Adult: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion
Doses are expressed in terms of the total ceftolozane/tazobactam combination: In combination with metronidazole: 1,500 mg 8 hourly via IV infusion over 1 hour for 4-14 days. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response. Child: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion
Doses are expressed in terms of the total ceftolozane/tazobactam combination: In combination with metronidazole: <18 years 30 mg/kg 8 hourly via IV infusion over 1 hour for 5-14 days. Max: 1,500 mg/dose; 18 years Same as adult dose. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response. Dosage and treatment recommendations may vary between countries (refer to country-specific product guidelines).
Adult: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion per vial
Doses are expressed in terms of the total ceftolozane/tazobactam combination: 1,500 mg 8 hourly via IV infusion over 1 hour for 7 days. May switch to an appropriate oral treatment treatment once clinical improvement has been achieved. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response. Child: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion
Doses are expressed in terms of the total ceftolozane/tazobactam combination: <18 years 30 mg/kg 8 hourly via IV infusion over 1 hour for 7-14 days. Max: 1,500 mg/dose; 18 years Same as adult dose. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response. Dosage and treatment recommendations may vary between countries (refer to country-specific product guidelines).
Adult: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion
Doses are expressed in terms of the total ceftolozane/tazobactam combination: 3,000 mg 8 hourly via IV infusion over 1 hour for 8-14 days. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response. Child: Ceftolozane 1,000 mg and tazobactam 500 mg powder for solution for infusion
Doses are expressed in terms of the total ceftolozane/tazobactam combination: 18 years Same as adult dose. Treatment duration may vary and should be based on the severity of the disease and patient's clinical response.
Các sản phẩm có chứa hoạt chất Ceftolozane + Tazobactam tại Việt Nam?
Complicated intra-abdominal infection; Complicated urinary tract infections; Pyelonephritis:
Doses are expressed in terms of the total ceftolozane/tazobactam combination: Patients with ESRD undergoing haemodialysis: Initially, 750 mg, then a maintenance dose of 150 mg given 8 hourly for the remaining treatment period. On haemodialsyis days, doses must be given at the earliest possible time after each dialysis session.
CrCl (mL/min)
Dosage
15-29
375 mg 8 hourly.
30-50
750 mg 8 hourly.
All doses are administered via IV infusion over 1 hour.
Hospital-acquired pneumonia; Ventilator associated pneumonia:
Doses are expressed in terms of the total ceftolozane/tazobactam combination: Patients with ESRD undergoing haemodialysis: Initially, 2,250 mg, then a maintenance dose of 450 mg given 8 hourly for the remaining treatment period. On haemodialysis days, doses must be given at the earliest possible time after each dialysis session.
CrCl (mL/min)
Dosage
15-29
750 mg 8 hourly.
30-50
1,500 mg 8 hourly.
All doses are administered via IV infusion over 1 hour.
Hướng dẫn pha thuốc
Reconstitute the vial with 10 mL of sterile water for inj or NaCl 0.9% to make a final volume of approx 11.4 mL containing 1,000 mg of ceftolozane and 500 mg of tazobactam. Shake gently to dissolve. Further dilute the reconstituted solution by withdrawing the required volume and adding it to an infusion bag containing 100 mL of NaCl 0.9% or dextrose 5% in water.
Chống chỉ định
Hypersensitivity to any cephalosporin antibacterial agent or severe hypersensitivity to any other type of β-lactam antibacterial agent (e.g. penicillins or carbapenems).
Thận trọng
Patient with a history of any other type of hypersensitivity to cephalosporins, penicillins or other β-lactam antibacterial agents. Not recommended for use in paediatric patients with renal impairment. Moderate to severe renal impairment, including ESRD and haemodialysis patients. Neonates and children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Renal impairment, renal failure. Blood and lymphatic system disorders: Thrombocytosis, anaemia. Cardiac disorders: Atrial fibrillation, tachycardia, angina pectoris. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, constipation, dyspepsia, abdominal distention, gastritis, flatulence, paralytic ileus. General disorders and administration site conditions: Fever, infusion site reactions. Investigations: Increased ALT, AST, transaminases, alkaline phosphatase, GGT, and serum gamma-glutamyl transpeptidase; abnormal LFTs. Metabolism and nutrition disorders: Hypokalaemia, hyperglycaemia, hypomagnesaemia, hypophosphataemia. Nervous system disorders: Headache, dizziness, ischaemic stroke. Psychiatric disorders: Insomnia, anxiety. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Rash, urticaria. Vascular disorders: Hypotension, phlebitis, venous thrombosis. Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis), fungal or bacterial superinfection (e.g. Clostridioides difficile-associated diarrhoea, pseudomembranous colitis).
This drug may cause dizziness, if affected, do not drive or operate machinery.
Chỉ số theo dõi
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Evaluate the patient's allergy history before treatment initiation. Monitor serum creatinine and CrCl at baseline and daily in patients with varying renal function.
Tương tác
Tazobactam: Organic anion transporters 1 or 3 (OAT1 or OAT3) inhibitors (e.g. probenecid, diclofenac, cimetidine) may increase the plasma concentration of tazobactam.
Ảnh hưởng đến kết quả xét nghiệm
May cause a positive direct antiglobulin test (Coombs test).
Tác dụng
Description: Mechanism of Action: Ceftolozane is a 5th generation cephalosporin antibiotic. It exerts bactericidal activity by binding to 1 or more penicillin-binding proteins (PBPs) which inhibits the final transpeptidation step of peptidoglycan synthesis in the bacterial cell walls, thus leading to bacterial cell lysis and death.
Tazobactam is a penicillanic acid sulfone derivative. It irreversibly inhibits certain bacterial β-lactamases and covalently binds to some plasmid-mediated and chromosomal bacterial β-lactamases. This inhibition prevents ceftolozane from degradation by β-lactamases, thereby expanding its spectrum of activity. Pharmacokinetics: Distribution: Distributed into the pulmonary epithelial lining fluid.
Ceftolozane: Volume of distribution: 13.5 L. Plasma protein binding: Approx 16-21%.
Tazobactam: Crosses the placenta. Volume of distribution: 18.2 L. Plasma protein binding: 30%. Metabolism: Ceftolozane: Not metabolised.
Tazobactam: Partially metabolised via hydrolysis of the β-lactam ring into an inactive metabolite (M1). Excretion: Ceftolozane: Via urine (>95% as unchanged drug). Elimination half-life: Approx 3-4 hours.
Tazobactam: Via urine (>80% as unchanged drug). Elimination half-life: Approx 2-3 hours.
Đặc tính
Ceftolozane Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 53234134, Ceftolozane. https://pubchem.ncbi.nlm.nih.gov/compound/Ceftolozane. Accessed Dec. 26, 2024.
Tazobactam Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 123630, Tazobactam. https://pubchem.ncbi.nlm.nih.gov/compound/Tazobactam. Accessed Dec. 26, 2024.
Bảo quản
Intact vial: Store between 2-8°C. Protect from light. Diluted solution: Stable for 24 hours at <25°C or for 7 days between 2-8°C. Do not freeze.
J01DI54 - ceftolozane and beta-lactamase inhibitor ; Belongs to the class of other cephalosporins and penems. Used in the systemic treatment of infections.
Tài liệu tham khảo
Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 05/12/2024.Anon. Ceftolozane/Tazobactam. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/12/2024.Brayfield A, Cadart C (eds). Ceftolozane. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/12/2024.Brayfield A, Cadart C (eds). Tazobactam Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/12/2024.Ceftolozane and Tazobactam. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/12/2024.Ceftolozane and Tazobactam. UpToDate Lexidrug, Pediatric and Neonatal Lexi-Drugs Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 04/12/2024.Ceftolozane; Tazobactam. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 05/12/2024.Joint Formulary Committee. Ceftolozane with Tazobactam. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/12/2024.Merck Sharp & Dohme (New Zealand) Limited. Zerbaxa Powder for Injection data sheet 14 June 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 04/12/2024.Zerbaxa 1 g/0.5 g Powder for Concentrate for Solution for Infusion (Merck Sharp & Dohme [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/12/2024.Zerbaxa 1.5 g Powder for Solution for Injection (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/12/2024.Zerbaxa Injection, Powder, Lyophilized, for Solution (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/12/2024.Zerbaxa Powder for Solution for Injection (MSD Pharma [Singapore] Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 16/12/2024.
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