All medications have potential side effects, but in the case of azithromycin, the FDA issued a special recommendation warning about its dangers. Food and Drug Administration FDA is warning the public that azithromycin Zithromax or Zmax can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Note: Cystic Fibrosis News Today is strictly a news and information website about the disease.
It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Psychiatric: Aggressive reaction and anxiety. Significant abnormalities irrespective of drug relationship occurring during the clinical trials were reported as follows:.
Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. 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.
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. Reproductive and developmental toxicology studies have not been conducted using IV administration of azithromycin to animals. 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.
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. Pharmacokinetic studies with intravenous azithromycin have not been performed in older volunteers.
Pharmacokinetics of azithromycin following oral administration in older volunteers 65—85 years old were similar to those in younger volunteers 18—40 years old for the 5-day therapeutic regimen. 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. At the usual recommended doses, patients would receive mg 4. 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. Adverse reactions experienced in 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 for injection contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection.
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 C 38 H 72 N 2 O 12 , and its molecular weight is Azithromycin has the following structural formula:. Azithromycin is a macrolide antibacterial drug [see Microbiology 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. Since the mean C max of azithromycin following a mg IV dose given over 1 hr is higher than the mean C max of azithromycin following the administration of a mg oral dose, it is possible that QTc may be prolonged to a greater extent with IV azithromycin at close proximity to a one hour infusion of mg.
The mean C max , hour trough and AUC 24 values were 1. Similar pharmacokinetic values were obtained in patients hospitalized with community-acquired pneumonia who received the same 3-hour dosage regimen for 2—5 days. Following single-oral doses of mg azithromycin two mg capsules to 12 healthy volunteers, C max , trough level, and AUC 24 were reported to be 0.
Thus, plasma concentrations are higher following the intravenous regimen throughout the hour interval. Tissue concentrations have not been obtained following intravenous infusions of azithromycin, but following oral administration in humans azithromycin has been shown to penetrate into tissues, including skin, lung, tonsil, and cervix. Tissue levels were determined following a single oral dose of mg azithromycin in 7 gynecological patients. Approximately 17 hr after dosing, azithromycin concentrations were 2.
Following a regimen of mg on the first day followed by mg daily for 4 days, concentrations in the cerebrospinal fluid were 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 is a major route of elimination for unchanged drug, following oral administration. Azithromycin pharmacokinetics were investigated in 42 adults 21 to 85 years of age with varying degrees of renal impairment. Following the oral administration of a single 1, mg dose of azithromycin, mean C max and AUC 0— increased by 5.
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. Drug interaction studies were performed with oral 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.
Macrolide antibiotics are typically used to treat infections such as strep throat , syphilis , Lyme disease , and respiratory infections. The other macrolide antibiotics available in the United States are clarithromycin and erythromycin.
There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you. A: One difference is that while both of these drugs work by killing bacteria, they do it in different ways. Azithromycin belongs to the class of drugs called macrolide antibiotics, as described in this article.
Amoxicillin belongs to a class called beta-lactam antibiotics. This is a large class that includes drugs such as penicillin. Azithromycin and amoxicillin can be used to treat several of the same conditions. These include bronchitis , sinusitis , strep throat, pneumonia, ear infections, skin infections, and lower respiratory infections.
However, they have differences. Azithromycin can also be used to treat gonorrhea, mycobacterium avium complex, and pelvic inflammatory disease. And amoxicillin can also be used to treat urinary tract infections and H. The greatest difference to you may be how often you need to take them. Azithromycin may be taken once per day for 1 to 5 days, depending on the condition being treated. On the other hand, amoxicillin is often taken two or three times per day for 10 to 14 days.
Answers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional.
You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Bronchitis and pneumonia are two illnesses that people often confuse because they have many overlapping symptoms.
Learn more about the differences…. Bronchitis causes inflammation of the airways within the lungs. Find out about the symptoms of bronchitis, how it develops, and the treatment options…. A look at chronic sinusitis, long-term inflammation in the sinuses. Included is detail on home remedies and possible complications of the condition. Despite improved pharmacodynamic parameters, there is no evidence supporting its clinical efficacy over immediate-release azithromycin.
In future we look forward to the evolving role of nanotechnology in the pharmaceutical field as it both improves on previous therapy, such as with extended-release azithromycin, and also contributes to the development of novel treatments. National Center for Biotechnology Information , U.
Journal List Int J Nanomedicine v. Int J Nanomedicine. Published online Mar. David Amrol. Author information Copyright and License information Disclaimer. All rights reserved. This article has been cited by other articles in PMC.
Keywords: azithromycin, microspheres, acute bacterial sinusitis, community acquired pneumonia. Pharmacology Azithromycin is an azolide antibiotic which is similar in structure and function to macrolides, but has important differences. Clinical trials Three industry-sponsored clinical trials have been performed comparing 2 g azithromycin extended release with other FDA-approved antibiotics for community-acquired pneumonia and acute bacterial sinusitis. Pneumococcal macrolide resistance There is a growing number of S.
Drug—drug interactions and adverse effects Azithromycin has few drug interactions and does not interact with CYP3A unlike other macrolides. Administration Extended-release azithromycin is a 2 g formulation with a cherry-banana taste that is mixed with 60 mL of water by the pharmacist. Conclusion Extended-release azithromycin is the only FDA-approved single-dose antibiotic for the treatment of community acquired pneumonia and acute bacterial sinusitis.
References Amsden G. Pneumococcal macrolides resistance—myth or reality? J Antimicrob Chemother. Novel, single-dose microsphere formulation of azithromycin versus 7-day levofloxacin therapy for treatment of mild to moderate community acquired pneumonia in adults. Antimicrob Agents Chemother. Single-dose azithromycin microspheres vs clarithromycin extended release for the treatment of mild-to-moderate community-acquired pneumonia in adults. Pharmacokinetics of azithromycin in lung tissue, bronchial washing, and plasma in patients given multiple oral doses of and mg daily.
Pharmacol Res. Rationale for single and high dose treatment regimens with azithromycin. Pediatr Infect Dis J. Dilemma in trial design: do current study designs adequately evaluate antibiotic effectiveness in ABRS?
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