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

american health packaging - 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

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

teva pharmaceuticals usa, inc. - 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 patie

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

sandoz inc - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 5 mg in 1 ml - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbi

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

lupin pharmaceuticals, inc. - moxifloxacin hydrochloride monohydrate (unii: b8956s8609) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 5 mg in 1 ml - moxifloxacin ophthalmic solution, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin ophthalmic solution in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis di

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

msn laboratories private limited - moxifloxacin hydrochloride monohydrate (unii: b8956s8609) (moxifloxacin - unii:u188xyd42p) - moxifloxacin hydrochloride monohydrate 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

Izrael - angol - Ministry of Health

bayer israel ltd - moxifloxacin as hydrochloride - film coated tablets - moxifloxacin as hydrochloride 0.4 g - moxifloxacin - moxifloxacin - for the treatment of the following bacterial infections in patients of 18 years and older• respiratory infections : - uncomplicated acute bacterial sinusitis (abs) - acute exacerbations of chronic bronchitis (aecb) megaxin tablets should be used to treat adequately diagnosed abs and aecb only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection. - community acquired pneumonia, except severe cases. megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. • community-acquired spontaneous and wound infections of the skin and skin structure.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 moxifloxacin. therapy with megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Izrael - angol - Ministry of Health

bayer israel ltd - moxifloxacin as hydrochloride - film coated tablets - moxifloxacin as hydrochloride 0.4 g - moxifloxacin - moxifloxacin - for the treatment of the following bacterial infections in patients of 18 years and older• respiratory infections : - uncomplicated acute bacterial sinusitis (abs) - acute exacerbations of chronic bronchitis (aecb) megaxin tablets should be used to treat adequately diagnosed abs and aecb only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection. - community acquired pneumonia, except severe cases. megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. • community-acquired spontaneous and wound infections of the skin and skin structure.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 moxifloxacin. therapy with megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.consideration should be given to official guidance on the appropriate use of antibacterial agents.

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

sunshine lake pharma co., ltd. - 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 sk

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

aurobindo pharma limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 5 mg in 1 ml - moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: corynebacterium species* micrococcus luteus* staphylococcus aureus staphylococcus epidermidis staphylococcus haemolyticus staphylococcus hominis staphylococcus warneri* streptococcus pneumoniae streptococcus viridans group acinetobacter lwoffii* haemophilus influenza haemophilus parainfluenzae* chlamydia trachomatis *efficacy for this organism was studied in fewer than 10 infections. moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. risk summary there are no adequate and well-controlled studies with moxifloxacin in pregnant women to inform any drug-associated risks. oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses (see data) . data animal data embryo-fetal studies were conducted in pregnant rats administered with 20, 100, or 500 mg/kg/day moxifloxacin by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day [277 times the human area under the curve (auc) at the recommended human ophthalmic dose]. the no-observed-adverse-effect-level (noael) for developmental toxicity was 100 mg/kg/day (30 times the human auc at the recommended human ophthalmic dose). embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5, or 20 mg/kg/day moxifloxacin by intravenous administration on gestation days 6 to 20, to target the period of organogenesis. abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human auc at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death. the noael for developmental toxicity was 6.5 mg/kg/day (246 times the human auc at the recommended human ophthalmic dose). pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between gestation days 20 and 50, targeting the period of organogenesis. at the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting, and diarrhea were observed. smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human auc at the recommended human ophthalmic dose). the noael for fetal toxicity was 10 mg/kg/day (174 times the human auc at the recommended human ophthalmic dose). in a pre- and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100, and 500 mg/kg/day from gestation day 6 until the end of lactation. maternal death occurred during gestation at 500 mg/kg/day. slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human auc at the recommended human ophthalmic dose). the noael for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human auc at the recommended human ophthalmic dose). risk summary there is no data regarding the presence of moxifloxacin in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of moxifloxacin to an infant during lactation. a study in lactating rats has shown transfer of moxifloxacin into milk following oral administration. systemic levels of moxifloxacin following topical ocular administration are low [see clinical pharmacology (12.3)] , and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for moxifloxacin and any potential adverse effects on the breastfed child from moxifloxacin. the safety and effectiveness of moxifloxacin have been established in all ages. use of moxifloxacin is supported by evidence from adequate and well controlled studies of moxifloxacin in adults, children, and neonates [see clinical studies (14) ]. there is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals. no overall differences in safety and effectiveness have been observed between elderly and younger patients.

Egyesült Államok - angol - 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)] .