Cipro

DOSAGE AND ADMINISTRATION
Adults
CIPRO Tablets and Oral Suspension should be administered orally to adults as described in the Dosage Guidelines table. The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required.

Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

ADULT DOSAGE GUIDELINES
Infection Severity Dose Frequency Usual Durations†
Urinary Tract Acute Uncomplicated
Mild/Moderate
Severe/Complicated 250 mg
250 mg
500 mg q 12 h
q 12 h
q 12 h 3 Days
7 to 14 Days
7 to 14 Days
Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days
Lower Respiratory Tract Mild/Moderate
Severe/Complicated 500 mg
750 mg q 12 h
q 12 h 7 to 14 days
7 to 14 days
Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days
Skin and Skin Structure Mild/Moderate
Severe/Complicated 500 mg
750 mg q 12 h
q 12 h 7 to 14 Days
7 to 14 Days
Bone and Joint Mild/Moderate
Severe/Complicated 500 mg
750 mg q 12 h
q 12 h = 4 to 6 weeks
= 4 to 6 weeks
Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days
Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days
Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days
Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose
Inhalational anthrax(post-exposure)** 500 mg q 12 h 60 Days
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection havedisappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likelyto predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

Conversion of I.V. to Oral Dosing in Adults: Patients whose therapy is started with CIPRO I.V. may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

Equivalent AUC Dosing Regimens
Cipro Oral Dosage Equivalent Cipro I.V. Dosage
250 mg Tablet q 12 h 200 mg I.V. q 12 h
500 mg Tablet q 12 h 400 mg I.V. q 12 h
750 mg Tablet q 12 h 400 mg I.V. q 8 h

Adults with Impaired Renal Function: 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. The following table provides dosage guidelines for use in patients with renal impairment:

RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage.
30 – 50 250 – 500 mg q 12 h
5 – 29 250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
72 x serum creatinine (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, a unit dose of 750 mg may be administered at the intervals noted above. Patie nts should be carefully monitored.

Pediatrics
CIPRO Tablets and Oral Suspension should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and Clinical Studies)

Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

PEDIATRIC DOSAGE GUIDELINES
Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration
Complicated Urinary Tract or Pyelonephritis
(patients from 1 to 17 years ofage) Intravenous 6 to 10 mg/kg
(maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days*
Oral 10 mg/kg to 20 mg/kg
(maximum 750 mg per dose; not to be exceededeven in patients weighing > 51 kg) Every 12 hours
Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg
(maximum 400 mg per dose) Every 12 hours 60 days
Oral 15 mg/kg
(maximum 500 mg per dose) Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

HOW SUPPLIED

CIPRO (ciprofloxacin hydrochloride) Tablets are available as round, slightly yellowish film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with the word “BAYER” on one side and “CIP 250” on the reverse side. CIPRO is also available as capsule shaped, slightly yellowish film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and “CIP 500” on the reverse side. The 750 mg tablet is coded with the word “BAYER” on one side and “CIP 750” on the reverse side. CIPRO 250 mg, 500 mg, and 750 mg are available in bottles of 50, 100, and Unit Dose packages of 100.

Strength NDC Code Tablet Identification

Bottles of 50: 750 mg NDC 0085-1756-01 CIPRO 750
Bottles of 100: 250 mg NDC 0085-1758-01 CIPRO 250
500 mg NDC 0085-1754-01 CIPRO 500
Unit Dose
Package of 100: 250 mg NDC 0085-1758-02 CIPRO 250
500 mg NDC 0085-1754-02 CIPRO 500
750 mg NDC 0085-1756-02 CIPRO 750

Store below 30°C (86°F).

CIPRO Oral Suspension is supplied in 5% and 10% strengths. The drug product is composed of two components (microcapsules containing the active ingredient and diluent) which must be mixed by the pharmacist. See Instructions To The Pharmacist For Use/Handling.

Strengths Total volume after reconstitution Ciprofloxacin Concentration Ciprofloxacin contents per bottle NDC Code
5% 100 mL 250 mg/5 mL 5,000 mg 0085-1777-01
10% 100 mL 500 mg/5 mL 10,000 mg 0085-1773-01

Microcapsules and diluent should be stored below 25°C (77°F) and protected from freezing. Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing. A teaspoon is provided for the patient.

Instructions To The Pharmacist For Use/Handling Of CIPRO Oral Suspension:

CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. The drug product is composed of two components (microcapsules and diluent) which must be combined prior to dispensing.One teaspoonful (5 mL) of 5% ciprofloxacin oral suspension = 250 mg of ciprofloxacin.One teaspoonful (5 mL) of 10% ciprofloxacin oral suspension = 500 mg of ciprofloxacin.