USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]) , haemophilus influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies (14.3)] . mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or streptococcus pyogenes [see clinical studies (14.4)]. moxifloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus, escherichia coli, klebsiella pneumoniae, or enterobacter cloacae [see clinical studies (14.5)]. moxifloxacin tablets are indicated in adult patients for the treatment of complicated intra-abdominal infections (ciai) including polymicrobial infections such as abscess caused by susceptible isolates of escherichia coli, bacteroides fragilis, streptococcus anginosus, streptococcus constellatus, enterococcus faecalis, proteus mirabilis, clostridium perfringens, bacteroides thetaiotaomicron, or peptostreptococcus species [see clinical studies (14.6)] . moxifloxacin tablets are indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of yersinia pestis and prophylaxis of plague in adult patients. efficacy studies of moxifloxacin 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 (14.7)] . moxifloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (abs) caused by susceptible isolates of streptococcus pneumoniae, haemophilus influenzae , or moraxella catarrhalis [see clinical studies (14.1)] . because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions [see  warnings and precautions (5.1to 5.14)] and for some patients abs is self-limiting, reserve moxifloxacin tablets for treatment of abs in patients who have no alternative treatment options. moxifloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (abecb) caused by susceptible isolates of streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, methicillin-susceptible staphylococcus aureus, or moraxella catarrhalis [see clinical studies (14.2)]. because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions [see  warnings and precautions (5.1to 5.14)] and for some patients abecb is self-limiting, reserve moxifloxacin tablets for treatment of abecb in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs, moxifloxacin 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. moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see warnings and precautions (5.8)] . risk summary there are no available human data establishing a drug associated risk with the use of moxifloxacin. based on animal studies with moxifloxacin, moxifloxacin hydrochloride may cause fetal harm. moxifloxacin did not cause fetal malformations when administered to pregnant rats (iv and oral), rabbits (iv), and monkeys (oral) at exposures that were 0.24 to 2.5 times of those at the human clinical dose (400 mg/day moxifloxacin hydrochloride). however, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed (see data). advise pregnant women of the potential risk to the fetus. 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data animal reproductive and development studies were done in rats, rabbits and cynomolgus macaques. moxifloxacin did not cause fetal malformations when administered to pregnant rats during organogenesis (gestation days 6 to 17) at oral doses as high as 500 mg/kg/day or 0.24 times the maximum recommended human dose based on systemic exposure (auc), but decreased fetal body weights and slightly delayed fetal skeletal development were observed. intravenous administration of 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) to pregnant rats resulted in maternal toxicity and a marginal effect on fetal and placental weights and the appearance of the placenta (gestation days 6 to 17). fetal malformations were not observed at intravenous doses as high as 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) in litters of pregnant rats that received moxifloxacin during organogenesis (gestation days 6 to 17). intravenous administration of 20 mg/kg/day (approximately equal to the maximum recommended human oral dose based upon systemic exposure) to pregnant rabbits during organogenesis (gestation days 6 to 20) resulted in decreased fetal body weights and delayed fetal skeletal ossification. when rib and vertebral malformations were combined, there was an increased fetal and litter incidence of these effects in rabbits. signs of maternal toxicity in rabbits at this dose included mortality, abortions, marked reduction of food consumption, decreased water intake, body weight loss and hypoactivity. fetal malformations were not observed when pregnant cynomolgus macaques were given oral doses as high as 100 mg/kg/day (2.5 times the maximum recommended human dose based upon systemic exposure) during organogenesis (gestation days 20 to 50). an increased incidence of smaller fetuses was observed at 100 mg/kg/day in macaques. in a pre- and postnatal development study conducted in rats given oral doses from gestation day 6, throughout gestation and rearing to postpartum day 21, effects observed at 500 mg/kg/day (0.24 times the maximum recommended human dose based on systemic exposure (auc)) included slight increases in duration of pregnancy and prenatal loss, reduced pup birth weight and decreased neonatal survival. treatment-related maternal mortality occurred during gestation at 500 mg/kg/day in this study. risk summary it is not known if moxifloxacin is present in human milk. based on animal studies in rats, moxifloxacin may be excreted in human milk (see data). when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin hydrochloride and any potential adverse effects on the breastfed child from moxifloxacin hydrochloride or from the underlying maternal condition. data in lactating rats given a single oral dose of 4.59 mg/kg moxifloxacin (approximately 9 times less than the recommended human dose based on body surface area) 8 days postpartum, there was very low excretion of substance-related radioactivity into the milk, amounting to approximately 0.03% of the dose. effectiveness in pediatric patients and adolescents less than 18 years of age has not been established. moxifloxacin hydrochloride causes arthropathy in juvenile animals. limited information on the safety of moxifloxacin hydrochloride in 301 pediatric patients is available from the ciai trial [see boxed warning,  warnings and precautions (5.11)and nonclinical toxicology (13.2)]. active controlled trial in complicated intra-abdominal infection (ciai) the safety and efficacy of moxifloxacin hydrochloride in pediatric patients for the treatment of ciai has not been demonstrated. pediatric patients 3 months to <18 years of age (mean age of 12 ± 4 years) were enrolled in a single randomized, double-blind, active controlled trial in ciai including appendicitis with perforation, abscesses and peritonitis. pediatric patients were randomized (2:1) to receive either moxifloxacin hydrochloride or comparator. this study enrolled 451 patients who received study medication, 301 treated with moxifloxacin, and 150 with comparator. of the 301 pediatric patients treated with moxifloxacin hydrochloride, 15 were below the age of 6 years and 286 were between the ages of 6 to <18 years. patients received sequential intravenous/oral moxifloxacin hydrochloride or comparator (intravenous ertapenem followed by oral amoxicillin/clavulanate) for 5 to 14 days (mean duration was 9 days with a range of 1 to 24 days). the overall adverse reaction profile in pediatric patients was comparable to that of adult patients. the most frequently occurring adverse reactions in pediatric patients treated with moxifloxacin hydrochloride were qt prolongation 9.3% (28/301), vomiting, 6.6% (20/301), diarrhea 3.7% (11/301), arthralgia 3.0% (9/301), and phlebitis 2.7% (8/301) (see table 5). discontinuation of study drug due to an adverse reaction was reported in 5.3% (16/301) of moxifloxacin hydrochloride-treated patients versus 1.3% (2/150) of comparator-treated patients. the adverse reaction profile of moxifloxacin hydrochloride or comparator was similar across all age groups studied. musculoskeletal adverse reactions were monitored and followed up to 5 years after the end of study treatment. the rates of musculoskeletal adverse reactions were 4.3% (13/301) in the moxifloxacin hydrochloride-treated group versus 3.3% (5/150) in the comparator-treated group. the majority of musculoskeletal adverse reactions were reported between 12 and 53 weeks after start of study treatment with complete resolution at the end of the study [see  warnings and precautions (5.11)and nonclinical toxicology (13.2)]. table 5 incidence (%) of selected adverse reactions in ≥2.0% of pediatric patients treated with moxifloxacin hydrochloride in ciai clinical trial clinical response was assessed at the test-of-cure visit (28 to 42 days after end of treatment). the clinical response rates observed in the modified intent to treat population were 83.9% (208/248) for moxifloxacin hydrochloride and 95.5% (127/133) for comparator; see table 6. table 6: clinical response rates at 28 to 42 days after end of treatment in pediatric patients with ciai 1 the modified intent-to-treat (mitt) population is defined as all subjects who were treated with at least one dose of study medication and who have at least one pre-treatment causative organism from the intra-abdominal site of infection or from blood cultures. 2 difference in clinical cure rates (moxifloxacin hydrochloride - comparator) and 95% confidence intervals, presented as percentages, are based on stratified analysis by age group using mantel-haenszel methods. geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as moxifloxacin hydrochloride. 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 moxifloxacin hydrochloride to elderly patients especially those on corticosteroids. patients should be informed of this potential side effect and advised to discontinue moxifloxacin tablets and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see boxed warning, and warnings and precautions (5.2)]. 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 controlled multiple-dose clinical trials, 23% of patients receiving oral moxifloxacin hydrochloride were greater than or equal to 65 years of age and 9% were greater than or equal to 75 years of age. the clinical trial data demonstrate that there is no difference in the safety and efficacy of oral moxifloxacin hydrochloride in patients aged 65 or older compared to younger adults. in trials of intravenous use, 42% of moxifloxacin hydrochloride patients were greater than or equal to 65 years of age, and 23% were greater than or equal to 75 years of age. the clinical trial data demonstrate that the safety of intravenous moxifloxacin hydrochloride in patients aged 65 or older was similar to that of comparator-treated patients. in general, elderly patients may be more susceptible to drug-associated effects of the qt interval. therefore, moxifloxacin hydrochloride should be avoided in patients taking 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 (5.6), drug interactions (7.5), and clinical pharmacology (12.3)]. the pharmacokinetic parameters of moxifloxacin are not significantly altered in mild, moderate, severe, or end-stage renal disease. no dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (hd) or continuous ambulatory peritoneal dialysis (capd) [see dosage and administration (2), and clinical pharmacology (12.3)]. no dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (child-pugh classes a, b, or c). however, due to metabolic disturbances associated with hepatic insufficiency, which may lead to qt prolongation, moxifloxacin hydrochloride should be used with caution in these patients [see  warnings and precautions (5.6)and clinical pharmacology (12.3)] .

USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - 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 (5.1to 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 (5.1to 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 (5.1to 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

endoscopic supplies australia - 38810 - endoscopic forceps, biopsy, flexible - single use biopsy forceps intended to collect tissue endoscopically for histological examination.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

endo x - 34143 - endoscopic bite block, basic - the bite block is used as a mouth guard to protect the endoscope and the patient from damage during an endoscopic procedure.

USA - engelsk - NLM (National Library of Medicine)

endo pharmaceuticals, inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine 75 ug

USA - engelsk - NLM (National Library of Medicine)

endo pharmaceuticals, inc. - sumatriptan succinate (unii: j8bdz68989) (sumatriptan - unii:8r78f6l9vo) - sumatriptan 6 mg in 0.5 ml

Canada - engelsk - Health Canada

endo pharmaceuticals inc. - frovatriptan (frovatriptan succinate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate) 2.5mg - selective serotonin agonists

Canada - engelsk - Health Canada

endo pharmaceuticals inc. - frovatriptan (frovatriptan succinate) - tablet - 2.5mg - frovatriptan (frovatriptan succinate) 2.5mg - selective serotonin agonists

USA - engelsk - NLM (National Library of Medicine)

endo pharmaceuticals inc. - acrivastine (unii: a20f9xai7w) (acrivastine - unii:a20f9xai7w), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - acrivastine 8 mg - semprex-d capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. semprex-d capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see clinical pharmacology ). the efficacy of semprex-d capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials. semprex-d capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold. semprex-d capsules are contraindicated in patients with a known sensitivity to acrivastine, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. semprex-d capsules are contraindicated in patients with severe hypertension or severe coronary arte

USA - engelsk - NLM (National Library of Medicine)

endo pharmaceuticals inc. - isosorbide dinitrate (unii: ia7306519n) (isosorbide dinitrate - unii:ia7306519n) - isosorbide dinitrate 40 mg - dilatrate® -sr sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide dinitrate is contraindicated in patients who are allergic to it. do not use dilatrate® -sr in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, vardenafil, or avanafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia. do not use dilatrate® -sr in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.