When follow-up was provided, changes in laboratory tests appeared to be reversible. In multiple-dose clinical trials involving more than patients, 3 patients discontinued therapy because of treatment-related liver enzyme abnormalities and 1 because of a renal function abnormality.
Laboratory abnormalities seen in clinical trials for the prevention of disseminated Mycobacterium avium disease in severely immunocompromised HIV-infected patients. Causality of these laboratory abnormalities due to the use of study drug has not been established. 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.
Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Potential Drug-Drug Interaction With Macrolides Interactions with the following drugs listed below have not been reported in clinical trials with azithromycin; however, 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 or phenytoin are used with azithromycin careful monitoring of patients is advised. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure.
These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is presently unknown. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Physicians should be aware that allergic symptoms may reappear when symptomatic therapy is discontinued. Hepatotoxicity Abnormal liver function, hepatitis , cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death.
Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. Parents and caregivers should be informed to contact their physician if vomiting or irritability with feeding occurs.
QT Prolongation Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin.
In patients with renal impairment: In patients with hepatic impairment: A dose adjustment is not necessary for patients with mild to moderately impaired liver function see section 4.
Method of administration Azithromycin Tablets should be given as a single daily dose. The tablets may be taken with food. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Since liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin see section 4. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products.
Azithromycin administration should be stopped if liver dysfunction has emerged. In patients receiving ergotamine derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergotamine derivatives and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered see section 4.
Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides including azithromycin see section 4. Therefore as the following situations may lead to an increased risk for ventricular arrhytmias including torsade de pointes which can lead to cardiac arrest, azithromycin should be used with caution in patients with ongoing proarrhythmic conditions especially women and older people such as patients: Clostridium difficile associated diarrhoea CDAD has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhoea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Hypertoxin producing strains of C. CDAD must be considered in all patients who present with diarrhoea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antimicrobial agents. In case of CDAD anti-peristaltics are contraindicated. Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy see section 4. Safety and efficacy for the prevention or treatment of Mycobacterium Avium Complex MAC in children have not been established.
The following should be considered before prescribing azithromycin: Azithromycin tablets are not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to azithromycin and other antibiotics.
This should be taken into account when treating infections caused by Streptococcus pneumoniae. For this and for the prophylaxis of acute rheumatic fever penicillin is the treatment of first choice. Sinusitis Often, azithromycin is not the substance of first choice for the treatment of sinusitis. Acute otitis media Often, azithromycin is not the substance of first choice for the treatment of acute otitis media. Skin and soft tissue infections The main causative agent of soft tissue infections, Staphylococcus aureus, is frequently resistant to azithromycin.
Therefore, susceptibility testing is considered a precondition for treatment of soft tissue infections with azithromycin. Infected burn wounds Azithromycin is not indicated for the treatment of infected burn wounds. Sexually transmitted disease In case of sexually transmitted diseases a concomitant infection by T. In addition, there are postmarketing reports of TdP.
Major Loperamide should be used cautiously and with close monitoring with azithromycin. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes TdP , and cardiac arrest. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering azithromycin with lopinavir; ritonavir.
There have been case reports of QT prolongation and TdP with the use of azithromycin in post-marketing reports, and lopinavir; ritonavir has been associated with QT prolongation.
Major Avoid concurrent administration of macimorelin with drugs that prolong the QT interval, such as azithromycin. Use of these drugs together may increase the risk of developing torsade de pointes-type ventricular tachycardia. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of macimorelin is recommended.
Treatment with macimorelin has been associated with an increase in the corrected QT QTc interval. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of maprotiline with azithromycin is advised. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy elevated serum concentrations. Cases of long QT syndrome and TdP tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation.
Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering mefloquine with azithromycin. There is evidence that use of halofantrine after mefloquine causes a significant lengthening of the QTc interval.
Mefloquine alone has not been reported to cause QT prolongation; however due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval, such as azithromycin. Post-marketing use of azithromycin has been associated with cases of QT prolongation and TdP. Other drugs, such as mesoridazine, have been specifically established to have a causal association with QT prolongation and torsade de pointes and are contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin.
Major Use of azithromycin during the post-marketing period has been associated with cases of QT prolongation and torsade de pointes TdP. The need to coadminister methadone with drugs known to prolong the QT interval, such as azithromycin, should be done with extreme caution and a careful assessment of treatment risks versus benefits. Major The concomitant use of midostaurin and azithromycin may lead to additive QT interval prolongation.
If these drugs are used together, consider obtaining electrocardiograms to monitor the QT interval. In clinical trials, QT prolongation was reported in patients who received midostaurin as single-agent therapy or in combination with cytarabine and daunorubicin.
Reports of QT prolongation and torsade de pointes have been reported during postmarketing surveillance of azithromycin. Major Due to the potential for QT prolongation and torsade de pointes TdP , caution is advised when administering mifepristone with azithromycin.
Mifepristone has been associated with dose-dependent prolongation of the QT interval, and rare cases of QT prolongation and TdP have been reported with azithromycin during postmarketing use.
To minimize the risk of QT prolongation, the lowest effective mifepristone dose should always be used. Moderate There may be an increased risk for QT prolongation and torsade de pointes TdP during concurrent use of mirtazapine and azithromycin. Cases of QT prolongation, TdP, ventricular tachycardia, and sudden death have been reported during postmarketing use of mirtazapine, primarily following overdose or in patients with other risk factors for QT prolongation, including concomitant use of other medications associated with QT prolongation.
Major Concurrent use of moxifloxacin and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP. Prolongation of the QT interval has been reported with administration of moxifloxacin. Post-marketing surveillance has identified very rare cases of ventricular arrhythmias including TdP, usually in patients with severe underlying proarrhythmic conditions.
The likelihood of QT prolongation may increase with increasing concentrations of moxifloxacin, therefore the recommended dose or infusion rate should not be exceeded. According to the manufacturer, moxifloxacin should be avoided in patients taking drugs that can result in prolongation of the QT interval, such as azithromycin. During the post-marketing period, cases of QT prolongation and TdP were associated with azithromycin. Moderate Coadministration of nelfinavir and azithromycin results in increased azithromycin concentrations.
Dosage adjustments are not necessary, although patients should be monitored for azithromycin related adverse effects such as increased hepatic enzymes and hearing impairment. Major Avoid the concomitant use of nilotinib and azithromycin; significant prolongation of the QT interval may occur.
Sudden death and QT prolongation have been reported in patients who received nilotinib therapy. There have been case reports of QT prolongation and torsade de pointes with the use of azithromycin in post-marketing reports.
Sudden deaths and QT prolongation have been reported with nilotinib therapy. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and norfloxacin should be used together cautiously. Additionally, quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of norfloxacin.
These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and octreotide should be used together cautiously.
Arrhythmias, sinus bradycardia, and conduction disturbances have occurred during octreotide therapy. Since bradycardia is a risk factor for development of TdP, the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval.
Until further data are available, it is suggested to use octreotide cautiously in patients receiving drugs which prolong the QT interval. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering ofloxacin with azithromycin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia.
Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Cases of QT prolongation and TdP have also been reported with the post-marketing use of azithromycin. Major If azithromycin and ondansetron must be coadministered, ECG monitoring is recommended; closely monitor the patient for QT interval prolongation. Ondansetron has been associated with a dose-related increase in the QT interval and postmarketing reports of torsade de pointes TdP.
If ondansetron and another drug that prolongs the QT interval must be coadministered, ECG monitoring is recommended.
Azithromycin has also been associated with cases of QT prolongation and TdP during the post-marketing period. Major Avoid coadministration of azithromycin with osimertinib if possible due to the risk of QT prolongation and torsade de pointes TdP. If concomitant use is unavoidable, periodically monitor ECGs for QT prolongation and monitor electrolytes if coadministration of azithromycin with osimertinib is necessary; an interruption of osimertinib therapy with dose reduction or discontinuation of therapy may be necessary if QT prolongation occurs.
Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Major Monitor ECGs and electrolytes in patients receiving oxaliplatin and azithromycin concomitantly; correct electrolyte abnormalities prior to administration of oxaliplatin. QT prolongation and ventricular arrhythmias including fatal torsade de pointes TdP have been reported with oxaliplatin use in postmarketing experience. QT prolongation and TdP have also been spontaneously reported during azithromycin postmarketing surveillance.
Major Concurrent use of paliperidone and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP. If these drugs must be coadministered, close monitoring for QT interval prolongation is advised. Paliperidone has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the use of azithromycin during the post-marketing period.
Major QT prolongation has been reported with panobinostat therapy in patients with multiple myeloma in a clinical trial; use of panobinostat with other agents that prolong the QT interval is not recommended.
Obtain an electrocardiogram at baseline and periodically during treatment. Drugs with a possible risk for QT prolongation and torsade de pointes that should be used cautiously and with close monitoring with panobinostat include azithromycin. Major Cautious use of pasireotide and azithromycin is needed, as coadministration may have additive effects on the prolongation of the QT interval.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , coadministration of pazopanib and azithromycin is not advised; both pazopanib and azithromycin have been reported to prolong the QT interval. If these drugs must be given together, closely monitor the patient for QT interval prolongation. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering pentamidine with azithromycin. Pentamidine has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.
Minor Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering perphenazine with azithromycin. Perphenazine is also associated with a possible risk for QT prolongation.
Theoretically, perphenazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Major Chloramphenicol and macrolides are bactericidal or bacteriostatic via the same or similar mechanisms of action. Antagonism in vitro has been demonstrated. Minor Until more data are available, the manufacturer of azithromycin recommends caution and careful monitoring of patients who receive azithromycin with phenytoin.
Azithromycin was not implicated in clinical trials with drug interactions with phenytoin. However, specific drug interaction studies have not been performed with the combination of azithromycin and phenytoin. Major Pimavanserin may cause QT prolongation and should generally be avoided in patients receiving other medications known to prolong the QT interval, such as azithromycin. Coadministration may increase the risk for QT prolongation.
Severe Concurrent use of pimozide and macrolides e. Elevated pimozide concentrations occurring through inhibition of CYP3A4 can lead to QT prolongation, ventricular arrhythmias, and sudden death. Two sudden deaths have been reported when clarithromycin was added to pimozide therapy.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering posaconazole with azithromycin. Posaconazole has been associated with prolongation of the QT interval as well as rare cases of torsade de pointes Pravastatin: Major Due to the potential for QT interval prolongation with primaquine, caution is advised with other drugs that prolong the QT interval.
Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with primaquine include azithromycin. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering procainamide with azithromycin. Procainamide is associated with a well-established risk of QT prolongation and TdP, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.
Minor Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and prochlorperazine should be used together cautiously. Prochlorperazine is associated with a possible risk for QT prolongation. Theoretically, prochlorperazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering propafenone with azithromycin.
Azithromycin has been associated with cases of QT prolongation and TdP, reported during the postmarketing period. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering quetiapine with azithromycin. Limited data, including some case reports, suggest that quetiapine may be associated with a significant prolongation of the QTc interval in rare instances.
Additionally, azithromycin has been associated with cases of QT prolongation and TdP, reported during the post-marketing period. Major Concurrent use of quinine and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP. Quinine has been associated with prolongation of the QT interval and rare cases of TdP. Ranolazine is also associated with a possible risk for QT prolongation and torsade de pointes TdP ; therefore, concomitant use may have additive risk.
Azithromycin is also a substrate for and an inhibitor of P-glycoprotein transport, an energy-dependent drug efflux pump. The inhibition of P-glycoprotein, by drugs such as ranolazine may result in an increase in the concentration of azithromycin. Similarly, ranolazine also is a substrate for and an inhibitor of P-glycoprotein transport.
Coadministration with azithromycin may result in an increase in the plasma concentration of ranolazine. If ranolazine and azithromycin are coadministered, patients should be monitored closely for adverse effects of each agent. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and regadenoson should be used together cautiously.
Regadenoson has been associated with QT prolongation. Major Avoid coadministration of ribociclib with azithromycin due to an increased risk for QT prolongation and torsade de pointes TdP. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. There have been case reports of QT prolongation and Td with the use of azithromycin in postmarketing reports. Concomitant use may increase the risk for QT prolongation.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of risperidone with azithromycin is advised. If coadministration is chosen, and the patient has known risk factors for cardiac disease or arrhythmia, then the patient should be closely monitored clinically. Reports of QT prolongation and TdP during risperidone therapy are noted by the manufacturer, primarily in the overdosage setting.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering romidepsin with azithromycin. If these drugs must be coadministered, periodic ECG and electrolyte monitoring is recommended. Romidepsin has been reported to prolong the QT interval, and cases of QT prolongation and TdP have been reported with the postmarketing use of azithromycin. Major Avoid administering saquinavir boosted with ritonavir with other drugs that may prolong the QT interval, such as azithromycin.
Saquinavir boosted with ritonavir increases the QT interval in a dose-dependent fashion, which may increase the risk for serious arrhythmias such as torsade de pointes TdP.
If no acceptable alternative therapy is available, perform a baseline ECG prior to initiation of concomitant therapy and carefully follow monitoring recommendations. Major There have been postmarketing reports of QT prolongation and torsade de pointes TdP during treatment with sertraline and the manufacturer of sertraline recommends avoiding concurrent use with drugs known to prolong the QTc interval. Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: Major Prior or concomitant use of antibiotics with sodium picosulfate; magnesium oxide; anhydrous citric acid may reduce efficacy of the bowel preparation as conversion of sodium picosulfate to its active metabolite bis- p-hydroxy-phenyl -pyridylmethane BHPM is mediated by colonic bacteria.
If possible, avoid coadministration. Therefore, these antibiotics should be taken at least 2 hours before and not less than 6 hours after the administration of sodium picosulfate; magnesium oxide; anhydrous citric acid solution. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and solifenacin should be used together cautiously.
Solifenacin has been associated with dose-dependent prolongation of the QT interval. TdP has been reported with postmarketing use, although causality was not determined. This should be taken into consideration when prescribing solifenacin to patients taking other drugs that are associated with QT prolongation.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering sorafenib with azithromycin. Sorafenib has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the use of azithromycin during the post-marketing period. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , cautious use of sotalol with azithromycin is advised.
Sotalol administration is also associated with QT prolongation and TdP. Proarrhythmic events should be anticipated after initiation of sotalol therapy and after each upward dosage adjustment.
Other drugs, such as sparfloxacin, have been specifically established to have a causal association with QT prolongation and torsade de pointes and are contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and sulfamethoxazole; trimethoprim should be used together cautiously.
QT prolongation resulting in ventricular tachycardia and TdP has been reported during postmarketing use of sulfamethoxazole; trimethoprim. In addition, there have been case reports of QT prolongation and TdP with the use of azithromycin in postmarketing reports. Major Monitor patients for QT prolongation if coadministration of azithromycin with sunitinib is necessary.
Sunitinib can cause dose-dependent QT prolongation, which may increase the risk for ventricular arrhythmias, including torsades de points TdP.
Prolongation of the QT interval and TdP have been spontaneously reported during azithromycin postmarketing surveillance. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering tacrolimus with azithromycin. Tacrolimus causes QT prolongation, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.
Major Caution is advised with the concomitant use of tamoxifen with azithromycin due to an increased risk of QT prolongation and torsade de pointes TdP. Tamoxifen has been reported to prolong the QT interval, usually in overdose or when used in high doses.
Rare case reports of QT prolongation have also been described when tamoxifen is used at lower doses. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering telavancin with azithromycin.
Telavancin has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering telithromycin with azithromycin. Telithromycin is associated with QT prolongation and TdP, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin. Severe Coadministration is contraindicated due to the risk for QT prolongation and torsade de pointes TdP.
Consider alternative antihistamine therapy. Terfenadine has been specifically established to have a causal association with QT prolongation and TdP and is contraindicated for use with drugs that potentially cause QT prolongation, such as azithromycin. There have been case reports of QT prolongation and torsade de pointes TdP with the use of azithromycin in postmarketing reports.
Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering tetrabenazine with azithromycin. Tetrabenazine causes a small increase in the corrected QT interval QTc , and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.
Severe Because of the potential for torsade de pointes TdP , use of azithromycin with thioridazine is contraindicated. Thioridazine is associated with a well-established risk of QT prolongation and TdP.
Thioridazine is considered contraindicated for use along with agents that, when combined with a phenothiazine, may prolong the QT interval and increase the risk of TdP. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and tizanidine should be used together cautiously. Tizanidine administration may result in QT prolongation. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and tolterodine should be used together cautiously.
Tolterodine has been associated with dose-dependent prolongation of the QT interval, especially in poor CYP2D6 metabolizers. Major Avoid coadministration of azithromycin with toremifene if possible due to the risk of additive QT prolongation. If concomitant use is unavoidable, closely monitor ECGs for QT prolongation and monitor electrolytes; correct hypokalemia or hypomagnesemia prior to administration of toremifene.
Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner. Prolongation of the QT interval and torsade de pointes TdP have also been spontaneously reported during azithromycin in postmarketing surveillance.
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