Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: Get medical help right away if any of these rare but serious side effects occur: This medication may rarely cause a severe intestinal condition Clostridium difficile -associated diarrhea due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped.

Do not use anti- diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge , or other new symptoms. A very serious allergic reaction to this drug is rare.

However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: An allergic reaction to this medication may return even if you stop the drug.

Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and promethazine should be used together cautiously. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Major Due to the risk for serious colchicine toxicity including multi-organ failure and death, avoid coadministration of colchicine and azithromycin in patients with normal renal and hepatic function unless the use of both agents is imperative.

Coadministration is contraindicated in patients with renal or hepatic impairment because colchicine accumulation may be greater in these populations.

Azithromycin can inhibit colchicine's metabolism via P-glycoprotein P-gp , resulting in increased colchicine exposure. If coadministration in patients with normal renal and hepatic function cannot be avoided, adjust the dose of colchicine by either reducing the daily dose or the dosage frequency, and carefully monitor for colchicine toxicity. Specific dosage adjustment recommendations are available for the Colcrys product for patients who have taken a P-gp inhibitor like azithromycin in the past 14 days or require concurrent use: Moderate Use caution when administering conivaptan and azithromycin concurrently.

Conivaptan is an inhibitor of P-glycoprotein P-gp. Co-administration of conivaptan with P-gp substrates, such as azithromycin, may increase azithromycin exposure leading to increased or prolonged therapeutic effects and adverse events. Moderate In clinical evaluation, azithromycin mg was given once daily for 8 consecutive days in 30 postmenopausal women.

Azithromycin mg and a bazedoxifene 40 mg tablet were co-administered on Day 9. Azithromycin mg administration once daily continued on Days 10 to The clinical effect of this change is not known.

A reduction in bazedoxifene exposure may be associated with an increased risk of endometrial hyperplasia. Monitor patients for loss of efficacy and increased side effects during conjugated estrogens; bazedoxifene therapy. Major Monitor ECGs for QT prolongation and monitor electrolytes in patients receiving crizotinib concomitantly with azithromycin.

An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib patients if QT prolongation occurs. Crizotinib has also been associated with concentration-dependent QT prolongation.

Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and cyclobenzaprine should be used together cautiously. Cyclobenzaprine is associated with a possible risk of QT prolongation and TdP, particularly in the event of acute overdose.

Moderate Both cyclosporine and azithromycin are P-glycoprotein P-gp inhibitors and substrates; coadministration may lead to increased concentrations of either agent. In a case report, one patient had increased cyclosporine concentrations after administration of azithromycin and decreased cyclosporine concentrations after azithromycin discontinuation. Moderate Increased serum concentrations of dabigatran are possible when dabigatran, a P-glycoprotein P-gp substrate, is coadministered with azithromycin, a P-gp inhibitor.

Patients should be monitored for increased adverse effects of dabigatran. P-gp inhibition and renal impairment are the major independent factors that result in increased exposure to dabigatran. Moderate Systemic exposure of azithromycin, a P-glycoprotein P-gp substrate, may be increased when administered concurrently with daclatasvir, a P-gp inhibitor. Taking these drugs together could increase or prolong the therapeutic effects of azithromycin; monitor patients for potential adverse effects.

Major Increased concentrations of azithromycin may occur if it is coadministered with darunavir; exercise caution. Darunavir is an inhibitor of the efflux transporter P-glycoprotein PGP and azithromycin may be a P-glycoprotein substrate. Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Major Both ritonavir and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent.

In addition, the use of ritonavir could result in QT prolongation; QT prolongation and torsade de pointes TdP have been spontaneously reported during azithromycin postmarketing surveillance.

Concurrent use may result in additive risk of QT prolongation. Major Concurrent administration of azithromycin with dasabuvir; ombitasvir; paritaprevir; ritonavir may result in elevated plasma concentrations of all 5 drugs. Increased plasma concentrations increases the risk of adverse effects, some of which may be serious; azithromycin and ritonavir both have been associated with QT-prolongation. Azithromycin and ritonavir are inhibitors of the drug transporter P-glycoprotein P-gp , and all 5 drugs are P-gp substrates.

Caution and close monitoring are advised if these drugs are administered together. Major Concurrent administration of azithromycin with dasabuvir; ombitasvir; paritaprevir; ritonavir or ombitasvir; paritaprevir; ritonavir may result in elevated plasma concentrations of azithromycin and the components of the hepatitis C regimen.

Azithromycin and ritonavir are inhibitors of the drug transporter P-glycoprotein P-gp , and azithromycin, dasabuvir, ombitasvir, paritaprevir, and ritonavir are P-gp substrates.

Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised during coadministration of dasatinib and azithromycin. In vitro studies have shown that dasatinib has the potential to prolong cardiac ventricular repolarization prolong QT interval. Additionally, cases of QT prolongation and TdP have been reported during the post-marketing use of azithromycin. Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and daunorubicin should be used together cautiously.

Acute cardiotoxicity can occur during the administration of daunorubicin; although, the incidence is rare. In addition, daunorubicin is a P-glycoprotein P-gp substrate and azithromycin is a P-gp inhibitor, so coadministration may lead to increased anthracycline concentrations.

Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when coadministering degarelix and azithromycin.

Degarelix can cause QT prolongation, and azithromycin has been associated with cases of QT prolongation and TdP during the post-marketing period.

Prescribers need to weigh the potential benefits and risks of degarelix use in patients with prolonged QT syndrome or in patients taking azithromycin.

Major Halogenated Anesthetics should be used cautiously and with close monitoring with azithromycin. Halogenated Anesthetics can prolong the QT interval. Minor Desloratadine is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, desloratadine concentrations could be increased with coadministration.

Clinically relevant QTc prolongation may occur with deutetrabenazine. Moderate Dexamethasone is a substrate of P-glycoprotein PGP and azithromycin is a PGP inhibitor; therefore, dexamethasone concentrations could be increased with coadministration. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when coadministering quinidine with azithromycin.

Quinidine is associated with QT prolongation and TdP, and rare cases of QT prolongation and TdP have been reported during the post-marketing use of azithromycin. In addition, both quinidine and azithromycin are P-glycoprotein P-gp substrates and inhibitors, which may lead to increased serum concentrations of either drug when given concomitantly. Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.

It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported.

It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use.

Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives.

These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances.

Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries e. Moderate Elevated digoxin concentrations have been observed when certain macrolide antibiotics, including azithromycin, have been coadministered with digoxin. Monitor patients who take both azithromycin and digoxin for possible digoxin toxicity and reduce digoxin dose as necessary.

Digoxin is a substrate for the drug efflux pump P-glycoprotein P-gp ; azithromycin is a substrate and inhibitor of P-gp. Inhibition of P-gp in the intestinal cell wall may lead to increased oral absorption and decreased renal and non-renal clearance of digoxin. Minor Until more data are available, the manufacturer of azithromycin recommends caution and careful monitoring of patients who receive azithromycin and either ergotamine or dihydroergotamine concurrently.

The simultaneous use of certain ergot alkaloids with certain macrolides may produce ergot toxicity. Moderate Both diltiazem and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent.

Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering disopyramide with azithromycin. Disopyramide is associated with QT prolongation and TdP, and cases of QT prolongation and TdP have been reported during the post-marketing use of azithromycin. Minor Docetaxel is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, docetaxel concentrations could be increased with coadministration.

Severe Coadministration of dofetilide and azithromycin is contraindicated since there is an increased risk for QT prolongation and torsade de pointes TdP. Azithromycin has been associated with cases of QT prolongation and TdP, reported during the post-marketing period.

Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering dolasetron with azithromycin. Concurrent use may increase the risk fo QT prolongation.

Major Case reports indicate that QT prolongation and torsade de pointes TdP can occur during donepezil therapy. Donepezil is considered a drug with a known risk of TdP. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with donepezil include azithromycin. Major Avoid coadministration of azithromycin and doxorubicin if possible. If not possible, closely monitor for increased side effects of doxorubicin including myelosuppression and cardiotoxicity.

Azithromycin inhibits P-glycoprotein P-gp and doxorubicin is a major substrate of P-gp. Clinically significant interactions have been reported when doxorubicin was coadministered with inhibitors of P-gp, resulting in increased concentrations and clinical effect of doxorubicin. Additionally, acute cardiotoxicity can occur during the administration of doxorubicin; although, the incidence is rare.

Azithromycin also has a possible risk for QT prolongation and torsades de pointes TdP. Severe Dronedarone administration is associated with a dose-related increase in the QTc interval. The increase in QTc is approximately 10 milliseconds at doses of mg twice daily the FDA-approved dose and up to 25 milliseconds at doses of mg twice daily. Although there are no studies examining the effects of dronedarone in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation.

The concomitant use of dronedarone with other drugs that prolong the QTc may induce Torsade de Pointes TdP and is contraindicated.

There have been case reports of QT prolongation and TdP with the use of azithromycin in post-marketing reports. Additionally, dronedarone may inhibit P-glycoprotein P-gp and azithromycin is a P-gp substrate; therefore, increased concentrations of azithromycin may occur with concomitant administration. Major Droperidol should not be used in combination with any drug known to have potential to prolong the QT interval, such as azithromycin.

Droperidol administration is associated with an established risk for QT prolongation and torsade de pointes TdP. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. If coadministration cannot be avoided, use extreme caution; initiate droperidol at a low dose and increase the dose as needed to achieve the desired effect.

Additionally, azithromycin may inhibit P-glycoprotein P-gp and droperidol is a P-gp substrate; therefore, increased concentrations of droperidol may occur with concomitant administration.

Drospirenone; Ethinyl Estradiol; Levomefolate: No dosage adjustment is required in patients with atrial fibrillation. Edoxaban is a P-glycoprotein P-gp substrate and azithromycin is a P-gp inhibitor. Increased concentrations of edoxaban may occur during concomitant use of azithromycin; monitor for increased adverse effects of edoxaban.

Major According to the manufacturer, clinically significant interactions are not expected with efavirenz and azithromycin. However, use of these medications together may increase the risk for QT prolongation and torsade de pointes TdP. QT prolongation has been observed with use of efavirenz. Moderate Eletriptan is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, eletriptan concentrations could be increased with coadministration.

Major Coadministration of azithromycin and eliglustat may result in increased concentrations of azithromycin and an increased risk of QT prolongation. If coadministration is necessary, use caution and monitor closely.

Azithromycin is a P-glycoprotein P-gp substrate associated with post-marketing case reports of QT prolongation and torsade de pointes TdP. Emtricitabine; Rilpivirine; Tenofovir alafenamide: Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering rilpivirine with azithromycin.

Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: Emtricitabine; Tenofovir disoproxil fumarate: Major Due to the potential for QT prolongation and torsade de pointes TdP , caution is advised when administering azithromycin with epirubicin. Acute cardiotoxicity can occur during the administration of epirubicin; although, the incidence is rare.

Major Concurrent use of eribulin and azithromycin should be avoided due to an increased risk for QT prolongation and torsade de pointes TdP. If these drugs must be coadministered, ECG monitoring is recommended; closely monitor the patient for QT interval prolongation. Eribulin 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 Avoid use of azithromycin and erythromycin together as this would be considered duplicate therapy.

Cross-resistance with gram-positive organisms would be expected. Additionally, the risk for QT prolongation and torsade de pointes TdP increases if these drugs are administered together. Erythromycin has been associated with QT prolongation and TdP, and cases of QT prolongation and TdP have been reported during post-marketing use of azithromycin.

Major Due to a possible risk for QT prolongation and torsade de pointes TdP , azithromycin and escitalopram should be used together cautiously. Escitalopram has been associated with a risk of QT prolongation and TdP.

Ethinyl Estradiol; Ethynodiol Diacetate: Ethinyl Estradiol; Norethindrone Acetate: Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate: Ethinyl Estradiol; Norethindrone; Ferrous fumarate: Major Monitor for an increased incidence of etoposide-related adverse effects if used concomitantly with azithromycin. Coadministration may increase etoposide concentrations. Azithromycin may be a P-glycoprotein substrate.

Increased concentrations of azithromycin may occur if it is coadministered with etravirine; exercise caution. Moderate Both simvastatin and azithromycin are P-glycoprotein P-gp inhibitors and substrates, so coadministration may lead to increased concentrations of either agent. Major Due to an increased risk for QT prolongation and torsade de pointes TdP , caution is advised when administering ezogabine with azithromycin. Ezogabine has been associated with QT prolongation, and cases of QT prolongation and TdP have been reported with the post-marketing use of azithromycin.

Moderate Fentanyl is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, fentanyl concentrations could be increased with coadministration.

Minor Fexofenadine is a substrate of P-glycoprotein P-gp and azithromycin is a P-gp inhibitor; therefore, fexofenadine concentrations could be increased with coadministration.

Major Cautious use of fingolimod with azithromycin is advised, as azithromycin has been associated with post-marketing reports of QT prolongation and torsade de pointes TdP. Fingolimod initiation results in decreased heart rate and may prolong the QT interval. After the first fingolimod dose, overnight monitoring with continuous ECG in a medical facility is advised for patients taking QT prolonging drugs with a known risk of TdP.

Fingolimod has not been studied in patients treated with drugs that prolong the QT interval, but drugs that prolong the QT interval have been associated with cases of TdP in patients with bradycardia. 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. 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. Warnings and Precautions Hypersensitivity Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis AGEP , Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy.

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.

Direct parents and caregivers 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. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Clostridium difficile-Associated Diarrhea CDAD CDAD has been reported with use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea 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 diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

The entire contents of the packet should be mixed thoroughly with two ounces approximately 60 mL of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than mg of azithromycin.

This dose can be administered as one single dose packet 1 g. This dose of Zithromax may be combined with the approved dosage regimen of rifabutin. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of azithromycin plus ethambutol at the discretion of the physician or health care provider. Dosage Forms and Strengths Zithromax mg tablets engraved on front with "PFIZER" and on back with "" are supplied as white, modified oval-shaped, film-coated tablets containing azithromycin dihydrate equivalent to mg azithromycin.

These are packaged in bottles of 30 tablets. Contraindications Hypersensitivity Zithromax is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug.

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. Direct parents and caregivers 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.

Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: Elderly patients may be more susceptible to drug-associated effects on the QT interval.

azithromycin 250/500 mg - oral, Zithromax

Major Periodically monitor electrolytes and ECGs in patients receiving concomitant treatment with ceritinib and azithromycin; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if Daily prolongation occurs, zithromax 1000mg daily. Caution and daily monitoring are advised if these drugs are used together. Major Due 1000mg a possible risk for QT prolongation and 1000mg de pointes TdPazithromycin and triptorelin should be used together cautiously. Minor Due to a possible risk for QT prolongation and torsade de pointes TdPazithromycin and short-acting beta-agonists should be used together cautiously, zithromax 1000mg daily. Venlafaxine is associated with a possible risk of QT prolongation; TdP has been reported with postmarketing use. QT prolongation zithromax torsade de pointes TdP have been spontaneously reported 1000mg azithromycin postmarketing surveillance. The concurrent use of other macrolides and warfarin in daily practice has been associated with increased anticoagulant effects. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. Appropriate antibacterial therapy and follow-up tests for these zithromax should be initiated zithromax infection is confirmed, zithromax 1000mg daily.

Asthma Story Asthma Azithromycin Asthma Zithromax Asthma Z-Pak Asthma

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