Ciprofloxacin

[INN] J01MA02

S4

SA EML: Primary

Route of administration: Oral, Injection

Special populations: Children, Renal impairment

Indications

Treatment of infections, caused by sensitive organisms, of the urinary, gastrointestinal and lower respiratory tracts, skin and soft tissue, and bone. It is the drug of choice for typhoid fever.

Pharmacokinetics

Oral bioavailability, 70–80%. Widely distributed with good penetration of tissues and bone. T½ = 4–5 hours, slightly longer in renal failure. It is metabolised in the liver. 40–50% of an oral dose is excreted unchanged in urine. Small amounts are excreted in the bile; 20–35% of an oral dose is excreted in the faeces in 5 days.

Contraindications

Known allergy to ciprofloxacin or other quinolones.

Cautions

Epilepsy or history of CNS disorders; G6PD deficiency; hepatic or renal impairment; patients <18 years of age.

Geriatrics: Older patients are particularly at risk of neurotoxicity.

Paediatrics: Studies have shown damage to cartilage of weight-bearing joints in immature animals. Therefore only use in patients under 18 years old for severe infections when there are no other alternatives.

Pregnancy: Animal studies show cartilage damage.

Lactation: Excreted in breast milk; use not recommended.

Drug interactions

Ciprofloxacin is an inhibitor of hepatic microsomal enzymes.

Theophylline: Clearance of theophylline is reduced, leading to increased serum levels.

Warfarin: Increased anticoagulant effect reported (variable and inconsistent); INR should be monitored.

Antacids and minerals: Concurrent use of sucralfate, antacids containing aluminium, calcium or magnesium, or oral iron, zinc or magnesium supplements reduce absorption.

Glibenclamide: Concomitant use may result in hypoglycaemia.

Probenecid interferes with renal secretion of ciprofloxacin and may increase ciprofloxacin concentrations.

Adverse effects

For all quinolones.

Generally well tolerated. The most frequent are gastrointestinal disturbances such as abdominal pain, nausea, vomiting and diarrhoea. Pseudomembranous colitis has occurred rarely.

CNS effects include headache, dizziness and restlessness; also drowsiness, insomnia, tremor, agitation, confusion, depression and, more rarely, hallucinations. Seizures are rare but may occur more commonly in patients with underlying CNS disease.

Hypersensitivity reactions include skin rash, urticaria, pruritus, photosensitivity reactions and, rarely, vasculitis, Stevens-Johnson syndrome, and anaphylaxis.

Other effects reported include QT prolongation and torsades de points (see ‘Prescribing drugs that may prolong the QT interval’), raised liver enzymes, hepatic necrosis, interstitial nephritis and blood disorders.

Reversible arthralgia has been reported.

There is an increased risk of tendinitis and tendon rupture, and rarely, an increased risk of aortic dissection or aneurysm.

Special prescriber’s points

  • Patients should be advised to maintain an adequate fluid intake; excessive alkalinity of the urine should be avoided.
  • Doses are best taken on an empty stomach.
  • Not suitable for administration by nasogastric tube.
  • Patients should be advised to stop treatment if symptoms of tendonitis and tendon rupture occur, and they should avoid exercise or use of the affected area.

    • Adult dose

    • Over 18 years. Oral, 250–750 mg twice daily, depending on the nature and the severity of infection. Prolonged therapy (4–6 weeks) is required in bone infections, chronic prostatitis and invasive salmonellosis in patients living with HIV. IV infusion over 60 minutes, 200–400 mg 8–12 hourly.
    • Urinary tract infection: Oral, 250–500 mg twice daily (250 mg as a single dose or twice daily for 3 days in acute uncomplicated cystitis in non-pregnant women). Prolonged-release: 500–1000 mg once daily for 3 days.
    • Meningococcal prophylaxis: Oral, 500 mg as a single dose.
    • Renal impairment: GFR 10–50 mL/min, 50–75% of dose; GFR <10 mL/min, 50% of dose.

      • Paediatric dose

      See paediatrics above.

      Where the benefits outweigh the risks:

      • Neonates, oral, 15 mg/kg/dose 12 hourly in the first 4 weeks of life, then 8 hourly. IV infusion over 30 minutes, 10 mg/kg/dose 12 hourly in the first 4 weeks of life, then 8 hourly.
      • Over 1 month old, oral, 5–10 mg/kg/dose (max. 500 mg) 12 hourly. IV, 4–7 mg/kg/dose (max. 300 mg) 12 hourly.
      • Severe infections (including cystic fibrosis): Oral, 20 mg/kg/dose (max. 750 mg) 12 hourly. IV, 10 mg/kg/dose (max. 400 mg) 8 hourly.
      • Meningococcal prophylaxis: Oral, 10 mg/kg as a single dose.

        • Preparations

        Ciprobay® Bayer Pharma tablets 250 mg, 500 mg, 750 mg); XR tablets 500 mg, 1 g; suspension 250 mg/5 mL; IV infusion 2 mg/mL in normal saline

        Austell-Ciprofloxacin®; Biotech Ciprofloxacin®; Cifran® Sun Pharma; Cifloc® Dr Reddy’s; Ciploxx® Cipla Medpro; Ciprofloxacin Actor®; Ciprol® Teva tablets 250 mg, 500 mg

        Ciprogen® Mylan tablets 250 mg, 500 mg; IV infusion 2 mg/mL

        Orpic® Aspen Pharmacare tablets 500 mg; IV infusion 2 mg/mL (as lactate)

        Dynafloc® Pharma Dynamics; Loxip® Aurobindo; Flopro® Novagen tablets 500 mg

        Ciprofloxacin Fresenius®; Spec-Topistin® IV infusion 2 mg/mL

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