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Drug Administration

Drug administration route

In a comparison of intravenous and oral ciprofloxacin in children, treatment associated adverse events were reported in 11% of children taking oral ciprofloxacin, compared with 19% of the children who were treated intravenously. In 31 children (1.5%) arthralgia occurred, but it was generally mild to moderate and resolved spontaneously.

Drug overdose

A patient developed acute renal insufficiency after ciprofloxacin overdose. This was mediated by tubulointerstitial nephritis with distal nephron apoptosis, as evidenced by renal biopsy.

Drug-Drug Interactions

Ciclosporin

In 42 patients who had received a kidney transplant, cases were treated with ciprofloxacin in the first 1-6 months after transplantation, and matched controls (two per case) were not. The proportion of cases with at least one episode of biopsy-proven rejection 1-3 months after transplantation (45%) was significantly higher than in the controls (19%). The authors speculated that ciprofloxacin increases rejection rates in renal transplant recipients by antagonizing ciclosporin-dependent inhibition of interleukin-2 production.

Clozapine

Ciprofloxacin can alter plasma clozapine concentrations, perhaps by inhibition of cytochrome P450 enzymes.

Didanosine

Didanosine one enteric-coated capsule/day (400 mg/day) did not affect the absorption of ciprofloxacin in 16 patients.

Glibenclamide

Hypoglycemia and raised serum concentrations of glibenclamide, which is metabolized by CYP2C9, occurred after treatment with ciprofloxacin for 1 week in a patient taking long-term glibenclamide.

Insulin

Hypoglycemia occurred in a patient treated with insulin and ciprofloxacin 500 mg bd.

Methadone

Ciprofloxacin, given to a patient who had been successfully treated with methadone for more than 6 years, caused profound sedation, confusion, and respiratory depression. This may have been due to inhibition of CYP1A2 and CYP3A4, two of the isozymes involved in the metabolism of methadone.

Methotrexate

Methotrexate elimination can be delayed by ciprofloxacin. Two adolescents with malignant diseases had reduced elimination of methotrexate (12 g/m2 4-hourly) when they took ciprofloxacin 500 mg bd.

Oral contraceptives

Some antibiotics can reduce the efficacy of oral contraceptives. However, there is pharmacokinetic evidence that plasma concentrations of oral contraceptive steroids are unchanged by co-administration of ciprofloxacin. Furthermore, ciprofloxacin (500 mg bd) did not interfere with the ovarian suppression produced by the oral contraceptive Marvelon (30 micrograms of ethiny-lestradiol plus 150 micrograms of desogestrel) in 24 healthy women in a randomized, double-blind, placebo-controlled, crossover trial.

Phenytoin

Ciprofloxacin may interact with phenytoin reducing phenytoin concentrations. • A lower than expected phenytoin serum concentration has been measured in a 78-year-old white woman with a grade III astrocytoma of the right parieto-occipital region treated with ciprofloxacin (500 mg bd). Increased renal excretion has been suggested to be at least partly responsible for the increased clearance. Besides this kinetic interaction, the possible epileptogenic potential of ciprofloxacin itself may contribute to the development of seizure activity.

Probenecid

The renal excretion of ciprofloxacin was reduced and plasma concentrations increased by probenecid.

Quinidine

Serum quinidine concentrations rose during concomitant administration of ciprofloxacin. The authors speculated that the mechanism was inhibition of cytochrome P450 by ciprofloxacin.

Rifamycins

Rifampicin-induced lupus-like syndrome is associated with combination therapy with ciprofloxacin, since rifampicin is metabolized by (among others) CYP3A4, which is inhibited by ciprofloxacin, and combined usage may lead to higher rifampicin blood concentrations.

Ropinirole

During co-administration of ciprofloxacin with ropinirole in 12 patients there was an increase in the plasma ropinirole concentration, which is metabolized by CYP1A2.

Warfarin

Ciprofloxacin can occasionally cause an exaggerated hypoprothombinemic response and bleeding in patients taking warfarin. In 66 patients (median age 72 years, range, the mean time to detection of the coagulo-pathy after ciprofloxacin challenge was 5.5 days. Hospitalization was reported in 15 cases, bleeding in 25, and death in one. The median INR was 10.0. Patients in their seventh decade and those requiring polypharmacy were most at risk.

Food-Drug Interactions

The systemic availability of ciprofloxacin is reduced by 30-36% when it is taken with dairy products.

Ciprofloxacin: Side Effects

Ciprofloxacin is a fluoroquinolone antibacterial drug with a wider spectrum of activity than nalidixic acid.

Observational studies

Antimicrobial prophylaxis to prevent inhalational anthrax has been recommended for people potentially exposed to Bacillus anthracis as a result of recent bioterrorist attacks. Of 3428 people taking ciprofloxacin, 666 (19%) reported severe nausea, vomiting, diarrhea, or abdominal pain; 484 (14%) reported fainting, light-headedness, or dizziness; 250 (7%) reported heartburn or acid reflux; and 216 (6%) reported rashes, hives, or an itchy skin. Of those taking ciprofloxacin, 287 (8%) stopped taking it, 116 (3%) because of adverse events, 27 (1%) because of fear of possible adverse events, and 28 (1%) because they “did not think it was needed”. The imaging of inflammation/infection withTm-labeled ciprofloxacin in 96 patients had a sensitivity of 81% and specificity of 87%. The positive and negative predictive values were 90 and 75% respectively. No adverse effects were reported.

Comparative studies

In a multicenter, double-blind study of 234 patients with acute bacterial exacerbations of chronic bronchitis, ciprofloxacin (500 mg bd) was associated with a trend toward a longer infection-free interval and a significantly higher bacteriological eradication rate compared with clarithromycin (500 mg bd) after 14 days. In a double-blind study, ciprofloxacin (500 mg bd) was associated with an infection-free interval and clinical response that were similar to those achieved with cefuroxime axetil (500 mg bd), but the bacteriological eradication rate associated with ciprofloxacin was significantly higher.

Ciprofloxacin: Organs and Systems

Cardiovascular

Ciprofloxacin causes prolongation of the QT interval.

Nervous system

Headache was recorded in 8% of patients taking ciprofloxacin Ciprofloxacin can cause confusion and general seizures. Ciprofloxacin can cause facial dyskinesia. Two cases of generalized painful dysesthesia associated with ciprofloxacin have been reported.

Sensory systems

Eyes

Bilateral acute visual loss, possibly due to toxic optic neuropathy, was observed after 4 weeks of treatment with ciprofloxacin 1.5 g/day and improved after withdrawal. Ciprofloxacin 0.3% ophthalmic drops can cause micro-precipitates of pure ciprofloxacin in the corneal epithelium. In four corneal transplantation patients treated preoperatively with ciprofloxacin 0.3% ophthalmic drops, there were microprecipitates associated with damaged corneal epithelium in two patients; another developed a macroprecipitate in a corneal ulcer. The crystalline precipitates were pure ciprofloxacin.

Ears

Topical 0.2% ciprofloxacin (0.2 ml od for 7 days) did not significantly affect the auditory brainstem response thresholds of guinea pigs, whereas 4% gentamicin (0.2 ml od for 7 days) resulted in total hearing loss. Topical 0.2% ciprofloxacin solution was effective and well tolerated in 232 patients with chronic suppurative otitis media; the most frequently reported adverse events were pruritus, stinging, and earache. Audiometric tests did not show changes attributable to ciprofloxacin. In children with tympanic membrane perforation, topical ciprofloxacin caused no signs of local intolerance or ototoxicity and did not result in significant serum concentrations.

Psychological, psychiatric

The administration of ciprofloxacin has been associated with psychosis and hypoactive delirium. • A 27-year-old woman developed an acute psychotic reaction following the use of ciprofloxacin eye-drops (1 drop hourly to each eye).

Hematologic

Ciprofloxacin has been associated with hemolysis in combination with a severe skin reaction in a young adult. Fatal ciprofloxacin-associated thrombotic thrombo-cytopenic purpura and thrombocytopenia have been reported.

Gastrointestinal

In a randomized, double-blind comparison of prulifloxacin 600 mg/day and ciprofloxacin 500 mg bd in 235 patients with acute exacerbations of chronic bronchitis, the most common treatment-related adverse event was gastric pain of mild or moderate intensity, reported in 8.5% of the patients taking prulifloxacin and 6.8% of those taking ciprofloxacin. Ciprofloxacin has been associated with diarrhea due to Clostridium difficile. In 27 patients the only significant risk factor for nosocomial C. difficile-associated diarrhea was the use of ciprofloxacin.

Liver

Ciprofloxacin causes a mild reversible rise in liver enzymes in 2-3% of patients. Acute hepatitis is rare, but has been reported in a 32-year-old man.

Pancreas

A report has suggested that ciprofloxacin can cause pancreatitis.

Urinary tract

Two cases of acute renal insufficiency due to necrotizing vasculitis associated with ciprofloxacin were reported in elderly patients. In two patients who underwent high-dose chemotherapy with autologous stem cell rescue, acute renal insufficiency developed while they were taking prophylactic ciprofloxacin; withdrawal resulted in prompt reversal of renal insufficiency. Ciprofloxacin-induced acute renal insufficiency has been reported in cancer patients undergoing high-dose chemotherapy and autologous stem cell rescue. A case report has suggested that ciprofloxacin overdose can lead to acute renal insufficiency characterized by acute tubular necrosis with distal nephron apoptosis.

  • An 18-year-old woman with cystic fibrosis had pronounced impairment of renal function after taking oral ciprofloxacin 750 mg tds (30 mg/kg/day) for 3 weeks; withdrawal led to normalization of renal function within 10 days. Hemolytic-uremic syndrome has been attributed to ciprofloxacin.
  • A 53-year-old white man was given chemotherapy for acute lymphoblastic leukemia and after 4 weeks recovered his blood cell count but developed a fever and was given oral ciprofloxacin 500 mg bd. After four doses he developed the typical features of hemolytic-uremic syndrome with microangiopathic hemolytic anemia. The ciprofloxacin was withdrawn, and he received five sessions of plasma exchange. He recovered completely. Bilateral hydronephrosis and acute renal insufficiency due to urinary tract stones predominantly composed of ciprofloxacin has been reported.

Skin

Ciprofloxacin can cause a fixed drug eruption, purpuric skin lesions, bullous pemphigoid, cutaneous vasculitis, and ultraviolet recall-like phenomenon.

Musculoskeletal

Tendinopathy

Ciprofloxacin can be associated with partial or complete tendinitis. Of 72 lung transplant recipients who received ciprofloxacin, 20 had Achilles tendon involvement (tendinitis 15, rupture). Tendon rupture occurred at a lower dosage of ciprofloxacin than tendinitis and the mean recovery duration was significantly longer. • Achilles tendon rupture without any sudden pain occurred in a 45-year-old female runner who developed bilateral tendinopathy of the Achilles tendon after repeated treatment with ciprofloxacin; histological analysis showed cystic changes with focal necrosis.

Arthropathy

The available data suggest that the incidence of arthrotoxicity in children taking ciprofloxacin is the same as in adults; the use of other fluoroquinolones is too rare to obtain clear information about the risks in children. In 12 children with sickle cell disease treated successfully for acute osteomyelitis with oral ciprofloxacin, transient bilateral Achilles tendon tendinitis occurred in one 5-year old. Another case was reported in a hemodialysis patient with a ciprofloxacin-associated Achilles tendon rupture. In 75 children with typhoid fever, aged under 6 years (mean age 32 months), ciprofloxacin had no adverse effects on growth or joints. In another study only 2 of 219 children treated with ciprofloxacin developed arthropathy, in one case transiently. In a necropsy study on children treated with ciprofloxacin 20-40 mg/kg/day for an average of 148 days, there were no chondrotoxic effects; however, synovial membranes showed signs of subacute synovitis, which had not been noted in life.

Data on more than 1500 children treated with ciprofloxacin suggest that the safety profile of ciprofloxacin in children and adolescents is similar to the profile in adults. Adverse events, mostly involving the gastrointestinal tract, were noted in 5-15% of patients. Reversible arthralgia occurred in 36 of 1113 patients, but there was no radiographic evidence of cartilage damage. An acute reversible arthropathy has been described in a child with cancer treated with a short course of ciprofloxacin for febrile neutropenia.

Immunologic

Anaphylactoid reactions occurred in 3 of about 3200 students who took ciprofloxacin 500 mg for chemoprophylaxis of meningococcal meningitis; two had no history of atopic illness. Additional adverse reactions were mild skin rashes in three students and nausea and vomiting in two.

Angioimmunoblastic lymphadenopathy is a rare disorder characterized by generalized lymphadenopathy, fever, hepatosplenomegaly, immune hemolytic anemia, and polyclonal hypergammaglobulinemia. Biopsy-proven angioimmunoblastic lymphadenopathy has been reported in a 79-year-old man who had received ciprofloxacin. A Jarisch-Herxheimer reaction to ciprofloxacin has been reported. • A 14-year-old girl developed tachycardia, hypotension, and disseminated intravascular coagulation after her first dose of oral ciprofloxacin 500 mg for presumed pyelonephritis. A peripheral blood smear showed spirochetes consistent with Borrelia species.

Susceptibility Factors

Age

Children In 36 premature infants, delivered at 25-35 weeks and with birth weights of 750-2050 g, ciprofloxacin (13.8 mg/ kg/day in two or three divided doses for 3-20 days) had good efficacy in 66% of cases. Thrombocytopenia (five cases), raised transaminases (three cases), hyper-bilirubinemia (three cases), and raised creatinine concentration (two patients) were reported as adverse events; one child developed femoral osteitis. In a Russian study of children with cystic fibrosis, the adverse effects of ciprofloxacin were chiefly gastrointestinal (nausea, stomach pain, diarrhea) and increased transaminase activity. One episode of arthrotoxicity was transient. There were no negative effects on growth and no chondrotoxicity. Oral ciprofloxacin (10 mg/kg bd) was as safe and effective as intramuscular ceftriaxone (50 mg/kg/day) in the treatment of acute invasive diarrhea in 201 children (aged 6 months to 10 years). Possible drug-related adverse events occurred in 8% and were mild and transient. Joints were normal during and after the completion of therapy in all patients.

Elderly people

In a retrospective analysis there were no clinically important differences in the safety profile of ciprofloxacin in patients aged under or over 65 years. The incidence of drug-related adverse events was higher in those under 65 years (25%) than in those aged 65 years or more (17%); the most common adverse events affected the gastrointestinal and central nervous systems.

Other features of the patient

Ten patients with peripheral arterial occlusive disease were scheduled to undergo elective percutaneous trans-luminal angioplasty after a single dose of ciprofloxacin 400 mg. Antibiotic concentrations were significantly reduced in ischemic lesions compared with healthy adipose tissue. However, improvement of arterial blood flow in the affected limb was associated with increased cure rates of soft tissue infections. The pharmacokinetics of intravenous ciprofloxacin have been studied in intensive care unit patients during continuous venovenous hemofiltration or hemo-diafiltration. Ciprofloxacin clearance was not altered. A dosage of 400 mg/day was sufficient to maintain effective drug plasma concentrations in patients undergoing continuous renal replacement therapy.

Dosage forms of Ciprofloxacin:
Apo-Ciproflox 0.3 % Solution Pms-Ciprofloxacin 0.3 % Solution Ciprofloxacin hcl powder Ciloxan 0.3 % Solution
Ciprofloxacin hcl 100 mg tablet Floxin otic singles Ciprofloxacin hcl 250 mg tablet Cipro 250 mg tablet
Ciprofloxacin hcl 500 mg tablet Floxin 300 mg tablet Ciprofloxacin hcl 750 mg tablet Cipro 500 mg tablet
Cipro 750 mg tablet Floxin 200 mg tablet Cetraxal 0.2% ear solution Floxin 400 mg tablet
Ciprofloxacin er 500 mg tablet Ciprofloxacin-Ciproflox HCl 500 mg 24 Hour tablet Cipro xr 500 mg tablet Cipro XR 1000 mg 24 Hour tablet
Cipro XR 500 mg 24 Hour tablet Ciprofloxacin er 1000 mg tablet ProQuin XR 500 mg 24 Hour tablet Ocuflox 0.3% eye drops
Ciprofloxacin-Ciproflox HCl 1000 mg 24 Hour tablet Cipro xr 1000 mg tablet Proquin xr 500 mg tablet Cipro hc otic suspension
Ciprofloxacin 0.3% eye drop Ciloxan 0.3% eye drops Ciprofloxacin HCl 0.3% Solution 2.5ml Bottle ProQuin XR 3 500 mg 24 Hour tablet Disp Pack
Ciprofloxacin HCl 0.3% Solution 5ml Bottle Ocuflox 0.3% Solution 5ml Bottle Ciloxan 0.3% Solution 5ml Bottle Floxin Otic 0.3% Solution 5ml Bottle
Ciloxan 0.3% Ointment 3.5 gm Tube Ciprofloxacin HCl 0.3% Solution 10ml Bottle Ocuflox 0.3% Solution 10ml Bottle Cipro 250 mg/5ml(5%) Suspension 100ml Bottle
Cipro HC 0.2-1% Suspension 10ml Bottle Cipro 500 mg/5ml(10%) Suspension 100ml Bottle Floxin Otic 0.3% Solution 10ml Bottle Cipro 400 mg Solution 40ml Vial
Ciprofloxacn-d5w 200 mg/100 ml Ciprofloxacin 200 mg/20 ml vial Cipro i.v. 200 mg/100 ml d5w Cipro i.v. 10 mg/ml viaфl

Synonyms of Ciprofloxacin:

Ciprofloxacin, Ciprofloxacin Dihydrochloride, Ciprofloxacin HCl, Ciprofloxacin Hydrochloride, Ciprofloxacin Monohydrochloride, Ciprofloxacina

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Therapeutic classes of Ciprofloxacin:

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