A fixed-dose combination (FDC) 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 like Pseudomonas aeruginosa, Acinetobacter baumannii, and ESBL-producing Enterobacteriaceae. It is primarily used for the empirical and definitive treatment of severe, life-threatening hospital-acquired infections, particularly in critical care settings in India.
Adult: Cefepime: 1-2 g IV every 8-12 hours. Amikacin: 15 mg/kg/day IV/IM, typically divided into 2-3 doses (e.g., 7.5 mg/kg every 12 hours). The FDC vial (Cefepime 1g + Amikacin 250mg) is typically administered as a single vial every 12 hours for a patient weighing ~65-70 kg, after loading dose if needed. MUST be based on ideal body weight (IBW) for Amikacin.
Note: For IV use only (IM possible but less common for this combination). Reconstitute with Sterile Water for Injection. Further dilute in 50-100 mL of compatible IV fluid (0.9% NaCl, D5W, LR). Infuse over 30-60 minutes. NEVER mix with other drugs in the same syringe or infusion bag. Administer Amikacin doses at evenly spaced intervals. Monitor vital signs during infusion.
This combination exhibits synergistic bactericidal action through two distinct mechanisms. Cefepime binds to Penicillin-Binding Proteins (PBPs), inhibiting the final transpeptidation step of peptidoglycan synthesis in the bacterial cell wall, leading to cell lysis. Amikacin binds irreversibly to the bacterial 30S ribosomal subunit, inhibiting protein synthesis and causing misreading of mRNA. The cell wall damage caused by Cefepime facilitates increased intracellular uptake of Amikacin, enhancing its effect.
Pregnancy: Amikacin is Pregnancy Category D (positive evidence of human fetal risk). Cefepime is Category B. This combination should be avoided in pregnancy unless the potential benefit justifies the potential risk to the fetus (e.g., life-threatening infection). Can cause fetal ototoxicity and nephrotoxicity.
Driving: Caution advised. Dizziness or vertigo from vestibular toxicity may impair the ability to drive or operate machinery.
| Furosemide/Ethacrynic acid | Potentiates ototoxicity and nephrotoxicity of Amikacin | Major |
| Vancomycin, Amphotericin B, Cisplatin | Additive nephrotoxicity and ototoxicity | Major |
| Neuromuscular blocking agents (e.g., Succinylcholine) | Enhanced and prolonged neuromuscular blockade, risk of apnea | Major |
| Penicillins (high-dose) | In vitro inactivation of Amikacin if mixed; administer separately | Moderate |
| Probenecid | May reduce renal tubular secretion of Cefepime, increasing its levels | Minor |
Same composition (Amikacin (250mg) + Cefepime (1000mg)), different brands: