A fixed-dose combination injectable antibiotic containing a fourth-generation cephalosporin (Cefepime) and an aminoglycoside (Amikacin). This combination provides broad-spectrum, synergistic bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including many multi-drug resistant (MDR) strains. It is primarily used for the empirical treatment of severe, life-threatening infections, especially in hospital settings, where Pseudomonas aeruginosa and other resistant pathogens are suspected. The combination leverages the extended spectrum of Cefepime with the potent anti-pseudomonal and anti-MRSA activity of Amikacin.
Adult: The standard dose is ONE vial (Cefepime 500mg + Amikacin 125mg) administered intravenously. Cefepime 500mg is typically given every 8-12 hours. Amikacin 125mg (equivalent to 12.5 mg/kg for a 10kg patient, but actual dosing is weight-based) is usually given once daily or every 12 hours. NOTE: This fixed-dose combination's Amikacin component is SUBTHERAPEUTIC for most adults. Standard Amikacin dosing is 15-20 mg/kg/day as a single dose or divided. Therefore, this combination is often used with ADDITIONAL separate vials of Amikacin to achieve the correct weight-based dose, or it may be used in specific pediatric weight bands.
Note: For Intravenous use only. Reconstitute with Sterile Water for Injection. Further dilute in 50-100 mL of compatible IV fluid (0.9% Sodium Chloride, 5% Dextrose, Lactated Ringer's). Administer as an IV infusion over 30-60 minutes. DO NOT MIX with other drugs in the same syringe or infusion bag. Flush line before and after administration. Amikacin is NOT for intrathecal use.
The combination exerts a synergistic bactericidal effect through two distinct primary mechanisms. Cefepime binds to Penicillin-Binding Proteins (PBPs), inhibiting the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to osmotic instability and cell lysis. Amikacin binds irreversibly to the bacterial 30S ribosomal subunit, inhibiting protein synthesis and causing misreading of the genetic code, leading to the production of non-functional or toxic peptides. The combination is often synergistic against organisms like Pseudomonas aeruginosa, where the cell wall damage from Cefepime enhances the penetration of Amikacin.
Pregnancy: Cefepime: Category B - No well-controlled studies; use if benefit justifies risk. Amikacin: Category D - Positive evidence of human fetal risk (ototoxicity). Should be avoided, especially in second and third trimesters, unless life-threatening infection with no safer alternative. TDM essential.
Driving: Caution advised. Dizziness, vertigo (from Amikacin), or encephalopathy (from Cefepime) may impair the ability to drive or operate machinery.
| Other Nephrotoxic drugs (Vancomycin, Amphotericin B, Loop diuretics like Furosemide, NSAIDs, Cisplatin) | Potentiated risk of acute kidney injury. Synergistic nephrotoxicity. | Major |
| Other Ototoxic drugs (Loop diuretics, Platinum chemotherapy, Vancomycin) | Increased risk of permanent hearing loss and vestibular damage. | Major |
| Neuromuscular blocking agents (Succinylcholine, Atracurium) or in Myasthenia Gravis | Amikacin can potentiate neuromuscular blockade, leading to prolonged apnea and respiratory depression. | Major |
| Penicillins (e.g., Piperacillin, Ticarcillin) in vitro | Can chemically inactivate Amikacin if mixed in the same IV solution. Administer separately. | Moderate |
| Probenecid | May competitively inhibit renal tubular secretion of Cefepime, leading to increased and prolonged blood levels. | Moderate |
Same composition (Amikacin (125mg) + Cefepime (500mg)), different brands: