(ciprofloxacin injection)

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIPROFLOXACIN INJECTION safely and effectively. See full prescribing information for CIPROFLOXACIN INJECTION.
CIPROFLOXACIN injection, for intravenous infusion.
Initial U.S. Approval: 1990

WARNING: 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 Injection (in 5% Dextrose Injection) 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 Injection immediately and avoid the use of fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), in patients who experience any of these serious adverse reactions (5.1)

  • Fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Ciprofloxacin Injection (in 5% Dextrose Injection) in patients with known history of myasthenia gravis. (5.5)
  • Because fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), have been associated with serious adverse reactions (5.1 to 5.16), reserve Ciprofloxacin Injection (in 5% Dextrose Injection) for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis (1.9)
    • Acute sinusitis (1.11)

INDICATIONS AND USAGE

Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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)
  • Nosocomial Pneumonia (1.4)
  • Empirical Therapy for Febrile Neutropenic Patients (1.5)
  • Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients (1.6)
  • Plague in Adult and Pediatric Patients (1.7)
  • Chronic Bacterial Prostatitis (1.8)
  • Lower Respiratory Tract Infections (1.9)
    • Acute Exacerbation of Chronic Bronchitis
  • Urinary Tract Infections (1.10)
    • Urinary Tract Infections (UTI)
    • Complicated UTI and Pyelonephritis in Pediatric Patients
  • Acute Sinusitis (1.11)

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.12)

DOSAGE AND ADMINISTRATION

*Adults with creatinine clearance 5 to 29 mL/min 250 to 500 mg q 18 h (2.3)

Adult Dosage Guidelines
Infection Dose Frequency Duration
Skin and Skin Structure 400 mg every 8 to 12 hours 7 to 14 days
Bone and Joint 400 mg every 8 to 12 hours 4 to 8 weeks
Complicated Intra-Abdominal 400 mg every 12 hours 7 to 14 days
Nosocomial Pneumonia 400 mg every 8 hours 10 to 14 days
Empirical Therapy In Febrile Neutropenic Patients 400 mg and Piperacillin 50 mg/kg every 8 hours
every 4 hours 		7 to 14 days
Inhalational anthrax (post-exposure) 400 mg every 12 hours 60 days
Plague 400 mg every 8 to 12 hours 14 days
Chronic Bacterial prostatitis 400 mg every 12 hours 28 days
Lower Respiratory Tract 400 mg every 8 to 12 hours 7 to 14 days
Urinary Tract 200 to 400 mg every 8 to 12 hours 7 to 14 days
Acute Sinusitis 400 mg every 12 hours 10 days
Pediatric Intravenous Dosing Guidelines
Infection Dose Frequency Duration
Complicated UTI and Pyelonephritis (patients from 1 to 17 years of age) 6 mg/kg to 10 mg/kg (maximum 400 mg per dose) Every 8 hours 10 to 21 days1
Inhalational Anthrax (Post-Exposure) 10 mg/kg (maximum
400 mg per dose) 		Every 12 hours 60 days
Plague 10 mg/kg (maximum
400 mg per dose) 		Every 8 to 12 hours 14 days

DOSAGE FORMS AND STRENGTHS

Ciprofloxacin Injection (in 5% Dextrose): 200 mg per 100 mL and 400 mg per 200 mL (3)

CONTRAINDICATIONS

  • Known hypersensitivity to ciprofloxacin injection or other quinolones (4.1, 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 first or subsequent doses of Ciprofloxacin Injection. Discontinue Ciprofloxacin Injection 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)
  • Clostridioides 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, central nervous system disturbance, local intravenous site reactions eosinophilia, headache, restlessness, and rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1 -800-441 -4100 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)

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)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2022
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