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異欄異欄.. 1 Natacyn Oph. Suspension 750 mg/15 ml/btl, 5%, 15 ml/btl natamycin 2009/6/4 2009 年 5.. 2 異 Cravit- CDC 500 mg/tab Fluoro-uracil Valeant (5- FU) 1000 mg/20 ml/vial levofloxacin 療 TB Cravit-CDC 500 mg/tab 量不 Vorotal-CDC 500 mg/tab 6 1 立流 Portal fluorouracil Fluorouracil5-FU 500 mg/10 ml /vial Fluoro-uracil Valeant (5- FU) 1000 mg/20 ml /vial 復 6 vial 量 2 度療 2009/6/2 2009/6/1 異.. 4 Ixabepilone Ixempra Injection ().. 4 Levetiracetam Keppra Oral Solution.. 8

Sofradex ear soln 8 ml/btl framycetin sulphate, gramicidin, dexamethasone 復 2009/5/26 Varidase tab streptokinase and streptodornase 類 Danzen EC 10 mg/tab Venalot Depot Dragees tab coumarin 15 mg and troxerutin 90 mg 2009/5/21 2009 年 5 1. Antiepileptic Drugs FDA FDA 更療精神 ( 神狀 )FDA 都 2008/12/16 2008/01/31 FDA 更了類殺 11 療精神臨 (pooled analysis) 不不 11 殺行 FDA 不殺參 FDA http://www.fda.gov/medwatch/safety/2008/safety08.h tm#antiepileptic 2009/5/5 Tegretol CR tablet 200 mg/tab (carbamazepine) Neurontin capsule 300 mg/cap (gabapentin) Lamictal tablet 50 mg/tab (lamotrigine) 樂 Keppra tablet 500 mg/tab (levetiracetam) Trileptal 6% oral suspension, 100 ml/btl (oxcarbazepine) Trileptal tablet 300 mg/tab Topamax tablet 100 mg/tab (topiramate) Topamax sprinkle capsule 25 mg/cap (topiramate) Depakine solution 200 mg /ml, 40 ml/btl (valproate sodium) Depakine lyophilized injection 400 mg/vial (valproate sodium) Depakine chrono tablet (333 mg valproate sodium & 145 mg valproic acid)/tab Sabril tablet 500 mg/tab (vigabatrin) 易 2. Testosterone gel products (AndroGel 1% and Testim 1%)

FDA 兩 (testosterone) AndroGel 1% Testim 1% 數例不不良 FDA 例暴露不良年不 FDA 陸暴露不良例不良異 () 行 AndroGel 1% Testim 1% 行泌泌量 FDA 降暴露率參 FDA tm#testosterone 2009/5/7 Androgel Gel 5 g/pack (testosterone) 3. Tarceva (erlotinib) OSI, Genentech FDA Tarceva Tarceva ( ) 落例例 Tarceva 來臨 Tarceva 療療 gemcitabine Tarceva 不切療參 FDA tm#tarceva 2009/5/12 Tarceva FC 150 mg/tab (erlotinib HCl) Tarceva FC 100 mg/tab (erlotinib HCl) 4. Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) AS Medication Solutions, LLC 2009 年 3 31 Caraco Digoxin, USP, 0.25 mg 2011 年 8 不 digoxin 量不 Caraco Pharmaceutical Laboratories, Ltd 441 (NDC number) 54569-5758-0 (30- count) 若參 FDA tm#paints 2009/5/12 5. Fun Express Water-based Face Paints for Children FDA FDA Oriental Trading Co., Omaha, Neb. Face Paint 不良不良都料 FDA 參 FDA

參 FDA tm#paints 2009/5/12 6. Simponi (golimumab) Centocor Ortho Biotech FDA TNF-α blockers Simponi (golimumab) FDA TNF-α blockers ( Cimzia (certolizumab pegol)enbrel (etanercept) Humira (adalimumab) Remicade (infliximab) (histoplasmosis) 都來療 Simponi 不良都便更不良 Centocor 勵不良 Centocor FDA MedWatch 參 FDA tm#simponi 2009/5/27 Enbrel for Injection 25 mg/vial (etanercept) (TNF-α blockers) Humira solution for injection prefilled syringe 40 mg/0.8 ml/syringe (adalimumab) 復 (TNF-α blockers) () 98 年 5 14 0980011069 9 Antineoplastics drugs 98 年 6 1 9.32. Nilotinib ( Tasigna)98/6 /1 1. 療 imatinib 400 mg () 不良 (Philadelphia chromosome) (CML) 年 2. 不良 3. Nilotinib dasatinib Ixabepilone Ixempra Injection ( ) 瑩狀 Ixempra(kit) (8 ml)ixempra 15 mg ixabepilone 異理 Ixabepilone (microtubule inhibitor) epothilone 類 Epothilone (tubulin)

裂 epothilone 裂利行裂 Ixabepilone epothilone 類 FDA taxanesanthracyclines capecitabine (Xeloda ) 療 taxanes 類 (multiple drug resistance gene; MDR gene) MDR MDR epothilone 不易 MDR 類 epothilone 療力 Ixabepilone 率 67-77% cytochrome P450 3A4 (CYP3A4) 30 不不都不量 6% 量 86%7 便 (65%) 21% 尿 52 1. FDA (1) 療 taxanesanthracyclines 類 capecitabine 療 (2) capecitabine 療 taxanes anthracyclines 類療 taxanes 類療 anthracyclines 類療 2. ixabepilone 不良見不良 - 神 ( 療 63%; 療 67%)( 療 48%; 療 31%) 療 ( 療 8%; 療 64%) 不不良 - 神 1. FDA(black box warning) 若數 ASTALT2.5 (upper limit of normal, ULN) (bilirubin)1(uln) 不 ixabepilonecapecitabine 療 2. -Cremophor EL (polyoxyethylated castor oil, ) ( 不良 3-4) 不 3. (neutrophil) 數 1,500 cells/mm 3 (platelet) 數 100,000 cells/mm 3 不 4. 3 神 7 ixabepilone 5. 4 不良 ixabepilone 6. 不 1. 不 (AST, ALT) ixabepilone 度率 2. 不良 3. capecitabine 療不良不 4. 度度神療 3 狀狀 5. CYP3A4 ixabepilone 度 6. CYP3A4ixabepilone 度降 7. 糖尿 ixabepilone 神率 8.

9. 狀 ( ) 不良量 FDAD 1. CYP3A4(ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, fosamprenavir, indinavir, nelfinavir, delavirdine, voriconazole) ixabepilone 度 2. CYP3A4(St. John's wort, phenobarbital, phenytoin, rifabutin, rifampin) ixabepilone 度降量 40 mg/m 2 3-6 3 (Body Surface Area, BSA) 2.2 m 2 (BSA)2.2 m 2 來量 1 理 H 1 H 2 corticosteroids 量 1. Ixabepilone 療不量數 ASTALT AST ALT 2.5 AST ALT 10 數 (Bilirubin) a 數 1 數 1.5 Ixabepilone 量 (mg/m 2 ) b 來量 40 mg/m 2 32 mg/m 2 AST ALT 10 AST ALT> 10 數 1.5-3 數 > 3 20 30 mg/m 2 不 ixabepilone a 數異不 Gilbert s disease b 量療量療量 c ULN= upper limit of normal 2. 量 Ixabepilone 療 Ixabepilone 量 / 療 2 a 神 (neuropathy) 7 3 神 < 7 療 (hold) 神數降 1 量 20 神不良療復療量 20% 3 神 7 ixabepilone 療不良數降 1 神 3 不良量 20 3 不良療復療量 20% 3 / 3 療不良數降 1 量療 4 不良都 ixabepilone a 療不良數 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0)

3. 量 Ixabepilone 療 / Ixabepilone 量療療 (neutrophil) < 500 數 >1,500 cells/mm 3 7 cells/mm 量 20 療復療量 20 capecitabine 療數 >1,000 cells/mm 3 療數 (Platelet)< 25,000 cells/mm 3 7 數 <50,000 cells/mm 3 療數 >100,000 cells/mm 量 20 數療復療量 20 capecitabine 療數 >50,000 cells/mm 3 capecitabine 療 4. IxempraCYP3A4 CYP3A4 IxabepiloneCYP3A4 CYP3A4 Ixabepilone 量量 20 mg/m 2 CYP3A4 1 ixabepilone 量冷 30 1. ixabepilone 度 2 mg/ml 1 ( 不 ) 2. lactated Ringer's injection 度 0.2-0.6 mg/ml 不 DEHP (diethylhexylphthalate) 6 3. ixabepilone 不 DEHP (diethylhexylphthalate) 0.2-1.2 µm inline filter3 不 6 冷 ( 2-8) 參料 1. DRUGDEX System:Klasco RK (Ed): DRUGDEX System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 06/04/2008). 2. Sweetman S (Ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press. Electronic version, Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 06/04/2008). 3. The circular from the manufacturer of Ixempra injection..

Levetiracetam Keppra Oral Solution 林林狀 mllevetiracetam 100 mg 理力 Levetiracetam 力異率 100% 不率 (10 ) 類 (acetamide) 不 cytochrome P450 療 ( 不 ) 療不良見暈力咽行異殺念行臨料 levetiracetam 不度量 1. : 量 500 mg2 臨 21 2500 mg 量 3 2. : 量兩 10 mg/kg220 mg/kg 量 60 mg/kg 25 不易參料 1. McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; ( 2008) 28:12.92. 2. DRUGDEX System:Klasco RK (Ed): DRUGDEX System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited:12/17/2008). 3. Physicians' Desk Reference (electronic version), Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: 12/17/2008). 4. The circular from the manufacturer of Keppra oral solution. 量神不量 FDAC levetiracetam pyrrolidine