Olaszország - angol - HMA (Heads of Medicines Agencies)

ceva salud animal - clostridium chauvoei 90 %, clostridium novyi alpha toxoid 3.5 iu/ml, clostridium perfringens a 1.1 iu/ml, clostridium perfringens type c toxoid 10 iu/ml, clostridium perfringens type d toxoid 5 iu/ml, clostridium septicum 2.5 iu/ml, clostridium sordelli 100 %, clostridium tetani toxoid 2.5 iu/ml - suspension for injection - sheep food - clostridium vaccine

Ausztrália - angol - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - clostridium haemolyticum; clostridium perfringens type b toxoid; clostridium perfringens type c toxoid; clostridium chauvoei whole cell culture; clostridium novyi tybe b toxiod and inactivated cells; clostridium perfringens type d toxoid; clostridium septicum - toxoid; clostridium tetani - toxoid; thiomersal; aluminium (adjuvant) - misc. vaccines or anti sera - clostridium haemolyticum vaccine-toxoid active 21.2 tcp u/ml; clostridium perfringens type b toxoid vaccine-toxoid active 30.6 tcp u/ml; clostridium perfringens type c toxoid vaccine-toxoid active 15.3 tcp u/ml; clostridium chauvoei whole cell culture vaccine-microbial active 30.0 %ferm/ml; clostridium novyi tybe b toxiod and inactivated cells vaccine-toxiod active 5.95 tcp u/ml; clostridium perfringens type d toxoid vaccine-toxoid active 55.3 tcp u/ml; clostridium septicum - toxoid vaccine-toxoid active 6.4 tcp u/ml; clostridium tetani - toxoid vaccine-toxoid active 3.0 lf u/ml; thiomersal mercury other 0.15 mg/ml; aluminium (adjuvant) mineral-aluminium other 0.0 mg/ml - immunotherapy - cattle | lamb | sheep | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ewe | hei - black disease | blackleg | dysentery | enterotoxaemia (pulpy kidney) | haemorrhagic enterotoxaemia | malignant oedema | post parturient gangrene | swelled head | tetanus | tick fever - bovine babesiosis | babesia bigemina | babesia bovis | clostridium perfringens type d | red water | redwater | tetanus vaccination

Írország - angol - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - lincomycin hydrochloride; spectinomycin sulfate tetrahydrate - solution for injection - 50, 100 milligram(s)/millilitre - lincomycin, combinations - cats, cattle, dogs, pigs - antibacterial

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - collagenase clostridium histolyticum -

Egyesült Államok - angol - NLM (National Library of Medicine)

torrent pharmaceuticals limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see dosage and administration (2.1) and clinical studies (14.2)] . mdrsp iso

Egyesült Államok - angol - NLM (National Library of Medicine)

aurobindo pharma limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - 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 (5.1 to 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 (5.1 to 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)].  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. 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)] .

Egyesült Államok - angol - NLM (National Library of Medicine)

acetris health, llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin  injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-sus

Egyesült Államok - angol - NLM (National Library of Medicine)

dr. reddy's laboratories limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinicalstudies (14.1 ) ]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see dosageand administration (2.1) and clinical studies (14.2) ]. mdrsp isolate

Egyesült Államok - angol - NLM (National Library of Medicine)

aurobindo pharma limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see  dosage and administration (2.1) and clinical studies (14.2 )]. mdrsp i

Egyesült Államok - angol - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli,  klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies ( 14.1)]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including  multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see dosage and administration ( 2.1) and clinical studies ( 14.2)]. mdrsp isolates are isolates resistant to two or more of the following antibacterials: penicillin (mic ≥2 mcg/ml), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to streptococcus pneumoniae (excluding multi-drug-resistant isolates [mdrsp]),  haemophilus influenzae, haemophilus parainfluenzae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see dosage and administration ( 2.1) and clinical studies ( 14.3)].  levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible staphylococcus aureus, enterococcus faecalis, streptococcus pyogenes, or proteus mirabilis [see clinical studies ( 14.5)]. levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible staphylococcus aureus, or streptococcus pyogenes. levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to escherichia coli, enterococcus faecalis, or methicillin-susceptible staphylococcus epidermidis [see clinical studies ( 14.6)]. levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in adults and pediatric patients, 6 months of age and older [see dosage and administration ( 2.2)].  the effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. the safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk [see clinical studies ( 14.9 )]. levofloxacin 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, 6 months of age and older [see dosage and administration ( 2.2)]. efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals [see clinical studies ( 14.10)]. levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to escherichia coli, klebsiella pneumoniae, or proteus mirabilis [see clinical studies ( 14.7)].  levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to enterococcus faecalis, enterobacter cloacae, escherichia coli, klebsiella pneumoniae, proteus mirabilis, or pseudomonas aeruginosa [see clinical studies (14.8) ]. levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by escherichia coli, including cases with concurrent bacteremia [see clinical studies (14.7, 14.8)]. levofloxacin tablets are indicated in adult patients  for the treatment of uncomplicated urinary tract infections (mild to moderate) due to escherichia coli, klebsiella pneumoniae, or staphylococcus saprophyticus. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1 to  5.15 )] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (abecb) due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1to  5.15 )] and for some patients abecb is self-limiting, reserve levofloxacin tablets for treatment of abecb in patients who have no alternative treatment options. levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (abs) due to streptococcus pneumoniae, haemophilus influenzae, or moraxella catarrhalis [see clinical studies ( 14.4)]. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1to  5.15)] and for some patients abs is self-limiting, reserve levofloxacin tablets for treatment of abs in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin 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. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see microbiology ( 12.4)] . therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. as with other drugs in this class, some isolates of pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see warnings and precautions ( 5.3)]. risk summary published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of levofloxacin to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (mrhd), respectively, did not result in teratogenicity. fetal toxicity was seen in the rat study, but was absent at doses up to 1.2 times the maximum recommended human dose (see data). 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 animal data levofloxacin was not teratogenic in an embryofetal development study in rats treated during organogenesis with oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the mrhd (based upon doses normalized for total body surface area). the oral dose of 810 mg/kg/day (high dose) to rats caused decreased fetal body weight and increased fetal mortality that was not seen at the next lower dose (mid-dose, 90 mg/kg/day, equivalent to 1.2 times the mrhd (based upon doses normalized for total body surface area). maternal toxicity was limited to lower weight gain in the mid and high dose groups. no teratogenicity was observed in an embryofetal development study in rabbits dosed orally during organogenesis with doses as high as 50 mg/kg/day, which corresponds to 1.1 times the mrhd (based upon doses normalized for total body surface area). maternal toxicity at that dose consisted of lower weight gain and decreased food consumption relative to controls and abortion in four of sixteen dams. risk summary published literature reports that levofloxacin is present in human milk following intravenous and oral administration ( see data ). there is no information regarding effects of levofloxacin on milk production or the breastfed infant. because of the potential risks of serious adverse reactions, in breastfed infants, for most indications, a lactating woman may consider pumping and discarding breast milk during treatment with levofloxacin and an additional two days (five half-lives) after the last dose. alternatively, advise a lactating woman that breastfeeding is not recommended during treatment with levofloxacin and for an additional two days (five half-lives) after the last dose [see use in specific populations (8.4) and clinical pharmacology (12.3)] . 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 levofloxacin 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 levofloxacin and any potential adverse effects on the breastfed child from levofloxacin or from the underlying maternal condition. data a published literature reports that peak levofloxacin human milk concentration was 8.2 mg/l at 5 hours after dosing in a woman who received 500 mg of intravenous, followed by oral, levofloxacin daily. for an infant fed exclusively with human milk (approximately 900 ml/day), an estimated maximum daily dose of levofloxacin through breastfeeding is 5 mg (i.e., approximately 1% of maternal daily dose). the above data come from a single case and may not be generalizable to the general population of lactating women. quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see warnings and precautions ( 5.12) and animal toxicology and/or pharmacology ( 13.2)]. inhalational anthrax (post-exposure) levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure). the risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. the safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied [see indications and usage (1.7),   dosage and administration ( 2.2 ) and clinical studies ( 14.9)]. plague levofloxacin is indicated in pediatric patients, 6 months of age and older, for treatment of plague, including pneumonic and septicemic plague due to yersinia pestis (y. pestis) and prophylaxis for plague. efficacy studies of levofloxacin could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals. the risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate [see indications and usage ( 1.8),  dosage and administration ( 2.2)  and clinical studies ( 14.10 )]. safety and effectiveness of levofloxacin in pediatric patients below the age of six months have not been established. pharmacokinetics following intravenous administration the pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose [see clinical pharmacology ( 12.3) and clinical studies ( 14.9) ]. dosage in pediatric patients with inhalational anthrax or plague for the recommended levofloxacin tablet dosage in pediatric patients with inhalational anthrax or plague, see dosage and administration ( 2.2 ). levofloxacin tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg. adverse reactions in clinical trials, 1,534 pediatric patients (6 months to 16 years of age) were treated with oral and intravenous levofloxacin. pediatric patients 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and pediatric patients greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days. levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see dosage and administration ( 2.2)]. a subset of pediatric patients in the clinical trials (1,340 levofloxacin-treated and 893 non-fluoroquinolone-treated) enrolled in a prospective, long-term surveillance study to assess the incidence of protocol-defined musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) during 60 days and 1 year following the first dose of the study drug. pediatric patients treated with levofloxacin had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in table 7. levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see dosage and administration ( 2.2 )]. table 7:  incidence of musculoskeletal disorders in pediatric clinical trial * non-fluoroquinolone: ceftriaxone, amoxicillin/clavulanate, clarithromycin † 2-sided fisher's exact test  ‡  there were 1,199 levofloxacin-treated and 804 non-fluoroquinolone-treated pediatric patients who had a one-year evaluation visit. however, the incidence of musculoskeletal disorders was calculated using all reported events during the specified period for all pediatric patients enrolled regardless of whether they completed the 1-year evaluation visit. arthralgia was the most frequently occurring musculoskeletal disorder in both treatment groups. most of the musculoskeletal disorders in both groups involved multiple weight-bearing joints. disorders were moderate in 8/46 (17%) children and mild in 35/46 (76%) levofloxacin-treated pediatric patients and most were treated with analgesics. the median time to resolution was 7 days for levofloxacin-treated pediatric patients and 9 for non-fluoroquinolone-treated children (approximately 80% resolved within 2 months in both groups). no pediatric patient had a severe or serious disorder and all musculoskeletal disorders resolved without sequelae. vomiting and diarrhea were the most frequently reported adverse reactions, occurring in similar frequency in the levofloxacin-treated and non-fluoroquinolone-treated pediatric patients. in addition to the adverse reactions reported in pediatric patients in clinical trials, adverse reactions reported in adults during clinical trials or post-marketing experience [see adverse reactions ( 6)] may also be expected to occur in pediatric patients. geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin. 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 levofloxacin to elderly patients especially those on corticosteroids. patients should be informed of this potential side effect and advised to discontinue  levofloxacin 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 ( 6.3)]. in phase 3 clinical trials, 1,945 levofloxacin-treated patients (26%) were ≥ 65 years of age. of these, 1,081 patients (14%) were between the ages of 65 and 74 and 864 patients (12%) were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. severe, and sometimes fatal, cases of hepatotoxicity have been reported post-marketing in association with levofloxacin. the majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see warnings and precautions ( 5.8)]. 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)]. elderly patients may be more susceptible to drug-associated effects on the qt interval. therefore, precaution should be taken when using levofloxacin with concomitant drugs that can result in prolongation of the qt interval (e.g., class ia or class iii antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known qt prolongation, uncorrected hypokalemia) [see warnings and precautions ( 5.11)]. the pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration. however, since the drug is known to be substantially excreted by the kidney, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [ see clinical pharmacology ( 12.3)]. clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance < 50 ml/min), requiring dosage adjustment in such patients to avoid accumulation. neither hemodialysis nor continuous ambulatory peritoneal dialysis (capd) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or capd [see dosage and administration ( 2.3)]. pharmacokinetic studies in patients with hepatic impairment have not been conducted. due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.