Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 500mg/vial
tablet
- 250mg
- 500mg
oral suspension
- 100mg/5mL
- 200mg/5mL
Community-acquired Pneumonia
Indicated for treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Pharyngitis or Tonsillitis
Indicated for treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative therapy in individuals who cannot use first-line therapy
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Uncomplicated skin/skin structure
Indicated for treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Acute bacterial exacerbations of chronic obstructive pulmonary disease
Indicated for treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
500 mg PO qDay for 3 days OR
Alternatively, 500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Acute bacterial sinusitis
Indicated for treatment of acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
500 mg PO qDay x 3 days
Genital Ulcer Disease (Chancroid)
Indicated for treatment of genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Efficacy in treatment of chancroid in women has not been established
1000 mg PO x 1 dose
Nongonococcal or Gonococcal Urethritis and Cervicitis
Indicated for treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae
1000 mg PO x 1 dose
Pelvic Inflammatory Disease
Indicated for treatment of pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial IV therapy
If anaerobic microorganisms are suspected of contributing to the infection, administer an antimicrobial agent with anaerobic activity in combination with azithromycin
Coronavirus Disease 2019 (COVID-19) (Off-label)
Data available as of March 25, 2020
Note: Limited data available; no drug is FDA approved to treat COVID-19
Azithromycin may be considered for use as part of an investigational protocol for patients with COVID-19
For more information, see the CDC website (link https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.html)
Additional Medscape COVID-19 references are available
- Coronavirus Disease 2019 (COVID-19) (link https://emedicine.medscape.com/article/2500114-overview)
- Novel Coronavirus Resource Center (link https://www.medscape.com/resource/coronavirus)
Cat Scratch Disease (Off-label)
>45.5 kg: 500 mg PO once, then 250 mg once daily for 4 days
Pertussis (Off-label)
500 mg PO once, then 250 mg once daily for 4 days
Endocarditis (Off-label)
Prophylaxis
500 mg PO 30-60 min before procedure
Current American Heart Association (AHA) guidelines recommend only for high-risk patients
Dosing Considerations
Use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria in order to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin
Limitations of use
-
Do not use in patients with pneumonia who may be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
- Patients with cystic fibrosis
- Patients with nosocomial infections
- Patients with known or suspected bacteremia
- Patients requiring hospitalization
- Elderly or debilitated patients
- Patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia)
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 500mg/vial
tablet
- 250mg
- 500mg
oral suspension
- 100mg/5mL
- 200mg/5mL
Acute Otitis Media
Indicated for treatment of acute otitis media in patient >6 months of age caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
<6 months: Safety and efficacy not established
≥6 months
- 30 mg/kg PO x 1 dose OR
-
Alternative dosing
- 10 mg/kg PO qDay for 3 days OR
- 10 mg/kg PO x 1 dose on Day 1 followed by 5 mg/kg on Days 2-5
Community-acquired Pneumonia
<6 months: Safety and efficacy not established
≥6 months: 10 mg/kg PO x 1 dose on Day 1, followed by 5 mg/kg PO on Days 2-5
Pharyngitis/Tonsillitis
Indicated for treatment of pharyngitis/tonsillitis in patients >2 years of age caused by Streptococcus pyogenes as an alternative therapy in individuals who cannot use first-line therapy
<2 years: Safety and efficacy not established
≥2 years: 12 mg/kg PO qDay for 5 days; not to exceed 500 mg/day
Chlamydia Trachomatis Infection (Off-label)
Treatment of cervicitis or urethritis
Children and adolescents ≥45 kg: 1 g PO as single dose
Cat Scratch Disease (Off-label)
≤45 kg: 10 mg/kg (not to exceed 500 mg/dose) PO as single dose; then 5 mg/kg (not to exceed 250 mg/dose) PO qDay on days 2 through 5
>45 kg: 500 mg PO once, then 250 mg once daily for 4 days
Dosing Considerations
Use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria in order to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin
Limitations of use
-
Do not use in patients with pneumonia who may be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
- Patients with cystic fibrosis
- Patients with nosocomial infections
- Patients with known or suspected bacteremia
- Patients requiring hospitalization
- Debilitated patients
- Patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- pimozide
azithromycin increases toxicity of pimozide by decreasing metabolism. Contraindicated. Risk of prolonged QTc interval.
Serious - Use Alternative (43)
- antithrombin alfa
azithromycin increases effects of antithrombin alfa by decreasing metabolism. Avoid or Use Alternate Drug.
- antithrombin III
azithromycin increases effects of antithrombin III by decreasing metabolism. Avoid or Use Alternate Drug.
- argatroban
azithromycin increases effects of argatroban by decreasing metabolism. Avoid or Use Alternate Drug.
- arsenic trioxide
arsenic trioxide and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.
- BCG vaccine live
azithromycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- bemiparin
azithromycin increases effects of bemiparin by decreasing metabolism. Avoid or Use Alternate Drug.
- bivalirudin
azithromycin increases effects of bivalirudin by decreasing metabolism. Avoid or Use Alternate Drug.
- cholera vaccine
azithromycin, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
- cisapride
azithromycin increases toxicity of cisapride by QTc interval. Avoid or Use Alternate Drug.
- cobicistat
cobicistat, azithromycin. Either increases levels of the other by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternative antibiotics with concomitant use of cobicistat coadministered with atazanavir or darunavir. .
- colchicine
azithromycin will increase the level or effect of colchicine by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid use of colchicine with P-gp inhibitors. If coadministration is necessary, decrease colchicine dose or frequency as recommended in prescribing information. Use of any colchicine product in conjunction with P-gp inhibitors is contraindicated in patients with renal or hepatic impairment.
- dalteparin
azithromycin increases effects of dalteparin by decreasing metabolism. Avoid or Use Alternate Drug.
- digoxin
azithromycin will increase the level or effect of digoxin by altering intestinal flora. Applies only to oral form of both agents. Avoid or Use Alternate Drug.
- dofetilide
dofetilide increases toxicity of azithromycin by QTc interval. Avoid or Use Alternate Drug.
- dronedarone
azithromycin and dronedarone both increase QTc interval. Contraindicated. Concomitant use of azithromycin and dronedarone may increase the risk of QT prolongation, cardiac arrhythmias.
- enoxaparin
azithromycin increases effects of enoxaparin by decreasing metabolism. Avoid or Use Alternate Drug.
- escitalopram
escitalopram increases toxicity of azithromycin by QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and azithromycin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- fondaparinux
azithromycin increases effects of fondaparinux by decreasing metabolism. Avoid or Use Alternate Drug.
- glasdegib
azithromycin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- heparin
azithromycin increases effects of heparin by decreasing metabolism. Avoid or Use Alternate Drug.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.
- inotuzumab
inotuzumab and azithromycin both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- lefamulin
lefamulin and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and azithromycin both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- ondansetron
azithromycin and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.
- panobinostat
azithromycin and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- phenindione
azithromycin increases effects of phenindione by decreasing metabolism. Avoid or Use Alternate Drug.
- pomalidomide
azithromycin increases levels of pomalidomide by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- protamine
azithromycin increases effects of protamine by decreasing metabolism. Avoid or Use Alternate Drug.
- ribociclib
ribociclib increases toxicity of azithromycin by QTc interval. Avoid or Use Alternate Drug.
- rimegepant
azithromycin will increase the level or effect of rimegepant by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
- riociguat
azithromycin will increase the level or effect of riociguat by decreasing metabolism. Avoid or Use Alternate Drug. Coadministration of riociguat (substrate of CYP isoenzymes 1A1, 2C8, 3A, 2J2) with strong CYP inhibitors may require a decreased initial dose of 0.5 mg PO TID; monitor for signs of hypotension and reduce dose if needed
- saquinavir
saquinavir, azithromycin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of QT prolongation and cardiac arrhythmias.
- topotecan
azithromycin will increase the level or effect of topotecan by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Product labeling for PO topotecan recommends avoiding concomitant use of P-gp inhibitors; the interaction with IV topotecan may be less severe but is still likely of clinical significance
- toremifene
azithromycin increases levels of toremifene by decreasing metabolism. Avoid or Use Alternate Drug. Concurrent use of toremifene with agents causing QT prolongation should be avoided. If concomitant use is required it's recommended that toremifene be interrupted. If interruption not possible, patients requiring therapy with a drug that prolongs QT should be closely monitored. ECGs should be obtained for high risk patients.
- typhoid vaccine live
azithromycin decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- umeclidinium bromide/vilanterol inhaled
azithromycin increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vandetanib
azithromycin, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.
- vemurafenib
vemurafenib and azithromycin both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.
- venetoclax
azithromycin will increase the level or effect of venetoclax by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If a P-gp inhibitor must be used, reduce the venetoclax dose by at least 50%. Monitor more closely for signs of venetoclax toxicities.
- vilanterol/fluticasone furoate inhaled
azithromycin increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- warfarin
azithromycin increases effects of warfarin by decreasing metabolism. Avoid or Use Alternate Drug.
Monitor Closely (146)
- afatinib
azithromycin increases levels of afatinib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Reduce afatinib daily dose by 10 mg if not tolerated when coadministered with P-gp inhibitors.
- alfuzosin
azithromycin and alfuzosin both increase QTc interval. Use Caution/Monitor.
- aluminum hydroxide
aluminum hydroxide decreases levels of azithromycin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- amiodarone
azithromycin will increase the level or effect of amiodarone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- amitriptyline
amitriptyline and azithromycin both increase QTc interval. Use Caution/Monitor.
- amoxapine
amoxapine and azithromycin both increase QTc interval. Use Caution/Monitor.
- apomorphine
azithromycin increases toxicity of apomorphine by QTc interval. Use Caution/Monitor.
- arformoterol
azithromycin increases toxicity of arformoterol by QTc interval. Use Caution/Monitor.
- artemether/lumefantrine
azithromycin and artemether/lumefantrine both increase QTc interval. Use Caution/Monitor.
- asenapine
azithromycin increases toxicity of asenapine by QTc interval. Use Caution/Monitor.
- atorvastatin
azithromycin will increase the level or effect of atorvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. If this combination is used, closely monitor for evidence of atorvastatin toxicity (eg, muscle aches or pains, renal dysfunction).
- balsalazide
azithromycin will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- bazedoxifene/conjugated estrogens
azithromycin will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- bedaquiline
azithromycin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- berotralstat
azithromycin increases levels of berotralstat by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Reduced berotralstat dose to 110 mg/day when coadministered with P-gp inhibitors.
- betrixaban
azithromycin increases levels of betrixaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Decrease betrixaban dose to 80 mg PO once, then 40 mg PO qDay if coadministered with a P-gp inhibitor.
- biotin
azithromycin will decrease the level or effect of biotin by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- calcium carbonate
calcium carbonate decreases levels of azithromycin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- cefdinir
azithromycin decreases effects of cefdinir by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- cefditoren
azithromycin decreases effects of cefditoren by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- cefoxitin
azithromycin decreases effects of cefoxitin by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- cefpodoxime
azithromycin decreases effects of cefpodoxime by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- cefuroxime
azithromycin decreases effects of cefuroxime by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- ceritinib
azithromycin increases levels of ceritinib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- cetirizine
azithromycin will increase the level or effect of cetirizine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- chloroquine
azithromycin increases toxicity of chloroquine by QTc interval. Modify Therapy/Monitor Closely.
chloroquine increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. - chlorpromazine
chlorpromazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- ciprofloxacin
azithromycin increases toxicity of ciprofloxacin by QTc interval. Use Caution/Monitor.
- citalopram
azithromycin and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
- clarithromycin
azithromycin and clarithromycin both increase QTc interval. Use Caution/Monitor.
- clofazimine
azithromycin increases toxicity of clofazimine by QTc interval. Modify Therapy/Monitor Closely.
- clomipramine
clomipramine and azithromycin both increase QTc interval. Use Caution/Monitor.
- conjugated estrogens
azithromycin will decrease the level or effect of conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- crizotinib
crizotinib and azithromycin both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
azithromycin increases toxicity of crizotinib by QTc interval. Use Caution/Monitor. - cyclosporine
azithromycin will increase the level or effect of cyclosporine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- dabigatran
azithromycin will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min
- desipramine
desipramine and azithromycin both increase QTc interval. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide and azithromycin both decrease serum potassium. Use Caution/Monitor.
- dienogest/estradiol valerate
azithromycin will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.
- disopyramide
azithromycin and disopyramide both increase QTc interval. Modify Therapy/Monitor Closely.
- dofetilide
azithromycin and dofetilide both increase QTc interval. Use Caution/Monitor.
- doxepin
doxepin and azithromycin both increase QTc interval. Use Caution/Monitor.
- droperidol
azithromycin and droperidol both increase QTc interval. Use Caution/Monitor.
- duvelisib
azithromycin will increase the level or effect of duvelisib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- edoxaban
azithromycin will increase the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Dose adjustment may be required with strong P-gp inhibitors. DVT/PE treatment: Decrease dose to 30 mg PO once daily. NVAF: No dose reduction recommended
- encorafenib
azithromycin increases toxicity of encorafenib by QTc interval. Use Caution/Monitor.
- entrectinib
azithromycin increases toxicity of entrectinib by QTc interval. Use Caution/Monitor.
- epinephrine
epinephrine and azithromycin both increase QTc interval. Use Caution/Monitor.
- epinephrine racemic
epinephrine racemic and azithromycin both increase QTc interval. Use Caution/Monitor.
- erythromycin base
azithromycin and erythromycin base both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of erythromycin base by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - erythromycin ethylsuccinate
azithromycin and erythromycin ethylsuccinate both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of erythromycin ethylsuccinate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - erythromycin lactobionate
azithromycin and erythromycin lactobionate both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of erythromycin lactobionate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - erythromycin stearate
azithromycin and erythromycin stearate both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of erythromycin stearate by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - escitalopram
azithromycin increases toxicity of escitalopram by QTc interval. Use Caution/Monitor.
- estradiol
azithromycin will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- estrogens conjugated synthetic
azithromycin will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- estropipate
azithromycin will decrease the level or effect of estropipate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- ezogabine
ezogabine, azithromycin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.
- fluconazole
azithromycin and fluconazole both increase QTc interval. Use Caution/Monitor.
- fluphenazine
fluphenazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- formoterol
azithromycin and formoterol both increase QTc interval. Use Caution/Monitor.
- fostemsavir
azithromycin and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemifloxacin
azithromycin increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor.
- gemtuzumab
azithromycin and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- glecaprevir/pibrentasvir
azithromycin will increase the level or effect of glecaprevir/pibrentasvir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- goserelin
goserelin increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- haloperidol
azithromycin and haloperidol both increase QTc interval. Use Caution/Monitor.
- histrelin
histrelin increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- hydroxyzine
hydroxyzine increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ibutilide
azithromycin and ibutilide both increase QTc interval. Modify Therapy/Monitor Closely.
- imipramine
imipramine and azithromycin both increase QTc interval. Use Caution/Monitor.
- indacaterol, inhaled
indacaterol, inhaled, azithromycin. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.
- indapamide
azithromycin and indapamide both increase QTc interval. Modify Therapy/Monitor Closely.
- indinavir
azithromycin will increase the level or effect of indinavir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- isradipine
azithromycin increases toxicity of isradipine by QTc interval. Use Caution/Monitor.
- itraconazole
azithromycin and itraconazole both increase QTc interval. Use Caution/Monitor.
- ketoconazole
azithromycin and ketoconazole both increase QTc interval. Use Caution/Monitor.
- lenvatinib
azithromycin and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- leuprolide
leuprolide increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- lofepramine
lofepramine and azithromycin both increase QTc interval. Use Caution/Monitor.
- lofexidine
azithromycin increases toxicity of lofexidine by QTc interval. Use Caution/Monitor.
- lopinavir
azithromycin increases toxicity of lopinavir by QTc interval. Use Caution/Monitor.
- loratadine
azithromycin will increase the level or effect of loratadine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- lovastatin
azithromycin will increase the level or effect of lovastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lumefantrine
azithromycin and lumefantrine both increase QTc interval. Use Caution/Monitor.
- maprotiline
maprotiline and azithromycin both increase QTc interval. Use Caution/Monitor.
- mestranol
azithromycin will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Modify Therapy/Monitor Closely.
- mifepristone
mifepristone, azithromycin. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.
- moxifloxacin
azithromycin and moxifloxacin both increase QTc interval. Use Caution/Monitor.
- naldemedine
azithromycin increases levels of naldemedine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor naldemedine for potential adverse effects if coadministered with P-gp inhibitors.
- nilotinib
azithromycin and nilotinib both increase QTc interval. Use Caution/Monitor.
- nintedanib
azithromycin increases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. If nintedanib adverse effects occur, management may require interruption, dose reduction, or discontinuation of therapy .
- nortriptyline
nortriptyline and azithromycin both increase QTc interval. Use Caution/Monitor.
- octreotide
azithromycin and octreotide both increase QTc interval. Use Caution/Monitor.
- octreotide (Antidote)
azithromycin and octreotide (Antidote) both increase QTc interval. Use Caution/Monitor.
- olanzapine
azithromycin increases toxicity of olanzapine by QTc interval. Use Caution/Monitor.
- olodaterol inhaled
azithromycin and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias
- osilodrostat
osilodrostat and azithromycin both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and azithromycin both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- oxaliplatin
oxaliplatin will increase the level or effect of azithromycin by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- ozanimod
ozanimod and azithromycin both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- pantothenic acid
azithromycin will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- pasireotide
azithromycin and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.
- pentamidine
azithromycin and pentamidine both increase QTc interval. Modify Therapy/Monitor Closely.
- perphenazine
perphenazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- pimozide
azithromycin and pimozide both increase QTc interval. Modify Therapy/Monitor Closely.
- piperacillin
azithromycin decreases effects of piperacillin by pharmacodynamic antagonism. Use Caution/Monitor. bacteriostatic agents may inhibit the effects of bactericidal agents.
- procainamide
azithromycin and procainamide both increase QTc interval. Modify Therapy/Monitor Closely.
- prochlorperazine
prochlorperazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- promazine
promazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- promethazine
promethazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- propafenone
azithromycin increases toxicity of propafenone by QTc interval. Use Caution/Monitor.
- protriptyline
protriptyline and azithromycin both increase QTc interval. Use Caution/Monitor.
- pyridoxine
azithromycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- pyridoxine (Antidote)
azithromycin will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- quetiapine
quetiapine, azithromycin. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.
- quinidine
quinidine and azithromycin both increase QTc interval. Modify Therapy/Monitor Closely.
- quinine
azithromycin and quinine both increase QTc interval. Use Caution/Monitor.
- ranolazine
azithromycin will increase the level or effect of ranolazine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- ribociclib
azithromycin increases toxicity of ribociclib by QTc interval. Use Caution/Monitor.
- rifabutin
azithromycin increases toxicity of rifabutin by decreasing metabolism. Use Caution/Monitor.
- rifampin
azithromycin will increase the level or effect of rifampin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- rifaximin
azithromycin increases levels of rifaximin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- rilpivirine
rilpivirine increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsades de Pointes.
- ritonavir
azithromycin will increase the level or effect of ritonavir by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- rivaroxaban
azithromycin increases levels of rivaroxaban by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Patients with renal impairment receiving rivaroxaban with drugs that are combined P-gp and weak or moderate CYP3A4 inhibitors may have significant increases in exposure compared with patients with normal renal function and no inhibitor use, since both pathways of rivaroxaban elimination are affected. Since these increases may increase bleeding risk, use rivaroxaban in this situation only if the potential benefit justifies the potential risk.
- romidepsin
azithromycin and romidepsin both increase QTc interval. Use Caution/Monitor.
azithromycin will increase the level or effect of romidepsin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. - selpercatinib
selpercatinib increases toxicity of azithromycin by QTc interval. Use Caution/Monitor.
- simvastatin
azithromycin will increase the level or effect of simvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- sodium bicarbonate
sodium bicarbonate decreases levels of azithromycin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- sodium citrate/citric acid
sodium citrate/citric acid decreases levels of azithromycin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
azithromycin decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.
- sorafenib
sorafenib and azithromycin both increase QTc interval. Use Caution/Monitor.
- sotalol
azithromycin and sotalol both increase QTc interval. Modify Therapy/Monitor Closely.
- tacrolimus
azithromycin will increase the level or effect of tacrolimus by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- talazoparib
azithromycin will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.
- thiamine
azithromycin will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- thioridazine
thioridazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- tobramycin inhaled
tobramycin inhaled and azithromycin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- tolvaptan
azithromycin will increase the level or effect of tolvaptan by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- trazodone
trazodone and azithromycin both increase QTc interval. Use Caution/Monitor.
- trifluoperazine
trifluoperazine and azithromycin both increase QTc interval. Use Caution/Monitor.
- trimipramine
trimipramine and azithromycin both increase QTc interval. Use Caution/Monitor.
- triptorelin
triptorelin increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- verapamil
azithromycin will increase the level or effect of verapamil by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- ziprasidone
azithromycin and ziprasidone both increase QTc interval. Use Caution/Monitor.
Minor (50)
- amoxicillin
azithromycin decreases effects of amoxicillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- ampicillin
azithromycin decreases effects of ampicillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- clozapine
azithromycin increases toxicity of clozapine by unspecified interaction mechanism. Minor/Significance Unknown. Enhanced CNS toxicity.
- dasatinib
azithromycin and dasatinib both increase QTc interval. Minor/Significance Unknown.
- degarelix
azithromycin increases toxicity of degarelix by QTc interval. Minor/Significance Unknown.
- deutetrabenazine
azithromycin increases toxicity of deutetrabenazine by QTc interval. Minor/Significance Unknown.
- dicloxacillin
azithromycin decreases effects of dicloxacillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- dolasetron
azithromycin and dolasetron both increase QTc interval. Minor/Significance Unknown.
- ergotamine
azithromycin increases levels of ergotamine by unknown mechanism. Minor/Significance Unknown.
- eribulin
azithromycin increases toxicity of eribulin by QTc interval. Minor/Significance Unknown.
- flecainide
azithromycin and flecainide both increase QTc interval. Minor/Significance Unknown.
- flucloxacillin
azithromycin decreases effects of flucloxacillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- fluoxetine
azithromycin and fluoxetine both increase QTc interval. Minor/Significance Unknown.
- foscarnet
azithromycin and foscarnet both increase QTc interval. Minor/Significance Unknown.
- iloperidone
azithromycin and iloperidone both increase QTc interval. Minor/Significance Unknown.
- lapatinib
azithromycin and lapatinib both increase QTc interval. Minor/Significance Unknown.
- levofloxacin
azithromycin and levofloxacin both increase QTc interval. Minor/Significance Unknown.
- mefloquine
azithromycin increases toxicity of mefloquine by QTc interval. Minor/Significance Unknown.
- methadone
azithromycin and methadone both increase QTc interval. Minor/Significance Unknown.
- nafcillin
azithromycin decreases effects of nafcillin by pharmacodynamic antagonism. Minor/Significance Unknown. bacteriostatic antibiotics may interfere with the bactericidal actions of penicillins.
- ofloxacin
azithromycin and ofloxacin both increase QTc interval. Minor/Significance Unknown.
- oxacillin
azithromycin decreases effects of oxacillin by pharmacodynamic antagonism. Minor/Significance Unknown. bacteriostatic antibiotics may interfere with the bactericidal actions of penicillins.
- paliperidone
azithromycin and paliperidone both increase QTc interval. Minor/Significance Unknown.
- paroxetine
azithromycin and paroxetine both increase QTc interval. Minor/Significance Unknown.
- pazopanib
azithromycin and pazopanib both increase QTc interval. Minor/Significance Unknown.
- penicillin G aqueous
azithromycin decreases effects of penicillin G aqueous by pharmacodynamic antagonism. Minor/Significance Unknown.
- penicillin VK
azithromycin decreases effects of penicillin VK by pharmacodynamic antagonism. Minor/Significance Unknown.
- pimavanserin
azithromycin increases toxicity of pimavanserin by QTc interval. Minor/Significance Unknown.
- pitolisant
azithromycin increases toxicity of pitolisant by QTc interval. Minor/Significance Unknown.
- pivmecillinam
azithromycin decreases effects of pivmecillinam by pharmacodynamic antagonism. Minor/Significance Unknown.
- posaconazole
azithromycin and posaconazole both increase QTc interval. Minor/Significance Unknown.
- ranolazine
azithromycin and ranolazine both increase QTc interval. Minor/Significance Unknown.
- risperidone
azithromycin and risperidone both increase QTc interval. Minor/Significance Unknown.
- ruxolitinib
azithromycin will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- sertraline
azithromycin increases toxicity of sertraline by QTc interval. Minor/Significance Unknown.
- solifenacin
azithromycin increases toxicity of solifenacin by QTc interval. Minor/Significance Unknown.
- sulfamethoxazole
azithromycin and sulfamethoxazole both increase QTc interval. Minor/Significance Unknown.
- sunitinib
azithromycin increases toxicity of sunitinib by QTc interval. Minor/Significance Unknown.
- telavancin
azithromycin and telavancin both increase QTc interval. Minor/Significance Unknown.
- temocillin
azithromycin decreases effects of temocillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- tetrabenazine
azithromycin increases toxicity of tetrabenazine by QTc interval. Minor/Significance Unknown.
- thiothixene
azithromycin increases toxicity of thiothixene by QTc interval. Minor/Significance Unknown.
- ticarcillin
azithromycin decreases effects of ticarcillin by pharmacodynamic antagonism. Minor/Significance Unknown.
- trimethoprim
azithromycin and trimethoprim both increase QTc interval. Minor/Significance Unknown.
- trimipramine
azithromycin increases toxicity of trimipramine by QTc interval. Minor/Significance Unknown.
- tropisetron
azithromycin and tropisetron both increase QTc interval. Minor/Significance Unknown.
- vardenafil
azithromycin increases toxicity of vardenafil by QTc interval. Minor/Significance Unknown.
- venlafaxine
azithromycin and venlafaxine both increase QTc interval. Minor/Significance Unknown.
- voriconazole
azithromycin and voriconazole both increase QTc interval. Minor/Significance Unknown.
- vorinostat
azithromycin increases toxicity of vorinostat by QTc interval. Minor/Significance Unknown.
Adverse Effects
>10%
High single dose therapy
- Diarrhea (52.8%)
- Nausea (32.6%)
- Abdominal pain (27%)
- Loose stool (19.1%)
1-10%
Elevated ALT, AST, creatinine (4-6%)
Elevated LDH, bilirubin (1-3%)
Community-acquired pneumonia
- Pain at injection site (6.5%)
- Diarrhea (4.3%)
- Nausea (3.9%)
- Local inflammation (3.1%)
- Abdominal pain (2.7%)
- Vomiting (1.4%)
Pelvic inflammatory disease
- Diarrhea (8.5%)
- Nausea (6.6%)
- Vaginitis (2.8%)
- Abdominal pain (1.9%)
- Anorexia (1.9%)
- Rash and pruritus (1.9%)
<1%
Dyspepsia
Flatulence
Mucositis
Oral Moniliasis
Gastritis
Headache
Somnolence
Bronchospasm
Taste perversion
Leukopenia
Neutropenia
Decreased platelet count
Elevated serum alkaline phosphatase
Postmarketing Reports
Allergic: Arthralgia, edema, urticaria and angioedema
Cardiovascular: Arrhythmias (eg, ventricular tachycardia), hypotension, QT prolongation, and torsades de pointes
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis
Hematopoietic: Thrombocytopenia
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope
Psychiatric: Aggressive reaction and anxiety
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss
Warnings
Contraindications
Hypersensitivity to azithromycin, erythromycin, any macrolides or ketolides
History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
Cautions
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death; discontinue treatment immediately if signs and symptoms of hepatitis occur
Infantile Hypertrophic Pyloric Stenosis (IHPS) has been reported; advise direct parents and caregivers if vomiting or irritability with feeding occurs
Clostridium difficile associated diarrhea (CDAD) has been reported, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, discontinue ongoing antibacterial use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation as clinically indicated
Exacerbations of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported
Antibacterial agents used to treat nongonococcal urethritis may mask or delay the symptoms of incubating syphilis; all patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea performed at the time of diagnosis; if infection confirmed, initiate appropriate antibacterial therapy and follow-up tests for these diseases
Local IV site reactions have been reported with IV azithromycin
Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
QT prolongation
- Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been reported with macrolides, including azithromycin
- Elderly patients may be more susceptible to drug-associated effects on the QT interval
-
Consider the risk of QT prolongation for at-risk groups including:
- Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
- Patients on drugs known to prolong the QT interval
- Patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
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
- Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported
- If an allergic reaction occurs, discontinue drug and institute appropriate therapy
- Be aware that allergic symptoms may reappear after symptomatic therapy has been discontinued
Drug interaction overview
- Coadministration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations; closely monitor for adverse reactions of azithromycin
- Spontaneous postmarketing reports suggest that coadministration of azithromycin may potentiate the effects of oral anticoagulants (eg, warfarin), although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin; carefully monitor prothrombin time while patients are receiving azithromycin and oral anticoagulants concomitantly
- Drug interactions with digoxin, colchicine or phenytoin have been observed when combined other macrolide; until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised
Bronchiolitis obliterans
- August 3, 2018: FDA issues warning letter to healthcare providers
- Increased relapse and mortality observed with azithromycin in the clinical trial entitled ALLOZITHRO (evaluation of the efficacy of azithromycin to prevent bronchiolitis obliterans syndrome [BOS] after allogenic hematopoietic stem cell transplantation [HSCT])
- The study was terminated early after an increased risk of relapses was observed in patients taking azithromycin compared with placebo
- Azithromycin is not indicated for prophylaxis of bronchiolitis obliterans syndrome (BOS) in patients undergoing HSCT and should not be used off-label for this condition
Pregnancy & Lactation
Pregnancy
Available data on use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- 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 500 mg based on body surface area
Lactation
Present in human milk
Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin
No data available on the effects of azithromycin on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition
Clinical considerations
Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Binds to 50S ribosomal subunit of susceptible microorganisms and blocks dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest; does not affect nucleic acid synthesis
Concentrates in phagocytes and fibroblasts, as demonstrated by in vitro incubation techniques; in vivo studies suggest that concentration in phagocytes may contribute to drug distribution to inflamed tissues
Absorption
Absolute bioavailability: 38% (250-mg capsules)
Peak plasma concentration
- Oral (3-day regimen): 0.44 mcg/mL (Day 1); 0.54 mcg/mL (Day 3)
- Oral (5-day regimen): 0.43 mcg/mL (Day 1); 0.24 mcg/mL (Day 5)
- IV: 1.14 mcg/mL (healthy volunteers); 3.63 mcg/mL (hospitalized patients)
AUC
- Oral (3-day regimen): 17.4 mcg⋅hr/mL
- Oral (5-day regimen): 154.9 mcg⋅hr/mL
- IV: 8.03 mcg⋅hr/mL (healthy volunteers); 9.6 mcg⋅hr/mL (hospitalized patients)
Effects of food
- Oral suspension: When administered with food, peak plasma concentration increased by 56% and AUC unchanged
- Tablets: No effect
Distribution
Protein bound: 51% (0.02 mcg/mL); 7% (2 mcg/mL)
Elimination
Clearance: 630 mL/min (single 500-mg oral and IV dose)
Half-life
- Oral (3-day regimen): 71.8 hr
- Oral (5-day regimen): 68.9 hr
Excretion
- IV, 1st dose: 11%
- IV, 5th dose: 14%
- Oral: 6% (unchanged)
- Biliary excretion is a major route of elimination for unchanged drug, following oral administration
Administration
IV Incompatibilities
Y-site: Amikacin, aztreonam, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, ciprofloxacin, clindamycin, droperidol, famotidine, fentanyl, furosemide, gentamicin, imipenem, cilastatin, ketorolac, levofloxacin, morphine, piperacillin-tazobactam, ondansetron(?), potassium chloride, ticarcillin-clavulanate, tobramycin
Other IV substances, additives, or medications should not be added to azithromycin, or infused simultaneously through the same IV line
IV Compatibilities
0.9% NaCl
0.45% NaCl)
Dextrose 5% in Water (D5W)
Lactated Ringer Solution (LR)
D5W in 0.45% NaCl with 20 mEq KCl
D5W in LR
D5W in 0.3% NaCl
D5W in 0.45% NaCl
Normosol-M in D5W
Normosol-R in D5W
IV Preparation
Add 4.8 mL of sterile water for injection to 500-mg vial; final concentration is (100 mg/mL); shake vial until all of the drug is dissolved
Visually inspect vial for particulate matter before administration; discard if particular matter is present
Dilute reconstituted drug in either a 250-mL (final concentration 2 mg/mL) or 500-mL IV bag (final concentration 1 mg/mL)
IV Administration
1 mg/mL diluted solution: Infuse over 3 hr
2mg/mL diluted solution: Infuse over 1 hr
Oral Suspension Preparation
Final concentration after reconstitution is 100 mg/5 mL
- Add 9 mL of water to 300-mg bottle
Final concentration after reconstitution is 200 mg/5 mL
- Add 9 mL of water to 600-mg bottle
- Add 12 mL of water to 900-mg bottle
- Add 15 mL of water to 1200-mg bottle
Oral Administration
Tablets and oral suspension: Take with or without food
Oral suspension: Shake well before use; refer to prescribing information for dosing information
Storage
Unopened vial: Store at <30ºC (86ºF)
Reconstituted vial: Store at <30ºC (86ºF) for 24 hr
Diluted solutions: Store <30ºC (86ºF) for 24 hr OR refrigerate at 5ºC (41ºF)
Reconstituted oral suspension: Store at 5-30ºC (41-86ºF) and use within 10 days; discard after full dosing is completed
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Zithromax oral - | 250 mg tablet |  | |
| Zithromax oral - | 250 mg tablet |  | |
| Zithromax oral - | 600 mg tablet |  | |
| Zithromax oral - | 200 mg/5 mL suspension |  | |
| Zithromax oral - | 200 mg/5 mL suspension |  | |
| Zithromax oral - | 200 mg/5 mL suspension |  | |
| Zithromax oral - | 100 mg/5 mL suspension |  | |
| Zithromax oral - | 500 mg tablet |  | |
| Zithromax oral - | 1 gram miscellaneous |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| azithromycin intravenous - | 500 mg vial |  | |
| Zithromax intravenous - | 500 mg vial |  | |
| Zithromax Z-Pak oral - | 250 mg tablet | | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 100 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 100 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 250 mg tablet | | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 100 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 100 mg/5 mL suspension |  | |
| azithromycin oral - | 600 mg tablet |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 1 gram miscellaneous |  | |
| azithromycin oral - | 1 gram miscellaneous |  | |
| azithromycin oral - | 500 mg tablet |  | |
| azithromycin oral - | 250 mg tablet |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 200 mg/5 mL suspension |  | |
| azithromycin oral - | 100 mg/5 mL suspension |  | |
| azithromycin oral - | 600 mg tablet |  | |
| Zithromax TRI-PAK oral - | 500 mg tablet | | |
| Azasite ophthalmic (eye) - | 1 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
azithromycin oral
AZITHROMYCIN POWDER PACKET - ORAL
(ay-ZITH-roe-MYE-sin)
COMMON BRAND NAME(S): Zithromax
USES: Azithromycin is an antibiotic (macrolide-type). This single-dose form of the medication is used to treat certain infections, including genital infections. It works by stopping the growth of bacteria.This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.This form of azithromycin is not intended for use by children.
HOW TO USE: Take this medication by mouth, with or without food. Taking it with food may help reduce stomach upset. Mix the contents of one packet in 2 ounces (60 milliliters) of water. Drink this right away. Add another 2 ounces of water, mix, and drink the entire amount.Antacids containing aluminum or magnesium may decrease the absorption of azithromycin if taken at the same time. If you take an antacid that contains aluminum or magnesium, wait at least 2 hours before or after taking azithromycin.Tell your doctor if your condition persists or worsens.
SIDE EFFECTS: Stomach upset, diarrhea/loose stools, nausea, vomiting, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. 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: hearing changes (such as decreased hearing, deafness), eye problems (such as drooping eyelids, blurred vision), difficulty speaking/swallowing, muscle weakness, signs of liver problems (such as unusual tiredness, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worseUse 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: fever that doesn't go away, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.An allergic reaction to this medication may return even if you stop the drug. If you have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking azithromycin, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics (such as erythromycin, clarithromycin, telithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, a certain muscle disease (myasthenia gravis).Azithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using azithromycin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using azithromycin safely.Azithromycin may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Many drugs besides azithromycin may affect the heart rhythm (QT prolongation), including amiodarone, chloroquine, disopyramide, dofetilide, dronedarone, hydroxychloroquine, ibutilide, pimozide, procainamide, quinidine, sotalol, among others.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2020. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
