Revisions of PRECAUTIONS (FY2017)

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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
	Adrenaline (preparations indicated for emergency supplemental treatment of anaphylactic reactions caused by allergens in vespid venom, food, drugs and other allergens)
	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)
	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
	Aripiprazole hydrate Aripiprazole hydrate Paliperidone palmitate Haloperidol decanoate Risperidone (injections)
	Clozapine
	Blonanserin
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)
March 20, 2018	Tolvaptan
	Selexipag
	Clopidogrel sulfate Clopidogrel sulfate/aspirin
	Anagliptin
	Anagliptin
	Linagliptin Teneligliptin hydrobromide hydrate Teneligliptin hydrobromide hydrate/canagliflozin hydrate
	Sterile talc
February 13, 2018	Gardenia fruit Gardenia fruit Gardenia fruit Gardenia fruit
	Inchinkoto extract Inchinkoto extract Inchinkoto extract Orengedokuto extract Orengedokuto extract Orengedokuto extract Orengedokuto extract Kamishoyosan extract Kamishoyosan extract Kamishoyosan extract Shiniseihaito extract Shiniseihaito extract
	Unseiin extract Unseiin extract Kamikihito extract Kamikihito extract Kamikihito extract Keigairengyoto extract Gorinsan extract Gorinsan extract Saikoseikanto extract Saikoseikanto extract Shishihakuhito extract Seijobofuto extract Seihaito extract Bofutsushosan extract Bofutsushosan extract Bofutsushosan extract Ryutanshakanto extract Ryutanshakanto extract Ryutanshakanto extract
	Efavirenz
	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)
	Iomeprol Iomeprol
	Products containing gardenia fruit (OTC drugs)
January 11, 2018	Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aripiprazole Aripiprazole hydrate Aripiprazole hydrate
	Teriparatide (genetical recombination)
	Teriparatide acetate Teriparatide acetate
	Edoxaban tosilate hydrate Edoxaban tosilate hydrate
	Ipilimumab (genetical recombination)
	Lenvatinib mesilate
November 28, 2017	Clozapine
	Gadoxetate sodium Gadoteridol Meglumine gadoterate Gadobutrol
	Gadodiamide hydrate Gadodiamide hydrate Meglumine gadopentetate Meglumine gadopentetate
October 17, 2017	Levetiracetam Levetiracetam Levetiracetam
	Chlorhexidine hydrochloride/ diphenhydramine salicylate/ hydrocortisone acetate/ benzalkonium chloride concentrated solution 50
	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
	Products containing chlorhexidine gluconate or products containing chlorhexidine hydrochloride (OTC drugs)
	Linagliptin
	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
	Potassium clavulanate/ amoxicillin hydrate Potassium clavulanate/ amoxicillin hydrate
	Moxifloxacin hydrochloride (oral dosage form)
September 12, 2017	Dabigatran etexilate methanesulfonate
	Palivizumab (genetical recombination)
	Interferon beta
August 3, 2017	Riociguat
	Warfarin potassium Warfarin potassium Warfarin potassium
	Azithromycin hydrate Azithromycin hydrate Azithromycin hydrate Azithromycin hydrate Azithromycin hydrate
	Azithromycin hydrate
	Laninamivir octanoate hydrate
July 4, 2017	Tramadol hydrochloride Tramadol hydrochloride
	Tramadol hydrochloride
	Tramadol hydrochloride/ acetaminophen
	Dihydrocodeine phosphate/ dl-methylephedrine hydrochloride/ chlorpheniramine maleate Dihydrocodeine phosphate/ dl-methylephedrine hydrochloride/ chlorpheniramine maleate Dihydrocodeine phosphate/ dl-methylephedrine hydrochloride/ chlorpheniramine maleate
	Dihydrocodeine phosphate/diprophylline/ dl-methylephedrine hydrochloride/ diphenhydramine salicylate/ acetaminophen/bromovalerylurea
	Codeine phosphate hydrate/cherry bark extract Dihydrocodeine phosphate/ platycodon fluidextract/ glycyrrhiza extract/ plantago herb extract/peony root extract
	Codeine phosphate hydrate Codeine phosphate hydrate Codeine phosphate hydrate Codeine phosphate hydrate Codeine phosphate hydrate Dihydrocodeine phosphate Dihydrocodeine phosphate Dihydrocodeine phosphate
	Dihydrocodeine phosphate/ ephedrine hydrochloride/ ammonium chloride
	Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs) (preparations with the administration for patients younger than 2 years old)
	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)
	Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs) (preparations without the administration for patients younger than 12 years old)
	Loxoprofen sodium hydrate (Cataplasms/Gel Patches) Loxoprofen sodium hydrate(Tape) Loxoprofen sodium hydrate(Gel) Loxoprofen sodium hydrate(Spray)
	Hydroxocobalamin
	Nivolumab (genetical recombination)
	Fluconazole Fluconazole Fluconazole Fluconazole Fluconazole Fosfluconazole
	Patch test products containing gold (I) sodium thiosulfate
	Loxoprofen sodium hydrate (dermatologic preparation) (guidance-mandatory drugs)
May 30, 2017	Treprostinil
	Dulaglutide (genetical recombination)
	Bosutinib hydrate
	Pneumococcal vaccine
April 20, 2017	Denosumab (genetical recombination) (drug product with the indication for osteoporosis)
	Pembrolizumab (genetical recombination)
	Caspofungin acetate