Ciprofloxacin (Page 2 of 11)

1.12 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with Ciprofloxacin Injection may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.

As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

2 DOSAGE AND ADMINISTRATION

Ciprofloxacin injection should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.

2.1 Dosage in Adults

The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.

Table 1: Adult Dosage Guidelines

1. Due to the designated pathogens (see Indications and Usage.)

2. Used in conjunction with metronidazole.

3. Begin administration as soon as possible after suspected or confirmed exposure.

Infection 1 Dose Frequency Usual 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-Abdominal2 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 Ciprofloxacin400 mg and Piperacillin50 mg/kg every 8 hoursevery 4 hours 7 to 14 days
Inhalational Anthrax (Post-Exposure)3 400 mg every 12 hours 60 days
Plague3 400 mg every 8 to 12 hours 14 days
Chronic Bacterial Prostatitis 400 mg every 12 hours 28 days
Lower Respiratory Tract Infections 400 mg every 8 to 12 hours 7 to 14 days
Urinary Tract Infections 200 mg to 400 mg every 8 to 12 hours 7 to 14 days
Acute Sinusitis 400 mg every 12 hours 10 days

Conversion of Intravenous to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin injection may be switched to ciprofloxacin tablets or oral suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

Table 2: Equivalent AUC Dosing Regimens
Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection Dosage
250 mg Tablet every 12 hours 200 mg intravenous every 12 hours
500 mg Tablet every 12 hours 400 mg intravenous every 12 hours
750 mg Tablet every 12 hours 400 mg intravenous every 8 hours

2.2 Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.

Table 3: Pediatric Dosage Guidelines

1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

2. Begin drug administration as soon as possible after suspected or confirmed exposure.

3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

Infection Dose (mg/kg) Frequency Total Duration
Complicated Urinary Tract or Pyelonephritis(patients from 1 to 17 years of age)1 6 mg/kg to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 8 hours 10 to 21 days1
Inhalational Anthrax(Post-Exposure)2 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days
Plague2,3 10 mg/kg (maximum 400 mg per dose) Every 8 to 12 hours 14 days

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