Ciprofloxacin

 

1. Generic & Brand Names

• Generic: Ciprofloxacin HCl

• Brands: Cipro® (Global), Ciloxan® (ophthalmic), Proquin® XR (ER)

• Formulations:

  • Tablets (100mg, 250mg, 500mg, 750mg)

  • Extended-release (500mg, 1000mg)

  • IV infusion (200mg/100mL, 400mg/200mL)

  • Oral suspension (250mg/5mL, 500mg/5mL)

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2. Drug Class & Mechanism

• Class: Fluoroquinolone antibiotic (2nd generation)

• Mechanism: Inhibits DNA gyrase & topoisomerase IV → bactericidal

• Spectrum:

  • Gram-negative: E. coli, P. aeruginosa, Salmonella, Shigella, Campylobacter

  • Gram-positive: Limited (not for MRSA/penicillin-resistant Strep)

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3. FDA-Approved Uses

Infection Type	Key Pathogens	First-Line?
Complicated UTI	E. coli, K. pneumoniae	Alternative
Acute Pyelonephritis	P. aeruginosa (suspected)	Yes
Prostatitis	Enterobacteriaceae	First-line
Infectious Diarrhea	Campylobacter, Shigella	Severe cases only
Typhoid Fever	S. typhi (MDR strains)	Yes

⚠️ Restricted Use (FDA 2016/2018):

• Reserved for infections with no alternative options due to severe safety risks.

• Avoid for uncomplicated UTIs, sinusitis, bronchitis.

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4. Dosing Regimens

Infection Type	Adult Dose	Duration
Uncomplicated UTI	250 mg PO q12h	3 days
Complicated UTI/Pyelonephritis	500 mg PO q12h OR 400 mg IV q12h	7-14 days
Acute Prostatitis	500 mg PO q12h	28 days
Infectious Diarrhea	500 mg PO q12h	5-7 days
Renal Dose Adjustment: ↓ by 50% if CrCl <30 mL/min

Key Administration Notes:

• Take PO 2h before/6h after antacids/Ca²⁺/Fe²⁺/Zn²⁺ (chelation ↓ absorption)

• Hydrate well → prevents crystalluria

• IV Infusion: Administer over 60 min (rapid infusion → hypotension)

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5. Black Box Warnings (FDA)

1. Tendon Rupture:

   • Risk ↑ in >60 yrs, steroid users, organ transplant

   • May occur months after treatment; discontinue at first sign of pain/swelling

2. Peripheral Neuropathy:

   • Irreversible nerve damage (pain/burning/weakness)

3. CNS Effects:

   • Seizures, psychosis, suicidal thoughts

4. Exacerbates Myasthenia Gravis:

   • Avoid in patients with MG → respiratory failure risk

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6. Side Effects

Common (≥10%)	Serious (Discontinue Immediately)
Nausea/vomiting	Tendon rupture (Achilles>shoulder)
Diarrhea	QT prolongation → Torsades
Headache	Aortic aneurysm/dissection
Rash	Hypersensitivity (anaphylaxis)
Photosensitivity	C. difficile colitis

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7. Critical Drug Interactions

Medication	Risk	Action
Theophylline	↑ Levels → seizures/tachycardia	↓ Theophylline dose 30%
Warfarin	↑ INR → bleeding	Monitor INR daily
Corticosteroids	↑ Tendon rupture risk	Avoid combo
Antidiabetics	↑ Hypoglycemia (glyburide/insulin)	Monitor glucose

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8. Resistance & Stewardship

• Resistance Rising:

  40% E. coli UTIs in US show fluoroquinolone resistance (IDSA 2023)

• When to Avoid:

  • Uncomplicated cystitis (use nitrofurantoin/fosfomycin)

  • Community-acquired pneumonia (no Strep coverage)

  • Gram-positive infections (use TMP-SMX/β-lactams)

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9. Pediatric Use

• Contraindicated for routine infections in children (cartilage damage risk)

• Exceptions:

  • Complicated UTIs/pyelonephritis (≥1 yr)

  • Anthrax exposure

  • Dose: 10-20 mg/kg IV q12h (max 400 mg/dose)

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10. Storage & Handling

• Tablets: 15-30°C (59-86°F); protect from light

• Oral Suspension:

  • Refrigerate (2-8°C/36-46°F)

  • Discard after 14 days

• IV Solution: Discard unused portions

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Clinical Practice Guidelines

✅ Appropriate Use:

• Pyelonephritis with suspected Pseudomonas

• Traveler's diarrhea (severe/Campylobacter)

• Chronic bacterial prostatitis
  ❌ Avoid For:

• Uncomplicated UTIs, strep throat, viral infections

• Patients with tendon disorders or CNS disease

⚠️ Mandatory Patient Counseling:

• "Stop drug and call MD immediately for tendon pain/mood changes."

• "Avoid sun exposure (use SPF 50+)."

• "Do not take with dairy/antacids/vitamins."

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Alternatives to Ciprofloxacin

Infection	Preferred Agents
Uncomplicated UTI	Nitrofurantoin, Fosfomycin
GI Infections	Azithromycin (Campylobacter), Ceftriaxone (Shigella)
Pyelonephritis	Ceftriaxone, Ertapenem

📊 Efficacy Data:

• Complicated UTI cure rate: 78% vs. 82% for ceftriaxone (CID 2022)

• Resistance in E. coli UTIs: 42% US, >60% Asia (WHO 2023)

Prescribing Status: Restricted in US/EU; requires prior authorization for non-approved indications. Report adverse events to FDA MedWatch.