ADMINISTRATION ROUTES:
IV, PO, NG
ALTERNATIVE NAMES:
Ciproxin
ICU INDICATIONS:
- Treatment of infections caused by susceptible organisms
PRESENTATION AND ADMINISTRATION:
IV:
200 mg / 100 mL (solution in Normal saline)
Store at room temperature. Administer required dose over not less than 60 minutes. Solution is usually infused undiluted but can be mixed with other compatible IV fluids.
Compatible with the following IV fluids:
Normal saline, 5% Dextrose, 10% Dextrose, Hartmanns, Glucose and sodium chloride
Do not mix with any infusion solution or medicines
PO/NG:
250 mg, 500 mg and 750 mg tablets
250 mg/5 mL and 500 mg/100 mL suspension
Tablets can be crushed and dispersed in water for NG administration (check brand with pharmacist)
DOSAGE:
IV:
400 mg 8-12 hrly
PO:
500 mg BD
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose in renal impairment
| GFR (ml/min) | DOSE |
|---|---|
| <10 | 50% of normal dose |
| 10-20 | 50% of normal dose |
| >20-50 | dose as in normal renal function |
Dose in renal replacement therapy
| MODALITY | DOSE |
|---|---|
| CAPD | PO: 250-500 mg BD; IV: 100 mg BD |
| HD | PO: 250-500 mg BD; IV 100-200 mg BD |
| CVVHDF | PO: 500-750 mg BD; IV: 200-400 mg BD |
DOSAGE IN PAEDIATRICS:
IV:
4 - 7 mg/kg BD
PO:
5 - 10 mg/kg BD
Note: Ciprofloxacin is indicated in paediatric patients for inhalational anthrax (postexposure). The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate in this setting. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the paediatric population for other indications due to an increased incidence of adverse events compared to other agents
CLINICAL PHARMACOLOGY:
Ciprofloxacin is a quinolone antibiotic which has a bactericidal action through inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms and has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections
Aerobic Gram-Positive Microorganisms:
- Enterococcus faecalis (many strains are only moderately susceptible)
- Staphylococcus aureus (methicillin-susceptible strains only)
- Staphylococcus epidermidis (methicillin-susceptible strains only)
- Staphylococcus saprophyticus
- Streptococcus pneumoniae (penicillin-susceptible strains only)
- Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms:
- Campylobacter jejuni
- Citrobacter diversus, Citrobacter freundii
- Enterobacter cloacae
- Escherichia coli
- Haemophilus influenzae
- Haemophilus parainfluenzae
- Klebsiella pneumoniae
- Moraxella catarrhalis
- Morganella morganii
- Neisseria gonorrhoeae
- Proteus mirabilis, Proteus vulgaris
- Providencia rettgeri, Providencia stuartii
- Pseudomonas aeruginosa
- Salmonella typhi
- Serratia marcescens
- Shigella boydii, Shigella dysenteriae, Shigella flexneri, Shigella sonnei
Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile
CONTRAINDICATIONS:
- Hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobials
WARNINGS:
Central Nervous System Disorders:
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin
Hypersensitivity Reactions:
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Severe hypersensitivity reactions characterised by rash, fever, eosinophilia, jaundice, and hepatic necrosis with fatal outcome have also been rarely reported in patients receiving ciprofloxacin along with other drugs
Pseudomembranous Colitis:
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild to life-threatening
Peripheral Neuropathy:
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paraesthesias, hypoaesthesias, dysaesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin
Tendon Effects:
Ruptures of the shoulder, hand, achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ciprofloxacin
PRECAUTIONS:
General:
Prescribing ciprofloxacin tablets and oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Laboratory Tests:
No tests in addition to usual ICU tests are indicated
Drug/Laboratory Test Interactions:
None of note
IMPORTANT DRUG INTERACTIONS IN ICU:
SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar serious adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.
Concurrent administration of a quinolone, including ciprofloxacin, with oral multivalent cation-containing products such as magnesium/aluminium antacids, sucralfate, didanosine chewable/buffered tablets or paediatric powder, other highly buffered drugs, or products containing calcium, iron, or zinc may substantially decrease its absorption, resulting in serum and urine levels considerably lower than desired.
Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin
The concomitant administration of ciprofloxacin with the sulphonylurea glyburide has, on rare occasions, resulted in severe hypoglycaemia.
Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly. Quinolones, including ciprofloxacin, have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives.
Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.
Non-steroidal anti-inflammatory drugs (but not aspirin) in combination of very high doses of quinolones have been shown to provoke convulsions in preclinical studies.
ADVERSE REACTIONS:
Body as a Whole:
Headache, abdominal pain/discomfort, foot pain, pain, pain in extremities, injection site reaction
Cardiovascular System:
Palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, phlebitis, tachycardia, migraine, hypotension
Respiratory:
Dyspnoea, epistaxis, laryngeal or pulmonary oedema, hiccough, haemoptysis, bronchospasm, pulmonary embolism
Central Nervous System:
Restlessness, dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalisation, depression, paraesthesia, abnormal gait, grand mal convulsion
Digestive System:
Painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis
Haematological System:
Lymphadenopathy, petechia
Renal/Urogenital:
Interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain
Skin:
Allergic reaction, pruritus, urticaria, photosensitivity, flushing, fever, chills, angioedema, oedema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating