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VELOSEF 1 GM ( CEPHRADINE ) POWDER FOR SOLUTION FOR IM / IV INJECTION VIAL
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VELOSEF 1 GM ( CEPHRADINE ) POWDER FOR SOLUTION FOR IM / IV INJECTION VIAL
Cephradine Injection Monograph
- Generic Name: Cephradine
- Brand Names: Velosef (varies by region)
- Drug Class: First-generation cephalosporin antibiotic
1. Description
Cephradine is a semisynthetic cephalosporin antibiotic derived from cephalexin. It is active against a broad spectrum of gram-positive and some gram-negative bacteria. It works by inhibiting bacterial cell wall synthesis.
Cephradine is a semisynthetic cephalosporin antibiotic derived from cephalexin. It is active against a broad spectrum of gram-positive and some gram-negative bacteria. It works by inhibiting bacterial cell wall synthesis.
2. Composition
Each vial contains:
- Cephradine (as sterile cephradine monohydrate): 250 mg, 500 mg, or 1 g
- Excipients: Sodium hydroxide or hydrochloric acid may be used for pH adjustment.
3. Indications
Cephradine injection is indicated for the treatment of infections caused by susceptible organisms, including:
- Respiratory tract infections
- Skin and soft tissue infections
- Bone and joint infections
- Urinary tract infections
- Septicemia
- Post-surgical infections
4. Dosage and Administration
Adults:
- Mild to moderate infections: 500 mg–1 g IM or IV every 6–12 hours
- Severe infections: Up to 2 g IV every 6–8 hours
- Maximum daily dose: 8 g/day
Children:
- 25–50 mg/kg/day IM or IV in divided doses every 6–12 hours
- Severe infections: Up to 100 mg/kg/day in divided doses
Method of Administration:
- IM: Reconstitute with sterile water for injection
- IV: Reconstitute and dilute with suitable IV fluids (e.g., normal saline, 5% dextrose)
5. Contraindications
- Known hypersensitivity to cephradine or other cephalosporins
- History of severe hypersensitivity (e.g., anaphylaxis) to penicillins
6. Warnings and Precautions
- Use with caution in patients with renal impairment – adjust dosage.
- Monitor for signs of allergic reactions or superinfection.
- Cross-sensitivity with penicillins may occur.
- Prolonged use may result in overgrowth of non-susceptible organisms (e.g., Candida).
7. Adverse Reactions
Common:
- Gastrointestinal: Nausea, vomiting, diarrhea
- Hypersensitivity: Rash, urticaria
Rare but serious:
- Anaphylaxis
- Stevens-Johnson syndrome
- Hemolytic anemia
- Neutropenia
8. Drug Interactions
- Nephrotoxic agents (e.g., aminoglycosides): Increased risk of renal toxicity
- Oral contraceptives: Cephalosporins may reduce efficacy
- Probenecid: Delays renal excretion, increases serum levels
9. Storage
- Store dry powder below 25°C.
- Reconstituted solution should be used immediately or within specified stability period (varies by formulation and diluent).
- Protect from light and moisture.
10. Mechanism of Action
Cephradine inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to lysis and death of susceptible bacteria.
11. Spectrum of Activity
Sensitive organisms:
- Staphylococcus aureus (non-MRSA)
- Streptococcus pneumoniae
- Escherichia coli
- Proteus mirabilis
- Klebsiella pneumoniae
Not active against:
- MRSA
- Pseudomonas aeruginosa
- Enterococci
- Anaerobes
12. Pregnancy and Lactation
- Pregnancy Category B: Animal studies show no fetal harm. Use only if clearly needed.
- Lactation: Small amounts excreted in breast milk; use with caution.
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