Brand name : SEFDIN (Cefepime)

SEFDIN (Cefepime) ® (cefepime hydrochloride) for Injection

Product (generic name) SEFDIN (Cefepime) ® (cefepime hydrochloride) for Injection

Indication SEFDIN (Cefepime) ® (cefepime hydrochloride) for Injection is indicated for the treatment of the following infections:

* Pneumonia
* Empiric therapy for febrile neutropenic patients
* Uncomplicated and complicated UTIs, including pyelonephritis
* Uncomplicated skin and skin-structure infections
* Complicated intra-abdominal infections

SEFDIN (Cefepime) is indicated in the treatment of the above infections caused by susceptible strains of designated microorganisms.

Therapeutic Focus Area Infectious Diseases - intravenous antibiotic

Product Description SEFDIN (Cefepime) ® (cefepime hydrochloride) for Injection is a semi-synthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. SEFDIN (Cefepime) is a fourth-generation injectable cephalosporin antibiotic used by pulmonologists, infectious disease specialists, internal medicine physicians, hematologists and oncologists to treat patients with serious and/or potentially life-threatening infections.

Dosage Strengths 500 mg, 1 g and 2 g of cefepime

Mode of Administration Injectable for IV/IM use.

Prescribing Information SEFDIN (Cefepime) - without a prescriptions

INDICATIONS AND USAGE SEFDIN (Cefepime)
SEFDIN (Cefepime) is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION): Pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated
with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species. Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for
empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with
an underlying hematologic malignancy, or with se vere or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime
monotherapy in such patients. (See CLINICAL STUDIES.) Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by
Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli,
Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases
associated with concurrent bacteremia with these microorganisms. Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillinsusceptible
strains only) or Streptococcus pyogenes. Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by
Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See CLINICAL STUDIES.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of SEFDIN (Cefepime)
and other antibacterial drugs, SEFDIN (Cefepime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric
selection of therapy.

Important Safety SEFDIN (Cefepime)
Information In North American clinical trials of SEFDIN (Cefepime) ® (cefepime hydrochloride) for Injection at a dose of 0.5 to 2 g q12h, the most common adverse events were local reactions (3%), including phlebitis (1.3%), pain and/or inflammation (0.6%); rash (1.1%). SEFDIN (Cefepime) is contraindicated in patients who have had an immediate hypersensitivity reaction to SEFDIN (Cefepime) , a cephalosporin, a penicillin, or any other ß-lactam antibiotic.

Clostridium difficile associated diarrhea (CDAD) occurs with use of nearly all antibacterial agents, including SEFDIN (Cefepime) ®, and severity ranges from mild diarrhea to fatal colitis. Antibacterial agent use alters the normal flora of the colon leading to overgrowth of C. difficile. Consider CDAD in all patients presenting with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.