(ciprofloxacin injection)
Ciprofloxacin injection should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.
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.
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. | ||||||
| Infection1 | 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 | Ciprofloxacin 400 mg and Piperacillin 50 mg/kg |
every 8 hours every 4 hours |
7 to 14 days | |||
| Inhalational Anthrax (Post-Exposure)3 | 400 mg | every 12 hours |
60 days | |||
| Infection1 | Dose | Frequency | Usual Duration | |||
| 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)].
| 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 |
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.
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 |
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
| Creatinine Clearance (mL/min) | Dose |
| >30 | See Usual Dosage. |
| 5 to 29 | 200 to 400 mg every 18 to 24 hours |
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
| Men – Creatine clearance (mL/min) = | Weight (kg) x (140 – age) | |
| 72 x serum creatine (mg/dL) |
Women - 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment and hepatic insufficiency, careful monitoring is suggested.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
Flexible Containers
Ciprofloxacin injection is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.
Caution: After removing the overwrap check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container as sterility may be compromised. Use only if solution is clear and the container is undamaged.
Intravenous Infusion
Ciprofloxacin injection should be administered by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.
Hydration of Patients Receiving Ciprofloxacin Injection
Adequate hydration of patients receiving ciprofloxacin injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see Warnings and Precautions (5.17), Adverse Reactions (6.1), Nonclinical Toxicology (13.2) and Patient Counseling Information (17)].
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