Cefepime HCl + Sulbactam for Injection 1.5 g

Brand Names:   Empime-S Injection

Composition

Each vial contains:

• Cefepime Hydrochloride equivalent to Cefepime 1000 mg
• Sulbactam Sodium equivalent to Sulbactam 500 mg
• Total Strength: 1.5 g

Pharmacological Class

• Fourth Generation Cephalosporin Antibiotic + Beta-Lactamase Inhibitor

Mechanism of Action

• Cefepime inhibits bacterial cell wall synthesis and is highly effective against both Gram-positive and Gram-negative bacteria.
• Sulbactam inhibits beta-lactamase enzymes produced by resistant bacteria, thereby enhancing Cefepime's effectiveness.

Indications / Uses

Used in the treatment of moderate to severe bacterial infections, including:

• Hospital-acquired pneumonia
• Severe respiratory tract infections
• Urinary tract infections (UTI)
• Intra-abdominal infections
• Septicemia (bloodstream infections)
• Skin and soft tissue infections
• Gynecological infections
• Bone and joint infections
• Febrile neutropenia
• ICU and multidrug-resistant infections

Spectrum of Activity

Effective against:

• Pseudomonas aeruginosa
• Klebsiella species
• Escherichia coli
• Proteus species
• Enterobacter species
• Acinetobacter species
• Staphylococcus aureus
• Streptococcus pneumoniae

Dosage and Administration

• Administered by Intravenous (IV) infusion/injection or Intramuscular (IM) injection.
• Typical adult dosage: 1.5 g every 8–12 hours, depending on infection severity and renal function.
• Dosage adjustment required in patients with kidney impairment.

Reconstitution

Usually reconstituted with:

• 10 mL Sterile Water for Injection (for IV use)
• Lidocaine or Sterile Water for IM use (as per prescribing information)

Common Side Effects

• Injection site pain
• Nausea and vomiting
• Diarrhea
• Rash
• Headache
• Fever

Serious Adverse Effects

• Allergic reactions / anaphylaxis
• Severe diarrhea due to Clostridioides difficile
• Seizures (especially in renal impairment)
• Neutropenia
• Elevated liver enzymes

Contraindications

• Hypersensitivity to Cefepime, Sulbactam, Cephalosporins, or Penicillins

Precautions

• Use cautiously in patients with:
  • Renal impairment
  • History of seizures
  • Allergy to beta-lactam antibiotics
  • Gastrointestinal disorders such as colitis
• Complete the full antibiotic course to avoid resistance.

Use in Pregnancy and Lactation

• Use only when prescribed by a physician after evaluating benefits and risks.

Storage

• Store below 25°C in a dry place.
• Protect from light.
• Use immediately after reconstitution.

Packaging

• One vial of Cefepime HCl + Sulbactam for Injection 1.5 g
• May include one ampoule of Sterile Water for Injection

Tags: Cefepime HCl + Sulbactam for Injection 1.5 g