Anti-fungal Products (Photericin)
  
Photericin B
Amphotericin B
For injection USP

COMPOSITION
Each Vial Contains
Amphotericin B USP.....50mg

As sterile,freeze-dried powder for reconstitution
• Photericin B is an antifungal polyene antibiotic obtained from a strain of
Streptomyces nodosus.
• It is a polyene antibiotic that acts by binding to sterols in cell membranes of sensitive fungi, with subsequent leakage of intracellular contents and cell death to change in membrane permeability

Indication
• should be administered primarily to patients with progressive, potentially life-
   threatening fungal infections
• This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis, and esophageal candidiasis in patients with normal neutrophil counts.
• Cryptococcal meningitis is a common opportunistic infection in HIV patients with CD4 count <100 cells /ul
 
• Fungus cryptococcal neoformans can cause a severe form of meningitis which is fatal without treatment
• Treatment is with iv amphotericin B infusion 0.7mg/kg for two weeks
• Secondary prophylaxis with fluconazole is needed after amphotericin or recurrence rate of cryptococcal meningitis is very high
• specifically intended to treat potentially life-threatening fungal infections:
• aspergillosis
• cryptococcosis
• blastomycosis
• systemic candidiasis
• histoplasmosis
• zygomycosis including mucormycosis
• infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis.

DOSAGE AND ADMINISTRATION
• CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded.
• Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest
• should be administered by slow intravenous infusion.
• Intravenous infusion should be given over a period of approximately 2 to 6 hours (depending on the dose) observing the usual precautions for intravenous
   therapy
• The recommended concentration for intravenous infusion is 0.1 mg/mL (1 mg/10 mL)
• A single intravenous test dose (1 mg in 20 mL of 5% dextrose solution) administered over 20 to 30 minutes may be preferred.
• The patient's temperature, pulse, respiration, and blood pressure should be recorded every 30 minutes for 2 to 4 hours.
• In patients with good cardio-renal function and a well tolerated test dose, therapy is usually initiated with a daily dose of 0.25 mg/ kg of body weight.
• However, in those patients having severe and rapidly progressive fungal infection, therapy may be initiated with a daily dose of 0.3 mg/kg of body weight.
• In patients with impaired cardio-renal function or a severe reaction to the test dose, therapy should be initiated with smaller daily doses (i.e., 5 to 10 mg).
• Depending on the patient's cardio-renal status ,doses may gradually be increased by 5 to 10 mg per day to final daily dosage of 0.5 to 0.7 mg/kg.
• Sporotrichosis
• Therapy with intravenous amphotericin B for sporotrichosis has ranged up to 9 months with a total dose up to 2.5 g.
• Aspergillosis
• Aspergillosis has been treated with amphotericin B intravenously for a period up to 11 months with a total dose up to 3.6 g.

Preparation of Solutions
• Reconstitute as follows:
• An initial concentrate of 5 mg /mL is first prepared by rapidly expressing 10 mL Sterile Water for Injection, using a sterile needle (minimum diameter: 20 gauge)
   and syringe.
• Shake the vial immediately until the colloidal solution is clear.
• The infusion solution, providing 0.1 mg amphotericin B per mL, is then obtained by further dilution (1:50) with 5% Dextrose Injection, USP of pH above 4.2.
• The pH of each container of Dextrose Injection should be ascertained before use.
• Commercial Dextrose Injection usually has a pH above 4.2; however, if it is below 4.2, then 1 or 2 mL of buffer should be added to the Dextrose Injection before
   it is used to dilute the concentrated solution of amphotericin B.
• The recommended buffer has the following composition:
• Dibasic sodium phosphate (anhydrous) 1.59 g
• Monobasic sodium phosphate (anhydrous) 0.96 g
• Water for Injection, USP qs 100.0 Ml
• The buffer should be sterilized before it is added to the Dextrose Injection, either by filtration through a bacterial retentive stone, mat, or membrane, or by
   autoclaving for 30 minutes at 15 lb pressure (121° C).

CONTRAINDICATIONS
• This product is contraindicated in those patients who have shown hypersensitivity to amphotericin B or any other component in the formulation
• unless, in the opinion of the physician, the condition requiring treatment is life-threatening

Warning and precautions
• Pregnancy
• adequate and well-controlled studies have not been conducted in pregnant women, this drug should be used during pregnancy only if clearly indicated.
• Nursing Mothers
• It is not known whether amphotericin B is excreted in human milk. advise a nursing mother to discontinue nursing.
• Pediatric Use
• Safety and effectiveness in pediatric patients have not been established through adequate and well-controlled studies.

SIDE EFFECTS
• Although some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance, often at less than the full
therapeutic dose.
• The adverse reactions most commonly observed are:
• General (body as a whole): fever (sometimes accompanied by shaking chills usually occurring within 15 to 20 minutes after initiation of treatment); malaise;
weight loss.
• Cardiopulmonary: hypotension; tachypnea.
• Gastrointestinal: anorexia; nausea; vomiting; diarrhea; dyspepsia; cramping epigastric pain.
• Hematologic: normochromic, normocytic anemia.
• Local: pain at the injection site with or without phlebitis or thrombophlebitis.
• Musculoskeletal: generalized pain, including muscle and joint pains.
• Neurologic:headache.
• Renal: decreased renal function and renal function abnormalities

OVERDOSE
• Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest

Storage
• Store the powder for reconstitution under refrigeration (2-8)’C
• Protect from light

Presentation
• Photericin B........................vial of 15 ml
 photericin乙
两性霉素B
对于注射药典

组成
每管含有
两性霉素B USP ..... 50毫克

为无菌冻干粉重建
•Photericin B是一种抗真菌多烯抗生素的应变所得链霉菌nodosus。
•它是一种多烯抗生素结合在细胞膜上的甾醇敏感的真菌，随后泄漏内的内容和细胞死亡改变细胞膜的通透性

迹象
应管理主要为病人与进步，潜在的生命
威胁真菌感染
这种烈性药物不应被用于治疗非侵入性真菌感染，如鹅口疮，念珠菌，在患者的食管念珠菌正常的中性粒细胞计数。
•隐球菌性脑膜炎是一种常见的艾滋病患者机会性感染CD4细胞计数<100细胞/ UL

•真菌隐球菌新型隐球菌引起的脑膜炎，严重的形式，这是未经治疗的致命
•治疗是两个星期，两性霉素B与静脉滴注0.7mg/kg后霉素或隐球菌性脑膜炎复发率非常高，需要与氟康唑的二级预防
•专门用于治疗真菌感染的潜在威胁生命的：
•曲菌
•隐球菌
•芽
•系统性念珠菌
•组织胞浆菌病
•zygomycosis包括毛霉菌病
易感物种的有关Conidiobolus和Basidiobolus由于感染，孢子丝菌病。

剂量和用法
注意：在任何情况下，总剂量为每日1.5毫克/公斤，超出。
两性霉素B过量可导致潜在的致命性心脏或心肺逮捕
•应缓慢静脉滴注管理。
•静脉滴注应给予超过了约2至6小时内（取决于剂量静脉的观察通常的预防措施）
治疗
•推荐静脉滴注的浓度为0.1毫克/毫升（1 mg/10毫升）
•单一的静脉注射试验剂量在20毫升5％葡萄糖溶液（1毫克），管理超过20至30分钟，可优先考虑。
病人的体温，脉搏，呼吸，血压应为2至4小时，每30分钟记录。
•具有良好的心，肾功能和良好的耐受性试验剂量的患者，治疗通常开​​始与每日剂量为0.25毫克/公斤体重。
然而，在那些有严重和迅速进步的真菌感染的患者，治疗可发起与每日剂量为0.3毫克/公斤体重。
•在患者心，肾功能受损或严重反应的试验剂量，治疗应发起较小的每日剂量（即5至10毫克）。
•对病人的心，肾功能状态而定，剂量可逐步增加5至10毫克，每天到最后每日剂量0.5至0.7毫克/千克。
•孢子丝菌病
静脉注射两性霉素B治疗孢子丝菌病之间长达​​9个月，总剂量为2.5克。
•曲霉
•曲菌已与两性霉素B治疗静脉注射一段时间长达11个月与总剂量为3.6克。

解的制备
•改建为如下：
•5毫克/毫升的初始精矿首先准备迅速表达注射用无菌水10毫升，使用无菌针头（最小直径：20号）和注射器。
•立即摇动小瓶直至胶体溶液是明确的。
输液，提供0.1毫克每毫升两性霉素B，然后将得到进一步的稀释（1:50），与5％葡萄糖注射液，USP pH值高于4.2。
•每个容器中的葡萄糖注射液的pH值应在使用前确定。
•商业葡萄糖注射液通常有一个pH值在4.2以上;然而，如果是低于4.2，则1或2毫升缓冲应加入葡萄糖注射液前它是用来稀释浓缩液的两性霉素B
•推荐的缓冲区有以下组成：
磷酸氢二钠（无水）1.59Ğ
•磷酸二氢钠（无水）0.96Ğ
•注射用水，USP QS 100.0毫升缓冲区应消毒之前，它被添加到葡萄糖注射液，经过滤，通过细菌保持石头，垫，或膜，或由在15磅压力（121℃）灭菌30分钟。

禁忌
•本产品在两性霉素B或在配方中的任何其他组件显示过敏的患者禁忌除非在医生的意见，需要治疗的条件是危及生命

警告和注意事项
•怀孕
•充分和良好对照的研究尚未在孕妇中进行的，这种药物应在怀孕期间使用，只有当明确表示。
•哺乳母亲
它不知道是否在人类乳汁中排出的两性霉素B。奉劝哺乳的母亲停止哺乳。
•儿童使用
•在儿科病人的安全和有效性尚未建立充分和良好对照的研究。

副作用
•虽然有些病人可能会容忍两性​​霉素B静脉注射没有太大的困难，大多会出现一些不容忍，往往在不到全
治疗剂量。
•最常观察到的不良反应有：
•秘书长（作为一个整体的身体）：发热（有时伴有寒战开始治疗后，通常发生在15至20分钟内）;不适;
减肥。
•心肺：低血压，呼吸急促。
•胃肠道：厌食，恶心，呕吐，腹泻，消化不良，腹部绞痛上腹疼痛。
•血液：normochromic，正细胞性贫血。
•本地：在无静脉炎或血栓性静脉炎或注射部位的疼痛。
•肌肉骨骼：全身疼痛，包括肌肉和关节痛。
•神经系统：头痛。
肾：肾功能下降，肾功能异常

过量
两性霉素B过量可导致潜在的致命性心脏或心肺逮捕

存储
•存放在冷藏（2-8）“C重建粉
•由轻保护

介绍
•Photericin B. ....................... 15毫升的小瓶