Ciprofloxacin

Ciprofloxacin

60760-074

60760-074

ANDA208921

C73584

December 16, 2020

USA

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN TABLETS, for oral use Initial U.S. Approval: 1987WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. • Fluoroquinolones,including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1), including: • Tendinitis and tendon rupture ( 5.2) • Peripheral neuropathy ( 5.3) • Central nervous system effects ( 5.4) Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions ( 5.1) • Fluoroquinolones,including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis. ( 5.5) • Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions (5.1-5.16), reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications: • Acute exacerbation of chronic bronchitis ( 1.10) • Acute uncomplicated cystitis ( 1.11) • Acute sinusitis (1.12) RECENT MAJOR CHANGES Dosage and Administration (2.4) 05/2020 INDICATIONS AND USAGE Ciprofloxacin 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 ( 1.1) • Bone and Joint Infections ( 1.2) • Complicated Intra-Abdominal Infections ( 1.3) • Infectious Diarrhea ( 1.4) • Typhoid Fever (Enteric Fever) ( 1.5) • Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) • Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) • Plague in adult and pediatric patients ( 1.8) • Chronic Bacterial Prostatitis ( 1.9) • Lower Respiratory Tract Infections ( 1.10) • Acute Exacerbation of Chronic Bronchitis • Urinary Tract Infections ( 1.11) • Urinary Tract Infections (UTI) • Acute Uncomplicated Cystitis • Complicated UTI and Pyelonephritis in Pediatric Patients • Acute Sinusitis ( 1.12) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13) DOSAGE AND ADMINISTRATION Adult Dosage Guidelines (2) Infection (2) Dose (2) Frequency (2) Duration (2) Skin and Skin Structure (2) 500 -750 mg (2) every 12 hours (2) 7 to 14 days (2) Bone and Joint (2) 500-750 mg (2) every 12 hours (2) 4 to 8 weeks (2) Complicated Intra-Abdominal (2) 500 mg (2) every 12 hours (2) 7 to 14 days (2) Infectious Diarrhea (2) 500 mg (2) every 12 hours (2) 5 to 7 days (2) Typhoid Fever (2) 500 mg (2) every 12 hours (2) 10 days (2) Uncomplicated Gonorrhea (2) 250 mg (2) single dose (2) single dose (2) Inhalational anthrax (post-exposure) (2) 500 mg (2) every 12 hours (2) 60 days (2) Plague (2) 500–750 mg (2) every 12 hours (2) 14 days (2) Chronic Bacterial Prostatitis (2) 500 mg (2) every 12 hours (2) 28 days (2) Lower Respiratory Tract (2) 500 -750 mg (2) every 12 hours (2) 7 to 14 days (2) Urinary Tract (2) 250-500 mg (2) every 12 hours (2) 7 to 14 days (2) Acute Uncomplicated Cystitis (2) 250 mg (2) every 12 hours (2) 3 days (2) Acute Sinusitis (2) 500 mg (2) every 12 hours (2) 10 days (2) (2) • Adults with creatinine clearance 30–50 mL/min 250–500 mg q 12 h (2.3) (2) • Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h (2.3) (2) • Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) (2.3) (2) (2) Pediatric Oral Dosage Guidelines (2) Infection (2) Dose (2) Frequency (2) Duration (2) Complicated UTI and Pyelonephritis (1 to 17 years of age) (2) 10–20 mg/kg (maximum 750 mg per dose (2) Every 12 hours (2) 10–21 days (2) Inhalational Anthrax (Post-Exposure) (2) 15 mg/kg (maximum 500 mg per dose) (2) Every 12 hours (2) 60 days (2) Plague (2) 15mg/kg (2) (maximum 500 mg per dose) (2) Every 8 to 12 hours (2) 14days (2) DOSAGE FORMS AND STRENGTHS Tablets: 250 mg, 500 mg (3) CONTRAINDICATIONS • Known hypersensitivity to ciprofloxacin or other quinolones ( 4.1, 5.6, 5.7) • Concomitant administration with tizanidine ( 4.2) WARNINGS AND PRECAUTIONS • Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin. Discontinue ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1, 5.6, 5.7) • Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. ( 5.8) • Clostridium difficile-associated diarrhea: Evaluate if colitis occurs. ( 5.11) • QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. ( 5.12, 7, 8.5) ADVERSE REACTIONS The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Yiling Pharmaceutical, Inc. at 1-877-736-5697 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Interacting Drug Interaction Theophylline Serious and fatal reactions. Avoid concomitant use. Monitor serum level ( 7) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time, INR, and bleeding ( 7) Antidiabetic agents Hypoglycemia including fatal outcomes have been reported. Monitor blood glucose ( 7) Phenytoin Monitor phenytoin level ( 7) Methotrexate Monitor for methotrexate toxicity ( 7) Cyclosporine May increase serum creatinine. Monitor serum creatinine ( 7) Multivalent cation-containing products including antacids, metal cations or didanosine Decreased ciprofloxacin absorption. Take 2 hours before or 6 hours after ciprofloxacin ( 7) USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding. ( 8.2) See Full Prescribing Information for use in pediatric and geriatric patients ( 8.4, 8.5) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 5/2020

HUMAN PRESCRIPTION DRUG LABEL

3

063050751