|Manufacturer:||Bayer HealthCare Pharmaceuticals Inc.|
CIPRO Tablets:Active ingredient: ciprofloxacinInactive ingredients: cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycolCIPRO Oral Suspension:Active ingredient: ciproflxacinInactive ingredients: 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.CIPRO XR:Active ingredient: ciprofloxacin Inactive ingredients: crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.CIPRO I.V.:Active ingredient: ciprofloxacin Inactive ingredients: lactic acid as a solubilizing agent, hydrochloric acid for pH adjustment Revised October 2008 This Medication Guide has been approved by the U.S.Food and Drug Administration.Manufactured by:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470Made in GermanyDistributed by:Schering PloughSchering CorporationKenilworth, NJ 07033CIPRO is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation.Rx Only81532274, R.0Bay o 9867/q 393910/0814212©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A.
CIPRO XR is indicated only for the treatment of urinary tract infections, including acute uncomplicated pyelonephritis, caused by susceptible strains of the designated microorganisms as listed below.
CIPRO XR and ciprofloxacin immediate-release tablets are not interchangeable.
Please see DOSAGE AND ADMINISTRATION for specific recommendations.Uncomplicated Urinary Tract Infections (Acute Cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticusa.Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosaa.Acute Uncomplicated Pyelonephritis caused by Escherichia coli.a Treatment of infections due to this organism in the organ system was studied in fewer than 10 patients.THE SAFETY AND EFFICACY OF CIPRO XR IN TREATING INFECTIONS OTHER THAN URINARY TRACT INFECTIONS HAS NOT BEEN DEMONSTRATED.
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 CIPRO XR may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
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.To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO XR and other antibacterial drugs, CIPRO XR 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.
Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.Concomitant administration with tizanidine is contraindicated.(See PRECAUTIONS: Drug Interactions.)
Tendinopathy and Tendon Rupture: Fluoroquinolones, including CIPRO XR, are associated with an increased risk of tendinitis and tendon rupture in all ages.
This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair.
Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported.
The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.
Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.
Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported.
CIPRO XR should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.
Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.THE SAFETY AND EFFECTIVENESS OF CIPRO XR IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND NURSING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS: Pediatric Use, Pregnancy, and Nursing Mothers subsections.) The oral administration of ciprofloxacin caused lameness in immature dogs.
Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage.
Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species.
(See ANIMAL PHARMACOLOGY.)Cytochrome P450 (CYP450): Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway.
Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (e.g.
theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug.Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin.
Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts.
These reactions may occur following the first dose.
If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted.
As with all quinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g.
severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g.
certain drug therapy, renal dysfunction).
(See PRECAUTIONS: General,Information for Patients,Drug Interactions and ADVERSE REACTIONS.)SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE.
These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure.
Although similar serious adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated.
If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy.
Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
Only a few patients had a history of hypersensitivity reactions.
Serious anaphylactic reactions require immediate emergency treatment with epinephrine.
Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin.
These events may be severe and generally occur following the administration of multiple doses.
Clinical manifestations may include one or more of the following: fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome);vasculitis; arthralgia; myalgia; serum sickness;allergic pneumonitis;interstitial nephritis; acute renal insufficiency or failure;hepatitis; jaundice; acute hepatic necrosis or failure;anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS).
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CIPRO, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin.Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.