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According to OBRA, use of antibiotics should be limited to confirmed or suspected bacterial infections. Antibiotics are non-selective and may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis. Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions.
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. Developmental toxicity studies in animals showed no drug-induced fetal malformations at doses up to 4 times the adult human daily dose of mg based on body surface area ; however, decreased viability and delayed development were observed in the offspring of pregnant rats given azithromycin at a dose equivalent to 4 times the adult human daily dose from day 6 of pregnancy through weaning.
Azithromycin is present in human breast milk. Non-serious adverse reactions have been reported in breast-fed infants after maternal administration of azithromycin. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for azithromycin and any potential adverse effects on the breast-fed infant from azithromycin or the underlying maternal condition.
Monitor the breast-fed infant for diarrhea, vomiting, or rash. There are no available data on the effects of azithromycin on milk production. Azithromycin breast milk concentrations were measured in 20 women receiving a single 2 g oral dose during labor. Azithromycin was present in breast milk up to 4 weeks after dosing. Another study of 8 women receiving azithromycin IV before incision of cesarean section showed azithromycin was present in breast milk up to 48 hours later.
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The adverse event rate was similar to that seen in babies in a control group whose mothers were treated with amoxicillin 8. Only 10 mothers in the study received azithromycin, 6 received clarithromycin, 2 received erythromycin, and the remainder were treated with roxythromycin. Use azithromycin with caution and with proper monitoring in young infants and neonates; there have been reports of infantile hypertrophic pyloric stenosis IHPS occurring in young infants after azithromycin therapy. Because azithromycin is sometimes used for the treatment of conditions that are associated with significant mortality or morbidity e.
Inform parents and other caregivers to contact their physician if vomiting or irritability with feeding occurs. A male predominance was also observed, as all 8 infants who developed IHPS were boys. No infants aged 43 to 90 days at the time of azithromycin exposure developed IHPS ; however, there have been 2 case reports of older infants developing IHPS 89 and 94 days old at diagnosis, respectively. Direct sunlight UV exposure should be minimized during therapy with systemic azithromycin. Photosensitivity has been reported as an allergic reaction to azithromycin.
Azithromycin should be discontinued at the first sign of erythema. Zithromax azithromycin for injection contains a total of 4. At the usual recommended doses, patients would receive 4. The sodium amounts should be considered in patients with requirements for sodium restriction or blunted natriuresis to salt loading i. Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. Thus, patients who wear contact lenses should avoid wearing them while being treated with azithromycin ophthalmic solution Azasite for an ocular infection.
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving systemic azithromycin therapy.
While azithromycin may be used to treat certain sexually transmitted diseases STD , the drug may mask or delay the symptoms of incubating syphilis when given as part of an STD treatment regimen. Initiate appropriate therapy and perform follow-up testing as recommended based upon sexually transmitted disease diagnosis.
Do not use azithromycin for long-term prophylaxis of bronchiolitis obliterans syndrome BOS in patients with cancers of the blood or lymph nodes i. Abarelix: Major There have been case reports of QT prolongation and torsade de pointes TdP with the use of azithromycin in post-marketing reports. If azithromycin and another drug that prolongs the QT interval must be coadministered, ECG monitoring is recommended; closely monitor the patient for QT interval prolongation.
Abarelix is associated with a possible risk for QT prolongation and torsade de pointes TdP based on varying levels of documentation. In addition to avoiding concurrent drug interactions, the potential for TdP can be reduced by avoiding the use of QT prolonging drugs in patients at substantial risk for TdP. Examples of general risk factors for TdP include congenital long QT syndrome, female sex, elderly patients, significant bradycardia, hypokalemia, hypomagnesemia, and underlying cardiac disease e.
Aclidinium; Formoterol: Moderate Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and long-acting beta-agonists should be used together cautiously. There have been case reports of QT prolongation and TdP with the use of azithromycin in postmarketing reports.
Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses, when associated with hypokalemia, or when used with other drugs known to prolong the QT interval. This risk may be more clinically significant with long-acting beta-agonists as compared to short-acting beta-agonists.
Albuterol: Minor Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and short-acting beta-agonists should be used together cautiously.
Albuterol; Ipratropium: Minor Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and short-acting beta-agonists should be used together cautiously. Alfuzosin: Moderate Consider the risk of QT prolongation which can be fatal when administering azithromycin to patients on other QT prolonging agents such as alfuzosin. QT prolongation and torsade de pointes TdP have been spontaneously reported during azithromycin postmarketing surveillance.
Alfuzosin may prolong the QT interval in a dose-dependent manner. If antacids must be taken, stagger the administration of the antacid and azithromycin. Amiodarone: Major If possible, avoid coadministration of amiodarone and drugs known to prolong the QT interval. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after discontinuation of amiodarone. Reports of QT prolongation and torsade de pointes TdP have been spontaneously reported during azithromycin postmarketing surveillance.
QT prolongation was reported in a year old woman receiving azithromycin and amiodarone. The patient had a history of stable congestive heart failure and a posterior communicating artery aneurysm. Additional medications included furosemide, enalapril, and aspirin. Therapy with azithromycin was started at mg PO on day 1, followed by mg PO once daily for 4 days. Sinus bradycardia with marked QT prolongation and increased QT dispersion were noted on day 3 of treatment. Amitriptyline: Minor Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and tricyclic antidepressants TCAs should be used together cautiously.
TCAs share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy elevated serum concentrations.
Amitriptyline; Chlordiazepoxide: Minor Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and tricyclic antidepressants TCAs should be used together cautiously. Amlodipine; Atorvastatin: Moderate Monitor for evidence of rhabdomyolysis if atorvastatin is coadministered with azithromycin.
A clinically significant pharmacokinetic interaction was not observed when atorvastatin was administered with azithromycin in a drug interaction study. However, a case series in the World Health Organization Adverse Drug Reaction WHO-ADR database was suggestive of a possible drug interaction resulting in rhabdomyolysis between statins, including atorvastatin, and azithromycin. Amoxicillin; Clarithromycin; Lansoprazole: Major Both clarithromycin and azithromycin are macrolide antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may increase the risk for QT prolongation and torsade de pointes TdP.
Clarithromycin is associated with an established risk for QT prolongation and TdP, and cases of QT prolongation and TdP have been reported during post-marketing use of azithromycin. Amoxicillin; Clarithromycin; Omeprazole: Major Both clarithromycin and azithromycin are macrolide antibiotics and coadministration would represent duplicate therapy. Anagrelide: Major Torsades de pointes TdP and ventricular tachycardia have been reported with anagrelide.
In addition, dose-related increases in mean QTc and heart rate were observed in healthy subjects.
Why is this medication prescribed?
A cardiovascular examination, including an ECG, should be obtained in all patients prior to initiating anagrelide therapy. Monitor patients during anagrelide therapy for cardiovascular effects and evaluate as necessary. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with anagrelide include azithromycin. Apomorphine: Moderate Consider the risk of QT prolongation which can be fatal when administering azithromycin to patients on other QT prolonging agents such as apomorphine. There have been case reports of QT prolongation and torsade de pointes TdP with the post-market use of azithromycin.
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Limited data indicate that QT prolongation is also possible with apomorphine administration; the change in QTc interval is not significant in most patients receiving dosages within the manufacturer's guidelines. Arformoterol: Moderate Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and long-acting beta-agonists should be used together cautiously. Aripiprazole: Moderate Consider the risk of QT prolongation which can be fatal when administering azithromycin to patients on other QT prolonging agents such as aripiprazole.
QT prolongation has occurred during therapeutic use of aripiprazole and following overdose. Arsenic Trioxide: Major If possible, use of azithromycin should be discontinued prior to initiating arsenic trioxide therapy, as coadministration may lead to increased risk for QT prolongation and torsade de pointes TdP.
Azithromycin has been associated with cases of QT prolongation and TdP during post-marketing use. Cases of TdP and complete atrioventricular block have also been reported with arsenic trioxide; QT prolongation should be expected with the use of arsenic trioxide. Artemether; Lumefantrine: Major Due to an increased risk for QT prolongation and torsade de pointes TdP , concurrent use of azithromycin with artemether; lumefantrine should be avoided. Consider ECG monitoring if azithromycin must be used with or after artemether; lumefantrine treatment.