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【药品名称】

  通用名称：氟康唑胶囊

 

  英文名称：Fluconazole Capsules

 

【主要成份】 本品主要成分为氟康唑。

【成 份】

   分子量：C13H12F2N6O

 

【适应症/功能主治】 用于治疗口咽部和食道念珠菌感染；播散性念珠菌病，包括腹膜炎、肺炎、尿路感染等；念珠菌外阴阴道炎。尚可用于骨髓移植患者接受细胞毒类药物或放射治疗时，预防念珠菌感染的发生。

【规格型号】 50mg*7s（辉瑞）

【用法用量】 口服。成人。播散性念珠菌病：首次剂量0.4g，以后一次0.2g，一日1次，至少4周，症状缓解后至少持续2周。食道念珠菌病：首次剂量0.2g，以后一次0.1g，一日1次，持续至少3周，症状缓解后至少持续2周。根据治疗反应，也可加大剂量至一次0.4g，一日1次。口咽部念珠菌病：首次剂0.2g，以后一次0.1g，一日1次，疗程至少2周。念珠菌外阴阴道炎：单剂量，0.15g。预防念珠菌病：有预防用药指征者0.2～0.4g，一日1次。肾功能不全者若只需给药1次，不用调节剂量；需多次给药时，第一及第二日应给常规剂量，此后应按肌酐清除率来调节给药剂量。小儿 治疗方案尚未建立。有资料报道起始剂量按体重一日3～6mg/kg，一日1次，治疗少数出生2周至14岁的小儿患者，结果是安全的。

【不良反应】 1．常见消化道反应，表现为恶心、呕吐、腹痛或腹泻等。 2．过敏反应：可表现为皮疹，偶可发生严重的剥脱性皮炎（常伴随肝功能损害）、渗出性多形红斑。 3．肝毒性：治疗过程中可发生轻度一过性血清氨基转移酶升高，偶可出现肝毒性症状，尤其易发生于有严重基础疾病（如艾滋病和癌症）的患者。 4．可见头晕、头痛。 5．某些患者，尤其有严重基础疾病（如艾滋病和癌症）的患者，可能出现肾功能异常。 6．偶可发生周围血象一过性中性粒细胞减少和血小板减少等血液学检查指标改变，尤其易发生于有严重基础疾病（如艾滋病和癌症）的患者。

【禁 忌】 对氟康唑或其他三唑类药物过敏的患者禁用。

【注意事项】 1．本品与其他吡咯类药物可发生交叉过敏反应，因此对任何一种吡咯类药物过敏者禁用本品。 2．由于本品主要自肾排出，因此治疗中需定期检查肾功能。用于肾功能减退患者需减量应用。 3．本品目前在免疫缺陷者中的长期预防用药，已导致念珠菌属等对氟康唑等吡咯类抗真菌药耐药性的增加，故需掌握指征，避免无指征预防用药。 4．治疗过程中可发生轻度一过性血清氨基转移酶升高，偶可出现肝毒性症状。因此用本品治疗开始前和治疗中均应定期检查肝功能，如肝功能出现持续异常，或肝毒性临床症状时均需立即停用本品。 5．本品与肝毒性药物合用、需服用本品两周以上或接受多倍于常用剂量的本品时，可使肝毒性的发生率增高，故需严密观察，在治疗前和治疗期间每两周进行一次肝功能检查。 6．本品应用疗程应视感染部位及个体治疗反应而定。一般治疗应持续至真菌感染的临床表现及实验室检查指标显示真菌感染消失为止。隐球菌脑膜炎或反复发作口咽部念珠菌病的艾滋病患者需用本品长期维持治疗以防止复发。 7．接受骨髓移植者，如严重粒细胞减少已先期发生，则应预防性使用本品，直至中性粒细胞计数上升至1×109/L以上后7天。 8．肾功能损害者，可按前述方案调整用药剂量（见【用法用量】）；血液透析患者在每次透析后可给予本品一日量，因为3小时血液透析可使本品的血药浓度降低约50%。
请仔细阅读说明书并遵医嘱使用。

【儿童用药】 本品对小儿的影响缺乏充足的研究资料，虽然少数出生2周至14岁小儿患者以每日3～6mg/kg（按体重）剂量治疗未发生不良反应，但小儿仍不宜应用。

【老年患者用药】 肾功能无减退的老年患者无须调整剂量。肾功能减退的老年患者须根据肌酐清除率调整剂量。

【孕妇及哺乳期妇女用药】 1．动物试验中，本品高剂量给予动物时可出现流产、死胎增多、幼年动物肋骨畸形、腭裂等变化。虽然在人类中未发现此类情况，但孕妇仍应禁用。 2．尚无母乳中含本品浓度的数据，故哺乳期妇女慎用或服用本品时暂停哺乳。

【药物相互作用】 1．本品与异烟肼或利福平合用时，可使本品的浓度降低。 2．本品与甲苯磺丁脲、氯磺丁脲和格列吡嗪等磺酰脲类降血糖药合用时，可使此类药物的血药浓度升高而可能导致低血糖，因此需监测血糖，并减少磺酰脲类降血糖药的剂量。 3．高剂量本品和环孢素合用时，可使环孢素的血药浓度升高，致毒性反应发生的危险性增加，因此必须在监测环孢素血药浓度并调整剂量的情况下方可谨慎应用。 4．本品与氢氯噻嗪合用，可使本品的血药浓度升高。 5．本品与茶碱合用时，茶碱血药浓度约可升高13%，可导致毒性反应，故需监测茶碱的血药浓度。 6．本品与华法林等双香豆素类抗凝药合用时，可增强双香豆素类抗凝药的抗凝作用，致凝血酶原时间延长，故应监测凝血酶原时间并谨慎使用。 7．本品与苯妥英钠合用时，可使苯妥英钠的血药浓度升高，故需监测苯妥英钠的血药浓度。

【药物过量】 尚不明确。

【药理毒理】 1．药理,本品属吡咯类抗真菌药。抗真菌谱较广。口服及静注本品对人和各种动物真菌感染，如念珠菌感染（包括免疫正常或免疫受损的人和动物的全身性念珠菌病）、新型隐球菌感染（包括颅内感染）、糠秕马拉色菌、小孢子菌属、毛癣菌属、表皮癣菌属、皮炎芽生菌、粗球孢子菌（包括颅内感染）及荚膜组织胞浆菌、斐氏着色菌、卡氏枝孢霉等有效。本品的体外抗菌活性明显低于酮康唑，但本品的体内抗菌活性明显高于体外作用。 本品的作用机制主要为高度选择性干扰真菌的细胞色素P-450的活性，从而抑制真菌细胞膜上麦角固醇的生物合成。 2.毒理,本品对真菌依赖的细胞色素P-450酶具有高度选择性。一日服用本品0.5g，连续28天，已证明对男性的血浆睾丸素浓度及育龄期妇女的甾体激素浓度均无影响。

【药代动力学】 口服吸收良好，且不受食物、抗酸药、H2受体阻滞药的影响。空腹口服本品约可吸收给药量的90%。单次口服本品100mg，平均血药峰浓度（Cmax）为4.5～8mg/L。表观分布容积（Vd）接近于体内水分总量。本品血浆蛋白结合率低（11%～12%），在体内广泛分布于皮肤、水疱液、腹腔液、痰液等组织体液中，尿液及皮肤中药物浓度约为血药浓度的10倍；水疱皮肤中约为2倍；唾液、痰、水疱液、指甲中与血药浓度接近；脑膜炎症时，脑脊液中本品的浓度可达血药浓度的54%～85%。本品少量在肝脏代谢。主要自肾排泄，以原形自尿中排出给药量的80%以上。血消除半衰期（t1/2β）为27～37小时，肾功能减退时明显延长。血液透析或腹膜透析可部分清除本品。

【贮 藏】 密封。

 

 

 

 

Description

This medicine suppresses proliferation of fungi (a type of mold) and shows antifungal effect by blocking actions of enzymes required for synthesis of the components of fungal cell membrane.
It is usually used to treat fungemia, mycosis of respiratory tract, mycosis of gastrointestinal tract, mycosis of urinary tract and fungal meningitis due to Candida or Cryptococcus, and vaginitis and vulvovaginitis caused by Candida, or to prevent deep mycosis in patients undergoing hematopoietic stem cell transplantation.

Presentation

20capsules

Feature

Active Ingredients

Fluconazole 50mg

Effect/Efficacy

This medicine suppresses proliferation of fungi (a type of mold) and shows antifungal effect by blocking actions of enzymes required for synthesis of the components of fungal cell membrane.
It is usually used to treat fungemia, mycosis of respiratory tract, mycosis of gastrointestinal tract, mycosis of urinary tract and fungal meningitis due to Candida or Cryptococcus, and vaginitis and vulvovaginitis caused by Candida, or to prevent deep mycosis in patients undergoing hematopoietic stem cell transplantation.

Usage/Dosage

[Adults]
For candidiasis: In general, take 50 to 100 mg of the active ingredient at a time, once a day.
For cryptococcosis: In general, take 50 to 200 mg of the active ingredient at a time, once a day. For severe or refractory mycosis, the dosage may be increased up to 400 mg a day.
For prevention of deep mycosis in patients undergoing hematopoietic stem cell transplantation: In general, take 400 mg of the active ingredient at a time, once a day.
For vaginitis and vulvovaginitis caused by Candida: In general, take 150 mg of the active ingredient at a time, once a day.
[Children]
For candidiasis: In general, take 3 mg of the active ingredient per kilogram of body weight at a time, once a day.
For cryptococcosis: In general, take 3 to 6 mg of the active ingredient per kilogram of body weight at a time, once a day. For severe or refractory mycosis, the dosage may be increased up to 12 mg per kilogram of body weight a day.
For prevention of deep mycosis in patients undergoing hematopoietic stem cell transplantation: In general, take 12 mg of the active ingredient per kilogram of body weight at a time, once a day. The dosage may be adjusted according to the condition.
The maximum daily dose is 400 mg.
[Newborns]
For newborns up to 14 days old, give the same dose of the active ingredient as children every 72 hours.
For newborns 15 days old or over, give the same dose of the active ingredient as children every 48 hours.
This medicine contains 50 mg of the active ingredients in a capsule. 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.

Cautions

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, breastfeeding or possibly pregnant.
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.)
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.

Contraindication

The most commonly reported adverse reactions include rash, nausea, hiccup, loss of appetite, diarrhea, stomach discomfort, abdominal pain, headache, stiffness of fingers, hypouresis, edema, fever and malaise. 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.
swelling of eyelid/lips/tongue, itch, dizziness [shock, anaphylaxis]
fever, redness and swelling of skin/mucosa with rash or blisters, conjunctival hyperemia [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
fever, anemic symptoms, bleeding tendency [blood disorder]
decreased urine output, edema, headache [acute renal failure]
general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver disorder]
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.