Page 1 103 9 …………………………………………………. Combivir

103
………………………………………………….
Combivir ® 150 mg/300mg/tab………………………....................
Isentress ® 400 mg/ tab………………..………………….............
103
7
103
9
9
HIV
。
1981
Immunodeficiency Virus)
CD4
200/ml
(HIV, Human
。
1993
(HIV)
AIDS
HIV
。
HIV
(AIDS)
6~12
HIV
HIV
。
。
..
~10
(
HIV
gp120/41
RNA
(
)
(reverse transcriptase)
(DNA)
1995
10%
DNA
)
3
CD4
(CD4
HIV
RNA)
DNA
(
plasma viral load
RNA
)
4-5
50% CD4
1
5-10
。
(NRTIs)(NNRTIs)(reverse transcription)
RNA
DNA
(PIs)Fusion inhibitor-
(1).
(NRTIs)+
(2).
(NRTIs)+
(3).
(NRTIs)
50~60
:
1.
2.
3.
4.
5.
6.
7.
(NNRTIs)
(PIs)
(
)
3TC 150mg/tab
Lamivudine
NRTI
Kivexa 300mg/600mg/tab
Lamivudine+Abacavir(ABC)
NRTI
Combivir 150mg/300mg/tab
Lamivudine+Zidovudine(ZDV)
NRTI
Viread 300mg/tab
Tenofovir(TDF)
NRTI
Stocrit 600mg/tab
Efavirenz(EFV)
NNRTI
Viramune 200mg/tab
Nevirapine(NVP)
NNRTI
Edurant 25mg/tab
Rilpivirine(RPV)
NNRTI
Reyataz 200mg/cap; 150mf/cap
Atazanavir(ATV)
Darunavir(DRV )
Norvir 100mg/soft cap
Ritonavir(RTV)
600 mg
200 mg
25 mg
Lopinavir+Ritonavir(LPV/r)
Isentress 400mg/tab
Raltegravir(RAL)
100mg
TDF EFV
400 mg
ATV/r
300
mg/100
mg
800 mg RTV 100 mg
RTV
100 mg~400 mg
PI
PI
INSTI
RTV
.
PI
Kaletra 200mg/50mg/tab
300mg
300 mg
PI
Prezista 400mg/tab
150 mg
400 mg
RTV
/
ZDV/3TC/NVP*(Duovir-N)
ZDV/3TC*+NVP(Combivir+Viramune)
ZDV/3TC*+EFV(Combivir+Stocrit)
ZDV/3TC*+RPV(Combivir+ Edurant)
ZDV
TDF+3TC+NVP(Viread+3TC+Viramune)
HBV
NVP
TDF+3TC+EFV(Viread+3TC+ Stocrit)
TDF+FTC+EFV*(Atripla)
ABC/3TC+EFV(
)( Kivexa+ Efavir
TDF
TDF
Immupnyn )
ABC/3TC*+NVP(Kivexa+Viramune)
ZDV/3TC*+MVC(Combivir+Celsentri)
ZDV/3TC*+LPV/r*(Combivir+Kaletra)
(
)
CCR5
,
NNRTI
ZDV/3TC*+DRV(800)/r(100)
(Combivir+Prezista+Norvir)
ZDV/3TC*+ATV(300)/(100) (Combivir+Reyataz+Norvir)
ZDV/3TC*+ATV(400) (Combivir+Reyataz)
ZDV/3TC*+RAL(Combivir+ Isentress)
17500
20140301
Combivir ® tablets
Lamivudine …………150 mg
Zidovudine …………300 mg
Lamivudine zidovudine HIV-1
HIV
lamivudine
HIV-2
zidovudine
(kinase)
5'-triphosphate(TP)
Combivir HIV-1 HIV-2
(monophosphate)
DNA
Lamivudine-TP
zidovudine-TP
HIV-1
(1)
(2)
(3)
(4)
30 kg
21
14
30 kg
21 kg
14 kg
1/2
1/2
lamivudine
Combivir®
Lamivudine
0.5 lamivudine
0.34L/h/kg
zidovudine
Combivir
lamivudine zidovudine
(AUC)
(Cmax,tmax)
Combivir
Zidovudine
zidovudine
2-4
CSF/
(CSF)
5
Zidovudine
1
5'-glucuronide
1.1
7
1.6 L/h/kg
Zidovudine
0.12
Lamivudine
0.32 L/h/kg
50-80 %
HIV
、
、
、
、
、
、
、
、
。
C
lamivudine zidovudine
Combivir®
Combivir®
mmol/L)
lamivudine zidovudine
(< 0.75×109/L)
30°C
Combivir ™ tablets
Micromedex 2.0
HIV
Combiver®
(< 7.5 g/dL
4.65
Isentress® Film Coated Tablets 400 mg
raltegravir potassium 400 mg
Raltegravir
HIV-1
Raltegravir
HIV-1
HIV-1
HIV-1
HIV-1
HIV-1
Raltegravir
DNA
DNA。
:
400
(3%)
(2%-9.3%)
Raltegravir
(0%~9%)
。
(4%)
3
83%
raltegravir
23% glucuronide
1.
9%
51%
9
Rifampin
raltegravir
raltegravir
2.
HIV
raltegravir
NNRTI) tipranavir + ritonavir (
3.
atazanavir
raltegravir
4.
tenofovir
raltegravir
( 800 mg bid)
efavirenz
)
etravirine (
tenofovir
raltegravir
5.
4
C
raltegravir
HIV
HIV
30℃
1.
2. Micromedex 2.0
103
7-9
OADA10 Adalat 10mg/cap (Nifedipine)
OAKIN
Biperiden 2mg/tab (Biperiden)
OADA10 Sindipine 10mg (Nifedipine )
OAKIN Akinfree 2mg/tab (Biperiden)
OARHE Arheuma 20 mg/tab (Leflunomide)
OARHE Arheuma 10 mg/tab (Leflunomide)
OLADO Ladogal 200mg/cap (Danazol)
OLADO Danalol 200mg/cap (Danazol)
Moduretic tab (amiloride 5 mg,
OMODU
hydrochlorothiazide 50 mg)
OSALA Salazopyrin 500mg/tab (Sulfasalazine)
OVBC
Vitamin B complex ( thiamine 50 mg, riboflavin
5 mg, pyridoxine 5 mg, cyanocobalamin 5 mg )
OMODU
Anzat tab (amiloride 5 mg,
hydrochlorothiazide 50 mg)
OSALA Salazine 500mg/tab (Sulfasalazine)
OVBC
Aelocon SC
( thiamine 50 mg, riboflavin 5 mg )
ICALG1 Glucal Black 5ml/amp
ICALG Calglon inj
IDOPA
IDOPA Dopavate 200 mg/5ml/amp
IMECO
Dopmin 200mg/5ml/amp
Methycobal 500 mcg/ml/amp
(Mecobalamin)
IMECO
Combeplex inj.1ml/amp
IVBC
(Vit. B1 100 mg, B2 5 mg, B6 5 mg,
EOEST
Flulon eye drop 0.1% 5ml/bot
( Fluorometholone )
Oestro gel 0.6mg/gm ; 30 g/tube
( Estradiol)
EWART Wartec cream 5g/tub (Podophyllotoxin)
EZOVC
Zovirax® cream 5% 2 g/tube
(Acyclovir )
Mecobal 500mcg/ml;2ml/amp
(Mecobalamin)
B-complex inj. 1ml/amp
IVBC
Nicotinamide 50 mg, Sodium pantothenate 5 mg)
PFLU1
10ml/amp
( Vit. B1 100 mg, B2 5 mg, B6 5 mg,
Nicotinamide 50 mg, Sodium pantothenate 5 mg)
PFLU1
EOEST
EWART
EZOVC
Foxone oph. Suspension 0.1%
( Fluorometholone )
Ladiol gel 0.6mg/gm ; 30 g/tube ( Estradiol)
Wart DEL cream 1.5g/g; 5g/tub
(Podophyllotoxin)
Aclovir cream 50 gm/g; 5 g/tube
(Acyclovir )
1
EJOYL
2
IACLS
Joyla cream 15 g/tube (Aluminum HCl 50mg/g,
DC
Cetrimide 10 mg/g)
Aclasta 5mg/100ml solution for infusion
(Zoledronic acid)
5ml/bot
DC
(
103/7/2
)
Zofran®
8 mg/4ml/amp
( Ondansetron )
IZOFR
1.
(Health Canada)
serotonin antagonists
dolasetron
(
:
granisetron
ondansetron
1. Serotonin syndrome
palonosetron)
serotonin
(
:
MAOI
serotonin syndrome
(
SSRI
)
2.
serotonin syndrome
)
2.
:
serotonin
syndrome
103/7/2
serotonin
Voluven ®
Hydroxyethyl starch
6% 500 mL/bag
(O-2 Hydroxyethyl starch
60 g,
(
NaCl 9g)
)
Hydroxyethyl starch
IVOLU
HAES-steril
10 % 500mll/bag
(O-2 Hydroxyethyl starch
100g, NaCl 9g.)
IHAES
103/7/2
Thado® 50mg/cap
thalidomide
(Thalidomide)
(
:
OTHAD
)
1.
thalidomide
24
(
50mlU/ mL)
(Amelia)
(-)
(Phocomelia)
(
2.
thalidomide
)
(
)
40%
3. thalidomide
thalidomide
thalidomide
4.
。
103/07/24
Tynen®
20mg/ml/vial
(Docetaxel )
ITYXA
FDA
docetaxel
1.
docetaxel
docetaxel
2.
3.
103/8/13
Nicardipine
nicardipine
10 mg/amp
(Nicardipine)
IPERD
。
1.
2.
IV injection
IV infusion
(1).
3-5mg/h
15
15
0.5
1mg
15 mg/
h
2-4mg/h
(2).
/
/
1-5mg/h
30
0.5mg/h
15
mg/h
(3).
0.5-5mcg/kg/min
1-4 mcg/kg/min
103/08/25
Xylocaine ®
jelly 30 g/tube
FDA
lidocaine
:
(Lidocaine)
1.
lidocaine
EXYLJ
lidocaine
103/9/4
Sindine® aqueous
2.
lidocaine
1.
100 mg/ml;
120 ml/bot
(A)
EBIW1
Sindine alcohol
(B)
200 ml/bot
EBIA2
(C)
2.
Hibiscrub
cellulitis
3800 ml/
septic arthritis
EHIBI
phlebitis
bacteremia
(
:
-
sepsis
https://adr.fda.gov.tw/Manager/WebLogin.aspx )
103
1
-25
(96%)
-0
103
-1
(4%),
(0%)
7
103
編
懷疑藥物/商品名
碼
7-9
-0
9
(0%)
103
7-9
ADR
藥品分類
不良事件症狀
處置
1 cephazolin1g/vial (lofalin)
antibiotics
cephalexin 藥敏記錄修正
cephalexine與 cephazolin之side chain 不同,未更動
2 ketorolac inj 30mg/amp(kerolac)
NSAIDs
3 fenofibrate 160mg/tab (lipathyl)
antilipimic agents
analgesics and antipyretics藥敏
刪除analgesics and antipyretics 記錄
記錄修正
myalgia
停藥,改用fluvastatin
4 amoxicillin 500mg/cap(amoxicillin)
antibiotics
skin rash
停藥,改用cefaclor
5 flavoxate 200mg/tab(foxate)
antispasmodics
dizziness
停藥
6 imipenam+cilastatin 500mg(Tienam)
antibiotics
rash
停藥
7 methimazole 5mg/tab(methimazole)
antithyroid agents
rash
停藥,改用procil
8 chlorpromazine 100mg/tab(coliman)
antipsychotics
somnolence
停藥
9 ertapenam 1g/vial(invanz)
antibiotics
seizure
使用抗痙攣藥物,完成抗生素療程
10 glibenclamide+metformin (glucomet)
OHA
hypoglycemia
衛教低血糖處置
11 benzathine penicillinG2.4MIU/vial
antibiotics
akin rash
停藥,給予症狀治療藥物
12 中藥
中藥
skin rash
停藥,給予症狀治療藥物
13 methimazole 5mg/tab(methimazole)
antithyroid agents
mild fever
續服藥物,並囑密切觀察症狀
14 metformin
OHA
hypoglycemia
誤用他人的藥品
15 famotidine 20mg/tab (gaster-D)
H2-blocker
fatigue, dizziness
停藥,改用aligitab, magocain
16 cephazolin1g/vial (lofalin)
antibiotics
skin rash
停藥
17 propylthiouracil 50mg/tab(Polupi)
antithyroid agents
rash
停藥,改用methimazole