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. CIPRO Tablets or Oral Suspension may be administered to adult patients when clinically indicated at the discretion of the physician. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration (2.7)].

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. CIPRO should be administered as described in Table 3. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration (2.7)].

Dosage Modifications in Patients with Renal Impairment

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.

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

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. Patients should be carefully monitored.

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).

Important Administration Instructions

Directions for Reconstitution of the CIPRO Microcapsules for Oral Suspension

CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. CIPRO oral suspension is composed of two components (microcapsules and diluent) that must be combined prior to dispensing.

Preparation of the suspension:

Step1	The small bottle contains the microcapsules, the large bottle contains the diluent.	Step 2	Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left.
Step 3	Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension.	Step 4	1. Remove the top layer of the diluent bottle label (to reveal the CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use.

Step 5: Write the expiration date of the re-constituted oral suspension on the bottle label.

Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing.

No additions should be made to the mixed final ciprofloxacin suspension. CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics.

Administration Instructions for CIPRO for Oral Suspension After Reconstitution

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Shake CIPRO Oral Suspension vigorously each time before use for approximately 15 seconds.

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Administer CIPRO Oral Suspension using the co-packaged graduated teaspoon provided for the patient (see Figure 1)

Figure 1: Co-packaged 5 mL graduated teaspoon

The Co-packaged graduated teaspoon (5mL) is provided, with markings for 1/2 (2.5 mL) and 1/1 (5 mL)

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After use, clean the graduated teaspoon under running water with dish detergent and dry thoroughly.

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Do Not chew the microcapsules in the CIPRO Oral Suspension, instead swallow them whole.

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Water may be taken afterwards.

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Reclose the bottle properly after each use according to instructions on the cap.

After treatment has been completed, CIPRO Oral Suspension should not be reused.

Dosing of CIPRO for Oral Suspension using the Co-Packaged Spoon in Adults and Pediatric Patients

Table : 5% Cipro for Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution

* A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient.

1Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)]

2Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)]; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)]

3Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)]

* A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient.

1Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)]

2Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)]; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)]

3Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)]