Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

vivimed labs limited - azithromycin anhydrous (unii: j2klz20u1m) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - azithromycin tablets, usp are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin tablet, usp taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)]. treatment of disseminated mac disease azithromycin tablet, usp taken in combination with ethambutol, is indicated for the treatment of disseminated mac infections in persons with advanced hiv infection [see use in specific populations (8.4) and clinical studies (14.1)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspe

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

cardinal health - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg in 5 ml - azithromycin for injection, usp is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.  as recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see dosage and administration for dosing recommendations. community-acquired pneumonia due to chlamydia pneumoniae, haemophilus influenzae, legionella pneumophila, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus, or streptococcus pneumoniae in patients who require initial intravenous therapy. pelvic inflammatory disease due to chlamydia trachomatis, neisseria gonorrhoeae, or mycoplasma hominis in patients who require initial intravenous therapy.  if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection, usp. azithromycin for injection, usp should be

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

proficient rx lp - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 200 mg in 5 ml - azithromycin for oral suspension usp is indicated for the treatment of patients with mild to moderate infections (pneumonia: see warnings ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. as recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see dosage and administration for specific dosing recommendations. acute bacterial exacerbations of chronic obstructive pulmonary disease due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. acute bacterial sinusitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae . community-acquired pneumonia due to chlamydophila pneumoniae, haemophilus influenzae, mycoplasma pneumoniae or streptococcus pneumoniae in patients appropriate for oral therapy. note: azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. note: penicillin by the intramuscular route is the usual drug of choice in the treatment of streptococcus pyogenes infection and the prophylaxis of rheumatic fever. azithromycin for oral suspension usp is often effective in the  eradication of susceptible strains of streptococcus pyogenes from the nasopharynx. because some  strains are resistant to azithromycin for oral suspension usp, susceptibility tests should be performed when patients are treated with azithromycin for oral suspension usp. data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available. uncomplicated skin and skin structure infections due to staphylococcus aureus, streptococcus pyogenes, or streptococcus agalactiae. abscesses usually require surgical drainage. urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae . genital ulcer disease in men due to haemophilus ducreyi (chancroid). due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. azithromycin for oral suspension usp, at the recommended dose, should not be relied upon to treat syphilis. antimicrobial agents used in high doses for short periods of time to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. all patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis. appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed. appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin, usp. therapy with azithromycin for oral suspension usp may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension usp and other antibacterial drugs, azithromycin for oral suspension usp 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. see precautions, pediatric use and clinical studies, pediatric patients. acute otitis media   caused by haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. (for specific dosage recommendation, see dosage and administration .) community-acquired pneumonia due to chlamydophila pneumoniae, haemophilus influenzae, mycoplasma pneumoniae or streptococcus pneumoniae in patients appropriate for oral therapy. (for specific dosage  recommendation, see dosage and administration .) note: azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (for specific dosage recommendation, see dosage and administration .) note: penicillin by the intramuscular route is the usual drug of choice in the treatment of streptococcus pyogenes infection and the prophylaxis of rheumatic fever. azithromycin for oral suspension usp is often effective in the eradication of susceptible strains of streptococcus pyogenes from the nasopharynx. because some  strains are resistant to azithromycin for oral suspension usp, susceptibility tests should be performed when patients are treated with azithromycin for oral suspension usp. data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available. appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. therapy with azithromycin for oral suspension usp may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin any macrolide or ketolide antibiotic. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

direct rx - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 200 mg in 5 ml - azithromycin for oral suspension usp is indicated for the treatment of patients with mild to moderate infections (pneumonia: see warnings) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. as recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see dosage and administration for specific dosing recommendations. adults acute bacterial exacerbations of chronic obstructive pulmonary disease due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. acute bacterial sinusitis due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumoniae. community-acquired pneumonia due to chlamydophila pneumoniae, haemophilus influenzae, mycoplasma pneumoniae or streptococcus pneumoniae in patients appropriate for oral therapy. note: azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illne

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

fresenius kabi usa, llc - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg in 5 ml - azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to chlamydophila pneumoniae , haemophilus influenzae , legionella pneumophila , moraxella catarrhalis , mycoplasma pneumoniae , staphylococcus aureus , or streptococcus pneumoniae in patients who require initial intravenous therapy. due to chlamydia trachomatis , neisseria gonorrhoeae , or mycoplasma hominis in patients who require initial intravenous therapy. if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection. azithromycin for injection should be followed by azithromycin by the oral route as required.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

athenex pharmaceutical division, llc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg in 5 ml - azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. due to chlamydophila pneumoniae, haemophilus influenzae, legionella pneumophila, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus, or streptococcus pneumoniae in patients who require initial intravenous therapy. due to chlamydia trachomatis , neisseria gonorrhoeae , or mycoplasma hominis in patients who require initial intravenous therapy. if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection. azithromycin for injection should be followed by azithromycin by the oral route as required [see dosage and administration ( 2)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drugs. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. risk summary available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations 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 human data available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. animal data reproductive and developmental toxicology studies have not been conducted using iv administration of azithromycin to animals. azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. in rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. in a pre- and post-natal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. effects in the offspring were noted at 200 mg/kg/day during the post-natal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre- and post-natal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. risk summary azithromycin is present in human milk (see data) . non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see clinical considerations) . there are no available data on the effects of azithromycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. clinical considerations advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. data azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. in another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established. in controlled clinical studies, azithromycin has been administered to pediatric patients (age 6 months to 16 years) by the oral route. for information regarding the use of azithromycin for oral suspension in the treatment of pediatric patients, [see indications and usage ( 1), and dosage and administration ( 2)] of the prescribing information for azithromycin for oral suspension 100 mg/5 ml and 200 mg/5 ml bottles. pharmacokinetic studies with intravenous azithromycin have not been performed in older volunteers. pharmacokinetics of azithromycin following oral administration in older volunteers (65 to 85 years old) were similar to those in younger volunteers (18 to 40 years old) for the 5-day therapeutic regimen. in multiple-dose clinical trials of intravenous azithromycin in the treatment of community-acquired pneumonia, 45% of patients (188/414) were at least 65 years of age and 22% of patients (91/414) were at least 75 years of age. no overall differences in safety were observed between these subjects and younger subjects in terms of adverse reactions, laboratory abnormalities, and discontinuations. similar decreases in clinical response were noted in azithromycin- and comparator-treated patients with increasing age. azithromycin for injection contains 114 mg (4.96 meq) of sodium per vial. at the usual recommended doses, patients would receive 114 mg (4.96 meq) of sodium. the geriatric population may respond with a blunted natriuresis to salt loading. the total sodium content from dietary and non-dietary sources may be clinically important with regard to such diseases as congestive heart failure. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions ( 5.4)] .

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

apotex corp. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin 500 mg in 10 ml - azithromycin for injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. as recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see dosage and administration for dosing recommendations. community-acquired pneumonia due to chlamydia pneumoniae, haemophilus influenzae, legionella pneumophila, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus, or streptococcus pneumoniae in patients who require initial intravenous therapy. pelvic inflammatory disease due to chlamydia trachomatis, neisseria gonorrhoeae, or mycoplasma hominis in patients who require initial intravenous therapy. if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with a

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

greenstone llc - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. non-gonococcal urethritis and cervicitis due to chlamydia trachomatis. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)]. treatment of disseminated mac disease azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated mac infections in persons with advanced hiv infection [see use in specific populations (8.4) and clinical studies (14.1)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infection

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

fresenius kabi usa, llc - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg in 5 ml - azithromycin for injection, usp is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.   as recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see dosage and administration for dosing recommendations. community-acquired pneumonia due to chlamydia pneumoniae, haemophilus influenzae, legionella pneumophila, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus, or streptococcus pneumoniae in patients who require initial intravenous therapy. pelvic inflammatory disease due to chlamydia trachomatis, neisseria gonorrhoeae, or mycoplasma hominis in patients who require initial intravenous therapy.  if anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithrom

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

rebel distributors corp. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin - unii:f94ow58y8v) - azithromycin monohydrate 100 mg in 5 ml - azithromycin for oral suspension is indicated for the treatment of patients with mild to moderate infections (pneumonia: see warnings ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. as recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see dosage and administration for specific dosing recommendations. acute bacterial exacerbations of chronic obstructive pulmonary disease due to haemophilus influenzae, moraxella catarrhalis, or streptococcus pneumoniae . acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . community-acquired pneumonia due to chlamydia pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. note: azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe ill