【药品名称】
商品名称：酮康唑片
英文名称：Ketoconazole Tablets
【主要成份】 主要化学成分为酮康唑。
【成 份】
化学名：1-乙酰基-4[4-[2-(2,4-二氯苯基)-2(1H-咪唑-1-甲基)-1,3二氧戊环-4-甲氧基]苯基]-哌嗪
分子式：C26H28Cl2N4O4
分子量：531.44
【性 状】 本品为白色至微红色片。
【适应症/功能主治】全身真菌感染，如全身念珠菌病、副球孢子菌病、组织胞浆菌病。
【规格型号】0.2g*10s*3板
【用法用量】本品须在医生指导下使用。 成人： 深部真菌感染：口服，每日1～2次，每次1片（200mg）。 皮肤感染：口服，每日1次，一次1片（200mg），与饭同服。必要时，可增至每日1次，一次2片（400mg），或每日2次，一次1片（200mg）。
【不良反应】个别患者有胃肠道不适、恶心、头痛、头晕、畏光、感觉异常、血小板减少症。偶见药疹、发痒及脱发，少数患者有过敏反应的报告。 极少数患者可发生肝损害（多数为特异体质），这种反应多发生于有肝病史或药敏史的患者，在及时停药后一般均可恢复。
【禁 忌】本品禁用于患急慢性肝病的患者或已知对本品过敏的患者。
【注意事项】服用本品的患者，特别是50岁以上的妇女、有肝病病史、对药物耐受性差、曾服用灰黄霉素及同时服用对肝脏有损害的药物的患者，应注意肝损害反应，如异常疲劳感，尿色深黄，粪便色淡或出现黄疸等症状。 需服用本品2周以上的患者，治疗前应先做肝功检查，治疗期间每间隔2周必须进行肝功复查。如出现上述肝损害症状应立即做肝功检查，确诊有肝病应立即停止用药。
【儿童用药】本品用于体重低于15kg 的儿童的资料有限，因此不建议小儿使用本品。
【老年患者用药】老年患者慎用。
【孕妇及哺乳期妇女用药】对孕妇尚无研究资料，因此，在孕期不应使用本品，除非可能的利益大于对胎儿潜在的危险。 本品可从母乳中排出，因此哺乳妇女服用本品时应停止哺乳。
【药物相互作用】由于本品的吸收依赖于足够的胃液分泌，因此应避免与抑制胃液分泌的药物（如抗胆碱能药、抗酸药、H2受体拮抗药等）同时服用。如需同时服用这类药物时，应至少间隔2小时以上分别服用。 利福平、异烟肼与酮康唑同时服用可使后者的血药浓度降低，故不应同时服用。 由于酮康唑抑制某些肝氧化酶，故可降低依赖此酶代谢的药物的清除。
【药物过量】本品无特殊的解毒药。如出现服药过量，应采用包括支持疗法在内的治疗。在服药后的1个小时内，可进行洗胃治疗，必要时可给予活性炭。
【药理毒理】生殖毒性研究中，高浓度的酮康唑，母体毒性剂量(不低于80mg/kg/天)，会损伤雌性大鼠的生育能力，产生胚胎毒性和幼仔畸形[少指(趾)和蹼指(趾)]。剂量为40mg/kg的大鼠和家兔试验中，酮康唑没有胚胎毒性和致畸性，且对生育能力无影响。160mg/kg以下任何剂量的酮康唑对小鼠无致畸作用。
【药代动力学】酮康唑是一种二元弱碱，酸性环境有助于溶解和吸收。与餐同服酮康唑单剂量0.2g，1－2小时后，血药浓度峰值平均可达3.5μg/ml。
【贮 藏】密封。
【包 装】0.2g*10s*3板/盒
英文说明 What is ketoconazole?
Ketoconazole is an antifungal medication that fights infections caused by fungus.
Ketoconazole is not for use in treating fungal infections of the fingernails or toenails. This medicine is also not for use in treating prostate cancer or Cushing syndrome.
This medicine should be used only when you cannot use other antifungal medications.Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.
Ketoconazole may also be used for purposes not listed in this medication guide.
What is the most important information I should know about ketoconazole?
This medicine should be used only when you cannot use other antifungal medications.Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.
Call your doctor at once if you have any signs of liver damage, such as nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Some medicines can interact with ketoconazole and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs: alprazolam, cisapride, dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergotamine, lovastatin, methadone, midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, or triazolam. Certain drug interactions can cause life-threatening irregular heartbeats.
Call your doctor right away if you have a headache with chest pain and severe dizziness, and fast or pounding heartbeats.
What should I discuss with my healthcare provider before taking ketoconazole?
You should not use ketoconazole if you are allergic to it, or if you have liver disease.
Some medicines can interact with ketoconazole and should not be used at the same time. Certain drug interactions can cause life-threatening irregular heartbeats. Your doctor may need to change your treatment plan if you use any of the following drugs:
alprazolam, midazolam, or triazolam;
cisapride or pimozide;
dihydroergotamine or ergotamine;
disopyramide, dofetilide, dronedarone, eplerenone, nisoldipine, quinidine, or ranolazine;
lovastatin or simvastatin; or
methadone.
To make sure ketoconazole is safe for you, tell your doctor if you have:
any history of liver problems;
problems with your adrenal gland;
personal or family history of long QT syndrome; or
if you also use certain antibiotics, heart rhythm medication, migraine headache medicine, anti-malaria medication, or medicine to treat depression or mental illness.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.
Ketoconazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medicine to a child without medical advice.
How should I take ketoconazole?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ketoconazole.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not share this medicine with another person, even if they have the same symptoms you have.
While using ketoconazole, you may need frequent blood tests to check your liver function.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Ketoconazole will not treat a viral infection such as the common cold or flu.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking ketoconazole?
Avoid taking antacids, stomach acid reducers, or medicines to treat stomach ulcer or gastroesophageal reflux disease (Axid, Nexium, Pepcid, Prevacid Prilosec, sucralfate, Tagamet, Zantac, and others). These medications can make it harder for your body to absorb ketoconazole.
Avoid drinking alcohol. It may increase your risk of liver damage while you are taking ketoconazole.
Ketoconazole side effects
Get emergency medical help if you havesigns of an allergic reaction: hives; fever; difficulty breathing, chest pain; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
unusual weakness or tired feeling, nausea and vomiting; or
liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
Common side effects may include:
mild nausea or stomach pain;
diarrhea; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ketoconazole dosing information
Usual Adult Dose for Blastomycosis:
Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Adult Dose for Chromomycosis:
Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Adult Dose for Coccidioidomycosis:
Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Adult Dose for Histoplasmosis:
Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Adult Dose for Paracoccidioidomycosis:
Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Pediatric Dose for Blastomycosis:
2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Pediatric Dose for Chromomycosis:
2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Pediatric Dose for Coccidioidomycosis:
2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Pediatric Dose for Histoplasmosis:
2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
Usual Pediatric Dose for Paracoccidioidomycosis:
2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)
Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.
Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis
What other drugs will affect ketoconazole?
Many drugs can interact with ketoconazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ketoconazole. Give a list of all your medicines to any healthcare provider
Where can I get more information?
Your pharmacist can provide more information about ketoconazole.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 11.03.
Date modified: December 03, 2017
Last reviewed: May 26, 2016
