Neofloxin IV Infusion

Indications

Neofloxin is designed to combat a range of infections caused by susceptible bacteria, including single and mixed infections. It is effective against organisms resistant to other antibiotics such as Aminoglycosides, Penicillins, and Cephalosporins.

Due to its ability to achieve high antibacterial concentrations in serum, body tissues, and urine following oral administration, Neofloxin is recommended for a variety of infections. These include urinary tract infections, respiratory tract infections, gastrointestinal infections, gonorrhea, and sepsis. Its extensive tissue penetration and enhanced antibacterial activity make it suitable for use either alone or in combination with other antibiotics, such as Aminoglycosides or beta-lactam antibiotics, particularly in severe cases like neutropenia or suspected anaerobic infections.

Neofloxin is indicated for the treatment of:

• Severe Systemic Infections: Including sepsis, bacteremia, peritonitis, infections in immunosuppressed individuals, and infected burns in intensive care units.
• Respiratory Tract Infections: Such as lobar pneumonia, bronchopneumonia, chronic bronchitis, cystic fibrosis exacerbations, and empyema.
• Urinary Tract Infections: Covering both uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, and epididymitis.
• Skin and Soft Tissue Infections: Including infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, and infected burns.
• Gastrointestinal Infections: Such as enteric fever and infective diarrhea.
• Biliary Tract Infections: Including cholangitis, cholecystitis, and empyema of the gall bladder.
• Intra-abdominal Infections: Such as peritonitis and intra-abdominal abscesses.
• Bone and Joint Infections: Including osteomyelitis and septic arthritis.
• Pelvic Infections: Including salpingitis, endometritis, and pelvic inflammatory diseases.
• Eye, Ear, Nose, and Throat Infections: Such as otitis media, sinusitis, mastoiditis, and tonsillitis.
• Gonorrhea: Covering urethral, rectal, and pharyngeal infections caused by beta-lactamase producing organisms or those moderately sensitive to penicillin.

Pharmacology

Neofloxin, a synthetic quinolone antibiotic, possesses a broad spectrum of activity. It is effective against most gram-negative aerobic bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa. It also targets gram-positive aerobic bacteria, including both penicillinase-producing and non-penicillinase-producing staphylococci, though some strains of streptococci may be resistant. Neofloxin’s bactericidal action disrupts bacterial DNA synthesis by inhibiting DNA gyrase.

After oral administration, Neofloxin is rapidly absorbed and widely distributed throughout body tissues and fluids, with a half-life of approximately 3.5 hours. Between 30% to 50% of the dose is excreted unchanged in the urine within 24 hours.

Dosage

Dosage varies based on the infection type, severity, bacterial sensitivity, and patient characteristics:

• Adults: Typically, 100-750 mg twice daily.
  • Urinary Tract Infections: 250-500 mg twice daily.
  • Respiratory Tract Infections: 250-500 mg twice daily, with 750 mg twice daily for Streptococcus pneumonia.
  • Gonorrhea: A single dose of 250 or 500 mg.
  • Other Infections: 500-750 mg twice daily.
  • Cystic Fibrosis: 750 mg twice daily, considering lower body weight.
• Renal Impairment: Dose adjustments are usually needed only for severe impairment. A reduced dose by half may be required based on serum levels.
• Elderly: No dosage adjustment necessary despite higher serum levels.
• Children and Adolescents: Use with caution due to potential arthropathy. Dosage ranges from 7.5-15 mg/kg/day divided into two doses, if the benefit outweighs risks.

Duration of Treatment

• Acute Infections: Typically 5 to 10 days, with treatment extending three days beyond symptom resolution.
• Extended-Release Tablets: For uncomplicated urinary tract infections, 1000 mg once daily for three days.
• IV Infusion:
  • Urinary Tract Infection: 200 mg every 12 hours for mild to moderate, 400 mg every 12 hours for severe or complicated cases.
  • Respiratory Tract Infection: 400 mg every 12 hours for mild to moderate, 400 mg every 8 hours for severe cases.
  • Nosocomial Pneumonia: 400 mg every 8 hours for 10-14 days.
  • Skin Infections: 400 mg every 12 hours for mild to moderate, 400 mg every 8 hours for severe cases.
  • Bone and Joint Infections: 400 mg every 12 hours for mild to moderate, 400 mg every 8 hours for severe cases.
  • Intra-abdominal Infections: 400 mg every 12 hours for 7-14 days.
  • Acute Sinusitis: 400 mg every 12 hours for 10 days.
  • Chronic Bacterial Prostatitis: 400 mg every 12 hours for 28 days.

Administration

• Inspect the infusion bag for leaks and ensure it is not cloudy or contains precipitates.
• Avoid using flexible bags in series connections.
• Ensure proper setup and administration flow.

Interactions

Avoid concurrent use with magnesium or aluminum-containing antacids, sucralfate, and products containing calcium, iron, or zinc. These should be taken two hours after or six hours before Neofloxin. Avoid milk and dairy products during treatment as they can significantly reduce absorption.

Contraindications

Not recommended for individuals with hypersensitivity to Ciprofloxacin or other quinolones.

Side Effects

May include gastrointestinal issues (nausea, diarrhea, vomiting), central nervous system disturbances (headache, dizziness), hypersensitivity reactions (rash, pruritus), joint pain, mild photosensitivity, and transient liver enzyme increases. Risk of hypoglycemia and mental health effects.

Pregnancy and Lactation

Use is not recommended during pregnancy due to potential risks. Ciprofloxacin is excreted in breast milk, so its use is not advised for nursing mothers.

Precautions and Warnings

Use cautiously in patients with CNS disorders or conditions predisposing to seizures. Avoid interactions with certain antacids and dairy products.

Use in Special Populations

Neofloxin is not a first-choice drug for pediatric use.

Overdose Effects

May result in seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment, and crystalluria.

Therapeutic Class

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs.

Storage Conditions

Store below 30°C, protected from light and moisture. Keep out of reach of children.