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Chang Gung Drug Safety Newsletter 103 8 ...................................... 2 lidocaine .................................................... 2 FDA testosterone ................................................ 3 hydroxyethyl starch .................. 3 nicardipine .............. 4 ....................................................... 5 103 7 ............................................................... 8
10

Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

Aug 15, 2020

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Page 1: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

Chang Gung Drug Safety Newsletter

103 8

...................................... 2

lidocaine

.................................................... 2

FDA testosterone

................................................ 3

hydroxyethyl starch .................. 3

nicardipine .............. 4

....................................................... 5

103 7 ............................................................... 8

Page 2: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

2

103 8

: http://adr.doh.gov.tw/default.asp ( 103/08/28 )

( )

( ) 1

2

( ) 1

2

4 ( )

1

2

( ) 1

2

lidocaine

( 103/08/20 )

FDA lidocaine

lidocaine

FDA

a.

teething ring b.

c. FDA

1. lidocaine

2. lidocaine

1. lidocaine

Page 3: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

3

2. lidocaine

3. lidocaine

FDA testosterone

( 103/08/12 )

FDA 2014 1 2 testosterone

FDA

testosterone testosterone

EMA

Health Canada

FDA 2014 6 testosterone

(venous blood clots as a possible

consequence of polycythemia)

(venous thromboembolism,

VTE) (deep vein thrombosis, DVT) (pulmonary embolism, PE)

1.

2.

1.

2.

hydroxyethyl starch ( 103/08/11

)

hydroxyethyl starch

( ) hydroxyethyl starch

( )

( ) : 1.

2. / (

Page 4: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

4

)

3.

90 HES 90

4.

5.

HES

6.

nicardipine ( 103/08/07

)

nicardipine

( )

( ) IV injection

IV infusion 1. 3-5mg/h 15 0.5 1mg

15 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

Page 5: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

5

[1]

1. Carbamazepine:

25-61%

(hypersensitivity reaction) (granulomatous hepatitis)

(lymphadenopathy simulating biliary tract infection) 3-4

[2]

2. Phenobarbital:

(alkaline

phosphatase; ALP) γ- (gamma-glutamyl transferase; GGT)

(generalized hypersensitivity) (idiosyncratic reaction)

/

[2]

3. Phenytoin:

[2, 3] Phenytoin

1-6

10-38% ...

(transaminases) ALP [2]

4. Valproic acid:

80~90% (aminotransferase) ALP

(lactate dehydrogenase; LDH) GGT ≦

[2]

Page 6: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

6

[2, 4]

[2] [2, 4, 5]

5. Ethosuximide:

[1, 2]

6. Lamotrigine:

[2]

7. Oxcarbazepine:

oxcarbazepine

[2]

8. Tiagabine:

[2]

1. Topiramate:

20% 30%

… [2, 5]

[2]

2. Zonisamide:

70% [3]

[2]

3. Levetiracetam:

27%

(Child-Pugh Class C)

57%[2] [1, 2, 3, 5]

gabapentin vigabatrin

gabapentin [1, 3]

vigabatrin

[1, 3]

Page 7: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

7

1. Glenda Corrêa Borges de Lacerda. Treating Seizures in Renal and Hepatic Failure. J Epilepsy Clin Neurophysiol

2008; 14(Suppl 2):46-50.

2. Ahmed SN, Siddiqi ZA. Antiepileptic drugs and liver disease. Seizure. 2006 Apr;15(3):156-64.

3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin

Pharmacokinet. 2014 Jan;53(1):29-49.

4. Asconapé JJ. The selection of antiepileptic drugs for the treatment of epilepsy in children and adults. Neurol Clin.

2010 Nov;28(4):843-52.

5. Ruiz-Giménez J1, Sánchez-Alvarez JC, Cañadillas-Hidalgo F, Serrano-Castro PJ; Andalusian Epilepsy Society.

Antiepileptic treatment in patients with epilepsy and other comorbidities. Seizure. 2010 Sep;19(7):375-82.

Page 8: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

8

103 7

( 103 ) 159

145

3

1 Oxaliplatin dyspnea

hypersensitivity

2

Ceftazidime

Aceclofenac

Esomeprazole

SJS

TEN

3 Iohexol dyspnea

rash/ eruption

iohexol 7 oxaliplatin 6

levofloxacin teicoplanin 5

Page 9: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

9

103 ADR

Drug

1 Iohexol 7 dyspnea 1

rash/ eruption 1

itching 2

rash/ eruption 2

urticaria 1

2 Oxaliplatin 6 dyspnea 1

hypersensitivity 1

rash/ eruption 4

itching 2

sneeze/ running nose 2

abdominal pain 1

cough 1

respiratory distress 1

3 Levofloxacin 5 rash/ eruption 5

3 Teicoplanin 5 rash/ eruption 2

drug fever 1

itching 1

5 Cefazolin 4 rash/ eruption 2

5 Ceftazidime 4 SJS 1

TEN 1

rash/ eruption 2

5 Piperacillin+tazobactam 4 rash/ eruption 3

neutropenia 1

5 Vancomycin 4 itching 2

rash/ eruption 2

leukopenia 1

9 Aceclofenac 3 SJS 1

TEN 1

9 Acemetacin 3

9 Amoxycillin+clavulanic 3 itching 2

Acid rash/ eruption 2

9 Azathioprine 3 neutropenia 1

pancytopenia 1

9 Carboplatin 3 itching 2

nausea 1

rash/ eruption 1

vomiting 1

9 Ceftriaxone 3 drug fever 1

Page 10: Chang Gung Drug Safety Newsletter€¦ · 3. Anderson GD, Hakimian S. Pharmacokinetic of antiepileptic drugs in patients with hepatic or renal impairment. Clin Pharmacokinet. 2014

10

itching 1

rash/ eruption 2

9 Cisplatin 3 rash/ eruption 3

itching 2

hypotension 1

tachycardia 1

9 Diphenhydramine 3

9 Moxifloxacin 3 itching 1

rash/ eruption 1

9 Nalbuphine 3 vomiting 1

9 Oxcarbazepine 3

9 Phenytoin 3 rash/ eruption 2

SJS 1

TEN 1

1. : ; ; 7 ; ; : ;