懷孕藥品風險分類B級的藥物

懷孕藥品風險分類B級的藥物

皮膚科  王修含 醫師

懷孕時期的用藥,須相當謹慎,某些藥物可能影響胎兒的成長與安全,造成胎兒的畸形。美國FDA基於懷孕用藥的安全性,將懷孕藥品分為下列五級(詳細定義附於文後):

A級藥品:安全
B級藥品:可能安全
C級藥品:避免使用(對胎兒的影響尚不清楚),除非治療上的好處大於風險
D級藥品:避免使用(已證實對胎兒有危險),除非治療上的利益大於風險
X級藥品:具有致畸胎性(Teratogenicity)

B級藥品的定義為:「動物試驗的結果顯示,並無對胎兒有害的證據,但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.)
雖然動物試驗顯示對胚胎有不良作用,但針對懷孕婦女的對照研究中,無法證明對於胎兒的危險性。(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)

新式作法:懷孕與哺乳期標示規則(Pregnancy and Lactation Labeling Rule, PLLR)

由於「懷孕分級」系統的ABCDX分類系統過於簡化,對藥物的風險評定過於簡單,且可能造成混淆,無法有效且完整涵括妊娠、生產、授乳各時期的藥物風險變化,且無法指出對於女性與男性生殖系統潛在的風險,因此美國FDA決定揚棄舊式的「懷孕分級」系統,制定出新式的「懷孕與哺乳期標示規則」(Pregnancy and Lactation Labeling Rule, PLLR),此系統於2015年6月30日正式生效。

新式標示法,請參見「懷孕與哺乳期標示規則 (Pregnancy and Lactation Labeling Rule, PLLR)」 http://www.skin168.net/2016/02/PLLR-pregnancy-drug.html

雖然美國FDA以懷孕與哺乳期標示規則 (PLLR)取代懷孕分級」(Pregnancy categories),改用詳細的文字資訊取代簡略的字母代號,但已實行數十年的
懷孕分級」系統,仍有其參考價值,故亦收錄於後,可供快速查詢之用。

B級藥物列表:

一般常用藥物甚多,在此以台大醫院處方集所列的藥物為例,整理出懷孕藥品風險分類B級的安全藥物(藥物資料來源:台大醫院藥劑部提供)
本站文章版權所有,歡迎非商業性「部份」轉載(請勿全文轉載),轉載請註明作者姓名標示(皮膚科王修含醫師)與出處(skin168.netskin168.comskin168.org),禁止更動內文,並提供有效的本站超連結。】

學名
藥品中文名稱
商品名

    50% insulin lispro and 50% insulin lispro protamine                            
優泌樂-混合型50 
Humalog Mix50, 300 IU/3 mL/pen (DC) 

    50% insulin lispro and 50% insulin lispro protamine                            
優泌樂筆-混合型50 
Humalog Mix50 KwikPen, 300 IU/3 mL/pen 

    Acarbose                            
醣祿錠 
Glucobay Tablet 50 mg/tab 

    Acarbose                            
醣祿錠 
<試> Glucobay-200905056M 50 mg/tab 

    Acetaminophen                            
力停疼錠 
Tinten Tablet 500 mg/tab 

    Acetylcysteine                            
希那克注射劑 
Hidonac Injection (20%) 5 g/25 mL/btl 

    Acetylcysteine                            
愛克痰發泡錠 
Actein Effervescent Tablet 600 mg/tab 

    Acetylcysteine Sodium                            
安喀寶注射液 
Encore Injection 10%, 300 mg/3 mL/amp 

    Acyclovir                            
熱威樂素懸液劑 
Zovirax Suspension 40 mg/mL, 125 mL/btl 

    Acyclovir                            
熱威樂素乳膏劑 
Zovirax Cream 5% 2 g/tube 

    Acyclovir                            
熱威樂素眼用軟膏 
Zovirax Ophthalmic Ointment 3% 4.5 g/tube 

    Acyclovir                            
力克眼用軟膏 
Devirus Ophthalmic Ointment 3% 4.5 g/tube 

    Acyclovir                            
疱寧錠200毫克 
DeherpTablet 200 mg/tab 

    Adalimumab 40 mg/syringe                            
復邁針筒裝注射劑 
Humira 40 mg solution for injection prefilled syringe (40mg/ 0.8mL/ syringe) 

    Agalsidase Beta                            
法布瑞酶凍晶注射劑 
Fabrazyme for Injection 35 mg/vial 

    Alfuzosin HCl                            
扎特持續性藥效錠 
Xatral XL Tablet 10 mg/tab 

    Alprostadil                            
卡維傑特注射劑 
Caverject Sterile Powder 20 mcg/vial 

    Amorolfine HCl                            
樂指利抗甲癬油劑 
Loceryl Nail Lacquer 5% 3 mL/btl 

    Amoxicillin and Clavulanate Potassium                            
安滅菌靜脈注射劑 
Augmentin for IV Injection 500 mg amoxicillin & 100 mg clavulanic acid/vial (Na 3.1 mEq, K 1 mEq/1.2 g) 

    Amoxicillin and Clavulanate Potassium                            
安滅菌糖漿用粉劑 
Augmentin Powder for Oral Suspension 80 mg amoxicillin /mL,
2800 mg amoxicillin & 400 mg clavulanic acid/35 mL/btl 

    Amoxicillin and Clavulanate Potassium                            
安滅菌膜衣錠1公克 
Augmentin 1 g F.C. Tablet 875 mg amoxicillin & 125 mg clavulanic acid/tab 

    Amoxicillin Trihydrate                            
安蒙西林膠囊 
Amoxicillin Capsule 250 mg amoxicillin/cap 

    Amoxicillin Trihydrate                            
萬博黴素懸液用粉 
Amolin Powder for Oral Suspension 25 mg amoxicillin/mL, 60 mL/btl 

    Amphotericin B                            
防治黴靜脈凍晶注射劑 
Fungizone Intravenous Injection 50 mg/vial 

    Amphotericin B Liposomal                            
脂黴素微脂粒凍晶乾粉注射劑 
AmBisome for Injection 50 mg/vial 

    Ampicillin Sodium                            
安博黴素注射劑 
Ampolin for Injection 500 mg ampicillin/vial (Na 2.9-3.1 mEq/g potency) 

    Ampicillin Sodium and Sulbactam Sodium                            
優耐迅肌肉/靜脈注射劑 
Unasyn 1.5 g for Injection ampicillin 1000 mg & sulbactam 500 mg/vial (Na 5.0 mEq/vial) 

    Atazanavir                            
瑞塔滋膠囊 
Reyataz Capsule 150 mg/cap 

    Atazanavir                            
瑞塔滋膠囊 
Reyataz Capsule 200 mg/cap 

    Azelaic Acid                            
思麗安乳膏 
Skinoren Cream Micronized azelaic acid 20% in a cream vehicle, 30 g/tube 

    Azithromycin Dihydrate                            
日舒錠 
Zithromax Tablet 250 mg azithromycin/tab 

    Azithromycin Dihydrate                            
日舒懸液用粉, 47.78毫克/公克 
Zithromax Powder for Oral Suspension 40 mg azithromycin/mL, 15 mL/btl 

    Aztreonam                            
安達菌素乾粉注射劑 
Azactam for Injection 1 g/vial 

    Bambuterol HCl                            
幫肺克錠 
Bambec Tablet 10 mg/tab 

    Basiliximab                            
新睦樂凍晶注射劑 
Simulect for Injection 20 mg/vial 

    Betahistine Mesylate                            
敏使朗錠 
Merislon Tablet 12 mg/tab 

    Bevacizumab                            

<試>Avastin-BO20906 400 mg/16 mL/vial 

    Bevacizumab                            

<試>Bevacizumab-ML25602 100 mg /4 mL/ vial 

    Bevacizumab                            

<試>Bevacizumab-MO22923 400 mg /16 mL/vial 

    Brimonidine Tartrate                            
艾弗目眼藥水 
Alphagan P Ophthalmic Solution 0.15% 5 mL/btl 

    Bromocriptine Mesylate                            
保乳調錠 
Parlodel Tablet 2.5 mg/tab 

    Budesonide                            
可滅喘都保定量粉狀吸入劑 
Pulmicort Turbuhaler 200 mcg/dose, 100 doses/btl 

    Budesonide                            
可滅喘懸浮吸入液1公絲/2公撮 
Pulmicort Respules Nebulising Suspension for Inhalation 1 mg/2 mL/respule 

    Budesonide                            
帝舒滿定量噴霧液 
Duasma Metered Dose Inhaler 200 mcg/puff, 200 puffs/btl 

    Buspirone HCl                            
百事隆錠 
Busron Tablet 10 mg/tab 

    Buspirone HCl                            
怡必隆錠 
Sepirone Tablet 10 mg/tab 

    Cabergoline                            
過乳降錠 
Dostinex Tablet 0.5 mg/tab 

    Carboplatin                            

<試> Paraplatin-MO22923 450 mg/45 mL/vial 

    Carnitine                            
加力體能咀嚼錠 
Carnitene Chewable Tablet 1 g/tab 

    Carnitine                            
加力體能注射劑 
Carnitene Injection 1 g/5 mL/amp 

    Cefazolin Sodium                            
信華注射劑 
Cefa for Injection 1 gm cefazolin/vial (Na 2.1 mEq/g potency) 

    Cefazolin Sodium                            
克法妥黴素注射劑 
Kofatol for Injection 1 gm cefazolin/vial (Na 2.1 mEq/g potency) 

    Cefepime HCl                            
邁菌平注射劑 
Maxipime for Injection 500 mg cefepime /vial 

    Cefixime                            
速復適康(希復欣)膠囊 
Cefspan Capsule 100 mg/cap 

    Cefmetazole Sodium                            
賜乎滅達榮靜脈注射劑 
Cefmetazon for Injection 500 mg cefmetazole/vial (Na 2.12 mEq/g potency) (停產) 

    Cefmetazole Sodium                            
喜達隆注射劑 
Cetazone Injection 500 mg cefmetazole/vial (Na 2.12 mEq/g potency) 

    Cefotaxime Sodium                            
可活能靜脈注射劑 
Claforan for Injection 500 mg cefotaxime/vial (Na 2.1 mEq/g potency) 

    Cefpirome Sulfate                            
喜活能乾粉注射劑 
Cefrom Powder for IV Injection 1 g cefpirome/vial (Na 4.7 mEq/g potency)

    Ceftazidime                            
祐坦賜福乾粉注射劑 
Tatumcef Powder for Injection 500 mg with 59 mg Na2CO3/vial (Na 2.3 mEq/g potency) 

    Ceftibuten                            
協復鼎膠囊 
Seftem Capsule 100 mg/cap 

    Ceftriaxone Sodium                            
羅氏芬靜脈注射劑 
Rocephin for Injection 500 mg ceftriaxone/vial (Na 3.6 mEq/g potency) 

    Cefuroxime Axetil                            
欽納特錠 
Zinnat Tablet 250 mg cefuroxime/tab 

    Cefuroxime Axetil                            
欽納特懸液劑 
Zinnat Powder for Oral Suspension 125 mg cefuroxime/5 mL, 50 mL/btl 

    Cefuroxime Sodium                            
西力欣注射劑 
Zinacef for Injection 750 mg cefuroxime/vial (Na 2.4 mEq/g potency) 

    Cephalexin                            
信保欣膠囊 
Cephalexin Capsule 250 mg/cap 

    Cephalexin                            
優力黴素口服懸液用顆粒 
Ulexin for Oral Suspension 25 mg/mL, 60 mL/btl 

    Cephradine Arginine                            
優復捷愛黴素注射劑 
U-Save-A for Injection 0.5 g cephradine/vial (Na free) 

    Cetirizine 2HCl                            
驅特異內服液劑 
Zyrtec Oral Solution 1 mg/mL, 60mL/btl 

    Chlorhexidine Gluconate                            
@ 克羅淨 濃液劑 5% 
@ Kilgerm Concentrate 5% 5 L/btl  

    Chlorhexidine Gluconate                            
希必定濃液劑 
@ Hibitane Concentrate Solution 5% 5 L/btl 

    Chlorhexidine Gluconate                            
希必潔外用液 
Hibiscrub 4% with Detergent 5 L/btl 

    Cholera Vaccine (Vibrio cholerae O1 & Cholera toxin B Subunit)                            

Dukoral Inactivated Vaccine 3 mL/vial 

    Cisatracurium                            
肌弛適注射劑 
Nimbex Injection 10 mg/5 mL/amp 

    Clindamycin HCl                            
利達信黴素膠囊 
Lindacin Capsule 150 mg clindamycin/cap 

    Clindamycin Phosphate                            
麗歐迅外用液 
Cleocin T Topical Solution 1% 30 mL/btl 

    Clindamycin Phosphate                            
克林達黴素注射液150公絲  
Clindamycin injection 150mg (150mg/mL, 300 mg/amp) 

    Clindamycin Phosphate                            
克力欣注射液150公絲/公撮 
Clincin inj. 300 mg/2 mL/amp 

    Clopidogrel                            
保栓通膜衣錠 
Plavix Film-Coated Tablet 75 mg/tab 

    Clopidogrel                            
保栓通膜衣錠 
@ Plavix Film-Coated Tablet 300 mg/tab 

    Clopidogrel or placebo                            

<試> Clopidogrel-H7T-MC-TABY (b) 75 mg/tab 33 tab/ btl 

    Clopidogrel or placebo                            

<試> Clopidogrel-H7T-MC-TABY (b) 75 mg/tab 4 tab/ btl 

    Clozapine                            
可致律錠 
Clozaril Tablet 100 mg/tab 

    Cromolyn Sodium                            
克視敏點眼液 
Cusicrom Eye Drops 2% 10 mL/btl (停產) 

    Cromolyn Sodium                            
克鼻敏鼻用噴液劑 
Cusicrom Nasal Spray 4% 15 mL/btl (停產) 

    Cromolyn Sodium                            
艾麗鼻用噴液劑 
Allergocrom Nasal Spray Solution 2% 2.8 mg/spray, 15 mL/btl 

    Cromolyn Sodium                            
艾麗點眼液 
Allergocrom Eye Drops 20 mg/mL, 10 mL/btl 

    Cyproheptadine                            
安清敏錠 
Antisemin Tablet 4 mg/tab 

    Cyproheptadine                            
佩你安錠 
Pilian Tablet 4 mg/tab  

    Cyproheptadine                            
希普利敏液 
Cypromin Solution 0.4 mg/mL, 120 mL/btl 

    Dalteparin Sodium                            
弗列明注射劑2500單位/公撮 
Fragmin Injection 10000 IU/4 mL/amp (1 mg=156.25 IU) 

    Daptomycin                            
可倍行注射劑 
Cubicin Injection 350 mg/vial (DC) 

    Daptomycin                            
救必辛注射劑 
Cubicin Injection 500 mg/vial 

    deferasirox                            
易解鐵可溶錠 125毫克/錠 
Exjade Dispersible Tablet 125 mg/tab 

    Desflurane                            
輸活能液態吸入劑 
@Suprane 240 mL/btl 

    Desmopressin Acetate                            
迷你寧注射劑 
Minirin Injection 4 mcg/mL/amp 

    Desmopressin Acetate                            
迷你寧鼻腔噴霧劑 
Minirin Nasal Spray 250 mcg/25 doses/2.5 mL/btl 

    Desmopressin Acetate                            
迷你寧錠 
Minirin Tablet 0.1 mg/tab 

    Dexchlorpheniramine Maleate                            
特息敏錠2公絲(右氯敏) 
Dex-CTM Tablet 2 mg/tab  

    Dexchlorpheniramine Maleate                            
舒敏錠 
Somin Tablet 2 mg/tab 

    Dicloxacillin Sodium                            
達可西林膠囊 
Dacocilin Capsule 250 mg/cap (Na 0.6 mEq/cap) 

    Dicyclomine HCl                            
便治爾錠 
Bentyl Tablet 10 mg/tab 

    Didanosine                            
惠妥滋持續性膠囊250公絲 
Videx EC Delay-Release Capsule 250 mg/cap 

    Didanosine                            
惠妥滋持續性藥效膠囊400公絲 
Videx EC Delay-Release Capsule 400 mg/cap 

    Diphenhydramine HCl                            
鹽酸二苯胺明注射液 
Diphenhydramine HCl Injection 3%, 30 mg/1 mL/amp  

    Diphenhydramine HCl                            
鹽酸二苯胺明注射液 
Injectio Diphenhydramini Hydrochloridi 3%, 30 mg/1 mL/amp 

    Dipyridamole                            
心妙健注射液 
Shinmiochien Injection 10 mg/2 mL /amp 

    Dobutamine HCl                            
優達命注射液 
Utamine Injection 250 mg dobutamine/20 mL/vial 

    Dobutamine HCL                            
得寶明塩酸塩注射劑 
Dobutamine Hydrochloride 250 mg dobutamine/20 mL/vial  

    Domperidone                            
胃利空懸液劑 
Wempty Suspension 60 mg/60 mL/btl 

    Domperidone                            
道喜錠 
Dosin Tablet 10 mg/tab 

    Doxepin HCl                            
普膚乳膏 
Ichderm Cream 5% 15 g/tube 

    Emtricitabine and tenofovir disoproxil fumarate                            
<免費>舒發泰膜衣錠 
免費Truvada Tablet emtricitabine 200 mg & tenofovir disoproxil fumarate 300 mg/tab 

    Emtricitabine and tenofovir disoproxil fumarate                            
舒發泰膜衣錠 
Truvada Tablet emtricitabine 200 mg & tenofovir disoproxil fumarate 300 mg/tab 

    Enoxaparin Sodium                            
克立生注射劑 
Clexane Injection 60 mg (6000 anti-factor Xa IU)/0.6 mL/syringe 

    Epoprostenol Sodium                            
服療能注射劑 
Flolan 500 mcg/vial 

    Epoprostenol Sodium                            
(免費)服療能注射劑 
(Free) Flolan 500 mcg/vial 

    Eptifibatide                            
應治凝注射液 
Integrilin Injection 75 mg/100 mL/vial 

    Eptifibatide or placebo                            

<試>Eptifibatide bolus-EFC6204 20 mg/10 mL/vial 

    Eptifibatide or placebo                            

<試>Eptifibatide infusion-EFC6204 75 mg/100 mL/vial 

    ertapenem sodium                            
益滿治注射劑 
Invanz for Injection 1 g/vial 

    Erythromycin Estolate                            
優樂黴素口服懸濁液用顆粒 
Ulosina for Oral Suspension 25 mg/mL, 60 mL/btl  

    Erythromycin Lactobionate                            
威黴素靜脈注射劑 
Erythrocin Lactobionate-IV for Injection 500 mg erythromycin/vial 

    Esomeprazole Magnesium                            
耐適恩錠 
Nexium Tablet 40 mg (as magnesium trihydrate)/tab 

    Esomeprazole or placebo                            

<試> D961HPC00001 20 mg/tab, 224 tab/box 

    Esomeprazole Sodium                            
耐適恩注射劑 
Nexium Powder for Injection and Infusion, equivalent to 40 mg/vial 

    Etanercept                            
恩博凍晶注射劑(DC) 
Enbrel for Injection 25 mg/vial (DC) 

    Etanercept                            
恩博針筒裝注射劑 
Enbrel Solution for Injection in Pre-filled Syringe 25 mg/0.5 mL/syringe 

    Ethambutol HCl                            
孟表多片劑  
Myambutol Tablet 400 mg/tab  

    Ethambutol HCl                            
醫肺妥膜衣錠 
Ebutol F.C. Tablet 400 mg/tab 

    Etravirine                            
英特萊錠 
Intelence Tablets 100 mg/tab 

    Famotidine                            
蓋舒泰D口溶錠 
Gaster D Tablet 20 mg/tab 

    Famotidine                            
蓋舒泰注射液 
Gaster Injection 20 mg/amp 

    Fenoterol HBr                            
適喘寧液 
Strolin Liquid 0.5 mg/mL, 60 mL/btl 

    Ferric-Hydroxide-Sucrose Complex                            
鐵補 注射液 
Fe-Back Injection 2% 100 mg Fe+3/ 5 mL/ vial 

    Flavoxate HCl                            
伏順 膜衣錠 
Foxate F.C. Tablet 200 mg/tab 

    Fluorescein                            
服攝得點眼液2% 
Corircusi Fluorescein Eye Drops 2% 1mL/btl (常備) 

    Galantamine HBr                            
利憶靈持續藥效膠囊16毫克 
Reminyl Prolonged Release Capsule 16mg/cap 

    Galsulfase                            
(無) 
Naglazyme Injection 5 mg/5 mL/vial 

    Glatiramer Acetate                            
可舒鬆注射液20公絲 
Copaxone 20mg solution for injection (Pre-filled syringe) 

    Glucagon                            
昇糖精 
GlucaGen for Injection 1 mg(=1 IU)/vial 

    Glyburide                            
固利康錠 
Gliben Tablet 5 mg/tab 

    Glycopyrrolate                            
格比平注射劑 0.2毫克/毫升 
Glycopyrodyn Injection 0.2mg/mL/amp 

    Gonadorelin Acetate                            
黃體形成荷爾蒙分泌荷爾蒙注射液 
LH-RH Injection 100 mcg/1 mL/amp 

    Granisetron HCl                            
康您適強錠 
Kytril Tablet 1 mg granisetron/tab 

    Granisetron HCl                            
康您適強注射劑 
Kytril Injection 3 mg granisetron/3 mL/amp 

    Granisetron HCl                            
康您適強注射劑 
<試> Kytril-MO22201 3 mg/3 mL/amp 

    Granisetron HCl                            
(兒癌基金會) 康您適強錠 
(兒癌基金會) Kytril Tablet 1 mg granisetron/tab 

    Granisetron HCl                            
(兒癌基金會) 康您適強注射劑 
(兒癌基金會) Kytril Injection 3 mg granisetron/3 mL/amp 

    Granisetron HCl                            
(兒癌基金會) 康您適強注射劑 
(兒癌基金會) Kytril Injection 1 mg granisetron/1 mL/amp 

    Granisetron HCl                            
嘔速停靜脈注射劑 
<試>Otril-T1210 1 mg /mL/vial 

    Granisetron HCl                            
嘔速停靜脈注射劑 
<試>Otril-T1210 3 mg /3 mL/vial 

    Human Papillomavirus Bivalent (Types 16,18) Recombinant Vaccine                            
保蓓[二價人類乳突病毒(第16,18型)基因重組疫苗]  
Cervarix Vaccine 0.5 mL/vial, Human Papillomavirus vaccine Type 16 and 18 (Recombinant, AS04 adjuvanted) 

    Human Papillomavirus Recombinant Vaccine Quadrivalent (types 6, 11, 16, 18)                            
嘉喜[四價人類乳突病毒(第6,11,16,18型)基因重組疫苗] 
Gardasil Injection 0.5 mL/syringe 

    Human Papillomavirus Recombinant Vaccine Quadrivalent (types 6, 11, 16, 18)                            
嘉喜[四價人類乳突病毒(第6,11,16,18型)基因重組疫苗] 
<試>Gardasil-V501-020-10 Inj 0.5 mL/ vial 

    Imiquimod                            
樂得美乳膏 
Aldara Cream 5% 250 mg/packet 

    Indapamide                            
鈉催離持續性藥效錠 
Natrilix SR Tablet 1.5 mg/tab 

    Insulin Aspart                            
諾和瑞 諾芯管(筆型胰島素) 
NovoRapid Penfill 300 U/3 mL/penfill 

    Iodixanol                            
易渠派克注射劑(常備藥) 
@Visipaque Injection 100 mL/btl, I: 320 mg/mL 

    Iohexol                            
安你拍克注射劑 
Omnipaque Injection 75.5% 100 mL/vial, I: 350 mg/mL 

    Iopromide                            
優照維斯碘 
Ultravist 370 Injection 76.9% 200 mL/btl, I: 370 mg/mL 

    Iopromide                            
優照維斯碘 
Ultravist 300 Injection 62.3% 100 mL/btl, I: 300 mg/mL 

    Ioversol                            
加拿大歐得利320造影劑 
Optiray 320 Injection 68% 200 mL/btl, I:320 mg/mL 

    Ipratropium Bromide                            
定喘樂單一劑量吸入液 
Atrovent Nebulizer Solution UDV 500 mcg/2 mL/vial 

    Isophane Insulin Suspension                            
優泌林-中效型(NPH型人體胰島素) 
Humulin N (NPH) 1000 U/10 mL/vial 

    Isophane Insulin Suspension 70% & Insulin 30%                            
優泌林-混合型(70/30) 
Humulin 70/30 1000 U/10 mL/vial (NPH : RI = 7:3) 

    Lactulose                            
樂可樂舒液劑 
Lactulose Liquid 600 mg/mL, 500mL/btl 

    Lactulose                            
杜化液  
Duphalac Liquid 667 mg/mL, 500 mL/btl  

    Lactulose                            
樂可樂舒液劑 
Lactulose Liquid 600 mg/mL, 500 mL/btl 

    Lansoprazole                            
泰克胃通口溶錠 
Takepron OD Tablet 30 mg/tab 

    Laronidase                            
艾德酶靜脈注射用溶液 
Aldurazyme concentrated solution 2.9 mg/5mL/vial 

    Levobupivacaine hydrochloride                            
開洛凱因®注射劑 
@ Chirocaine® 5 mg/mL, 10 mL/amp (不計價常備) 

    Levocetirizine                            
驅異樂膜衣錠 
Xyzal Film-coated Tablet 5 mg/tab 

    Lidocaine                            
遠疼貼貼片 
Lidopat Patch 5% 700 mg/patch 

    Lidocaine and Epinephrine                            
口內寧注射液 
@Ora Inj. Cartridge 1.8 mL/cartridge (DC) 

    Lidocaine HCl                            
苦息樂卡因注射液 
@Xylocaine 2% 20 mL/vial (injection for local anesthesia) 

    Lidocaine HCl                            
苦息樂卡因凝膠 
@Xylocaine 2% 30 g/tube (jelly for topical anesthesia) 

    Lidocaine HCl                            
苦息樂卡因黏液 (DC) 
@Xylocaine 2% 100 mL/btl (viscous solution for surface anesthesia) (DC) 

    Lidocaine HCl                            
苦息樂卡因噴霧劑 
@Xylocaine 10% 50 mL/btl (solution for spray) 

    Lidocaine HCl                            
靜注用苦息樂卡因注射液 
Xylocaine 2% for IV Injection 100 mg/5 mL/amp 

    Lidocaine HCl                            
苦息樂卡因液1% 
@Xylocaine 1% 5 mL/amp (solution for topical anesthesia) 

    Loperamide HCl                            
優腹寧錠 
Ufunin Tablet 2 mg/tab 

    Loperamide HCl                            
易必寧膠囊 
Lopedin Capsule 2 mg/cap  

    Loratadine and Pseudoephedrine Sulfate                            
康瑞斯持續性藥效錠 
Clarinase Repetabs Tablet, loratadine 5 mg and pseudoephedrine sulfate 120 mg/tab 

    memantine HCL                            
憶必佳膜衣錠10公絲 
Ebixa Film-coated Tablet 10mg/tab  

    memantine HCL                            
滅擾膜衣錠10毫克 
Manotin F.C. Tablets 10mg/tab 

    Meropenem Trihydrate                            
美平乾粉注射劑 
Mepem for Injection 500 mg meropenem/vial 

    Mesalamine                            
阿腸克錠 
Asacol Tablet 400 mg/tab 

    Mesalamine                            
安腸克栓劑 
Asacol Suppository 500 mg/supp 

    Mesalamine                            
頗得斯安持續性藥效錠 
Pentasa SR Tablet 500 mg/tab 

    Mesalamine                            
阿腸克浣腸劑 
Colasa Enema 2 g/100 mL/btl 

    Mesalamine                            
頗得斯安栓劑 
Pentasa Suppository 500 mg/pill  

    Mesna                            
優路保注射液 
Uromitexan Injection 400 mg/4 mL/amp 

    Metformin HCl                            
泌樂寬膜衣錠 
Glibudon F.C. Tablet 500 mg/tab 

    Metformin HCl                            
庫魯化錠850公絲 
Glucophage Tablet 850 mg/tab 

    Metformin HCl                            

<試> Glucophage-200905056M 500 mg/tab 

    Metformin HCl                            

<試>Metformin-1245.24 500 mg/tab 420 tab/box 

    Metoclopramide HCl                            
安適胃寧液 
Aswell Solution 60 mg/60 mL/btl (0.767 mg metoclopramide/mL) 

    Metoclopramide HCl                            
胃斯妥持效膠囊 
Gastro-Timelets SR Capsule 30 mg/cap (25.37 mg metoclopramide/cap) 

    Metoclopramide HCl                            
胃明朗膜衣錠 
Promeran Tablet 5 mg/tab (3.84 mg metoclopramide/tab) 

    Metoclopramide HCl                            
腹寧朗注射液 
Primperan Injection 10 mg/2 mL/amp (7.67 mg metoclopramide/amp) 

    Metoclopramide HCl                            
補樂美淨糖衣錠 
Prometin Tablet 5 mg/tab (3.84 mg metoclopramide/tab) 

    Metronidazole                            
愛汝清注射液 
Anegyn Injection 500 mg/100 mL/bag (Na 28 mEq/g) 

    Metronidazole                            
服立治兒錠 
Flagyl Oral Tablet 250 mg/tab 

    Metronidazole                            
柔潔凝膠 
Metrogel 0.75% 15 g/tube 

    Montelukast Sodium                            
欣流咀嚼錠 
Singulair Chewable Tablet 5 mg montelukast /tab 

    Montelukast Sodium                            
欣流膜衣錠 
Singulair Film Coated Tablet 10 mg montelukast /tab 

    Montelukast Sodium                            
欣流咀嚼錠 
Singulair Chewable Tablet 4 mg montelukast /tab 

    Mupirocin                            
百多邦黴素軟膏 
Bactroban Ointment, Mupirocin 2% in a polyethylene glycol base, 15 g/tube 

    Nalbuphine HCl                            
芯奔靜脈注射液 
Bain Injection 10 mg/1 mL/amp 

    Nevirapine                            
衛滋錠 
Viramune Tablet 200 mg/tab 

    Nevirapine                            
衛滋內服懸液 
(CDC 母子垂直感染) Viramune Oral Susp 10 mg/1mL. 240 mL/ btl 

    Nicorandil                            
喜革脈錠 
Sigmart Tablet 5 mg/tab 

    Octreotide Acetate                            
善得定注射液 
Sandostatin Injection 0.1 mg octreotide/1 mL/amp 

    Octreotide Acetate                            
善得定長效緩釋注射劑 
Sandostatin LAR for Injection 20 mg octreotide in microspheres/vial 

    Omalizumab                            
樂無喘凍晶注射劑 
Xolair Powder and Solvent for Solution for Injection 150 mg/vial 

    Ondansetron HCl                            
卓弗蘭注射劑 
Zofran Injection 8 mg ondansetron/4 mL/amp 

    Ondansetron HCl                            
卓弗蘭膜衣錠 
Zofran Tablet 8 mg ondansetron/tab 

    Ondansetron HCl                            
(兒癌基金會) 卓弗蘭膜衣錠 
(兒癌基金會) Zofran Tablet 8 mg ondansetron/tab 

    Ondansetron HCl                            
(兒癌基金會) 卓弗蘭注射劑 
(兒癌基金會) Zofran Injection 8 mg ondansetron/4 mL/amp 

    Ondansetron HCl                            
(兒癌基金會) 卓弗蘭注射劑 
(兒癌基金會) Zofran Injection 4 mg ondansetron/2 mL/amp 

    Orlistat                            
羅氏鮮膠囊 
Xenical Capsule 120 mg/cap 

    Oxacillin Sodium                            
撲萄黴素注射劑 
Prostaphlin for Injection 500 mg oxacillin/vial (Na 2.8 mEq/g potency) 

    Oxybutynin Choride (eq to Oxibutinina Hcl 5 mg)                            
歐舒緩釋錠 5 毫克 
Oxbu Extended-release Tablets 5 mg/tab 

    Paclitaxel                            

<試>Taxol-MO22923 30 mg /1 vial / box 

    Palonosetron HCl                            
嘔立舒注射劑 
Aloxi Solution for Injection 0.25 mg palonosetron/5 mL/vial 

    Pantoprazole Sodium                            
保衛康治潰樂凍晶注射劑 
Pantoloc i.v. Injection 40 mg pantoprazole/vial 

    Pantoprazole Sodium                            
保衛康治潰樂腸溶膜衣錠40毫克 
Pantoloc Gastro-Resistant Tablet 40 mg/tab 

    Penicillin G Benzathine                            
利達平注射劑 
Retarpen for Injection 2.4 MU penicillin G/vial (1.8 g/vial) 

    Penicillin G Sodium                            
基青黴素鈉注射液用粉 
Penicillin G Sodium for Injection 3MU base/vial (Na 2.0 mEq/MU) 

    Pentosan Polysulfate Sodium                            
愛泌羅膠囊 (DC) 
Elmiron Capsule 100 mg/cap (DC) 

    Pergolide Mesylate                            
協良行錠 
Celance Tablet 0.05 mg/tab 

    Pergolide Mesylate                            
協良行錠 
Celance Tablet 0.25 mg/tab 

    Phenazopyridine HCl                            
順路寧糖衣錠 
Sronin S.C. Tablet 50 mg/tab 

    Piperacillin Sodium and Tazobactam Sodium                            
達梭黴素涷晶注射劑 
Tazocin Lyo-Injection 2 g piperacillin & 0.25 g tazobactam/vial (Na+ 2.79 mEq/g potency) 

    Prasugrel or placebo                            

<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 34 tab/btl 

    Prasugrel or placebo                            

<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 34 tab/btl 

    Prasugrel or placebo                            

<試> Prasugrel-H7T-MC-TABY (b) 10 mg/tab 3 tab/btl 

    Prasugrel or placebo                            

<試> Prasugrel-H7T-MC-TABY (b) 5 mg/tab 34 tab/btl 

    Praziquantel                            
凱光錠 (帕多奎) 
Kaicide Tablet 600 mg/tab 

    progesterone                            
快孕隆8%陰道凝膠 
Crinone 8% vaginal gel, 90 mg/tube 

    Progesterone, Micronized                            
優潔通軟膠囊 
Utrogestan Soft Capsule 100 mg/cap 

    Propofol                            
飛可復注射劑 (2%) 
@Fresofol Injection 1000 mg/50 mL/vial 

    Propofol                            
普洛福靜脈注射液 
@ Propofol-Lipuro 200 mg/ 20 mL/amp

    Propofol                            
雷可孚注射劑10公絲/公撮 
@ Recofol Injection 200mg/ 20 mL/amp 

    Propofol                            
飛可復1%注射劑 
@Fresofol Injection 200 mg/ 20 mL/amp 

    Psyllium Hydrophilic Mucilloid                            
康賜爾散劑 
Konsyl 1 g/g, 6 g/pack 

    Rabeprazole Sodium                            
百抑潰膜衣錠 
Pariet Tablet 20 mg/tab 

    Ranitidine HCl                            
善胃得注射液 (DC) 
Zantac Injection 50 mg ranitidine/2 mL/amp (DC) 

    Regular Insulin Inj                            
優泌林-常規型(常規型人體胰島素
Humulin R 1000 IU/10 m/vial 

    Rifabutin                            
淨核膠囊 
Mycobutin Capsule 150 mg/cap 

    Ritodrine HCl                            
妳得寶注射劑 
Yutopar Injection 50 mg/5 mL/amp 

    Ritodrine HCl                            
妳得寶錠 
Yutopar Tablet 10 mg/tab 

    Ritonavir                            
諾億亞軟膠囊 
Norvir Capsule 100 mg/cap 

    Rivastigmine                            
憶思能穿皮貼片
Exelon Patch 9 mg/5 cm2, 4.6 mg/24 hr/pce 

    Rivastigmine Hydrogen Tartrate                            
憶思能膠囊 
Exelon Capsule 1.5 mg/cap 

    Rivastigmine Hydrogen Tartrate                            
憶思能膠囊 
Exelon Capsule 4.5 mg/cap 

    Rivastigmine Hydrogen Tartrate                            
憶思能膠囊 (釋出處方) 
Exelon Capsule 3 mg/cap (釋出處方) 

    Saxagliptin                            
昂格莎膜衣錠 
Onglyza Film-coated Tablet 5 mg/tab 

    Saxagliptin or Placebo                            

<試> Saxagliptin-D1680C00003 2.5 mg/tab, 105 tab/btl 

    Saxagliptin or Placebo                            

<試> Saxagliptin-D1680C00003 5 mg/tab, 105 tab/btl 

    Sevoflurane                            
西福銳吸入用液劑 
@Ultane 250 mL/btl 

    Sildenafil Citrate                            
威而鋼膜衣錠 
Viagra Film-coated Tablet 100 mg/tab 

    Sildenafil citrate                            
瑞肺得膜衣錠20毫克 
Revatio Film-Coated Tablet 20mg/tab 

    Sildenafil Citrate                            
威而鋼小兒分包 
Viagra 2 mg/pack (1/50 tab) 

    Sildenafil Citrate                            
威而鋼小兒分包 
Viagra 5 mg/pack (1/20 tab) 

    Sildenafil citrate                            

<試>Revatio A1481156 10 mg /1 tab 90 tab/ btl 

    Sildenafil citrate                            

<試>Revatio A1481156 20 mg /1 tab 90 tab/ btl 

    Sildenafil citrate                            

<試>Revatio A1481156 40 mg /1 tab 90 tab/ btl 

    Sildenafil citrate                            

<試>Revatio A1481156 80 mg /1 tab 90 tab/ btl 

    Silodosin                            
優列扶膠囊4毫克 
Urief Capsule 4 mg/cap 

    Silver Sulfadiazine                            
膚美淨軟膏 
Flamazine Cream 1% 500 g/box 

    Silver Sulfadiazine                            
灼膚星乳膏 
Sulfasil Cream 1% 50 g/tube 

    Sitagliptin or placebo                            
佳糖維100 毫克 膜衣錠 
<試>Sitagliptin-200904052M 100 mg/tab 35 tab/btl 

    Sitagliptin or placebo                            

<試> Sitagliptin-082-00 100 mg/tab 200 tab/btl 

    Sitagliptin or placebo                            

<試> Sitagliptin-082-00 25 mg/tab 200 tab/btl 

    Sitagliptin Phosphate                            
佳糖維100 毫克 膜衣錠 
Januvia FC Tablet , equivalent to sitagliptin 100 mg/tab 

    Somatostatin Acetate                            
速妥善注射劑 
Somatosan for Injection 3 mg somatostatin/amp

    Somatostatin Acetate                            
施他寧注射劑 
Stilamin for Injection 3 mg somatostatin/amp 

    Sotalol HCl                            
心得治錠160公絲 
Cardol Tablet 160 mg/tab 

    Sterculia and Frangula                            
樂瑪可顆粒劑 
Normacol Plus Granules 7 g/sachet 

    Sucralfate                            
舒胃泰懸浮液 
Sucrate Gel Suspension 1 g/5 mL/sachet 

    Sulfasalazine                            
撒樂腸溶錠500公絲 
Salazine Enteric-coated Tablet 500 mg/tab 

    Tadalafil                            
犀利士膜衣錠 
Cialis Film-coated Tablet 5 mg/tab 

    Tamsulosin HCl                            
活路利淨D口溶錠 
Harnalidge D Tablet 0.2 mg/tab 

    Telbivudine                            
喜必福膜衣錠600毫克 
Sebivo Film-coated Tablet 600 mg/tab 

    Telbivudine                            
喜必福膜衣錠600毫克 for CDC 
Sebivo Film-coated Tablet 600 mg/tab for CDC 

    Telbivudine                            
喜必福膜衣錠600毫克 for 移植 
Sebivo Film-coated Tablet 600 mg/tab for 移植 

    Tenofovir Disoproxil Fumarate                            

<試> Viread-PP22512 300 mg/tab 30 tab/btl 

    Tenofovir Disoproxil Fumarate                            
惠立妥膜衣錠 
(後天免疫專用) Viread 300 mg/tab 

    Tenofovir Disoproxil Fumarate                            
惠立妥膜衣錠 
(Cash) Viread Tablet 300 mg/tab 

    Tenofovir Disoproxil Fumarate                            
惠立妥膜衣錠 (for CDC approval) 
Viread Tablet (for CDC approval) 300 mg/tab 

    Tenofovir Disoproxil Fumarate                            
惠立妥膜衣錠 
(器官移植專用) Viread Tablet 300 mg/tab 

    Tenofovir Disoproxil Fumarate                            

<試> Viread- 201010078M 300 mg/tab 

    Terbinafine HCl                            
療黴舒錠 
Lamisil Tablet 250 mg terbinafine/tab 

    Terbutaline Sulfate                            
撲咳喘吸入液 
Bricanyl Solution for Nebulizing 5 mg/2 mL/single dose plastic unit 

    Ticarcillin Disodium and Clavulanate Potassium                            
特泯菌靜脈注射劑 
Timentin for Injection 1.5 g ticarcillin & 100 mg clavulanic acid/vial (Na 8mEq, K 0.5mEq/vial) 

    Ticlopidine HCl                            
利血達膜衣錠 
Licodin F.C. Tablet 250 mg/tab 

    Tirofiban                            
雅瑞濃縮輸注液 
Aggrastat Concentrate for Infusion 12.5 mg/50 mL/vial 

    Tranexamic Acid                            
斷血炎注射液 10% 
Transamin Injection 10%, 1000 mg/10 mL/amp 

    Tranexamic Acid                            
斷血炎膠囊 
Transamin Capsule 250 mg/cap 

    Trastuzumab                            

<試>Herceptin-BO20906 150 mg/vial 

    Trastuzumab                            
賀癌平凍晶注射劑 
Herceptin for Injection 440 mg/vial 

    Trastuzumab                            
賀癌平凍晶注射劑 
<試>Herceptin-ML19200 440 mg/vial 

    Tropisetron HCl                            
耐嘔伴靜脈注射液 
Navoban Injection 5 mg tropisetron/5 mL/amp (DC) 

    Urokinase                            
血栓溶素 
Urokinase for Injection 60000 IU/vial 

    Urokinase or placebo                            
血栓溶素 
<試> Urokinase-200908047M 60000 IU / vial 

    Ursodiol                            
吾立甦錠小兒分包 25 mg/pack 
Urso 25 mg/pack for pediatric use only 

    Ursodiol                            
吾立甦錠小兒分包 20 mg/pack 
Urso 20 mg/pack for pediatric use only 

    Ursodiol                            
吾立甦錠小兒分包 16.7 mg/pack 
Urso 16.7 mg/pack for pediatric use only 

    Ursodiol                            
吾立甦錠 
Urso Tablet 100 mg/tab 

    Ursodiol                            
吾立甦錠小兒分包33.3 mg/pack 
Urso 33.3 mg/pack for pediatric use only 

    Ustekinumab                            
(無) 
<專>免費 Stelara Injection 45 mg /0.5mL/syringe 

    Ustekinumab                            
(無) 
<專> (自費) Stelara Injection 45 mg /0.5mL/syringe 

    Valacyclovir HCL                            
祛疹易錠 
Valtrex Tablet 500 mg valacyclovir/tab 

    Vardenafil                            
樂威壯膜衣錠 
Levitra Film-coated Tablet 20 mg/tab 



































































































































 





































































































































































































































































































































































































































































































































懷孕藥物分類(US FDA Pregnancy category definitions):


 級別
Category
定義/描述
Definition/Description
A
針對懷孕婦女妥善設計,且有對照組的研究中,無法證明使用此藥會增高胎兒異常的危險。
Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
B
動物試驗的結果顯示,並無對胎兒有害的證據,但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.)
(or)
雖然動物試驗顯示對胚胎有不良作用,但針對懷孕婦女的對照研究中,無法證明對於胎兒的危險性。(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)
C
動物試驗顯示對胚胎有不良作用,但缺乏針對人類懷孕婦女妥善設計且有對照組的研究。(Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.)
(or)
針對動物或人類懷孕婦女,目前缺乏妥善設計且有對照組的研究,可證明此藥物的危險性。(No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.)
D
針對孕婦的控制實驗或觀察研究中,已證實此藥對胎兒有危險性。但在考量利弊得失下,此藥對於治療的利益可能大於潛在的危險性。
Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
X
針對動物或孕婦的控制實驗或觀察研究中,已顯示此藥會造成胚胎異常,而且禁用於已經或可能懷孕的婦女。(註:藥物導致的傷害大於可能的利益)
Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.
 註:本表原文引用自美國FDA網站
http://www.fda.gov/fdac/features/2001/301_preg.html
http://en.wikipedia.org/wiki/File:Pregnancy_comparison.jpg