COM BAYER INSERTS CIPROXR PDF

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If you are a consumer or patient please visit this version. Acute sinusitis 1. CIPRO is a fluoroquinolone antibacterial indicated in adults 18 years of age and older with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO and other antibacterial drugs, CIPRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Serious and fatal reactions. Avoid concomitant use. Monitor serum level 7. Anticoagulant effect enhanced. Monitor prothrombin time, INR, and bleeding 7. Hypoglycemia including fatal outcomes have been reported. Monitor blood glucose 7. Monitor phenytoin level 7. Monitor for methotrexate toxicity 7. May increase serum creatinine.

Monitor serum creatinine 7. Multivalent cation-containing products including antacids, metal cations or didanosine. CIPRO is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

CIPRO is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. CIPRO is indicated in adult patients for treatment of complicated intra-abdominal infections used in combination with metronidazole caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

CIPRO is indicated in adult patients for treatment of typhoid fever enteric fever caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

CIPRO is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions 5. CIPRO is indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax post-exposure to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies CIPRO is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

CIPRO is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.

CIPRO is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. CIPRO is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter koseri , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis.

CIPRO is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus. CIPRO is indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections cUTI and pyelonephritis due to Escherichia coli [see Use in Specific Populations 8. CIPRO, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions 5.

CIPRO is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO and other antibacterial drugs, CIPRO 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. If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered.

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 may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin.

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. Dosing and initial route of therapy that is, IV or oral for cUTI or pyelonephritis should be determined by the severity of the infection.

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:.

In patients with severe infections and severe renal impairment, a unit dose of 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. Concomitant administration of CIPRO with dairy products like milk or yogurt or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, CIPRO may be taken with a meal that contains these products.

Assure adequate hydration of patients receiving CIPRO to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones. If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.

CIPRO oral suspension is composed of two components microcapsules and diluent that must be combined prior to dispensing. The small bottle contains the microcapsules, the large bottle contains the diluent. Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left. Pour the microcapsules completely into the larger bottle of diluent.

Do not add water to the suspension. No additions should be made to the mixed final ciprofloxacin suspension. Complicated Urinary Tract or Pyelonephritis patients from 1 to 17 years of age 1. CIPRO is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions 5.

Concomitant administration with tizanidine is contraindicated [see Drug Interactions 7 ]. Fluoroquinolones, including CIPRO, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects hallucinations, anxiety, depression, insomnia, severe headaches, and confusion.

Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions 5. In addition, avoid the use of fluoroquinolones, including CIPRO, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions 5. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff the shoulder , the hand, the biceps, the thumb, and other tendons.

Tendinitis or tendon rupture can occur, within hours or days of starting CIPRO, or as long as several months after completion of fluoroquinolone therapy.. Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Other factors 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. Discontinue CIPRO immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including CIPRO, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions 6.

Fluoroquinolones, including CIPRO, have been associated with an increased risk of peripheral neuropathy. These reactions may occur following the first dose. Advise patients receiving CIPRO to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care. Fluoroquinolones, including CIPRO, have been associated with an increased risk of seizures convulsions , increased intracranial pressure pscudotumor cerebri , dizziness, and tremors.

CIPRO, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. As with all fluoroquinolones, use CIPRO with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke , or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold for example, certain drug therapy, renal dysfunction.

Fluoroquinolones, including CIPRO, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.

Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including CIPRO. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:. Discontinue CIPRO immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions 6.

Serious and occasionally fatal hypersensitivity anaphylactic reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including CIPRO. 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 and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated [see Adverse Reactions 6. Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients.

The cause for the increased risk has not been identified.

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