What are the precautions when prescribing ciprofloxacin (Cipro)?

Ciprofloxacin Precautions

Ciprofloxacin carries a black box warning for tendinopathy and tendon rupture, particularly affecting the Achilles tendon, with highest risk in patients over 60 years, those on corticosteroids, and transplant recipients. 1

Critical Black Box Warnings

Tendon Complications

• Tendinitis and tendon rupture can occur during treatment or months after completion, most commonly involving the Achilles tendon but also affecting rotator cuff, hand, biceps, and thumb tendons 1
• Risk factors include age >60 years, concurrent corticosteroid use, kidney/heart/lung transplant recipients, strenuous physical activity, renal failure, and previous tendon disorders like rheumatoid arthritis 1
• Discontinue ciprofloxacin immediately if patient experiences pain, swelling, inflammation, or rupture of any tendon 1
• Advise patients to rest and contact their provider to switch to a non-quinolone antibiotic at first sign of tendinitis 1

Age-Specific Contraindications and Restrictions

Pediatric Patients (<18 years)

• Use only for FDA-approved indications: inhalational anthrax (post-exposure) and complicated urinary tract infections/pyelonephritis 1
• Ciprofloxacin causes permanent cartilage lesions in weight-bearing joints of immature animals, and increased joint-related adverse events occur in children compared to adults 1
• Maximum pediatric dose: 1 g per day, dosed at 10-15 mg/kg every 12 hours 2, 3
• Avoid in children under 18 years when alternative antibiotics exist, though can be used when necessary with careful monitoring 2

Pregnancy

• Safety and effectiveness have not been established in pregnant women 1
• Use only for life-threatening infections where benefits outweigh risks (e.g., inhalational anthrax where high mortality outweighs drug risk) 2
• Fluoroquinolones should be avoided during pregnancy; use ampicillin, cefotaxime, ceftriaxone, or TMP-SMZ as alternatives for infections like Salmonella 2

Geriatric Patients (≥65 years)

• Elderly patients have substantially increased risk for severe tendon disorders including rupture, especially when combined with corticosteroids 1
• Greater susceptibility to QT interval prolongation; avoid concomitant use with Class IA/III antiarrhythmics 1
• Dose adjustment required when creatinine clearance <30 mL/min 1

Central Nervous System Precautions

• Convulsions, increased intracranial pressure, toxic psychosis, dizziness, confusion, tremors, hallucinations, depression, and rarely suicidal thoughts can occur after the first dose 1
• Discontinue immediately if CNS reactions occur 1
• Use with extreme caution in patients with seizure disorders, severe cerebral arteriosclerosis, epilepsy, or other conditions that lower seizure threshold 1

Critical Drug Interactions

Theophylline

• Serious and fatal reactions including cardiac arrest, seizures, status epilepticus, and respiratory failure have been reported with concurrent use 1
• If concomitant use unavoidable, monitor theophylline serum levels closely and adjust dosage 1
• Ciprofloxacin inhibits CYP1A2, increasing theophylline concentrations 1

Other CYP1A2 Substrates

• Coadministration with drugs metabolized by CYP1A2 (methylxanthines, tizanidine) results in increased plasma concentrations and clinically significant pharmacodynamic side effects 1

QT-Prolonging Medications

• Avoid concurrent use with Class IA or III antiarrhythmics, particularly in elderly patients 1
• Monitor for uncorrected hypokalemia and known QT prolongation 1

Hypersensitivity Reactions

• Serious and occasionally fatal anaphylactic reactions can occur after the first dose 1
• Reactions may include cardiovascular collapse, loss of consciousness, pharyngeal/facial edema, dyspnea, urticaria, and itching 1

Monitoring Requirements

For Prolonged or High-Dose Therapy

• ECG monitoring at baseline, 2 weeks, and after adding any QT-prolonging medication 4, 3
• Blood glucose monitoring in diabetic patients due to hypoglycemia risk 4, 3
• Routine toxicity monitoring: complete blood count, renal function, liver function tests 3
• Consider therapeutic drug monitoring for severe infections with poor response (target trough 1-1.5 mg/L, peak 3-4.5 mg/L depending on dose) 3

Common Adverse Effects

• Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain (most common reason for discontinuation) 2, 3, 5
• Dermatological: rash, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis 3
• Overall adverse event rate approximately 9.3%, with severe reactions in 0.6% of patients 5
• Treatment discontinuation due to side effects occurs in 1.5% of patients 5

Special Clinical Situations

Respiratory Infections

• Not first-line for community-acquired pneumonia when penicillin-susceptible Streptococcus pneumoniae is the primary pathogen 6
• Appropriate for mixed infections or patients with predisposing factors for Gram-negative infections 6

Cystic Fibrosis

• Bacterial resistance develops more frequently in pseudomonal respiratory infections in cystic fibrosis patients 7
• Monitor closely for development of resistance during treatment 7