Zopime® 500 mg IV/IM Injection: Each vial contains sterile Cefepime Hydrochloride with L-Arginine USP, equivalent to Cefepime 500 mg.

Zopime® 1 g IV/IM Injection: Each vial contains sterile Cefepime Hydrochloride with L-Arginine USP, equivalent to Cefepime 1 g.

Zopime® (Cefepime Hydrochloride, USP) is a semi-synthetic, broad-spectrum, fourth-generation cephalosporin antibiotic for parenteral administration. Cefepime disrupts the synthesis of the peptidoglycan layer of bacterial cell walls, which is essential for maintaining cell wall structural integrity.

Zopime® is indicated in adults for the treatment of the following infections caused by susceptible bacteria:

Lower respiratory tract infections, including pneumonia and bronchitis.

Urinary tract infections, both complicated (e.g., pyelonephritis) and uncomplicated.

Skin and skin structure infections.

Septicemia.

Intra-abdominal infections, including peritonitis and biliary tract infections.

Empiric treatment of febrile neutropenia

The recommended adult and pediatric dosages and routes of administration are as follows:

Zopime® should be administered intravenously over approximately 30 minutes.

Moderate to Severe Pneumonia due to S. pneumoniae*, P. aeruginosa, K. pneumoniae, or Enterobacter species     1-2 g IV Every 12 hours  10

Empiric therapy for febrile neutropenic patients 2 g IV    Every 8 hours    7

Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*              0.5-1 g IV/IM     Every 12 hours  7-10

Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae  2 g IV    Every 12 hours  10

Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes         2 g IV    Every 12 hours  10

Complicated Intra-abdominal Infections 2 g IV    Every 12 hours  7-10

Pediatric Patients (2 months to 16 years)

The usual recommended dosage for pediatric patients up to 40 kg in weight is 50 mg per kg per dose, administered every 12 hours (or every 8 hours for febrile neutropenic patients), for durations as outlined above.

Vial Size              Amount of Diluent to Add (mL)

500 mg IV           5.0

500 mg IM         1.3

1 g IV    10.0

1 g IM   2.4

Zopime® is contraindicated in patients with a history of immediate hypersensitivity reactions to cefepime, cephalosporin-class antibiotics, penicillins, or other beta-lactam antibiotics.

Prolonged use may result in the overgrowth of non-susceptible organisms.

If an allergic reaction occurs, discontinue use and provide appropriate treatment.

Dosage should be adjusted in patients with impaired renal function.

Common adverse reactions include:

Hypersensitivity: Rash (1.8%), pruritus, urticaria.

Gastrointestinal: Nausea, vomiting, oral moniliasis, diarrhea (1.2%), colitis (including pseudomembranous colitis).

Central Nervous System: Headache.

Other: Fever, vaginitis, erythema.

Pregnancy: Category B. Use only if clearly needed.

Nursing Mothers: Cefepime is excreted in human breast milk in low concentrations. Exercise caution when administering to nursing women.

Pediatric Use: Not established for patients under 2 months of age.

Geriatric Use: Dosage adjustments are required for patients with renal insufficiency.

Monitor renal function if high doses of aminoglycosides are used concurrently due to the risk of nephrotoxicity and ototoxicity. Concomitant use with potent diuretics such as furosemide may increase nephrotoxicity risk.

Store in a cool, dry place below 25°C. Protect from light