United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - ciprofloxacin (unii: 5e8k9i0o4u) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 2 mg in 1 ml - ciprofloxacin 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. ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin 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. ciprofloxacin is indicated in adult patients for treatment of nosocomial pneumonia caused by haemophilus influenzae or klebsiella pneumoniae. ciprofloxacin is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see clinical studies (14.1)]. ciprofloxacin is indicated in adults and pediatric patients from birth to 17 years of age for treatment of 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.1 supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of october 2001 [see clinical studies (14.3)]. ciprofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to yersinia pestis (y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. 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 (14.4)] . ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. ciprofloxacin 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 pneumonia. ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumonia. ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis (aecb) caused by moraxella catarrhalis . because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see warnings and precautions (5.1- 5.16 )] and for some patients aecb is self-limiting, reserve ciprofloxacin for treatment of aecb in patients who have no alternative treatment options. urinary tract infection in adults ciprofloxacin 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 . complicated urinary tract infections and pyelonephritis in pediatric patients ciprofloxacin is indicated in pediatric patients 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 (8.4)] . although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see warnings and precautions ( 5.13 ), adverse reactions (6.1), use in specific populations (8.4), and nonclinical toxicology (13.2)]. ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae , streptococcus pneumoniae, or moraxella catarrhalis . because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see warnings and precautions (5.1– 5.16 )] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin 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 ciprofloxacin 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. ciprofloxacin 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 (5.7)]. concomitant administration with tizanidine is contraindicated [see drug interactions (7)]. prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data) . oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see data). these doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data while available studies cannot definitively establish the absence of risk, published data from prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin. a controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. in utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. the reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1% to 5%). rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). there were 70 ciprofloxacin exposures, all within the first trimester. the malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. no specific patterns of congenital abnormalities were found. the study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. no differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. however, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. animal data developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. in rats and mice, oral doses up to 100 mg/kg administered during organogenesis (gestation days, gd, 6-17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. in rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. in a series of rabbit developmental toxicology studies, does received oral or intravenous ciprofloxacin for one of the following 5 day periods: gd 6 to 10, gd 10 to 14, or gd 14 to 18, intended to cover the period of organogenesis. this was an attempt to mitigate the gastrointestinal intolerance observed in rabbits that receive antibacterials manifested by reduced maternal food consumption and weight loss, that can lead to embryofetal resorption or spontaneous abortion. an oral ciprofloxacin dose of 100 mg/kg (approximately 1.3 times the highest recommended clinical oral dose based on body surface area) caused excessive maternal toxicity confounding evaluation of the fetuses. a 30 mg/kg oral dose (approximately 0.4 times the highest recommended clinical oral dose) was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. intravenous administration of doses up to 20 mg/kg (approximately 0.3 times the highest recommended clinical oral dose based upon body surface area) to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. in peri-and post-natal studies, rats received ciprofloxacin doses up to 200 mg/kg/day (oral) or up to 30 mg/kg/day (subcutaneous) from gd 16 to 22 days postpartum. the 200 mg/kg dose is approximately 1.3-times the maximum recommended clinical oral dose based on body surface area. neither maternal toxicity nor adverse effects on growth and development of the pups were observed, including no sign of arthropathy on the rear leg joints of the pups. ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested when administered directly [see warnings and precautions (5.13) and nonclinical toxicology 13.2] . risk summary published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration. there is no information regarding effects of ciprofloxacin on milk production or the breastfed infant. because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies [see use in specific populations (8.4), (clinical considerations)], for most indications a lactating woman may consider pumping and discarding breast milk during treatment with ciprofloxacin and an additional two days (five half-lives) after the last dose. alternatively, advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin and for an additional two days (five half-lives) after the last dose. however, for inhalation anthrax (post exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on ciprofloxacin may be acceptable [see dosage and administration ( 2.2 ), pediatric use (8.4), and clinical studies (14.2)]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ciprofloxacin and any potential adverse effects on the breastfed child from ciprofloxacin or from the underlying maternal condition. clinical considerations ciprofloxacin may cause intestinal flora alteration of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see warnings and precautions ( 5.13 ) and nonclinical toxicology (13.2)]. ciprofloxacin is indicated for the treatment of cuti and pyelonephritis due to escherichia coli in pediatric patients 1 to 17 years of age. although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues [see adverse reactions (6.1) and clinical studies (14.2)]. ciprofloxacin is indicated in pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure). the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see dosage and administration (2.2) and clinical studies (14.3)]. ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to yersinia pestis (y. pestis) and prophylaxis for plague. efficacy studies of ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals. the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see indications and usage (1.7), dosage and administration (2.2), and clinical studies (14.4)]. geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. this risk is further increased in patients receiving concomitant corticosteroid therapy. tendinitis or tendon rupture can involve the achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see boxed warning, warnings and precautions (5.2), and adverse reactions (6.2)]. epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see warnings and precautions ( 5.8)] . in a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. no alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. however, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see dosage and administration (2.3) and clinical pharmacology (12.3)]. in general, elderly patients may be more susceptible to drug-associated effects on the qt interval. therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the qt interval (for example, class ia or class iii antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known qt prolongation, uncorrected hypokalemia) [see warnings and precautions ( 5.12 )]. 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 [see dosage and administration (2.3) and clinical pharmacology (12.3)]. in preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. the pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

United States - English - NLM (National Library of Medicine)

northstar rx llc - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg - ciprofloxacin tablets are 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. ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens , or pseudomonas aeruginosa. ciprofloxacin tablets are 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. ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli (enterotoxigenic isolates), campylobacter jejuni, shigella boydii † , shigella dysenteriae, shigella flexneri or shigella sonnei † when antibacterial therapy is indicated. † although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. ciprofloxacin tablets are 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. ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae [see warnings and precautions (5.17)] . ciprofloxacin tablets are 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.1 supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of october 2001 [see clinical studies (14.2)] . ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to yersinia pestis (y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. 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 (14.3)] . ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis . ciprofloxacin tablets are 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. ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumoniae . ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (aecb) caused by moraxella catarrhalis. because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions (5.1 to 5.16)] and for some patients aecb is self-limiting, reserve ciprofloxacin tablets for treatment of aecb in patients who have no alternative treatment options. urinary tract infections in adults ciprofloxacin tablets are 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. acute uncomplicated cystitis ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions (5.1 to 5.16)] and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options. complicated urinary tract infection and pyelonephritis in pediatric patients ciprofloxacin tablets are 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 (8.4)]. although effective in clinical trials, ciprofloxacin tablets are not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. ciprofloxacin tablets, like other  fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see warnings and precautions (5.13), adverse reactions (6.1), use in specific populations (8.4) and nonclinical toxicology (13.2)] . ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae, streptococcus pneumoniae, or moraxella catarrhalis . because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see  warnings and precautions (5.1  to 5.16) ] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets 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 ciprofloxacin tablets 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. ciprofloxacin tablets are 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 (5.7)]. concomitant administration with tizanidine is contraindicated [see drug interactions (7)]. risk summary prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data) . oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see data) . these doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data while available studies cannot definitively establish the absence of risk, published data from prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin. a controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. in utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. the reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1 to 5%). rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). there were 70 ciprofloxacin exposures, all within the first trimester. the malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. no specific patterns of congenital abnormalities were found. the study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. no differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. however, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. animal data developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. in rats and mice, oral doses up to 100 mg/kg administered during organogenesis (gestation days, gd, 6 to 17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. in rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. in a series of rabbit developmental toxicology studies, does received oral or intravenous ciprofloxacin for one of the following 5 day periods: gd 6 to 10, gd 10 to 14, or gd 14 to 18, intended to cover the period of organogenesis. this was an attempt to mitigate the gastrointestinal intolerance observed in rabbits that receive antibacterials manifested by reduced maternal food consumption and weight loss, that can lead to embryofetal resorption or spontaneous abortion. an oral ciprofloxacin dose of 100 mg/kg (approximately 1.3 times the highest recommended clinical oral dose based on body surface area) caused excessive maternal toxicity confounding evaluation of the fetuses. a 30 mg/kg oral dose (approximately 0.4 times the highest recommended clinical oral dose) was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. intravenous administration of doses up to 20 mg/kg (approximately 0.3 times the highest recommended clinical oral dose based upon body surface area) to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. in peri- and post-natal studies, rats received ciprofloxacin doses up to 200 mg/kg/day (oral) or up to 30 mg/kg/day (subcutaneous) from gd 16 to 22 days postpartum. the 200 mg/kg dose is approximately 1.3-times the maximum recommended clinical oral dose based on body surface area. neither maternal toxicity nor adverse effects on growth and development of the pups were observed, including no sign of arthropathy on the rear leg joints of the pups. ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested when administered directly [see warnings and precautions (5.13) and nonclinical toxicology 13.2] . risk summary published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration. there is no information regarding effects of ciprofloxacin on milk production or the breastfed infant. because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies [see use in specific populations (8.4), (clinical considerations)], for most indications a lactating woman may consider pumping and discarding breast milk during treatment with ciprofloxacin and an additional two days (five half-lives) after the last dose. alternatively, advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin and for an additional two days (five half-lives) after the last dose. however, for inhalation anthrax (post exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on ciprofloxacin may be acceptable [see dosage and administration (2.2), pediatric use (8.4), and clinical studies (14.2)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ciprofloxacin and any potential adverse effects on the breastfed child from ciprofloxacin or from the underlying maternal condition. clinical considerations ciprofloxacin may cause intestinal flora alteration of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see warnings and precautions (5.13) and nonclinical toxicology (13.2)] . complicated urinary tract infection and pyelonephritis ciprofloxacin is indicated for the treatment of cuti and pyelonephritis due to escherichia coli in pediatric patients 1 to 17 years of age. although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues [see adverse reactions (6.1) and clinical studies (14.1)]. inhalational anthrax (post-exposure) ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for inhalational anthrax (post-exposure). the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see dosage and administration (2.2) and clinical studies (14.2)]. plague ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to yersinia pestis (y. pestis) and prophylaxis for plague. efficacy studies of ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals. the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see indications and usage (1.8), dosage and administration (2.2) and clinical studies (14.3)].    geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. this risk is further increased in patients receiving concomitant corticosteroid therapy. tendinitis or tendon rupture can involve the achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see boxed warning , warnings and precautions (5.2) , and adverse reactions (6.2) ]. epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see warnings and precautions (5.9) ]. in a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. no alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. however, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see dosage and administration (2.3) and clinical pharmacology (12.3) ].   in general, elderly patients may be more susceptible to drug-associated effects on the qt interval. therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the qt interval (for example, class ia or class iii antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known qt prolongation, uncorrected hypokalemia) [see warnings and precautions (5.12) ].   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 [see dosage and administration (2.3) and clinical pharmacology (12.3)]. in preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. the pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - ciprofloxacin hydrochloride, quantity: 589.172 mg (equivalent: ciprofloxacin, qty 500 mg) - tablet, film coated - excipient ingredients: povidone; sodium starch glycollate type a; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 400 - ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: urinary tract infections; gonorrhoeal urethritis and cervicitis; gastroenteritis; bronchial infections; skin and skin structure infections; bone and joint infections; chronic bacterial prostatitis of mild to moderate severity. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: typhoid and paratyphoid infections and infections due to multi-resistant staphylococcus aureus are excluded from the above due to insufficient data. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. c

Australia - English - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - ciprofloxacin hydrochloride, quantity: 883.758 mg (equivalent: ciprofloxacin, qty 750 mg) - tablet, film coated - excipient ingredients: magnesium stearate; povidone; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 400 - ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: urinary tract infections; gonorrhoeal urethritis and cervicitis; gastroenteritis; bronchial infections; skin and skin structure infections; bone and joint infections; chronic bacterial prostatitis of mild to moderate severity. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: typhoid and paratyphoid infections and infections due to multi-resistant staphylococcus aureus are excluded from the above due to insufficient data. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. c

Australia - English - Department of Health (Therapeutic Goods Administration)

arrow pharma pty ltd - ciprofloxacin hydrochloride, quantity: 294.586 mg (equivalent: ciprofloxacin, qty 250 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; povidone; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 400 - ciprofloxacin is indicated for the treatment of infections caused by susceptible organisms in the conditions listed below: urinary tract infections; gonorrhoeal urethritis and cervicitis; gastroenteritis; bronchial infections; skin and skin structure infections; bone and joint infections; chronic bacterial prostatitis of mild to moderate severity. inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note: typhoid and paratyphoid infections and infections due to multi-resistant staphylococcus aureus are excluded from the above due to insufficient data. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. c

United States - English - NLM (National Library of Medicine)

unit dose services - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. ciprofloxacin 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 . ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by esche

Canada - English - Health Canada

mylan pharmaceuticals ulc - ciprofloxacin (ciprofloxacin hydrochloride, ciprofloxacin) - tablet (extended-release) - 500mg - ciprofloxacin (ciprofloxacin hydrochloride, ciprofloxacin) 500mg - quinolones

Canada - English - Health Canada

mylan pharmaceuticals ulc - ciprofloxacin (ciprofloxacin hydrochloride, ciprofloxacin) - tablet (extended-release) - 1000mg - ciprofloxacin (ciprofloxacin hydrochloride, ciprofloxacin) 1000mg - quinolones

United States - English - NLM (National Library of Medicine)

sandoz inc - ciprofloxacin (unii: 5e8k9i0o4u) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 2 mg in 1 ml - ciprofloxacin injection, usp is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. please see dosage and administration for specific recommendations. urinary tract infections caused by escherichia coli (including cases with secondary bacteremia), klebsiella pneumoniae, enterobacter cloacae, serratia marcescens, proteus mirabilis, providencia rettgeri, morganella morganii, citrobacter koseri (diversus), citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus epidermidis, staphylococcus saprophyticus, or vancomycin-susceptible enterococcus faecalis . lower respiratory infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, pseudomonas aeruginosa, haemophilus influenzae, haemophilus parainfluenzae , or penicillin-susceptible st

United States - English - NLM (National Library of Medicine)

mylan institutional inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin tablets are 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. ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin tablets are 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. ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli (enterotoxigenic isola