Cefepime


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intramuscular, Intravenous
Intra-abdominal infections, Lower respiratory tract infections, Skin and skin structure infections
Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. Mild to moderate cases: 1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may be increased to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7-10 days. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Child: >2 months ≤40 kg: 50 mg/kg 12 hourly for 10 days, may increase frequency to 8 hourly in more severe cases; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).

Intramuscular, Intravenous
Urinary tract infections
Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. For complicated and uncomplicated cases: Mild to moderate 0.5-1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may be increased to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7-10 days. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Child: >2 months ≤40 kg: 50 mg/kg 12 hourly for 10 days, may increase frequency to 8 hourly in more severe cases; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).

Intramuscular, Intravenous
Febrile neutropenia
Adult: Dose and route of administration may vary according to the severity of the infection, renal function and general condition of the patient. As empiric treatment: Mild to moderate cases: 1 g 12 hourly via IV inj or infusion over at least 30 minutes or IM inj. Severe cases: 2 g 12 hourly via IV inj or infusion over at least 30 minutes, may increase to 2 g 8 hourly for very severe infections. Max: 2 g 8 hourly. Usual treatment duration: 7 days or until neutropenia is resolved. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Child: >2 months ≤40 kg: 50 mg/kg 8 hourly for 7-10 days; >40 kg: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Suy thận
In patients with mild to moderate renal insufficiency, initial dose recommended is similar in patients with normal renal function.
CrCl (mL/min) Dosage
<11
Maintenance: 0.25-1 g 24 hourly.
11-29
Maintenance: 0.5-2 g 24 hourly.
30-60
Maintenance: 0.5-2 g 24 hourly or 2 g 12 hourly.

Patients undergoing haemodialysis:
Lower respiratory tract infections; Intra-abdominal infections; Skin and skin structure infections; Urinary tract infections:
1 g as loading dose on the 1st day, followed by 0.5 g 24 hourly; administer after dialysis during dialysis days.
Febrile neutropenia:
1 g 24 hourly; administer after dialysis during dialysis days.
Hướng dẫn pha thuốc
IV: Reconstitute vials labelled as 500 mg and 1 g or 2 g with 5 mL and 10 mL of compatible diluent, respectively, to yield a final concentration of 100 mg/mL (500 mg and 1 g vial) and 160 mg/mL (2 g vial). Dilute further in a compatible IV infusion fluid. IM: Reconstitute vials labelled as 500 mg or 1 g with 1.3 mL or 2.4 mL, respectively, of sterile water for inj, 0.9% NaCl, 5% dextrose in water, lidocaine 0.5% or 1%, or bacteriostatic water for inj to yield a final concentration of 280 mg/mL.
Tương kỵ
Incompatible with metronidazole, aminophylline, gentamicin, tobramycin, netilmicin, vancomycin, and ampicillin (at a concentration >40 mg/mL).
Chống chỉ định
Hypersensitivity to cefepime or other cephalosporins; history of severe hypersensitivity reactions (e.g. anaphylactic reaction) to other β-lactam antibacterial agents (e.g. penicillins, carbapenems, monobactams).
Thận trọng
Patient with history of non-severe hypersensitivity to other β-lactam agents, asthma, allergic diathesis, seizure disorder, gastrointestinal disease (particularly colitis). Children and elderly. Renal impairment. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Elevated INR; fungal or bacterial superinfection (prolonged use).
Blood and lymphatic system disorders: Anaemia, eosinophilia.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting.
General disorders and administration site conditions: Localised reactions (e.g. phlebitis, inflammation and/or pain), fever.
Investigations: Increased AST, ALT, alkaline phosphatase, blood bilirubin; prolonged partial thromboplastin time.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Hypersensitivity reactions; Pseudomembranous colitis, Clostridium difficile-associated diarrhoea; neurotoxicity e.g. encephalopathy, aphasia, myoclonus, seizures, non-convulsive status epilepticus (in patients with renal impairment who did not receive appropriate dosage adjustment).
IM/IV/Parenteral: B
Chỉ số theo dõi
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor renal function. Assess for signs and symptoms of anaphylaxis during the initial dose.
Quá liều
Symptoms: Encephalopathy (disturbance of consciousness including confusion, stupor, hallucinations, and coma), myoclonus, seizures, neuromuscular excitability, nonconvulsive status epilepticus. Management: Supportive treatment. In case of severe overdose, particularly in patients with renal insufficiency, haemodialysis is recommended and not peritoneal dialysis.
Tương tác
May potentiate the action of coumarin anticoagulants. May enhance the nephrotoxic effects of aminoglycosides or potent diuretics (e.g. furosemide).
Ảnh hưởng đến kết quả xét nghiệm
May cause false-positive results for Coombs test (without evidence of haemolysis) and urinary glucose with Cu reduction tests (e.g. Benedict's solution, Fehling's solution, Clinitest® tab).
Tác dụng
Description: Cefepime is a broad-spectrum, bactericidal antibiotic that is active against a wide range of Gram-positive and Gram-negative bacteria, including multiple strains resistant to aminoglycosides or 3rd generation cephalosporins. It acts by inhibiting the bacterial cell wall synthesis by binding to 1 or more penicillin-binding proteins (PBP) which interrupts the final transpeptidation step of peptidoglycan synthesis, leading to bacterial cell lysis and death. It is highly resistant to most β-lactamases.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed following IM inj. Time to peak plasma concentrations: 1-2 hours (IM); 0.5 hours (IV).
Distribution: Widely distributed in body fluids and tissues; highly concentrated in bile. Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 18 L. Plasma protein binding: Approx 20%.
Metabolism: Metabolised in the liver to N-methylpyrrolidinium, which is rapidly converted to the N-oxide.
Excretion: Via urine (85% as unchanged drug; <1% as N-methylpyrrolidinium, 6.8% as N-methylpyrrolidinium-N-oxide, 2.5% as cefepime epimer). Elimination half-life: Approx 2 hours.
Đặc tính

Chemical Structure Image
Cefepime

Source: National Center for Biotechnology Information. PubChem Database. Cefepime, CID=5479537, https://pubchem.ncbi.nlm.nih.gov/compound/Cefepime (accessed on Jan. 21, 2020)

Bảo quản
Store intact vials between 20-25°C. Protect from light. Once reconstituted, may store solutions diluted in 0.9% NaCl and 5% dextrose in water solutions between 20-25°C for 24 hours or between 2-8°C for 7 days. Storage recommendations may vary among individual products. Refer to detailed product guideline.
Phân loại MIMS
Cephalosporin
Phân loại ATC
J01DE01 - cefepime ; Belongs to the class of fourth generation cephalosporins. Used in the systemic treatment of infections.
Tài liệu tham khảo
AFT Pharmaceuticals Ltd. Cefepime-AFT 500 mg, 1 g, 2 g Powder for Injection data sheet 18 January 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 07/12/2021.

Altamax 1 g Powder for Injection [IM/IV] (JustRight Pharmaceuticals). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/12/2021.

Anon. Cefepime. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/02/2022.

Anon. Cefepime. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/12/2021.

Buckingham R (ed). Cefepime Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/12/2021.

Cefepime Injection, Powder, for Solution (Hospira, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/12/2021.

Joint Formulary Committee. Cefepime. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/12/2021.

Renapime 1 g Powder for Solution for Injection/Infusion (Renascience Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/12/2021.

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