Here begins the text.

Revisions of PRECAUTIONS (FY2017)

Posted date Nonproprietary name
(Click on each drug name for more information
[only available in Japanese language])
Detailed information on revisions of PRECAUTIONS
(from MHLW)
Summary of investigation results
(from PMDA)
March 27,
 2018
Propofol
Propofol
Propofol
Propofol
PDF PDF
Adrenaline (preparations indicated for
emergency supplemental treatment of
anaphylactic reactions caused by
allergens in vespid venom, food, drugs
and other allergens)
PDF PDF
Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions)

Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions)
PDF
Asenapine maleate
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
olanzapine
olanzapine
olanzapine
olanzapine
quetiapine fumarate
quetiapine fumarate
quetiapine fumarate
clocapramine hydrochloride hydrate
clocapramine hydrochloride hydrate
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine
hydrochloride/promethazine
hydrochloride/phenobarbital

chlorpromazine phenolphthalinate
spiperone
zotepine
timiperone
timiperone
haloperidol
haloperidol
haloperidol
haloperidol
paliperidone
pipamperone
hydrochloride

fluphenazine decanoate
fluphenazine maleate
brexpiprazole
prochlorperazine mesilate
prochlorperazine maleate
propericiazine
bromperidol
perphenazine
perphenazine
hydrochloride

perphenazine fendizoate
perphenazine maleate
perospirone
hydrochloride hydrate

mosapramine hydrochloride
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
levomepromazine hydrochloride
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate
PDF
Aripiprazole hydrate
Aripiprazole hydrate
Paliperidone palmitate
Haloperidol decanoate
Risperidone (injections)
PDF
Clozapine PDF
Blonanserin PDF
March 27,
 2018
Azithromycin hydrate (Tablets 250 mg/500 mg)
Azithromycin hydrate (Dry syrup)
Azithromycin hydrate (For pediatric use)
Azithromycin hydrate (For pediatric use)
Aztreonam
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin
Hydrate/potassium clavulanate

Amoxicillin
Hydrate/potassium clavulanate

Ampicillin Hydrate
Ampicillin Hydrate
Ampicillin Sodium
Ampicillin Sodium, Cloxacillin Sodium Hydrate (100mg preparation)
Imipenem Hydrate, Cilastatin Sodium
Imipenem Hydrate, Cilastatin Sodium
Erythromycin
Erythromycin Ethylsuccinate
Erythromycin Ethylsuccinate
Erythromycin Stearate
Ofloxacin (Tablets)
Kanamycin Monosulfate
Kanamycin Monosulfate
Kanamycin Sulfate
Clarithromycin
Clarithromycin
Clarithromycin
Clindamycin Hydrochloride
Clindamycin Phosphate (For injection)
Clindamycin Phosphate (For injection)
Chloramphenicol(For topical application)
Chloramphenicol(For oral use)
Chloramphenicol Sodium Succinate
Colistin Sodium Methanesulfonate
Colistin Sodium Methanesulfonate
Sitafloxacin Hydrate
Sitafloxacin Hydrate
Ciprofloxacin Hydrochloride Hydrate
Dibekacin Sulfate (For injection)
Dibekacin Sulfate (For injection)
Josamycin
Josamycin Propionate
Josamycin Propionate
Spiramycin Acetate
Sultamicillin Tosilate Hydrate
Sultamicillin Tosilate Hydrate
Sulfamethoxazole,Trimethoprim (For oral use)
Cefaclor
Cefaclor
Cefaclor
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalotin Sodium
Cefixime Hydrate
Cefepime Dihydrochloride Hydrate
Cefepime Dihydrochloride Hydrate
Cefozopran Hydrochloride
Cefotaxime Sodium
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hexetil Hydrochloride
Cefoperazone Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefditoren Pivoxil
Cefditoren Pivoxil
Cefdinir
Cefdinir
Cefdinir
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftizoxime Sodium
Ceftibuten Hydrate
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Cefpirome Sulfate
Cefpodoxime Proxetil
Cefpodoxime Proxetil
Cefminox Sodium Hydrate
Cefmetazole Sodium
Cefmetazole Sodium
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For ear and nose)
Cefroxadine Hydrate
Cefuroxime Axetil
Tetracycline Hydrochloride (For oral use)
Tetracycline Hydrochloride (For oral use)
Tebipenem Pivoxil
Demethylchlortetracycline Hydrochloride
Doxycycline Hydrochloride Hydrate
Tosufloxacin Tosilate Hydrate (Tablets)
Tosufloxacin Tosilate Hydrate (Tablets)
Tobramycin
Doripenem Hydrate
Nalidixic acid
Nalidixic acid
Norfloxacin (Tablets)
Norfloxacin (Tablets)
Bacampicillin Hydrochloride
Panipenem, Betamipron
Vancomycin Hydrochloride (Powder)
Pipemidic Acid Hydrate
Piperacillin Sodium
Piperacillin Sodium
Piperacillin Sodium
Faropenem Sodium Hydrate
Faropenem Sodium Hydrate
Prulifloxacin
Flomoxef Sodium
Benzylpenicillin Potassium
Benzylpenicillin Benzathine Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Sodium (For injection)
Fosfomycin Sodium (For injection)
Polymixin B Sulfate (Powder)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For injection)
Garenoxacin Mesilate Hydrate
Metronidazole (For oral use)
Metronidazole (For injection)
Meropenem Hydrate
Moxifloxacin hydrochloride (Tablets)
Latamoxef Sodium
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Roxithromycin
Lomefloxacin hydrochloride (For oral use)
PDF PDF
March 20,
 2018
Tolvaptan PDF PDF
Selexipag PDF PDF
Clopidogrel sulfate
Clopidogrel sulfate/aspirin
PDF
Anagliptin PDF PDF
Anagliptin PDF
Linagliptin

Teneligliptin hydrobromide hydrate

Teneligliptin hydrobromide hydrate/canagliflozin hydrate
PDF
Sterile talc PDF PDF
February 13,
 2018
Gardenia fruit
Gardenia fruit
Gardenia fruit
Gardenia fruit
PDF PDF
Inchinkoto extract
Inchinkoto extract
Inchinkoto extract 

Orengedokuto extract
Orengedokuto extract
Orengedokuto extract
Orengedokuto extract

Kamishoyosan extract
Kamishoyosan extract
Kamishoyosan extract

Shiniseihaito extract
Shiniseihaito extract
PDF
PDF
Efavirenz PDF PDF
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel, CT)
Iohexol (for urinary tract, blood vessel, CT)
PDF PDF
Iomeprol
Iomeprol
PDF
Products containing gardenia fruit
 (OTC drugs)
PDF PDF
January 11,
 2018
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole

Aripiprazole hydrate
Aripiprazole hydrate
PDF PDF
Teriparatide
 (genetical recombination)
PDF PDF
Teriparatide acetate
Teriparatide acetate
PDF
Edoxaban tosilate hydrate
Edoxaban tosilate hydrate
PDF PDF
Ipilimumab
 (genetical recombination)
PDF PDF
Lenvatinib mesilate PDF PDF
November 28,
2017
Clozapine PDF PDF
Gadoxetate sodium
Gadoteridol
Meglumine gadoterate
Gadobutrol
PDF PDF
Gadodiamide hydrate
Gadodiamide hydrate

Meglumine gadopentetate
Meglumine gadopentetate
PDF
October 17,
 2017
Levetiracetam
Levetiracetam
Levetiracetam
PDF PDF
Chlorhexidine hydrochloride/
diphenhydramine salicylate/
hydrocortisone acetate/
benzalkonium chloride concentrated solution 50
PDF PDF
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
PDF
Products containing chlorhexidine gluconate or products containing chlorhexidine hydrochloride (OTC drugs) PDF PDF
Linagliptin PDF PDF
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate

Lansoprazole/amoxicillin hydrate/
clarithromycin


Lansoprazole/amoxicillin hydrate/
metronidazole


Rabeprazole sodium/amoxicillin hydrate/clarithromycin

Rabeprazole sodium/amoxicillin hydrate/metronidazole

Vonoprazan fumarate/amoxicillin hydrate/clarithromycin

Vonoprazan fumarate/amoxicillin hydrate/metronidazole
PDF PDF
Potassium clavulanate/
amoxicillin hydrate

Potassium clavulanate/
amoxicillin hydrate
PDF
Moxifloxacin hydrochloride
(oral dosage form)
PDF PDF
September 12,
 2017
Dabigatran etexilate methanesulfonate PDF PDF
Palivizumab (genetical recombination) PDF PDF
Interferon beta PDF PDF
August 3,
2017
Riociguat PDF PDF
Warfarin potassium
Warfarin potassium
Warfarin potassium
PDF PDF
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
PDF PDF
Azithromycin hydrate PDF
Laninamivir octanoate hydrate PDF PDF
July 4,
2017
Tramadol hydrochloride
Tramadol hydrochloride
PDF PDF
Tramadol hydrochloride PDF
Tramadol hydrochloride/
acetaminophen
PDF
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate


Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate


Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
PDF
Dihydrocodeine phosphate/diprophylline/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/bromovalerylurea
PDF
Codeine phosphate hydrate/cherry bark extract

Dihydrocodeine phosphate/
platycodon fluidextract/
glycyrrhiza extract/
plantago herb extract/peony root extract
PDF
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate

Dihydrocodeine phosphate
Dihydrocodeine phosphate
Dihydrocodeine phosphate
PDF
Dihydrocodeine phosphate/
ephedrine hydrochloride/
ammonium chloride
PDF
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 2 years old)
PDF
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 12 years old and without the administration for patients younger than 2 years old)
PDF
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations without the administration for patients younger than 12 years old)
PDF
Loxoprofen sodium hydrate
(Cataplasms/Gel Patches)

Loxoprofen sodium hydrate(Tape)
Loxoprofen sodium hydrate(Gel)
Loxoprofen sodium hydrate(Spray)
PDF PDF
Hydroxocobalamin PDF PDF
Nivolumab
(genetical recombination)
PDF PDF
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fosfluconazole
PDF PDF
Patch test products containing gold (I) sodium thiosulfate PDF PDF
Loxoprofen sodium hydrate
(dermatologic preparation)
(guidance-mandatory drugs)
PDF PDF
May 30,
2017
Treprostinil PDF PDF
Dulaglutide
(genetical recombination)
PDF PDF
Bosutinib hydrate PDF PDF
Pneumococcal vaccine PDF PDF
April 20,
2017
Denosumab
 (genetical recombination)
(drug product with the indication for osteoporosis)
PDF PDF
Pembrolizumab
(genetical recombination)
PDF PDF
Caspofungin acetate PDF PDF

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

000044665
0
Revisions of PRECAUTIONS (FY2017)
/english/safety/info-services/drugs/revision-of-precautions/0005.html
en