Cipro-C

Approved Indications:

• Urinary Tract Infections (UTIs): Including acute uncomplicated cystitis, complicated UTIs, and pyelonephritis.
• Prostatitis: Acute and chronic bacterial prostatitis.
• Gastrointestinal Infections: Infectious diarrhea (e.g., E. coli, Shigella, Salmonella), typhoid fever.
• Respiratory Tract Infections: Complicated pneumonia, bronchitis in patients with risk factors or treatment failure.
• Skin and Soft Tissue Infections: Complicated cases, including cellulitis, abscesses, and diabetic foot infections.
• Bone and Joint Infections: Osteomyelitis, septic arthritis.
• Intra‑abdominal Infections: Diverticulitis, peritonitis, appendicitis (in combination therapy).
• Anthrax (Post‑Exposure Prophylaxis and Treatment): Inhalational and cutaneous.
• Plague: Pneumonic and bubonic plague (treatment and prophylaxis).
• Typhoid and Paratyphoid Fever

Off‑Label / Clinically Accepted Uses:

• Neisseria gonorrhoeae infections (where ciprofloxacin susceptibility is confirmed).
• Mycobacterium avium complex (MAC) prophylaxis in advanced HIV (usually secondary agents).
• Traveler’s diarrhea prophylaxis/treatment in select high-risk patients.
• Preventive use in neutropenic fever when fluoroquinolone-resistant risks are low.

Adults:

• Uncomplicated UTI: 250–500 mg every 12 hours for 3 days.
• Complicated UTI/Pyelonephritis/Prostatitis: 500 mg every 12 hours, durations ranging 7–14 days.
• Respiratory, Skin, Bone, GI Infections: 500–750 mg every 12 hours; for severe infections may use 750 mg twice daily for up to 14 days.
• Anthrax prophylaxis: 500 mg every 12 hours for 60 days.
• Plague: 500 mg every 12 hours for 10–14 days.

Elderly:

• Use standard doses; monitor renal function and adjust if necessary.

Pediatrics:

• Typically not recommended, except:
• Anthrax exposure: 10–15 mg/kg every 12 hours (maximum 500 mg).
• Pseudomonas infections: under specialist guidance.

Renal Impairment:

• CrCl 30–50 mL/min: Extend dosing interval to every 18 hours.
• CrCl <30 mL/min (and dialysis): After 250–500 mg dose, administer 250 mg every 24 hours; dose after dialysis if needed.

Hepatic Impairment:

• No specific adjustment; monitor for hepatic adverse effects if severe.

Administration:

• Oral or IV. Oral absorption decreases with quinolone‑binding agents (antacids, iron, zinc, sucralfate).
• IV to oral switch can be done once tolerant and improving.

Ciprofloxacin is a fluoroquinolone antibiotic that selectively inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, essential enzymes for DNA replication, transcription, repair, and recombination. By binding to and stabilizing enzyme‑DNA complexes, it disrupts DNA supercoiling and causes irreversible DNA strand breaks. This action triggers rapid bacterial cell death—especially potent against Gram‑negative organisms—and results in its broad-spectrum bactericidal effect.

• Absorption: Rapid oral absorption; bioavailability ~70–80%. Peak plasma concentrations in about 1–2 hours.
• Distribution: Widely distributed in tissues including prostate, lung, bone, joint fluid, and skin. ~20–30% plasma protein bound.
• Metabolism: Minimal metabolism; partly metabolized in liver via CYP1A2.
• Active Metabolites: Minor; mainly excreted unchanged.
• Elimination: Primarily renal (~40–50% unchanged); remainder via biliary/fecal routes.
• Half‑Life: Approximately 4–5 hours; extended in renal impairment.
• Onset: Rapid bactericidal action due to high concentration- and post‑antibiotic effects.

• Pregnancy: FDA Category C. Animal studies suggest possible arthropathy in immature animals; human data are limited. Use only if potential benefits outweigh risks.
• Lactation: Ciprofloxacin is excreted in breast milk at low levels. Potential cartilage adverse effects in nursing infants remain theoretical. Caution advised; consider alternatives during breastfeeding.

• Primary Therapeutic Class: Fluoroquinolone antibiotic
• Subclass: Second‑generation fluoroquinolone

• Known hypersensitivity to ciprofloxacin or other quinolones
• Concurrent administration with tizanidine
• History of quinolone‑related tendon disorders
• Severe myasthenia gravis
• Pediatric use: except for approved anthrax prophylaxis (due to risk of musculoskeletal toxicity)

• Tendonitis/Tendon Rupture: Particularly Achilles tendon; risk increases with age (>60), corticosteroids, renal impairment. Discontinue at first sign (pain, swelling).
• Central Nervous System (CNS) Effects: May cause seizures, confusion, hallucinations, especially in elderly or those with CNS disorders.
• QT Prolongation / Arrhythmias: Monitor in patients with electrolyte imbalance, QT‑prolonging drugs, or cardiac disease.
• Hypoglycemia/Hyperglycemia: Monitor blood glucose in diabetics, especially on sulfonylureas.
• Phototoxicity: Advise protective measures (sunlight).
• Exacerbation of Myasthenia Gravis: Avoid use in these patients.
• Clostridioides difficile‑associated Diarrhea (CDAD): Monitor for severe diarrhea.
• Renal Monitoring: Adjust dosing; risk of crystalluria—encourage hydration.

Common:

• Gastrointestinal: Nausea, diarrhea, abdominal discomfort
• CNS: Headache, dizziness, insomnia
• Skin: Rash, pruritus
• Musculoskeletal: Mild arthralgia

Serious / Rare:

• Tendon rupture or tendonitis
• Severe hypersensitivity: anaphylaxis
• Peripheral neuropathy
• Hepatotoxicity (elevated liver enzymes, rare hepatic failure)
• QT prolongation, arrhythmias
• Hematologic: neutropenia, thrombocytopenia (rare)

Timing: GI and CNS effects often early (within days); tendon issues may occur during or after therapy; neuropathy may persist.

• Antacids, Sucralfate, Multivitamins (Fe, Zn, Mg): Reduce ciprofloxacin absorption—administer ciprofloxacin 2 hours before or 4–6 hours after.
• Warfarin: May increase INR; monitor coagulation.
• Theophylline: May increase theophylline levels via CYP1A2 inhibition; monitor for toxicity.
• Caffeine: Decreased metabolism; excessive stimulation possible.
• QT‑Prolonging Agents (e.g. amiodarone): Additive effect; avoid combined use.
• Tizanidine: Contraindicated due to hypotension and CNS depression.
• Probenecid: Reduces clearance, increasing ciprofloxacin plasma levels.

• FDA (2023): Reiterated black‑box warnings on tendon rupture, peripheral neuropathy, and CNS effects; advised reserving fluoroquinolones for services lacking safer alternatives.
• WHO Essential Medicines List (2024): Retains ciprofloxacin for key severe bacterial infections and anthrax post‑exposure.
• NICE/IDSA (2023): Recommended judicious use and antibiotic stewardship; promote alternative agents for uncomplicated infections to limit resistance.

• Store tablets and oral suspension at 20 °C to 25 °C (room temperature).
• Protect from excessive moisture and direct light.
• Store oral suspension upright, tightly closed; discard unused portion per expiry instructions.
• Do not freeze.
• Keep out of reach of children.