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Pharmacodynamic properties Cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with in vitro antibacterial activity against facultative Gram-positive and Gram-negative bacteria. Pharmacokinetic properties The average plasma concentrations of cefepime observed in healthy adult male volunteers (n=9) at various times following single 30-minute infusions (IV) of cefepime 500 mg, 1 g, and 2 g. Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2.0 (±0.3) hours and total body clearance of 120.0 (±8.0) mL/min in healthy volunteers. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g. There is no evidence of accumulation in healthy adult male volunteers (n=7) receiving clinically relevant doses for a period of 9 days. Distribution The average steady-state volume of distribution of cefepime is 18.0 (±2.0) L. The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum. Cefepime is excreted in human milk. A nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day. Metabolism and Excretion Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide). Urinary recovery of unchanged cefepime accounts for approximately 85% of the administered dose. Less than 1% of the administered dose is recovered from urine as NMP, 6.8% as NMP-N-oxide, and 2.5% as an epimer of cefepime. Because renal excretion is a signicant pathway of elimination, patients with renal dysfunction and patients undergoing hemodialysis require dosage adjustment.

Действующего вещества – цефепима –1 г (в виде цефепима гидрохлорида и L-аргинина).

Pneumonia (moderate to severe), Empiric therapy for febrile neutropenia (The drug is not recommended in patients at high risk for severe infection (e.g., patients with sepsis, severe prolonged neutropenia, recent bone marrow transplantation, hematologic malignancies, etc..), Uncomplicated and complicated Urinary Tract Infections (including pyelonephritis), Complicated Intra-abdominal Infections (used in combination with metronidazole).

Cefepime hydrochloride is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillins or other beta-lactam antibiotics.

Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache. If any of these eects persist or worsen, tell your doctor or pharmacist promptly. dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, mental/mood changes (such as confusion, hallucinations), seizures, unusual weakness, yellowing eyes/skin. This medication may rarely cause a severe intestinal condition (Clostridium dicile-associated diarrhea) due to a type of resistant bacteria. This condition may occur weeks to months after treatment has stopped. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. white patches in your mouth, a change in vaginal discharge, or other new symptoms. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with this drug because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics.  Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insuciency, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function.  Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

The recommended adult and pediatric dosages and routes of administration are outlined in the following table Cefepime HCl for injection should be administered intravenously over approximately 30 minutes. Before administration ensure that the powder has been fully dissolved in the solution. Administration duration should be within 10 days. Pediatric patients (2 months up to 16 years) The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above. Patients with Renal Impairment In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Cefepime HCl for injection should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of Cefepime HCl for injection should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of Cefepime HCl for injection in patients with renal impairment are presented in below table. For Intravenous Infusion, Dilute with a suitable parenteral vehicle prior to intravenous infusion. Constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an intravenous container with one of the compatible intravenous uids listed in the Compatibility and Stability subsection. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES. Intramuscular Administration: For intramuscular administration, MAXIPIME (cefepime hydrochloride) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1 % Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol.

Store in hermetic container below 30℃