Drug Detail

Ciprofloxacin

Last Updated June 10, 2016

Trade Names

  • Ciprofloxacin hydrochloride, ciprofloxacin lactate: Ciprobay;
  • Ciprofloxacin lactate: Ciprobay, Austell-Ciprofloxacin: Biotech Ciprofloxacin, Cifran, Ciprofloxacin Actor, Cilofloc, Ciploxx, Cipro-Hexal, Ciprol, CPL Alliance Ciprofloxacin, Dynafloc, Cifloc, Ciprogen, Orpic, Loxip, Sabax Ciprofloxacin; Spec-Topistin

Drug Classification

Fluoroquinolone broad-spectrum antimicrobial

Formulations

250 mg, 500 mg, 750 mg tablets; 250 mg/5 mL oral suspensions; 2 mg/mL, intravenous infusion

Indications and Pharmacology

Indication: treatment of typhoid fever or infections caused by susceptible bacterial strains in the urinary, gastrointestinal, and lower respiratory tracts as well as skin, soft tissue, and bone; no longer indicated for tuberculosis treatment but used as a component of second-line treatment in South Africa.*

Mechanism of action: inhibition of topoisomerase II and IV enzymes, disrupting bacterial DNA replication, transcription, repair, recombination.

Pharmacokinetics: rapidly absorbed from gastrointestinal tract and widely distributed throughout body; Tmax 1-2 hours; half-life 4-5 hours.

Dosage

Adult Dose: 250-750 mg twice daily (higher doses used in tuberculosis treatment). Maximum dose 750 mg twice daily.*

Best taken on empty stomach.

Patients should be cautioned to maintain and adequate fluid intake.

Should not be taken with dairy or calcium-fortified juices alone but can be taken with meal containing these products.

Taking tablet formulation with food delays absorption but does not affect peak serum concentration; no delay when taking suspension formulation with food.

Use in Renal or Hepatic Insufficiency: 

  • Renal impairment:
    • Glomerular filtration rate 30-50 mL/min: 250-500 mg every 12 hrs
    • Glomerular filtration rate 5-29 mL/min: 250-500 mg every 19 hrs
    • On haemodialysis or peritoneal dialysis: 250-500 mg every 24 hrs (after dialysis).
  • No adjustments needed for hepatic insufficiency.

Use in Pregnancy and Breastfeeding: US Pregnancy Category C. Avoid in pregnancy and lactation.

Use in Children: If benefit outweighs risk of treatment. Oral: 20-30 mg/kg/day in 2 divided doses.*

Neonates: oral, 15 mg/kg/dose every 12 hours in first 4 weeks of life, then every 8 hours; IV, infuse over 30 minutes, 10 mg/kg/dose every 12 hours in first 4 weeks of life, then every 8 hours.

Older than 1 month of age: oral, 5-10 mg/kg/dose (maximum 500 mg) every 12 hours; IV, 4-7 mg/kg/dose (maximum 300 mg) every 12 hours.

Higher doses permitted for severe infection. 

Warnings

Contraindicated in patients with hypersensitivity to ciprofloxacin or any other quinolone antimicrobials.

Use caution in patients with history of central nervous system disorders including epilepsy, renal or hepatic impairment, and in paediatric patients (< 18 years old).

Concurrent administration of theophylline may cause serious and fatal reactions.

Increased risk of tendon ruptures, especially with concomitant corticosteroids.

Discontinue treatment if symptoms of tendonitis and/or tendon rupture occur, and avoid exercise or use of affected tendons or joints.

Avoid in patients with prolonged QT interval.

Patients should be cautioned to maintain adequate fluid intake.

Drug–Drug Interactions

Increased concentration or effects of concomitant medication: theophylline, warfarin, caffeine, phenytoin, methotrexate.

Increased concentration or effects of ciprofloxacin with concomitant probenecid.

Accelerated absorption of ciprofloxacin with concomitant metoclopramide.

Decreased absorption of ciprofloxacin with multivalent cation-containing products (eg, magnesium/aluminium antacids, sucralfate, didanosine chewable/buffered tablets or paediatric powder, highly buffered drugs, products containing calcium, zinc, or iron) ); administer ciprofloxacin 2 hours before or 6 hours after multivalent cation-containing products.

Associated with transient serum creatinine elevation with concomitant cyclosporine.

Rare reports of severe hypoglycaemia with concomitant sulfonylurea glyburide (glibenclamide).

Considerations for Special Populations

Elderly (> 65 years): may reach higher plasma concentrations than younger adults; renal function monitoring may be useful; increased risk of neurotoxicity.

Paediatric: associated with increased rate of adverse events involving joints and surrounding tissues.

Renal insufficiency: may require dose reduction.

Use with caution in patients with predisposition to seizures or lower seizure threshold.

See above for pregnancy and lactation.

Adverse Effects

Gastrointestinal; central nervous system: headaches, dizziness, drowsiness, insomnia, phototoxicity; arthralgia; hypersensitivity; cardiac disturbances (QT prolongation and torsades de points), tendonitis and tendon ruptures.

Seizures may occur in patients with underlying central nervous system disease.

*Recommendation from Wits Reproductive Health and HIV Institute.
Information from US Prescribing Information.