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

nucare pharmaceuticals,inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration ( 2)] - acute bacterial exacerbations of chronic bronchitis 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. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure

United States - English - 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)] .

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

pd-rx pharmaceuticals, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration ( 2)] - acute bacterial exacerbations of chronic bronchitis 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 appropria

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

lupin pharmaceuticals, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis 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. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections due to staphylococcus aureus , streptococcus pyogenes , or streptococcus agalactiae . - 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. [see use in specific populations (8.4) and clinical studies (14.2)] -   acute otitis media (>6 months of age) caused by haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae. -   community-acquired pneumonia (>6 months of age) due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae , or streptococcus pneumoniae in patients appropriate for oral therapy. -   pharyngitis/tonsillitis (>2 years of age) caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. 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 nosocomial 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). 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 drug. 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: 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 postnatal 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 postnatal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre-and postnatal 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. [see clinical pharmacology (12.3), indications and usage (1.2), and dosage and administration (2.2)] safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. pharyngitis/tonsillitis safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see warnings and precautions (5.4)]  

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

remedyrepack inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration ( 2)] - acute bacterial exacerbations of chronic bronchitis 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 appropria

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

remedyrepack inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration ( 2)] - acute bacterial exacerbations of chronic bronchitis 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 appropria

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

american health packaging - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - azithromycin tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis 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. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an altern

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

american health packaging - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - azithromycin tablets 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 tablets, taken alone or in combination with rifabutin at its approved dose, are 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 tablets, taken in combination with ethambutol, are 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 tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infection

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

lupin pharmaceuticals, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - azithromycin tablets 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 tablets, taken alone or in combination with rifabutin at its approved dose, are 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 tablets, taken in combination with ethambutol, are 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 tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strong

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

lake erie medical dba quality care products llc - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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 tablets 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. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catar