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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cipro Tablets and Cipro Oral Suspension and other antibacterial drugs, Cipro Tablets and Cipro Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cipro Description
Cipro (Ciprofloxacin hydrochloride) Tablets and Cipro (Ciprofloxacin*) Oral Suspension are synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:
Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:
Cipro film-coated tablets are available in 250 mg, 500 mg and 750 mg (Ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol.
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Ciprofloxacin Oral Suspension is available in 5% (5 g Ciprofloxacin in 100 mL) and 10% (10 g Ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of Ciprofloxacin microcapsules and diluent which are mixed prior to dispensing (See Instructions for Use/Handling ). The components of the suspension have the following compositions:
Microcapsules - Ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20.
Diluent - medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.
* Does not comply with USP with regard to "loss on drying" and "residue on ignition".
CLINICAL PHARMACOLOGY
Absorption:
Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range.
Dose
(mg) Maximum
Serum Concentration
(μg/mL) Area
Under Curve (AUC)
(μg•hr/mL)
250 1.2 4.8
500 2.4 11.6
750 4.3 20.2
1000 5.4 30.8
Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 μg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Serum concentrations increase proportionately with doses up to 1000 mg.
A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg Ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours. A 750 mg oral dose results in a Cmax similar to that observed with a 400 mg I.V. dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg Ciprofloxacin given every 12 hours.
Steady-state Pharmacokinetic Parameters Following Multiple Oral and I.V. DosesParameters 500 mg 400 mg 750 mg 400 mg
AUC (μg•hr/mL) q12h, P.O.
13.7a q12h, I.V.
12.7a q12h, P.O.
31.6b q8h, I.V.
32.9c
Cmax (μg/mL) 2.97 4.56 3.59 4.07
aAUC 0-12h
bAUC 24h=AUC0-12h x 2
cAUC 24h=AUC0-8h x 3
Distribution:
The binding of Ciprofloxacin to serum proteins is 20 to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs.
After oral administration, Ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations. Low levels of the drug have been detected in the aqueous and vitreous humors of the eye.
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