Finished product reference

Cefepime

Injection, Powder, for Solution · Parenteral · 1 g

List code
2416
Salt form
Hydrochloride

What it is and how it works

Mechanism of Action Cefepime is a cephalosporin antibacterial drug .

Indications

Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms: Pneumonia Empiric therapy for febrile neutropenic patients Uncomplicated and complicated urinary tract infections Uncomplicated skin and skin structure infections Complicated intra-abdominal infections (used in combination with metronidazole) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection and Dextrose Injection and other antibacterial drugs, Cefepime for Injection and Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Pneumonia Cefepime for Injection and Dextrose Injection is indicated for the treatment of pneumonia (moderate to severe) caused by Streptococcus pneumoniae (including cases associated with concurrent bacteremia), Pseudomonas aeruginosa , Klebsiella pneumoniae , or Enterobacter species.

Dosage and administration (summary)

For intravenous use only administered over approximately 30 minutes. Use this formulation of cefepime only in adult and pediatric patients who require the entire 1 or 2 gram dose and not any fraction thereof. ( 2.1 , 2.2 ) Recommended Dosing Schedule in Adult Patients with CrCL Greater than 60 mL/min * Site and Type of Infection Dose Frequency Duration (days) Moderate to severe pneumonia For Pseudomonas aeruginosa , use 2 g IV every 8 hours 1 or 2 g IV Every 8-12 hours 10 days Empiric therapy for febrile neutropenic patients 2 g IV Every 8 hours 7 days Or until resolution of neutropenia.

Contraindications

Patients with known immediate hypersensitivity reactions to cefepime or other cephalosporins, penicillins or other beta-lactam antibacterial drugs. Hypersensitivity to Cefepime or the Cephalosporin Class of Antibacterials, Penicillins, or Other Beta-lactam Antibacterials Cefepime for Injection and Dextrose Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam ant…

Warnings and precautions

Hypersensitivity reactions : Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. Neurotoxicity : May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime for Injection and Dextrose Injection occurs, discontinue the drug. Clostridio ides difficile- associated diarrhea (CDAD): Evaluate if diarrhea occurs.

Pregnancy

Pregnancy Risk Summary There are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarri…

Storage and supply

Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.

Source: Cefepime Hydrochloride (Cefepime Hydrochloride And Dextrose) — US FDA prescribing information, 2026-04-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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