Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly.
Interactions with digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin. No specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. 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.
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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 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 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. 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.
Based on body surface area, this dose is approximately 4 rats and 2 mice times an adult human daily dose of mg. Maternal toxicity reduced food consumption and body weight gain; increased stress at parturition was observed at the higher dose.
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. 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 mg was administered intravenously to 8 women prior to incision for cesarean section.
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Breastmilk colostrum samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. 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 ZITHROMAX 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. 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.
Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required. ZITHROMAX azithromycin tablets and azithromycin for oral suspension contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration.
Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is Azithromycin has the following structural formula:. After constitution, each 5 mL of suspension contains mg or mg of azithromycin. Azithromycin is a macrolide antibacterial drug.
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QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in healthy subjects who received either chloroquine mg alone or in combination with oral azithromycin mg, mg, and mg once daily. Co-administration of azithromycin increased the QTc interval in a dose- and concentration- dependent manner.
Two azithromycin mg tablets are bioequivalent to a single mg tablet. In a two-way crossover study, 12 adult healthy volunteers 6 males, 6 females received mg of azithromycin administered in single daily doses over either 5 days two mg tablets on day 1, followed by one mg tablet on days 2—5 or 3 days mg per day for days 1—3. The antibacterial activity of azithromycin is pH related and appears to be reduced with decreasing pH, However, the extensive distribution of drug to tissues may be relevant to clinical activity.
Azithromycin has been shown to penetrate into human tissues, including skin, lung, tonsil, and cervix. Extensive tissue distribution was confirmed by examination of additional tissues and fluids bone, ejaculum, prostate, ovary, uterus, salpinx, stomach, liver, and gallbladder. As there are no data from adequate and well-controlled studies of azithromycin treatment of infections in these additional body sites, the clinical significance of these tissue concentration data is unknown.
Following a regimen of mg on the first day and mg daily for 4 days, very low concentrations were noted in cerebrospinal fluid less than 0. In vitro and in vivo studies to assess the metabolism of azithromycin have not been performed. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues.
Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route of elimination. Azithromycin pharmacokinetics was investigated in 42 adults 21 to 85 years of age with varying degrees of renal impairment. Following the oral administration of a single 1. The pharmacokinetics of azithromycin in subjects with hepatic impairment has not been established. There are no significant differences in the disposition of azithromycin between male and female subjects.
No dosage adjustment is recommended based on gender. Pharmacokinetic parameters in older volunteers 65 to 85 years old were similar to those in young adults 18 to 40 years old for the 5-day therapeutic regimen. Dosage adjustment does not appear to be necessary for older patients with normal renal and hepatic function receiving treatment with this dosage regimen. In this study, azithromycin concentrations were determined over a 24 hr period following the last daily dose.
Patients weighing above Seventeen patients weighing Drug interaction studies were performed with azithromycin and other drugs likely to be co-administered. The effects of co-administration of azithromycin on the pharmacokinetics of other drugs are shown in Table 1 and the effects of other drugs on the pharmacokinetics of azithromycin are shown in Table 2. Co-administration of azithromycin at therapeutic doses had a modest effect on the pharmacokinetics of the drugs listed in Table 1.
No dosage adjustment of drugs listed in Table 1 is recommended when co-administered with azithromycin. Co-administration of azithromycin with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin. Nelfinavir significantly increased the C max and AUC of azithromycin. No dosage adjustment of azithromycin is recommended when administered with drugs listed in Table 2.
Azithromycin acts by binding to the 23S rRNA of the 50S ribosomal subunit of susceptible microorganisms inhibiting bacterial protein synthesis and impeding the assembly of the 50S ribosomal subunit. Azithromycin demonstrates cross resistance with erythromycin. The most frequently encountered mechanism of resistance to azithromycin is modification of the 23S rRNA target, most often by methylation. Ribosomal modifications can determine cross resistance to other macrolides, lincosamides, and streptogramin B MLS B phenotype.
Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections. The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration MIC less than or equal to the susceptible breakpoint for azithromycin against isolates of similar genus or organism group.
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However, the efficacy of azithromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. Long-term studies in animals have not been performed to evaluate carcinogenic potential. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay.
The relevance of these findings to patients being treated with azithromycin at the doses and durations recommended in the prescribing information is uncertain. Phospholipidosis intracellular phospholipid accumulation has been observed in some tissues of mice, rats, and dogs given multiple doses of azithromycin. It has been demonstrated in numerous organ systems e.
This effect has been shown to be reversible after cessation of azithromycin treatment. The significance of these findings for animals and for humans is unknown. Acute Bacterial Exacerbations of Chronic Bronchitis. In a randomized, double-blind controlled clinical trial of acute exacerbation of chronic bronchitis AECB , azithromycin mg once daily for 3 days was compared with clarithromycin mg twice daily for 10 days. The primary endpoint of this trial was the clinical cure rate at Days 21— The following outcomes were the clinical cure rates at the Days 21—24 visit for the bacteriologically evaluable patients by pathogen:.