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CINAVEROS 1000 mg

Anti-infective
Product

Cinnaveros

Active

Cefepime 1 gm

Category
Anti-infective
Indication

CINAVEROS is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms.
Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.

Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus

(methicillin-susceptible isolates only) or Streptococcus pyogenes.

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Dose

Adults

The usual adult dosage and route of administration of cefepime is 1 g administered intravenously or intramuscularly every 12 hours. However, the dosage and route vary according to the susceptibility of the causative organisms, the severity of the infection, and the condition and renal function of the patient. Guidelines for dosage of Cefepime are provided in Table 1. The usual duration of therapy is 7-10 days; however, more severe infections may require longer treatment.

Table 1: Recommended dosage schedule for adults with normal renal function (aged 12 years and over)

Severity of Infection Dose & route of administration Dosing Interval
Mild to moderate urinary tract infections 500 mg – 1 g I.V. or I.M. q12h
Mild to moderate infections other than UTI 1 g I.V. or I.M. q12h
Severe infections 2 g I.V. q12h
Very severe or life-threatening infections 2 g I.V. q8h

 

Surgical Prophylaxis

The dose recommendation for prophylaxis to prevent infection in adults undergoing intra-abdominal surgery is as follows:

A single 2 g I.V. dose of cefepime (as a 30-minute infusion) starting 60 minutes before initial surgical incision. A single 500 mg I.V. dose of metronidazole should be administered immediately following completion of the cefepime infusion. The metronidazole dose should be prepared and administered in accordance with official product labelling. Due to incompatibility, cefepime and metronidazole should not be mixed together in the same container; flushing of the intravenous line with a compatible fluid before infusion of the metronidazole is recommended.

If the surgical procedure lasts longer than 12 hours from the initial prophylactic dose, a second dose of cefepime followed by metronidazole should be administered 12 hours following the initial prophylactic dose.

 

Paediatrics (aged 2 months up to 12 years with normal renal function)

Usual recommended dosages:

Pneumonia, urinary tract infections, and skin and skin structure infections: Patients > 2 months of age with body weight ≤ 40 kg: 50 mg/kg q12h. For more severe infections, a dosage schedule of q8h can be used.

Empiric treatment of febrile neutropenia: Patients > 2 months of age with body weight ≤ 40 kg: 50 mg/kg q8h.