News Release


 

ZOSYN®, an Injectable Antibiotic Combination Product Receives an Approval for Peritonitis, Intra-abdominal Abscess, Cholecystitis, and Cholangitis (28/09/2012)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today that ZOSYN® 2.25 and ZOSYN® 4.5 for intravenous injection (generic name: tazobactam and piperacillin for injection), received an approval of new indications for the treatment of peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis in Japan.

ZOSYN® is an injectable antibacterial combination product consisting of the β-lactamase inhibitor tazobactam sodium and the semisynthetic antibiotic piperacillin sodium in a ratio of 1:8 in potency for intravenous administration. In July 2008, ZOSYN® was approved as a highly effective drug for septicemia, pneumonia, pyelonephritis, and complicated cystitis.

Taiho Pharmaceutical Co., Ltd. holds the marketing authorization of ZOSYN® in Japan and Taisho Toyama Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Akira Ohira) is marketing the product. ZOSYN® is currently available in approximately 90 countries. This intravenous antibiotic product is well recognized as a standard therapeutic agent for bacterial infections around the world.

This approval for wider indications will enable ZOSYN® to contribute to further infectious disease therapy for the patients in Japan.

Product specifications

Newly approved indications are underlined.

Brand name ZOSYN® 2.25 for Intravenous Injection ; ZOSYN® 4.5 for Intravenous Injection
Generic name Tazobactam and piperacillin for injection
Indication

Indicated bacteria:
Staphylococcus spp., Streptococcus spp., Streptococccus 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.

Indications:
Septicemia, pneumonia, pyelonephritis, complicated cystitis, peritonitis, intra-abdominal abscess, cholecystitis, and cholangitis

Dosage and administration

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 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 intravenously. 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.

When administered by intravenous infusion, ZOSYN® is administered after being dissolved in a compatible reconstitution diluent. When administered by bolus infusion, the drug is slowly injected after being dissolved in water for injection, saline or 5% glucose injection.

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 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 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.

When administered by intravenous infusion, ZOSYN® is administered after being dissolved in a compatible reconstitution diluent. When administered by bolus infusion, the drug is slowly injected after being dissolved in water for injection, saline or 5% glucose injection.


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