Summary of investigation results
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1 Summary of investigation results Products containing hydrate October 17, 2017 Non-proprietary name a. hydrate b. potassium clavulanate/ hydrate c. lansoprazole/ clarithromycin d. lansoprazole/ metronidazole e. rabeprazole sodium/ clarithromycin f. rabeprazole sodium/ metronidazole g. vonoprazan fumarate/ clarithromycin h. vonoprazan fumarate/ metronidazole Brand name (marketing authorization holder) a. Sawacillin Capsules 125 and 250, Sawacillin Fine Granules 10%, Sawacillin Tablets 250 (Astellas Pharma Inc.), Pasetocin Capsules 125 and 250, Pasetocin Fine Granules 10%, Pasetocin Tablets 250 (Aspen Japan K.K.), and others b. Augmentin Combination Tablets 125 SS and 250 RS, Clavamox Combination Dry Syrup for pediatric (GlaxoSmithKline K.K.) c. Lansap 400, 800 (Takeda Pharmaceutical Company Limited) d. Lampion Pack (Takeda Pharmaceutical Company Limited) e. Rabecure Pack 400, 800 (Eisai Co., Ltd.) f. Rabefine Pack (Eisai Co., Ltd.) g. Vonosap Pack 400, 800 (Takeda Pharmaceutical Company Limited) h. Vonopion Pack (Takeda Pharmaceutical Company Limited) Indications Refer to the attachment below. Summary of revision a. hydrate: Thrombocytopenia should be added with regard to the precaution against granulocytopenia in the Clinically Significant Adverse Reactions section.
2 b. potassium clavulanate/ hydrate: Thrombocytopenia should be added with regard to agranulocytosis and granulocytopenia in the Clinically Significant Adverse Reactions section. c, d, e, f, g, h. lansoprazole/ clarithromycin, lansoprazole/ metronidazole, rabeprazole sodium/ clarithromycin, rabeprazole sodium/ metronidazole, vonoprazan fumarate/ clarithromycin, vonoprazan fumarate/ metronidazole: Thrombocytopenia should be added with regard to the precaution against granulocytopenia ( hydrate) in the Clinically Significant Adverse Reactions section. Background of the revision and investigation results Cases of thrombocytopenia have been reported in patients treated with hydrate and potassium clavulanate/ hydrate in Japan. Following investigation results based on the opinions of expert advisors and the available evidence, the MHLW/PMDA concluded that revision of the package insert was necessary.
3 The number of reported adverse reactions and fatal cases in the last 3 fiscal years in Japan (in and after FY 2014) a. hydrate A total of 3 cases associated with thrombocytopenia have been reported (the causal relationship to the product could not be ruled out in those patients). No fatality has been reported. b. potassium clavulanate/ hydrate A total of 3 cases associated with thrombocytopenia have been reported (including 2 cases for which a causal relationship to the product could not be ruled out). No fatality has been reported. c. lansoprazole/ clarithromycin A total of 2 cases associated with thrombocytopenia have been reported*. No fatality has been reported. d. lansoprazole/ metronidazole No case associated with thrombocytopenia has been reported. e. rabeprazole sodium/ clarithromycin A case associated with thrombocytopenia has been reported*. No fatality has been reported. f. rabeprazole sodium/ metronidazole No case associated with thrombocytopenia has been reported. g. vonoprazan fumarate/ clarithromycin No case associated with thrombocytopenia has been reported. h. vonoprazan fumarate/ metronidazole No case associated with thrombocytopenia has been reported. NOTE: *Causal relationship has not been evaluated.
4 Attachment Non-proprietary name a. hydrate Brand Name (Marketing Authorization Holder Sawacillin Capsules 125, 250, Sawacillin Tablets 250 (Astellas Pharma Inc.), Pasetocin Capsules 125, 250, and Pasetocin Tablets 250 (Aspen Japan K.K.) and others Sawacillin Fine Granules 10% (Astellas Pharma Indications -susceptible strains of genus Staphylococcus, genus Streptococcus, Streptococcus pneumoniae, genus Enterococcus, Neisseria gonorrhoeae, Escherichia coli, Proteus mirabilis, Haemophilus influenza, Helicobacter pylori, Treponema pallidum Superficial skin infections, deep-seated skin infections, lymphangitis/lymphadenitis, chronic pyoderma, secondary infections following trauma, thermal burn, and surgical wound, secondary infections of erosions/ulcers, mastitis, osteomyelitis, pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia, secondary infection of chronic respiratory lesions, cystitis, pyelonephritis, prostatitis (acute/chronic), epididymitis, Neisseria gonorrhoeae infection, syphilis, intrauterine infection, uterine adnexitis, parametritis, dacryocystitis, hordeolum, otitis media, periodontal inflammation, pericoronitis, jaw inflammation, scarlet fever, for gastric/duodenal ulcer, mucosa-associated lymphoid tissue (MALT) lymphoma of the stomach, idiopathic thrombocytopenic purpura, and early -susceptible strains of genus Staphylococcus, genus
5 b. potassium clavulanate/ hydrate Inc.) and Pasetocin Fine Granules 10% and (Aspen Japan K.K.) and others Augmentin Combination Tablets 125SS, 250RS (GlaxoSmithKline K.K.) Streptococcus, Streptococcus pneumoniae, genus Enterococcus, Neisseria gonorrhoeae, Escherichia coli, Proteus mirabilis, Haemophilus influenza, Helicobacter pylori, and Treponema pallidum Superficial skin infections, deep-seated skin infections, lymphangitis/lymphadenitis, chronic pyoderma, secondary infections following trauma, thermal burn, and surgical wound, secondary infections of erosions/ulcers, mastitis, osteomyelitis, pharyngitis/laryngitis, tonsillitis, acute bronchitis, pneumonia, secondary infection of chronic respiratory lesions, cystitis, pyelonephritis, prostatitis (acute/chronic), epididymitis, Neisseria gonorrhoeae infection, syphilis, intrauterine infection, uterine adnexitis, parametritis, dacryocystitis, hordeolum, otitis media, periodontal inflammation, pericoronitis, jaw inflammation, scarlet fever, and stomach/duodenal ulcer -susceptible strains of genus Staphylococcus, Neisseria gonorrhoeae, Escherichia coli, genus Klebsiella, genus Proteus, Haemophilus influenza, genus Bacteroides, genus Prevotella (except Prevotella bivia) Superficial skin infections, deep-seated skin infections, lymphangitis/lymphadenitis, chronic pyoderma, pharyngitis/laryngitis, tonsillitis, acute bronchitis, secondary infection of chronic respiratory lesions, cystitis, pyelonephritis, Neisseria gonorrhoeae infection,
6 c. lansoprazole/ clarithromycin d. lansoprazole/ metronidazole Clavamox Combination Dry Syrup for pediatric (GlaxoSmithKline K.K.) Lansap 400, 800 (Takeda Pharmaceutical Company Limited) Lampion Pack (Takeda Pharmaceutical Company Limited) intrauterine infection, uterine adnexitis, and otitis media -susceptible strains of Streptococcus pneumoniae, (minimum inhibitory concentration of penicillin G. 2 μg/ml), Moraxella (Branhamella) catarrhalis, Haemophilus influenza, genus Staphylococcus, Escherichia coli, genus Klebsiella, genus Proteus, genus Bacteroides, genus Prevotella (except Prevotella bivia) Superficial skin infections, deep-seated skin infections, lymphangitis/lymphadenitis, chronic pyoderma, pharyngitis/laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis, otitis media and sinusitis /clarithromycin-susceptible strains of Helicobacter pylori /metronidazole-susceptible strains of Helicobacter pylori
7 e. rabeprazole sodium/ clarithromycin f. rabeprazole sodium/ metronidazole g. vonoprazan fumarate/ clarithromycin Rabecure Pack 400, 800 mg (Eisai Co., Ltd.) Rabefine Pack (Eisai Co., Ltd.) Vonosap Pack 400, 800 (Takeda Pharmaceutical Company Limited) /clarithromycin-susceptible strains of Helicobacter pylori /metronidazole -susceptible strains of Helicobacter pylori /clarithromycin-susceptible strains of Helicobacter pylori
8 h. vonoprazan fumarate/ metronidazole Vonopion Pack (Takeda Pharmaceutical Company Limited) /metronidazole -susceptible strains of Helicobacter pylori
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