Cefepime Injection

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Description

Cefepime Injection 1g

Healthy Inc is a specialized global supplier and exporter of Fourth-Generation Cephalosporins. We provide high-purity Cefepime Injection (1g / 500mg), sourced from WHO–GMP certified sterile injectable facilities. This “Empirical Specialist” is a top export to oncology wards, intensive care units (ICU), and government health ministries in Africa, LATAM, and Southeast Asia, serving as the first-line empirical monotherapy for febrile neutropenia and severe hospital-acquired infections.


Product Overview

This formulation contains Cefepime Hydrochloride, a fourth-generation cephalosporin buffered with L-Arginine for optimum stability and solubility.

The “Zwitterionic” Advantage:

  • Mechanism (The “Rapid Penetrator”): Cefepime is a Zwitterion (it carries both a positive and negative charge). This dipolar nature allows it to penetrate the outer cell membrane of Gram-negative bacteria much faster than third-generation cephalosporins. Once inside, it binds to Penicillin-Binding Proteins (PBP 2 and 3), causing cell lysis.
  • True Broad Spectrum: It bridges the gap between generations. It has the potent anti-pseudomonal activity of Ceftazidime (Gen 3) combined with the anti-staphylococcal activity of Cefazolin (Gen 1).
  • Enzyme Stability: It has low affinity for chromosomal beta-lactamases (AmpC), making it effective against resistant organisms that destroy other cephalosporins (e.g., Enterobacter, Serratia).

Product Composition & Strength

We supply this product as a Sterile Dry Powder for Injection in glass vials. It contains L-Arginine as a buffering agent (instead of sodium salts).

Active Ingredient Strength Therapeutic Role
Cefepime Hydrochloride USP/BP Equivalent to 1000 mg (1 g) Cefepime Severe Infection / Sepsis
Cefepime Hydrochloride USP/BP Equivalent to 500 mg Cefepime Pediatric / Moderate Infection
Buffer L-Arginine pH Stabilizer (Approx 725 mg per g)

*Pack Sizes: Tray of 1 Vial, 10 Vials, or Box of 1/10 Vials with Water for Injection (WFI).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.20.19 (Medicaments containing other antibiotics)
Dosage Form Powder for Injection (Dry Blend/Fill)
Packaging Type I Glass Vial (Sterile) with Flip-off Seal
Storage Store below 25°C. Protect from Light. (Powder may darken during storage; protect from heat).
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Thermal Stability: Cefepime is notoriously heat-sensitive and can degrade into N-Methylpyrrolidine (NMP). We use a controlled cold-chain manufacturing process and premium Type I glass to ensure the NMP levels remain well below USP limits throughout the shelf life.
  • Solubility: The L-Arginine blend is precisely calculated to ensure rapid dissolution (within 30 seconds) and a pH range of 4.0-6.0, minimizing injection site pain.

Therapeutic Indications (Human Use)

Indicated for the treatment of moderate to severe infections:

  • Febrile Neutropenia: Empirical monotherapy for immunocompromised patients.
  • Nosocomial Pneumonia: Hospital-acquired (HAP) and Ventilator-associated pneumonia (VAP) caused by Pseudomonas or Klebsiella.
  • Complicated UTIs: Pyelonephritis caused by multi-drug resistant E. coli.
  • Skin & Soft Tissue: Severe abscesses and wound infections (covers both Staph and Strep).
  • Intra-abdominal Infections: Complicated peritonitis (used with Metronidazole).

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

  • Route: Intravenous (IV) Infusion or Deep IM Injection.
  • Adults: 1 g to 2 g every 12 hours.
  • Severe Infections / Neutropenia: 2 g every 8 hours.
  • Renal Impairment (CRITICAL): Dose adjustment is mandatory if Creatinine Clearance < 60 ml/min. Failure to adjust leads to neurotoxicity.
  • Reconstitution: Dissolve 1g vial in 10ml WFI/Saline. Solution turns from pale yellow to amber (normal).

Safety Warnings (CRITICAL):

  • Neurotoxicity (Encephalopathy): In patients with kidney failure, accumulation of Cefepime can cause confusion, hallucinations, seizures, and coma (Cefepime-induced encephalopathy). Monitor renal function closely.
  • Penicillin Allergy: CONTRAINDICATED in patients with a history of anaphylaxis to beta-lactams.
  • Positive Coombs’ Test: Can cause a false-positive direct Coombs’ test (affecting blood cross-matching).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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