Ciprofloxacin

Product Information

• Name: PRO-CIPROFLOXACIN
• Active Ingredient: Ciprofloxacin hydrochloride
• Strengths: 250 mg, 500 mg, 750 mg tablets
• Manufacturer: PRODOC Ltée

Therapeutic Classification

• Class: Antibacterial Agent
• Mechanism of Action: Bactericidal activity through inhibition of bacterial DNA gyrase, affecting DNA replication and transcription.

Indications and Clinical Use

• Respiratory Tract Infections: Including acute exacerbation of chronic bronchitis and acute pneumonia.
• Urinary Tract Infections: Both upper and lower, including complicated and uncomplicated cystitis, pyelonephritis, and pyelitis.
• Chronic Bacterial Prostatitis: Caused by Escherichia coli.
• Skin and Soft Tissue Infections: Caused by various bacteria including Staphylococcus aureus and Streptococcus pyogenes.
• Bone and Joint Infections: Caused by Pseudomonas aeruginosa and Staphylococcus aureus.
• Infectious Diarrhea: When antibacterial therapy is indicated.
• Meningococcal Carriers: Treatment to eliminate meningococci from the nasopharynx.
• Typhoid Fever: Caused by Salmonella typhi.
• Uncomplicated Gonorrhea: Various sites including cervical, urethral, rectal, and pharyngeal infections.

Contraindications

• Hypersensitivity to ciprofloxacin or other quinolone antibacterial agents.
• Use in prepubertal patients and in patients with a history of tendon disorders related to quinolone treatment.

Warnings and Precautions

• CNS Effects: Including convulsions, increased intracranial pressure, and toxic psychosis.
• Tendinitis and Tendon Rupture: Increased risk, particularly in elderly patients on corticosteroids.
• Hypersensitivity Reactions: Including anaphylaxis.
• Photosensitivity: Risk of severe reactions; patients should avoid excessive sunlight or UV exposure.
• Pseudomembranous Colitis: Should be considered in patients with severe diarrhea.
• Renal and Hepatic Impairment: Use with caution and adjust dosage as necessary.

Adverse Reactions

• Common: Nausea, diarrhea, rash, liver enzyme elevation, eosinophilia.
• Serious: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, tendon rupture, psychiatric reactions, peripheral neuropathy, and prolongation of QT interval.

Drug Interactions

• Theophylline: May lead to elevated plasma levels and increased risk of adverse reactions.
• Antacids: Containing aluminum or magnesium can reduce absorption.
• Warfarin: Increased anticoagulant effect; monitor prothrombin time.
• Cyclosporine: Increased serum creatinine levels.

Dosage and Administration

• Adults:
  • Respiratory, Skin, and Bone Infections: 500-750 mg every 12 hours.
  • UTIs: 250-500 mg every 12 hours.
  • Gonorrhea: 500 mg single dose.
  • Typhoid Fever: 500 mg every 12 hours for 14 days.
  • Prostatitis: 500 mg every 12 hours for 28 days.
  • Renal Impairment: Dosage adjustment required based on creatinine clearance levels.

Storage and Stability

• Storage: Store at controlled room temperature between 15°C and 25°C.