Ciprofloxacin

CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections. • Bone and Joint Infections. • Complicated Intra-Abdominal Infections. • Infectious Diarrhea. • Typhoid Fever (Enteric Fever). • Uncomplicated Cervical and Urethral Gonorrhea. • Inhalational Anthrax post-exposure in adult and pediatric patients. • Plague in adult and pediatric patients. • Chronic Bacterial Prostatitis. • Lower Respiratory Tract Infections. • Acute Exacerbation of Chronic Bronchitis • Urinary Tract Infections. • Urinary Tract Infections (UTI) • Acute Uncomplicated Cystitis • Complicated UTI and Pyelonephritis in Pediatric Patients • Acute Sinusitis.

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents. Mechanism of Action The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

CIPRO Tablets and Oral Suspension should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 -750 mg every 12 hours 7 to 14 days Urinary Tract 250-500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days • Adults with creatinine clearance 30–50 mL/min 250–500 mg q 12 h.

• Known hypersensitivity to CIPRO or other quinolones. • Concomitant administration with tizanidine Hypersensitivity CIPRO is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components. Tizanidine Concomitant administration with tizanidine is contraindicated.

Boxed warning: Fluoroquinolones, including CIPRO ®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: • Tendinitis and tendon rupture. • Peripheral neuropathy. • Central nervous system effects. Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of CIPRO. Discontinue CIPRO at the first sign of skin rash, jaundice or any sign of hypersensitivity. • Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. • Clostridioides difficile -associated diarrhea: Evaluate if colitis occurs.

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Disabling and Potentially Irreversible Serious Adverse Reactions • Tendinitis and Tendon Rupture • Peripheral Neuropathy • Central Nervous System Effects Exacerbation of Myasthenia Gravis • Other Serious and Sometimes Fatal Adverse Reactions • Hypersensitivity Reactions • Hepatotoxicity • Risk of Aortic Aneurysm and Dissection • Serious Adverse Reactions with Concomitant Theophylline • Clostridioides difficile -Associated Diarrhea • Prolongation of the QT Interval • Musculoskeletal Disorders in Pediatric Patients • Photosensitivity/Phototoxicity • Development of Drug Resistant Bacteria The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash.

Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of CIPRO with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 11: Drugs That are Affected by and Affecting CIPRO Drugs That are Affected by CIPRO Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and CIPRO is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of CIPRO with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions.

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing. Strengths Total volume after reconstitution Ciprofloxacin Concentration Ciprofloxacin contents per bottle NDC Code 5% 100 mL 250 mg/5 mL 5,000 mg 50419-777-01 10% 100 mL 500 mg/5 mL 10,000 mg 50419-773-01 Store microcapsules and diluent below 25°C (77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F). The reconstituted product may be stored at 25°C (77°F) for 14 days, excursions are permitted from 15°C to 30°C (59°F to 86°F).