Description
Cefepime Hydrochloride Injection
Healthy Inc is a specialized global supplier and exporter of advanced Fourth-Generation Cephalosporins. We provide high-purity Cefepime Hydrochloride Injection, sourced from WHO–GMP certified sterile facilities. This “Empiric Therapy Specialist” is a top export to oncology centers, ICU critical care units, and government tender boards in Africa, LATAM, and Southeast Asia, specifically valued for its broad-spectrum activity against multi-drug resistant (MDR) Gram-negative pathogens, including Pseudomonas aeruginosa.
Product Overview
This formulation contains Cefepime Hydrochloride, a semi-synthetic, broad-spectrum, Fourth-Generation Cephalosporin antibiotic.
The “Neutropenia & Pseudomonas” Specialist:
- Zwitterionic Structure: Its unique chemical structure allows it to penetrate the outer cell wall of Gram-negative bacteria more rapidly than 3rd generation cephalosporins.
- Beta-Lactamase Stability: Highly resistant to hydrolysis by chromosomal beta-lactamases (AmpC), making it effective where other cephalosporins fail.
- Empiric Therapy: The drug of choice for Febrile Neutropenia (fever in cancer patients with low white blood cell counts) due to its superior coverage of hospital-acquired pathogens.
- Pseudomonas Potency: Comparable activity to Ceftazidime against Pseudomonas aeruginosa but with better Gram-positive coverage (Staph/Strep).
Product Composition & Strength
We supply this product as a Sterile Dry Powder in glass vials (requires reconstitution).
| Active Ingredient | Strength (Standard) | Chemical Equivalent | Role |
|---|---|---|---|
| Cefepime Hydrochloride USP/BP | 1000 mg (1 gm) | Eq. to Anhydrous Cefepime | Antibacterial Agent |
| (Pediatric Strength) | 500 mg | Eq. to Anhydrous Cefepime | Antibacterial Agent |
| L-Arginine | Q.S. | — | Buffering Agent (pH Stabilizer) |
| Sterile Water for Injection | 10 mL | — | Diluent (Supplied separately) |
*Pack Sizes: Single vial with WFI ampoule, or bulk hospital tray packs (10s/50s).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.19 (Medicaments containing Cephalosporins) |
| Dosage Form | Sterile Dry Powder for Injection (Reconstitution required) |
| Packaging | Clear Glass Vial with Flip-off Seal |
| Storage | Store below 25°C. Protect from light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate, CTD Dossier |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Color Stability: Cefepime powder can darken over time if not stabilized. Our formulation uses L-Arginine buffering to maintain potency and prevent significant color change during shelf life.
- Solubility: Processed for rapid dissolution to ensure immediate availability in emergency ICU settings.
Therapeutic Indications (Human Use)
Indicated for moderate to severe infections in Adults and Children:
- Febrile Neutropenia: Empiric treatment in immunocompromised patients.
- Pneumonia: Moderate to severe pneumonia, including Hospital-Acquired Pneumonia (HAP) and Ventilator-Associated Pneumonia (VAP).
- Urinary Tract: Complicated UTIs and Pyelonephritis (including cases associated with E. coli or Klebsiella).
- Skin & Skin Structure: Uncomplicated and complicated skin infections.
- Intra-abdominal Infections: Used in combination with Metronidazole for complicated abdominal sepsis.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Deep Intramuscular (IM) or Intravenous (IV) Infusion (over 30 mins).
- Adults: 1 gm to 2 gm every 12 hours (IV).
- Febrile Neutropenia: 2 gm every 8 hours for 7 days.
- Pediatrics: 50 mg per kg body weight every 12 hours.
- Renal Impairment: Dosage must be adjusted based on Creatinine Clearance (ClCr).
Safety Warnings:
- Neurotoxicity: High doses in patients with renal impairment can cause seizures, encephalopathy, or neuromuscular excitability. Renal function monitoring is crucial.
- Hypersensitivity: Contraindicated in patients allergic to Cephalosporins, Penicillins, or other Beta-lactams.
- Positive Coombs’ Test: May cause a false-positive Coombs’ test (affecting cross-matching of blood).
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
