News Release

May 18, 2017
Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Receives Approval for the Additional Indications of Complicated Skin and Soft Tissue Infections for ZOSYN®, an Injectable Antibiotic Combined with β-lactamase Inhibitor

Taiho Pharmaceutical Co., Ltd. announced today that it has received approval for the additional indications of complicated skin and soft tissue infections for its β-lactamase inhibitor combination product ZOSYN 2.25 and ZOSYN 4.5 for Intravenous Injection, and ZOSYN 4.5 for I.V. infusion bag (generic name: tazobactam and piperacillin) in Japan.

On the basis of the status of approval outside Japan and information of treatment guidelines, guidebooks, published reports, etc. in and outside Japan relating to complicated skin and soft tissue infections, the Japanese Ministry of Health, Labour and Welfare (MHLW) has acknowledged, on the basis of "Handling of Ethical Drugs for Off-label Use,"*1 that the efficacy and safety of ZOSYN are well-known in medical and pharmaceutical terms. This approval was therefore received without conducting new clinical studies in patients with complicated skin and soft tissue infections.

Taiho remains committed to making further contributions to patients and to medical practitioners engaged in the treatment of infectious diseases.

About ZOSYN

ZOSYN is an injectable antibacterial combination product consisting of the β-lactamase inhibitor tazobactam, which Taiho discovered, and the semisynthetic antibiotic piperacillin, which the Fujifilm Group’s Toyama Chemical Co., Ltd. discovered, in a ratio of 1:8 in potency for intravenous administration. Taiho holds the marketing authorization for ZOSYN in Japan, and Taisho Toyama Pharmaceutical Co., Ltd. is marketing the product.

In July 2008, ZOSYN was approved in Japan for the treatment of septicemia, pneumonia, pyelonephritis, and complicated cystitis in adults and children. In September 2012, it received approval for the indications of peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis and was later approved for febrile neutropenia in June 2015. ZOSYN has been approved in 105 countries*2 outside Japan. It is recommended as a first choice in the guidelines issued by medical societies including those in the U.S. and various European countries for the treatment of various infectious diseases, and ZOSYN is well recognized as a standard therapeutic agent for bacterial infections around the world.

About complicated skin and soft tissue infections

Complicated skin and soft tissue infections are general terms for purulent inflammations characterized by diffusion from the dermis to subcutaneous tissue. They are categorized as either superficial or complicated based on the extent and depth of the lesion site. Erosive, ulcerated secondary infections include bedsores, leg ulcers, radiation ulcers, and diabetic gangrene that extend to the deep skin layers. Moderate and severe conditions often require treatment with injectable antibiotics.

*1: Notification No. 4 of the Research and Development Division, PMSB/ELD Notification No. 104, February 1, 1999. Joint notification by Director, Research and Development Division, MHLW, and Director, Evaluation and Licensing Division, MHLW.

*2: As of October 2016 (latest)

Product specifications : Newly approved indication is underlined.

Brand Name

ZOSYN® 2.25 for Intravenous Injection; ZOSYN® 4.5 for Intravenous Injection; ZOSYN® 4.5 for I.V. Infusion Bag

Generic Name

tazobactam, piperacillin

Indications

1. Septicemia, complicated skin and soft tissue Infections, pneumonia, pyelonephritis, complicated cystitis, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis

Indicated bacteria:

Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae, Enterococcus spp., Moraxella (Branhamella) catarrhalis, Escherichia coli, Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., Haemophilus influenzae, Pseudomonas aeruginosa, Acinetobacter spp., Peptostreptococcus spp., Clostridium spp. (except C. difficile), Bacteroides spp., Prevotella spp.

2. Febrile neutropenia

Dosage and Administration

Dosage and Administration for ZOSYN 2.25 for Intravenous Injection; ZOSYN 4.5 for Intravenous Injection

1. For septicemia and pneumonia, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis:

The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily. In the case of pneumonia, the dosage may be increased to four times daily according to the symptoms and clinical condition. If necessary, the drug may be injected slowly as an intravenous bolus infusion.

The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, three times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The single-dose amount may be adequately decreased according to the symptoms and clinical condition. However, the upper limit of the dosage is equal to the one for adults: 4.5 g.

For complicated skin and soft tissue infections:

The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily. If necessary, the drug may be injected slowly as an intravenous bolus infusion.

For pyelonephritis and complicated cystitis:

The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, twice daily. The dosage may be increased to three times daily according to the symptoms and clinical condition. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion.

The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, twice daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. The dosage may be adequately decreased according to the symptoms and clinical condition. The dosage may also be increased to three times per day in accordance with the symptoms and the patient's condition. However, the upper limit of the dosage is equal to the one for adults: 4.5g.

2. For febrile neutropenia:

The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, four times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion.

The usual pediatric dosage for intravenous infusion is a 90 mg/kg single dose, four times daily. If necessary, ZOSYN may be injected slowly as an intravenous bolus infusion. However, the upper limit of the dosage is equal to the one for adults: 4.5 g.

Dosage and Administration for ZOSYN 4.5 for I.V. Infusion Bag

1. For septicemia and pneumonia, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis:

The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily. In the case of pneumonia, the dosage may be increased to four times daily according to the symptoms and clinical condition.

The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, three times daily. The dosage may be decreased according to the symptoms and clinical condition. However, the upper limit of the dosage is equal to the one for adults: 4.5g.

For complicated skin and soft tissue infections:

The usual adult dosage of ZOSYN for intravenous infusion is a 4.5 g single dose, three times daily.

For pyelonephritis and complicated cystitis:

The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, twice daily. The dosage may be increased to three times daily according to the symptoms and clinical condition.

The usual pediatric dosage for intravenous infusion is a 112.5 mg/kg single dose, twice daily. The dosage may be decreased according to the symptoms and clinical condition. It may also be increased to three times daily according to the symptoms and clinical condition. However, the upper limit of the dosage is equal to the one for adults: 4.5 g.

2. For febrile neutropenia

The usual adult dosage of ZOSYN for drip infusion is a 4.5 g single dose, four times daily.

The usual pediatric dosage for intravenous infusion is a 90 mg/kg single dose, four times daily. However, the upper limit of the dosage is equal to the one for adults: 4.5 g.

Information in this news release was current as of the original release date.

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