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

pfizer laboratories div pfizer inc - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - zithromax 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 zithromax, 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 zithromax, 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 zithromax and other antibacterial drugs, zithromax should be used only to treat infections that are prove

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

balkanpharma-razgrad ad - azithromycin (azithromycin dihydrate) - capsules hard - 500mg

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

pfizer laboratories div pfizer inc - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 500 mg in 5 ml - zithromax (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 zithromax. zithromax for injection should be followed by zithromax by the oral route as required. [see dosage and administration (2)] to reduce the development of drug-resistant bacteria and maintain the effectiveness of zithromax (azithromycin) and other antibact

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

lannett company, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) -

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

bluebay shandong co.,ltd - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin dihydrate - unii:5fd1131i7s) -

Kenya - English - Pharmacy and Poisons Board

riva pharma s.a.e free zone nasr city cairo egypt - azithromycin dihydrate eq. to azithromycin - powder for oral suspension - azithromycin dihydrate eq. to azithromycin… - azithromycin

Kenya - English - Pharmacy and Poisons Board

riva pharma s.a.e free zone nasr city cairo egypt - azithromycin dihydrate eq. to azithromycin - capsule, hard - azithromycin dihydrate eq. to azithromycin 500mg - azithromycin

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - azithromycin dihydrate, quantity: 524.05 mg (equivalent: azithromycin, qty 500 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; hyprolose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin - apo-azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. lower respiratory tract infections:,? acute bacterial bronchitis due to streptococcus pneumoniae, haemophilus influenzae or moraxella catarrhalis. ? community acquired pneumonia due to streptococcus pneumoniae or haemophilus influenzae in patients suitable for outpatient oral treatment. ? community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae.,2. upper respiratory tract infections:,? acute sinusitis due to streptococcus pneumoniae or haemophilus influenzae. ? acute streptococcal pharyngitis. note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. however, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. uncomplicated skin and skin structure infections:,? uncomplicated infections due to staphylococcus aureus, streptococcus pyogenes or streptococcus agalactiae. abscesses usually require surgical drainage.,4. sexually transmitted diseases: uncomplicated urethritis and cervicitis due to chlamydia trachomatis.,? note: at the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. as with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. ? apo-azithromycin is also indicated for the treatment of chlamydia trachomatis conjunctivitis and trachoma.

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

a-s medication solutions - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 200 mg in 5 ml - azithromycin for oral suspension 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. 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)

precision dose, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - 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. 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 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 contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug. azithromycin tablets are 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 3, 2, and 1 times, respectively, an adult human daily dose of 600 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 3 times an adult human daily dose of 600 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 3 (rats) and 2 (mice) times an adult human daily dose of 600 mg. in rabbits administered azithromycin at oral doses of 10 mg/kg/day, 20 mg/kg/day, 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 approximately equal to an adult human daily dose of 600 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 mg/kg/day 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. in controlled clinical studies, azithromycin has been administered to pediatric patients ranging in age from 6 months to 12 years. 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. hiv-infected pediatric patients: the safety and efficacy of azithromycin for the prevention or treatment of mac in hiv-infected children have not been established. safety data are available for 72 children 5 months to 18 years of age (mean 7 years) who received azithromycin for treatment of opportunistic infections. the mean duration of therapy was 242 days (range 3 to 2,004 days) at doses of < 1 mg/kg/day to 52 mg/kg/day (mean 12 mg/kg/day). adverse reactions were similar to those observed in the adult population, most of which involved the gastrointestinal tract. treatment- related reversible hearing impairment in children was observed in 4 subjects (5.6%). two (2.8%) children prematurely discontinued treatment due to adverse reactions: one due to back pain and one due to abdominal pain, hot and cold flushes, dizziness, headache, and numbness. a third child discontinued due to a laboratory abnormality (eosinophilia). the protocols upon which these data are based specified a daily dose of 10 mg/kg/day to 20 mg/kg/day (oral and/or iv) of azithromycin. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4,949) and 3% of patients (144/4,949) 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 responses 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)] azithromycin 600 mg tablets contain 2.1 mg of sodium per tablet. geriatric patients with opportunistic infections, including (mac) disease: safety data are available for 30 patients (65 to 94 years old) treated with azithromycin at doses > 300 mg/day for a mean of 207 days. these patients were treated for a variety of opportunistic infections, including mac. the adverse reaction was generally similar to that seen in younger patients, except for a higher incidence of adverse reactions relating to the gastrointestinal system and to reversible impairment of hearing. [see dosage and administration (2)]