50G/BOTTLE
原产地英文药品名:
KETOCONAZOLE
中文参考商品译名:
EXTINA 2%泡沫剂 50克/瓶
中文参考药品译名:
酮康唑
原产地国家批准上市年份:
2007/06/12
英文适应病症1:
Seborrheic dermatitis
临床试验期:
完成
中文适应病症参考翻译1:
皮脂溢性皮炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201271020333818.PDF)的“原文Priscribing Information”为准
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 部分中文酮康唑处方资料(仅供参考)

美国FDA批准2%酮康唑泡沫剂上市
    美国FDA批准Stiefel Laboratories 公司 2%酮康唑泡沫剂(ketoconazole,Extina)上市,局部治疗12岁及其以上患者的皮脂溢性皮炎。

    本品不同于治疗皮脂溢性皮炎的其它含2%酮康唑的乳膏、凝胶或洗剂,其采用VersaFoam HF(水醇制剂)技术制成,独特的通用局部释药载体可使药物快速被皮肤吸收。在Ⅲ期临床研究中,酮康唑泡沫剂的疗效优于安慰剂泡沫剂。按研究者全球判断标准记分:本品组治愈率为56%,安慰剂组为42%。

    Stiefel Laboratories 公司是世界上最大的专门从事皮肤科药品开发与生产的独立制药公司,2006年12月从Connetics引进了VersaFoam HF制备技术。

    本品一日2次(早晚各一次)用于患处,疗程为4周。本品采用VersaFoam HF技术,显示可持续对皮肤渗透、药物分布和释药。此外,对患者的益处还包括其可用于有头发和无头发的皮肤、吸收快和使用后不留残留物等。

GENERIC NAME: ketoconazole

BRAND NAME: Nizoral, Extina, Xolegel, Kuric

DRUG CLASS AND MECHANISM: Ketoconazole is an anti-fungal medication in the same family of drugs as fluconazole (Diflucan), itraconazole (Sporanox), and miconazole (Micatin, Monistat). It prevents growth of several types of fungi by preventing production of the membranes that surround fungal cells. The FDA approved ketoconazole in June 1981.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 200 mg; Shampoo: 1 and 2%; Cream: 2%, Gel: 2%, Foam: 2%

STORAGE: Tablets should be stored at room temperature, 15-25 C (59-77 F) and protected from moisture.
Store shampoo 1% between 2-30 C (35-86 F) and protect it from light and freezing.
Store shampoo 2% at or below 25 C (77 F) and protect it from light.
Store cream and foam at room temperature, 20-25 C (68-77 F).
Store gel between 15-30 C (59- 86 F).

PRESCRIBED FOR: Oral ketoconazole treats a variety of fungal infections such as candidiasis of the skin or mouth (thrush), blastomycosis, histoplasmosis, coccidiomycosis, and others. Ketoconazole is also used to treat fungal infections that have not responded to griseofulvin, another antifungal medication. Topical ketoconazole is used for treating ringworm, jock itch, athlete's foot, dandruff, and tinea versicolor.

DOSING: Ketoconazole may be taken with or without food. The oral dose range is 200-400 mg daily. Topical formulations are administered to affected areas once or twice daily.

DRUG INTERACTIONS: There are no known drug interactions with topical ketoconazole.

Ketoconazole tablets require stomach acidity to dissolve. Therefore, ketoconazole should be administered at least two hours before taking antacids or other acid reducing medications such as cimetidine (Tagamet) or ranitidine (Zantac). Combining ketoconazole with alcohol may cause a very unpleasant reaction (disulfiram reaction).

Rifampin (Rifadin, Rimactane, Rifamate, Rifater) reduces the blood concentration of oral ketoconazole, probably by increasing the elimination of fluconazole by the liver. This may reduce the effectiveness of ketoconazole.

Ketoconazole may increase the concentration of warfarin (Coumadin) in blood by reducing the elimination of warfarin. Therefore, the effect of warfarin may increase, leading to an increased tendency to bleed.

Ketoconazole also increases the concentration of phenytoin, (Dilantin) cyclosporine, zidovudine (Retrovir), theophylline (Theo-Dur, Respbid, Slo-Bid, Theo-24, Theolair, Uniphyl, Slo-Phyllin), tolbutamide, glyburide (Micronase, Diabeta, Glynase), glipizide (Glucotrol), protease inhibitors [for example, indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase, Fortovase)], midazolam (Versed) and triazolam (Halcion). Increased drug concentrations usually increase the incidence of side effects.

Ketoconazole also may reduce the elimination of some "statins" [for example, simvastatin (Zocor)] leading to an increase in the blood levels of statins and increasing the risk of side effects such as rhabdomyolysis (severe muscle injury).

PREGNANCY: Ketoconazole has not been adequately studied in pregnant women.

NURSING MOTHERS: A small amount of ketoconazole is secreted in breast milk. Nursing mothers should probably avoid breastfeeding while using ketoconazole.

SIDE EFFECTS: Ketoconazole is generally well tolerated. Ketoconazole can cause rash, itching, nausea, vomiting, abdominal pain, headache, dizziness, fatigue, impotence, and blood count abnormalities. Rarely, ketoconazole has serious allergic reactions (anaphylaxis). Also rarely, ketoconazole has been associated with severe depression, hair loss, and tingling sensations. Liver dysfunction has also been reported. Signs of liver problems include unusual fatigue, loss of appetite, nausea and vomiting, yellowing of the skin (jaundice), dark urine, and pale stools. Development of these symptoms while taking ketoconazole should be reported to a physician.

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 详细处方信息以本药内容附件PDF文件(201271020333818.PDF)的“原文Priscribing Information”为准
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更新日期: 2015-04-26
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