Febactum™ (Cefoperazone + Sulbactam Injection)
Product Description
Febactum™ is a combined antibiotic injection comprising Cefoperazone sodium and Sulbactam sodium. Cefoperazone, a third-generation cephalosporin antibiotic, works by disrupting the formation of bacterial cell walls, leading to bacterial lysis and death. Sulbactam acts as a beta-lactamase inhibitor, preventing bacteria from destroying Cefoperazone, thus enhancing the effectiveness of the antibiotic therapy. This potent dual-action formulation targets a broad spectrum of Gram-positive and Gram-negative bacteria, including multi-drug resistant strains, making Febactum™ invaluable in managing severe and complicated bacterial infections.
Indications
Febactum™ is used in the treatment of a variety of systemic infections such as:
Respiratory tract infections (pneumonia, bronchitis)
Urinary tract infections
Skin and soft tissue infections
Bone and joint infections
Intra-abdominal infections
Septicemia
Scientific and Clinical Data
Pharmacodynamics: Cefoperazone inhibits bacterial cell wall synthesis. Sulbactam extends the antibacterial spectrum by inhibiting beta-lactamase enzymes.
Pharmacokinetics: Exhibits rapid systemic absorption and distribution, with elimination primarily via the biliary system.
Clinical trials have demonstrated enhanced cure rates and infection control in patients treated with Cefoperazone/Sulbactam combination compared to Cefoperazone alone.
Spectrum of Activity: Active against Streptococcus, Staphylococcus aureus (methicillin-sensitive), Enterobacteriaceae, Pseudomonas aeruginosa, and anaerobes.
Dosage and Administration
Febactum™ should only be administered by healthcare professionals. The dosage regimen depends on infection type and severity, typically 1-2 grams administered intravenously or intramuscularly every 12 hours. Dosage adjustments are recommended for patients with renal or hepatic impairment. The full prescribed course should be completed to prevent resistance development.
Safety Profile and Precautions
Febactum™ is generally well tolerated. Possible adverse effects include allergic reactions, injection site pain, gastrointestinal disturbances, and transient changes in liver function tests. Use with caution in patients with known hypersensitivity to beta-lactam antibiotics. Not recommended during pregnancy or lactation unless clearly needed.
Storage and Handling
Store in a cool, dry place below 25°C. Protect from light. Use sterile techniques during preparation and administration.
Frequently Asked Questions
What is Febactum® used for?
Febactum® 1000mg/500mg Injection treats serious bacterial infections including pneumonia, intra-abdominal sepsis, urinary tract infections, skin infections, and surgical prophylaxis. It targets multi-drug resistant pathogens through its Cefoperazone-Sulbactam combination.
How is Febactum® administered?
Administer intravenously over 15-30 minutes or intramuscularly after reconstitution. Standard adult dosing is 2-4g daily divided every 12 hours, with adjustments for renal function or pediatrics (100-150mg/kg/day).
What are the common side effects?
Frequently reported effects include diarrhea, injection site pain, nausea, and rash. Serious reactions like anaphylaxis or Clostridioides difficile colitis occur rarely (<1%) and require immediate medical attention.
Who should not use Febactum®?
Contraindicated in patients with anaphylactic history to beta-lactams, severe renal/hepatic impairment, or known Sulbactam hypersensitivity. Use cautiously in pregnancy (Category B) and monitor neonates for kernicterus risk.
What precautions are necessary during treatment?
Monitor liver enzymes, renal function, and complete blood count, especially beyond 14 days. Avoid concurrent use with valproic acid due to reduced efficacy. Complete full course to prevent resistance development.
How should Febactum® be stored?
Store unopened vials at 2-8°C (refrigerated); do not freeze. Reconstituted solution stable for 24 hours at room temperature or 7 days refrigerated. Protect from light and discard unused portions.
Is Febactum® compatible with other medications?
Compatible with 0.9% NaCl, 5% dextrose, and most IV fluids. Incompatible with aminoglycosides in same line; flush between administrations. Consult pharmacist for specific Y-site compatibilities.
What is the regulatory status of Febactum®?
Manufactured by Fenestra Pharmaceuticals Pvt. Ltd. under CDSCO license (valid through 2026) at cGMP facility. Meets IP/BP/USP standards as a DCGI-registered branded generic.