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Azithromycin

Pronunciation

Class: Other Macrolides
VA Class: AM200
Chemical Name: [2R - (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)] - 13 - [2,6,Dideoxy - 3 - C - methyl - 3 - O - methyl - α - L - ribo - hexopyranosyl)oxy) - 2 - ethyl - 3,4,10 - trihydroxy - 3,5,6,8,10,12,14 - heptamethyl - 11 - [[3,4,6,trideoxy - 3 - (dimethylamino) - β - D - xylo - hexopyranosyloxy] - 1 - oxa - 6 - azacyclopentadecan - 15 - one
CAS Number: 83905-01-5
Brands: Zithromax, Zithromax Tri-Paks, Zithromax Z-Pak, Zmax

Introduction

Antibacterial; an azalide, a subclass of macrolide antibiotics.1 3 10 163 196 210 211 302

Uses for Azithromycin

Acute Otitis Media (AOM)

Treatment of AOM caused by H. influenzae, M. catarrhalis, or S. pneumoniae.1 94 106 139 174 175 176 177 179 203 211 294

Not a drug of first choice; considered an alternative for patients with type I penicillin hypersensitivity.203 294 S. pneumoniae resistant to amoxicillin may also be resistant to azithromycin and the drug may not be effective for AOM that fails to respond to amoxicillin.282

Pharyngitis and Tonsillitis

Treatment of pharyngitis or tonsillitis caused by susceptible Streptococcus pyogenes (group A β-hemolytic streptococci) when first-line therapy cannot be used.1 15 29 203 211 Often effective in eradicating susceptible S. pyogenes from the nasopharynx, but efficacy in the prevention of subsequent rheumatic fever has not been established to date.1

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;1 6 15 136 137 203 oral cephalosporins and oral macrolides are considered alternatives.6 15 136 137 203 Amoxicillin sometimes used instead of penicillin V, especially for young children.136 203

Consider that strains of S. pyogenes resistant to macrolides are common is some areas of the world (e.g., Japan, Finland) and azithromycin-resistant strains have been reported in the US.1 202 203 309 (See Selection and Use of Anti-infectives under Cautions),

GI Infections

Treatment of symptomatic enteric infections caused by Campylobacter jejuni.308 Recommended by CDC, NIH,308 IDSA,308 AAP, and others as a drug of choice for empiric treatment.15 142 203 308

Treatment of cryptosporidiosis in HIV-infected adults, adolescents, or children.256 307 308 Anti-infectives may suppress the infection, but none found to reliably eradicate Cryptosporidium.203 290 307 308 CDC, NIH, IDSA, and others state the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.290 307 308

Treatment of shigellosis caused by susceptible strains of Shigella dysenteriae, S. boydii, S. flexneri, or S. sonnei.15 142 203 307 316 317 318 Usual drugs of choice are fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin); alternatives are azithromycin, ampicillin, ceftriaxone, or co-trimoxazole.15 142 203 307 Because of increasing resistance, select anti-infective based on susceptibility patterns of locally circulating Shigella.203 317

Treatment of travelers’ diarrhea.319 320 359 360 372 Generally self-limited and may resolve within 3–4 days without anti-infective treatment;319 320 336 if diarrhea is moderate or severe, persists >3 days, or is associated with fever or bloody stools, short-term anti-infective therapy (1–3 days) may be indicated.203 319 336 372 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually recommended.319 320 336 372 Azithromycin is an alternative for those who should not receive fluoroquinolones (children, pregnant women) and may be drug of choice for travelers in areas with high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, Nepal) or those who have not responded after 48 hours of fluoroquinolone therapy.203 319 320 359 360 372

Treatment of severe diarrhea caused by enterotoxigenic Escherichia coli (ETEC).203 356 ETEC diarrhea generally is of moderate severity and self-limited, but may be severe.187 203 356 Anti-infectives not usually indicated, but AAP, CDC, and others suggest an anti-infective (e.g., azithromycin, co-trimoxazole, a fluoroquinolone, rifamycin) can be considered in addition to supportive care if diarrhea is severe or intractable and causative organism is susceptible.187 203 356

Treatment of dysentery caused by enteroinvasive E. coli (EIEC).203 AAP suggests that an oral anti-infective (e.g., azithromycin, ciprofloxacin, co-trimoxazole) can be used; whenever possible, select anti-infective based on in vitro susceptibility testing.203

Treatment of diarrhea associated with enteroaggregative E. coli (EAEC).331 A drug of choice, especially in children with severe or persistent illness.331

Role of anti-infectives in treatment of hemorrhagic colitis caused by shiga toxin-producing E. coli (STEC; formerly known as enterohemorrhagic E. coli [EHEC] or verotoxin-producing E. coli) unclear; most experts do not recommend use of anti-infectives in the treatment of enteritis caused by E. coli 0157:H7 since there is no evidence of benefit from such therapy.142 187 203

Respiratory Tract Infections

Treatment of acute bacterial sinusitis caused by susceptible Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.1 3 103 179 210 211 302

Treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) caused by H. influenzae, M. catarrhalis, or S. pneumoniae.1 3 15 96 97 98 179 210 211

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae (formerly Chlamydia pneumoniae) when oral therapy is indicated.1 3 15 29 91 99 100 101 159 179 203 210 211 302 329

Treatment of CAP caused by susceptible C. pneumoniae, H. influenzae, M. catarrhalis, Legionella pneumophila, M. pneumoniae, Staphylococcus aureus, or S. pneumoniae when initial IV therapy is indicated.196

Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).329 Do not use a macrolide alone for empiric treatment of CAP in hospitalized patients.329

For empiric outpatient treatment of CAP in previously healthy adults without risk factors for drug-resistant S. pneumoniae (DRSP), IDSA and ATS recommend monotherapy with a macrolide (azithromycin, clarithromycin, erythromycin) or, alternatively, doxycycline.329 If risk factors for DRSP are present (e.g., chronic heart, lung, liver, or renal disease, diabetes mellitus, alcoholism, malignancy, asplenia, immunosuppression, history of anti-infective treatment within the last 3 months), IDSA and ATS recommend monotherapy with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.329

Slideshow: The Shocking Truth About Antibiotic Resistance

For empiric inpatient treatment of CAP when treatment in an intensive care unit (ICU) is not necessary, IDSA and ATS recommend adults receive monotherapy with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, or moxifloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.329 For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) S. aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (gemifloxacin, levofloxacin, moxifloxacin).329

For empiric treatment of CAP in adults with risk factors for Ps. aeruginosa, IDSA and ATS recommend a combination regimen that includes an antipneumococcal, antipseudomonal β-lactam (cefepime, imipenem, meropenem, fixed combination of piperacillin and tazobactam) and ciprofloxacin or levofloxacin; one of these β-lactams, an aminoglycoside, and azithromycin; or one of these β-lactams, an aminoglycoside, and an antipneumococcal fluoroquinolone.329

Treatment of infections caused by L. pneumophila (Legionnaires’ disease).15 130 168 196 203 232 250 311 312 314 329 330 Drugs of choice are macrolides (usually azithromycin) or fluoroquinolones with or without rifampin.15 203 232 311 312 329 330

Treatment and postexposure prophylaxis of pertussis caused by Bordetella pertussis.15 28 138 203 324 325 326 329 333 334 (See Pertussis under Uses.)

Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections caused by susceptible S. aureus, S. pyogenes, or S. agalactiae (group B streptococci).1 3 210 211

Babesiosis

Treatment of babesiosis caused by Babesia microti.125 203 288 337

Regimens of choice for babesiosis are atovaquone in conjunction with azithromycin or quinine in conjunction with clindamycin.125 288 337 The clindamycin and quinine regimen may be preferred for severe babesiosis;288 in those with mild or moderate illness, the atovaquone and azithromycin regimen may be as effective and better tolerated than the quinine and clindamycin regimen.125 337 Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), substantial hemolysis, or compromised renal, hepatic, or pulmonary function.125 203 288

Bartonella Infections

Treatment of infections caused by B. henselae (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).15 203 261 310 Cat scratch disease generally self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infectives be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and such therapy probably is indicated in immunocompromised patients.203 261 310 Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.203 Optimum regimens have not been identified; some clinicians recommend azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.15 203 261 310

Treatment of bacteremia caused by Bartonella quintana;15 257 261 used in conjunction with ceftriaxone.257 261 307 Optimum anti-infective regimens have not been identified.257 259 260 307 310

Chancroid

Treatment of chancroid (genital ulcers caused by Haemophilus ducreyi).1 8 10 15 157 159 181 203 242

CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin for treatment of chancroid.8 15 159 181 203 242

Safety and efficacy of azithromycin established in men (not women),1 but has been effective for and is recommended by CDC for treatment of chancroid in women.8 157 159 181 203 262

HIV-infected patients and uncircumcised males may not respond to treatment as well as those who are HIV-negative or circumcised.242 CDC recommends that single-dose azithromycin or ceftriaxone regimens be used in HIV patients only if follow-up can be ensured.242

Chlamydial Infections

Treatment of uncomplicated urethritis or cervicitis caused by C. trachomatis.1 7 8 10 15 92 109 110 111 112 114 179 184 185 203 211 242 CDC and others recommend azithromycin or doxycycline as drug of choice for nongonococcal urethritis (NGU) or cervicitis.8 242 For recurrent or persistent urethritis in patients with NGU who have already been treated with a recommended regimen, CDC recommends metronidazole or tinidazole used in conjunction with azithromycin.242

A drug of choice for presumptive treatment of coexisting chlamydial infection in patients being treated for gonorrhea.8 242

A drug of choice for treatment of urogenital chlamydial infections in pregnant women.8 203 242

Treatment of ocular trachoma caused by C. trachomatis.15 29 112 114 189 203 217 301 354 370 373 374 375 376 A drug of choice;15 353 354 370 376 recommended for use in mass treatment programs.354 370 375 376

Treatment of chlamydial pneumonia in infants203 or chlamydial conjunctivitis in neonates (ophthalmia neonatorum caused by C. trachomatis).8 203 242

Alternative to tetracyclines for treatment of psittacosis caused by Chlamydophila psittaci (formerly Chlamydia psittaci),15 203 329 especially in children <8 years of age who should not receive tetracyclines.203

Treatment of lymphogranuloma venereum caused by C. trachomatis.203 242 CDC recommends doxycycline as drug of choice and erythromycin as an alternative; some experts suggest that azithromycin may be effective, but clinical data are lacking.203 242

Has been used to treat adults with CAD who have elevated anti-C. pneumoniae antibody titers (a possible risk factor for MI or CAD) in an attempt to reduce recurrent ischemic events;231 297 298 efficacy not proven to date.297 298

Cholera

Treatment of cholera caused by Vibrio cholerae 01 or 0139.350 351 352

A tetracycline or, alternatively, a fluoroquinolone or co-trimoxazole generally used for treatment of cholera in conjunction with fluid and electrolyte replacement therapy.15 142 203 Although further study is needed, azithromycin may be an alternative, especially for treatment of cholera in children or infections caused by V. cholerae resistant to tetracyclines and fluoroquinolones.350 351 352

Gonorrhea

Treatment of uncomplicated urethritis or cervicitis caused by susceptible Neisseria gonorrhoeae.1 179 182 183 190 191 242 303 305

Not recommended for routine treatment of gonorrhea.179 182 183 242 250 CDC and others state azithromycin can be used as an alternative for treatment of uncomplicated gonorrhea when preferred drugs cannot be used (e.g., in patients hypersensitive to cephalosporins when spectinomycin is unavailable and desensitization to cephalosporins is not an option).303 306 371 Although azithromycin is effective, CDC recommends the drug be used only when necessary because of concerns related to emerging resistance to macrolides.371

Granuloma Inguinale (Donovanosis)

Alternative for treatment of granuloma inguinale (donovanosis) caused by Klebsiella granulomatis (formerly Calymmatobacterium granulomatis).221 242 CDC recommends doxycycline as the drug of choice and azithromycin, ciprofloxacin, erythromycin, or co-trimoxazole as alternatives.242

Leptospirosis

Alternative for treatment of leptospirosis caused by Leptospira.363 365 Penicillin G is drug of choice for severe infections; tetracyclines (usually doxycycline) or ceftriaxone are recommended as alternatives for less severe infections.15 203 Azithromycin also has been effective.363 365

Lyme Disease

Alternative for treatment of early disseminated Lyme disease associated with erythema migrans, in the absence of neurologic involvement or third-degree AV heart block, when first-line agents cannot be used.15 124 179 211 226 227 288 IDSA, AAP, and others recommend oral doxycycline, oral amoxicillin, or oral cefuroxime as first-line therapy for treatment of early localized or early disseminated Lyme disease when oral therapy is appropriate;15 203 289 226 288 macrolides generally have been less effective than first-line agents.203 226 288 289

Malaria

Although further study is needed, has been used in conjunction with an antimalarial (e.g., chloroquine, quinine, artesunate [not commercially available in the US]) for treatment of uncomplicated malaria caused by Plasmodium falciparum, including multidrug-resistant strains.341 342 343 Should not be used alone as monotherapy for treatment of malaria.341 342

Although further study is needed, has been used for treatment or prevention of P. vivax malaria.344 345 When used for treatment, the rate of resolution of parasitemia reported for azithromycin was considerably slower than that reported for chloroquine.345

Mycobacterium avium Complex (MAC) Infections

Primary prevention (primary prophylaxis) of disseminated MAC infection in adults, adolescents, and children with advanced HIV infection.10 12 203 234 Recommended as a drug of choice for primary prevention of MAC in HIV-infected patients;234 usually used alone but has been used in conjunction with rifabutin.10 234

Treatment of disseminated MAC disease, including in HIV-infected adults, adolescents, and children.10 117 203 233 234 307 308 ATS, IDSA, CDC, NIH, and others recommend a regimen of clarithromycin (or azithromycin) and ethambutol with or without rifabutin.233 234 307 308 Clarithromycin usually the preferred macrolide for initial treatment; azithromycin can be substituted if clarithromycin cannot be used because of drug interactions or intolerance and is preferred in pregnant women.233 307 308

Prevention of recurrence (secondary prophylaxis) of disseminated MAC infection in HIV-infected adults, adolescents, and children.10 117 203 233 234 ATS, CDC, NIH, and IDSA recommend a macrolide (clarithromycin or azithromycin) given with ethambutol (with or without rifabutin).233 234 307 308

Treatment of pulmonary MAC infections in conjunction with other antimycobacterials.233 313 315 For initial treatment of nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a 3-times-weekly regimen of clarithromycin (or azithromycin), ethambutol, and rifampin in most patients.233 For initial treatment of fibrocavitary or severe nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a daily regimen of clarithromycin (or azithromycin), ethambutol, and rifampin (or rifabutin) and state that consideration can be given to adding amikacin or streptomycin during the first 2–3 months of treatment for extensive (especially fibrocavitary) disease or when previous therapy has failed.233 Although a 2-drug regimen of clarithromycin (or azithromycin) and ethambutol may be adequate for treatment of nodular/bronchiectatic MAC disease in some patients, such regimens should not be used in fibrocavitary disease because of the risk of emergence of macrolide resistance.233

Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.233

Mycobacterium abscessus, M. kansasii, and M. marinum Infections

Treatment of infections caused by M. abscessus.233 For serious skin, soft tissue, and bone infections, ATS and IDSA recommend a multiple-drug regimen of clarithromycin (or azithromycin) used in conjunction with a parenteral anti-infective (e.g., amikacin, cefoxitin, imipenem);233 surgery usually indicated for extensive disease, abscess formation, and when drug therapy is difficult.233 This multiple-drug regimen also has been used in the treatment of M. abscessus lung disease; anti-infectives may control symptoms and disease progression, but generally cannot produce long-term sputum conversion.233 Curative therapy may be possible in those with focal infections and limited lung disease if surgical resection is used in conjunction with a multiple-drug treatment regimen.233

Treatment of rifampin-resistant M. kansasii infections in conjunction with other antimycobacterials.233 ATS and IDSA recommend a 3-drug regimen based on results of in vitro susceptibility testing, including clarithromycin (or azithromycin), moxifloxacin, ethambutol, sulfamethoxazole, or streptomycin.233

Treatment of M. marinum infections.233 A regimen of clarithromycin and ethambutol has been used; based on experience in other mycobacterial infections, a regimen of azithromycin and ethambutol may be an alternative.233

Neisseria meningitidis Infections

Elimination of nasopharyngeal carriage of N. meningitidis.346 347 349

CDC and AAP consider rifampin, ceftriaxone, or ciprofloxacin the drugs of choice to eliminate nasopharyngeal carriage of N. meningitidis and for postexposure prophylaxis in household or other close contacts of patients with invasive meningococcal disease.203 349 Although further study is needed,349 CDC suggests azithromycin can be used as an alternative in areas where ciprofloxacin-resistant N. meningitidis have been reported (e.g., Minnesota, North Dakota).347

Pelvic Inflammatory Disease

Treatment of acute pelvic inflammatory disease (PID) caused by C. trachomatis, Mycoplasma hominis, or N. gonorrhoeae when initial IV therapy is considered necessary.196 197 If anaerobic bacteria are suspected, an anti-infective active against anaerobes should be used in conjunction with azithromycin.196 Although azithromycin is not included in CDC’s recommended or alternative regimens for treatment of PID,242 371 CDC states a regimen of amoxicillin and clavulanic acid, azithromycin, and metronidazole has demonstrated short-term clinical cure when used in outpatients.371

Pertussis

Treatment of pertussis caused by Bordetella pertussis and postexposure prophylaxis of pertussis in household and other close contacts of an individual with pertussis.15 28 138 203 324 325 326 333 334

Macrolides (azithromycin, clarithromycin, erythromycin) are the drugs of choice.15 138 203 326 333 334 Although erythromycin traditionally has been considered the drug of choice for treatment and postexposure prophylaxis of pertussis,15 138 203 326 333 334 azithromycin and clarithromycin appear to be as effective and may be associated with better compliance because shorter regimens are required and the drugs are better tolerated.203 324 333 334

For treatment and postexposure prophylaxis of pertussis in adults and children ≥1 month of age, CDC and AAP recommend azithromycin, clarithromycin, or erythromycin as drug of choice;203 334 co-trimoxazole is an alternative for those ≥2 months of age when a macrolide cannot be used.203 334 AAP and CDC state azithromycin is the preferred macrolide for treatment of pertussis in infants <1 month of age; however, safety and efficacy not established in this age group and only limited data are available.203 334

If given during the catarrhal stage of pertussis (approximately 1–2 weeks of nasal congestion, runny nose, mild sore throat, nonproductive cough, minimal or no fever), anti-infectives may reduce the duration and severity of symptoms and lessen the period of communicability.203 334 After paroxysmal cough is established, anti-infectives may not affect the course of illness but are recommended to limit spread of the disease to others.203

All household and other close contacts of an individual with suspected pertussis should receive anti-infective postexposure prophylaxis, regardless of age or vaccination status.198 203 Prophylaxis should be initiated within 21 days of exposure; if >21 days have elapsed since onset of cough in the index patient, prophylaxis has limited value but should be considered for those in households with high-risk contacts (e.g., young infants, pregnant women, individuals with contact with infants).203 In addition, all close contacts who are unvaccinated or incompletely vaccinated against pertussis should receive age-appropriate vaccination with a preparation containing pertussis antigens.198 203

Scrub Typhus

Alternative for treatment of scrub typhus caused by Orientia tsutsugamushi (formerly Rickettsia tsutsugamushi).362 363 364 Drug of choice usually is doxycycline;15 362 363 364 alternatives are chloramphenicol or a fluoroquinolone.15 362 364 Azithromycin may be a preferred alternative for treatment of scrub typhus in children or pregnant women or when scrub typhus was acquired in areas where doxycycline-resistant O. tsutsugamushi have been reported (e.g., South Korea, Thailand).362 363 364

Syphilis

Alternative for treatment of primary, secondary, or early latent syphilis in nonpregnant adults and adolescents hypersensitive to penicillin.242 292 293 358

Penicillin G is drug of choice for treatment of all stages of syphilis,8 203 242 but CDC, NIH, and IDSA state azithromycin can be considered for treatment of primary, secondary, or early latent syphilis in nonpregnant adults and adolescents hypersensitive to penicillin if close follow-up can be ensured.203 242 293 307

Use with caution and with close follow-up; efficacy not well documented (especially in HIV-infected individuals) and resistance and treatment failures reported.8 242 293 307 327 328

Toxoplasmosis

Treatment of infections caused by Toxoplasma gondii, including toxoplasmic encephalitis in HIV-infected patients127 128 129 296 307 and ocular toxoplasmosis;295 usually used in conjunction with pyrimethamine.295 296

CDC, NIH, IDSA, and others usually recommend pyrimethamine in conjunction with sulfadiazine and leucovorin for treatment of toxoplasmosis in adults and children, especially immunocompromised patients (e.g., HIV-infected individuals).125 307 308 Azithromycin in conjunction with pyrimethamine and leucovorin is one of several alternative regimens that can be considered in adults and adolescents when the regimen of choice cannot be used;307 this regimen has not been evaluated in children.308

Typhoid Fever and Other Salmonella Infections

Treatment of uncomplicated typhoid fever caused by susceptible Salmonella.15 321 322 323 332 361 Drugs of choice are fluoroquinolones (e.g., ciprofloxacin, ofloxacin), especially in areas with multidrug-resistant S. typhi (strains resistant to ampicillin, amoxicillin, chloramphenicol, co-trimoxazole); alternatives are azithromycin and third generation cephalosporins (cefotaxime, ceftriaxone, cefixime), especially for fluoroquinolone-resistant strains.15 203 332 361

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis in penicillin-allergic individuals with certain cardiac conditions who are undergoing certain dental procedures (i.e., procedures that involve manipulation of gingival tissue, the periapical region of teeth, or perforation of oral mucosa) or certain invasive respiratory tract procedures (i.e., procedures involving incision or biopsy of respiratory mucosa).201

Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with the highest risk of adverse outcome from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.201

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims;8 242 used in conjunction with IM ceftriaxone and oral metronidazole.242

Azithromycin Dosage and Administration

Administration

Administer orally1 10 302 or by IV infusion.196 Do not administer IM or by rapid IV injection.196

Oral Administration

Available as conventional film-coated tablets,1 conventional powder for oral suspension,1 and extended-release microspheres for oral suspension.302

Extended-release oral suspension is not bioequivalent to and is not interchangeable with conventional oral suspension or tablets.302

Conventional tablets: Administer orally without regard to meals;1 10 administering tablets with food may increase tolerability.8 10 Two 250-mg tablets are bioequivalent to one 500-mg tablet.1

Reconstituted conventional oral suspension: Administer orally without regard to meals.1 10 The safety of repeating a dose in children who vomit after receiving 30 mg/kg as a single dose has not been established.1 The single-dose 1-g packets should not be used to administer doses other than 1 g and are not for pediatric use.10

Reconstituted extended-release oral suspension: Administer as a single dose on an empty stomach (at least 1 hour before or 2 hours after a meal).302 Single-dose 2-g extended-release oral suspension is used only for the treatment of acute bacterial sinusitis and CAP in adults and is not for pediatric use.302 If patient vomits within 5 minutes of taking the 2-g dose, consider additional anti-infective treatment since only minimal drug absorption would have occurred.302 If patient vomits within 5–60 minutes after taking the dose, consider alternative anti-infective since insufficient data available regarding drug absorption under these circumstances.302 If patient with normal gastric emptying vomits ≥60 minutes after taking the 2-g dose, additional azithromycin doses or alternative treatment not required.302

Reconstitution

Conventional oral suspension: Reconstitute 1-g single-dose packet for oral suspension with 60 mL of water.10 The entire contents should be ingested immediately and an additional 60 mL of water should be added, mixed, and ingested to ensure complete consumption of the dose.10

Conventional oral suspension: Reconstitute multiple-dose bottles for oral suspension at time of dispensing.1 Add 9 mL of water to bottle containing 300 mg of azithromycin to provide a suspension of 100 g/5 mL.1 Add 9, 12, or 15 mL of water to bottles containing 600 mg, 900 mg, or 1.2 g of azithromycin, respectively, to provide suspensions with 200 mg/5 mL.1 Shake suspension well prior to administration of each dose.1

Extended-release oral suspension: Reconstitute at time of dispensing.302 Add 60 mL of water to bottle containing 2 g of azithromycin.302 Shake suspension well at time of dispensing and immediately prior to consumption.302 Entire bottle contents should be consumed as a single dose.302

IV Infusion

Administer by IV infusion.196

Azithromycin for IV infusion must be reconstituted and then further diluted prior to administration.196

Other IV substances, additives, or other drugs should not be added to azithromycin IV infusions and should not be infused simultaneously through the same IV line.196

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution

Reconstitute vial containing 500 mg of azithromycin by adding 4.8 mL of sterile water for injection and shaking the vial until the drug is dissolved.196 Since the vial contains a vacuum, a standard (non-automated) 5-mL syringe should be used to ensure that exact amount of diluent is added during reconstitution.196

Reconstituted solution contains 100 mg/mL.196

Dilution

Dilute to a concentration of 1 or 2 mg/mL by adding reconstituted azithromycin solution to 250 or 500 mL of a compatible IV solution.196 (See Solution Compatibility under Stability.)

Rate of Administration

Administer final solutions containing 1 mg/mL by IV infusion over 3 hours and those containing 2 mg/mL by IV infusion over 1 hour.196 Do not give 500-mg doses by IV infusion over a period <1 hour.196

Dosage

Available as azithromycin dihydrate; dosage expressed in terms of anhydrous azithromycin.1 10 196 302

Pediatric Patients

Acute Otitis Media (AOM)
Oral

Children ≥6 months of age: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days.1 Alternatively, 10 mg/kg as a single dose on day 1, followed by 5 mg/kg once daily on days 2–5.1 294

Pharyngitis and Tonsillitis
Oral

Children ≥2 years of age: 12 mg/kg (up to 500 mg) once daily for 5 days.1 93

GI Infections
Mild to Moderate Campylobacter jejuni Infections
Oral

Adolescents: 500 mg once daily for 7 days recommended by CDC, NIH, and IDSA.308 If bacteremia is present, continue treatment for ≥2 weeks and consider use of a second anti-infective (e.g., an aminoglycoside).308

Cryptosporidiosis
Oral

HIV-infected infants or children: 10 mg/kg as a single dose on day 1 followed by 5 mg/kg once daily (up to 600 mg daily) on days 2–10.307

HIV-infected adolescents: 10 mg/kg as a single dose on day 1 followed by 5 mg/kg once daily (up to 600 mg daily) on days 2–10.308

Optimum duration of treatment unknown;308 no anti-infective reliably eradicates Cryptosporidium.203 290 307 308

Shigella Infections
Oral

Children: 12 mg/kg (up to 500 mg) on day 1 followed by 6 mg/kg orally once daily (up to 250 mg daily) on days 2–5 has been used.308 318

Adolescents: 500 mg on day 1 followed by 250 mg once daily on days 2–5.308

Treatment of Travelers’ Diarrhea
Oral

Empiric treatment in children: 10 mg/kg once daily for 3 days.319 372

Severe Diarrhea Caused by Enterotoxigenic Escherichia coli (ETEC)
Oral

Children with severe or intractable diarrhea caused by susceptible strains: 10 mg/kg once daily for 2 days if use of an anti-infective is considered necessary.356

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral

Children ≥6 months of age: 10 mg/kg once daily for 3 days.1

Community-acquired Pneumonia
Oral

Children ≥6 months of age: 10 mg/kg as a single dose on day 1, followed by 5 mg/kg once daily on days 2–5.1 203 Efficacy of shorter regimens (e.g., 1–3 days) for treatment of CAP in children has not been established.1

Babesiosis
Oral

10 mg/kg (up to 500 mg) once on day 1, then 5 mg/kg (up to 250 mg) once daily for total of 7–10 days recommended by IDSA; used in conjunction with atovaquone (20 mg/kg [up to 750 mg] twice daily for 7–10 days).288

Others suggest 12 mg/kg once daily for 7–10 days in conjunction with atovaquone (20 mg/kg daily in 2 divided doses for 7–10 days).125

Bartonella Infections
Cat Scratch Disease Caused by Bartonella henselae
Oral

10 mg/kg on day 1 followed by 5 mg/kg once daily on days 2–5.310

Bartonella Infections in HIV-infected Individuals
Oral

Adolescents: 600 mg once daily for ≥3 months recommended by CDC, NIH, and IDSA.307 If relapse occurs, consider life-long secondary prophylaxis (chronic maintenance therapy) with erythromycin or doxycycline.307

Chancroid
Oral

Children weighing <45 kg: 20 mg/kg (maximum 1 g) as a single dose.203

Children weighing ≥45 kg: 1 g as a single dose.203

Only limited data on efficacy of single-dose azithromycin regimen for treatment of chancroid in HIV-infected patients; use only if follow-up can be ensured.242

Chlamydial Infections
Uncomplicated Chlamydial Urethritis or Cervicitis
Oral

Children <8 years of age weighing ≥45 kg: 1 g as a single dose.203 242

Children ≥8 years of age: 1 g as a single dose.203 242

Ocular Trachoma
Oral

20 mg/kg (up to 1 g) as a single dose.217 353 354 370 373 375 Alternatively, 20 mg/kg once weekly for 3 weeks203 217 301 or 20 mg/kg once every 4 weeks for a total of 6 doses.217

Single-dose regimen has been used in mass treatment programs,370 373 375 but multiple doses (e.g., once yearly for 3 years) may be necessary to minimize reservoirs of infection in high-prevalence areas.354 370 374 375

Chlamydial Pneumonia in Infants
Oral

20 mg/kg once daily for 3 days.8 203

Chlamydial Conjunctivitis in Neonates
Oral

20 mg/kg once daily for 3 days.8 242

Legionella Infections
IV

10 mg/kg (up to 500 mg) once daily for 5–10 days.203 If patient is improving, parenteral therapy may be switched to oral therapy.203

Leptospirosis
Oral

Children 5–18 years of age: 15 mg/kg daily in 2 divided doses for 7 days has been used.365

Lyme Disease
Early Localized or Early Disseminated Lyme Disease
Oral

10 mg/kg (up to 500 mg) once daily for 7–10 days.288 Macrolides generally less effective than first-line agents; monitor closely to ensure resolution of clinical manifestations.288

Mycobacterium avium Complex (MAC) Infections
Primary Prevention of MAC in Children <13 Years of Age with Advanced HIV Infection
Oral

20 mg/kg (up to 1.2 g) once weekly or 5 mg/kg (up to 250 mg) once daily.234

Initiate primary prophylaxis if CD4+ T-cell count is <750/mm3 in those <1 year, <500/mm3 in those 1–2 years, <75/mm3 in those 2–6 years, or <50/mm3 in those ≥6 years of age.234

Safety of discontinuing primary MAC prophylaxis in children whose CD4+ T-cell counts have increased as a result of highly active antiretroviral therapy has not been studied to date.234

Primary Prevention of MAC in Adolescents with Advanced HIV Infection
Oral

1.2 g once weekly given alone.234

Initiate primary prophylaxis if CD4+ T-cell count is <50/mm3.234 May be discontinued if there is immune recovery in response to antiretroviral therapy with an increase in CD4+ T-cell count to >100/mm3 sustained for ≥3 months.234 Reinitiate prophylaxis if CD4+ T-cell count decreases to <50–100/mm3.234

Treatment of Disseminated MAC in HIV-infected Infants and Children
Oral

10–12 mg/kg once daily (up to 500 mg daily) in conjunction with ethambutol (15–25 mg/kg once daily [up to 1 g daily]) with or without rifabutin (10–20 mg/kg once daily [up to 300 mg daily]) recommended by CDC, NIH, and IDSA.307

Treatment of Disseminated MAC in HIV-infected Adolescents
Oral

500–600 mg once daily in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300–450 mg once daily) recommended by ATS, CDC, IDSA, and NIH.308

Prevention of MAC Recurrence in HIV-infected Children <13 Years of Age
Oral

5 mg/kg (maximum 250 mg) once daily, given in conjunction with ethambutol (with or without rifabutin).234

Secondary prophylaxis to prevent MAC recurrence in HIV-infected children usually continued for life.234 The safety of discontinuing secondary MAC prophylaxis in children whose CD4+ T-cell count increases in response to antiretroviral therapy has not been studied.234

Prevention of MAC Recurrence in HIV-infected Adolescents
Oral

500–600 mg once daily in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily) recommended by CDC, NIH, and IDSA.234 308

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adolescents.234 Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 sustained for ≥6 months.234

Pertussis
Treatment or Postexposure Prophylaxis of Pertussis
Oral

Infants <6 months of age: 10 mg/kg once daily for 5 days recommended by AAP and CDC.203 334 Although only limited data available in infants <1 month of age, CDC states this dosage can be used when necessary for treatment or prophylaxis of pertussis in this age group.334

Children and infants ≥6 months of age: 10 mg/kg (up to 500 mg) once on day 1, followed by 5 mg/kg (up to 250 mg) once daily on days 2–5 recommended by CDC, AAP, and others.203 324 325 334

Adolescents: 500 mg once on day 1, then 250 mg once daily on days 2–5 recommended by CDC and AAP.203 334

Postexposure prophylaxis regimen is the same as the treatment regimen.203 334 When used for postexposure prophylaxis, initiate within 3 weeks of exposure or onset of cough in the index patient.203 334

Toxoplasmosis
Oral

Adolescents: 900–1200 mg once daily in conjunction with pyrimethamine and leucovorin recommended by CDC, NIH, and IDSA.308

Continue acute treatment for ≥6 weeks;308 longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.308

Typhoid Fever and Other Salmonella Infections
Oral

Children 3–17 years of age: 20 mg/kg (up to 1 g) once daily for 5–7 days.321 322 Dosage of 10 mg/kg (up to 500 mg) once daily for 7 days also has been used.361

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral

15 mg/kg (up to 500 mg) as a single dose given 30–60 minutes prior to the procedure.201

Prophylaxis in Sexual Assault Victims
Oral

Adolescents: 1 g as a single dose in conjunction with IM ceftriaxone and oral metronidazole.242

Adults

Pharyngitis and Tonsillitis
Oral

500 mg as a single dose on day 1, followed by 250 mg once daily on days 2–5.1

GI Infections
Mild to Moderate Campylobacter jejuni Infections
Oral

500 mg once daily for 7 days recommended by CDC, NIH, and IDSA.308 If bacteremia is present, continue treatment for ≥2 weeks and consider use of a second anti-infective (e.g., an aminoglycoside).308

Cryptosporidiosis
Oral

HIV-infected adults: 600 mg once daily for 4 weeks; has been given in conjunction with paromomycin (1 g twice daily for 12 weeks).256

Shigella Infections
Oral

500 mg on day 1 followed by 250 mg once daily on days 2–5.308 316 If bacteremia is present, continue for 14 days depending on the severity of infection.308

Treatment of Travelers’ Diarrhea
Oral

Empiric treatment: 1 g as a single dose.319 359 360 372 Alternatively, 500 mg once daily for 3 days.319 359 360 372

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral

Conventional tablets or oral suspension: 500 mg once daily for 3 days.1

Extended-release oral suspension: 2 g given as a single dose.302

Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease
Oral

500 mg once daily for 3 days or, alternatively, 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2–5.1 96 97 98 99

Mild to Moderate Community-acquired Pneumonia
Oral

Conventional tablets or oral suspension: 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2–5.1 3 96 97 98 99 211

Extended-release oral suspension: 2 g given as a single dose.302

Moderate to Severe Community-acquired Pneumonia When IV therapy is Necessary
IV, then Oral

Initiate treatment with an IV regimen of 500 mg once daily given for ≥2 days;196 197 then switch to an oral regimen of 500 mg once daily to complete 7–10 days of treatment.196 251

Legionnaires’ Disease
Oral

500 mg once daily.311 312 314 Usual duration is 3–5 days for mild to moderate infections in immunocompetent patients; longer duration of treatment (at least 7–10 days or 3 weeks) may be necessary to prevent relapse in those with more severe infections or with underlying comorbidity or immunodeficiency.311 312

IV

500 mg once daily.311 312 314 Usual duration is 3–5 days for mild to moderate infections in immunocompetent patients; longer duration of treatment (at least 7–10 days or 3 weeks) may be necessary to prevent relapse in those with more severe infections or with underlying comorbidity or immunodeficiency.311 312

Skin and Skin Structure Infections
Oral

500 mg as a single dose on day 1, followed by 250 mg once daily on days 2–5.1 10 107 108

Babesiosis
Oral

0.5–1 g once on day 1, then 250 mg once daily for total of 7–10 days recommended by IDSA; used in conjunction with atovaquone (750 mg twice daily for 7–10 days).288 Higher azithromycin dosage (0.6–1 g daily) may be used in immunocompromised patients.288

Others suggest 600 mg once daily for 7–10 days in conjunction with atovaquone (750 mg twice daily for 7–10 days).125

Bartonella Infections
Cat Scratch Disease Caused by Bartonella henselae
Oral

500 mg on day 1 followed by 250 mg once daily on days 2–5.310

Bartonella Infections in HIV-infected Patients
Oral

600 mg once daily for ≥3 months recommended by CDC, NIH, and IDSA.308 If relapse occurs, consider life-long secondary prophylaxis (chronic maintenance therapy) with erythromycin or doxycycline.308

Chancroid
Oral

1 g as a single dose.1 8 242

Only limited data on efficacy of single-dose azithromycin regimen for treatment of chancroid in HIV-infected patients; use only if follow-up can be ensured.242

Chlamydial Infections
Uncomplicated Chlamydial Urethritis or Cervicitis
Oral

1 g as a single dose.1 7 8 10 109 112 114 184 185 242

Recurrent or Persistent Urethritis
Oral

CDC recommends a single 1-g dose in conjunction with a single 2-g dose of oral metronidazole or tinidazole.242

Ocular Trachoma
Oral

20 mg/kg (up to 1 g) as a single dose.112 114 189 353 354 370 Alternatively, 1 g once weekly for 3 weeks.301

Single-dose regimen has been used in mass treatment programs,370 373 375 but multiple doses (e.g., once yearly for 3 years) may be necessary to minimize reservoirs of infection in high-prevalence areas.354 370 374 375

Lymphogranuloma Venereum
Oral

1 g once weekly for 3 weeks may be effective.242

Cholera
Oral

A single dose of 1 g has been used for treatment of cholera caused by V. cholerae O1 or O139.350

Gonorrhea
Uncomplicated Gonorrhea
Oral

2 g as a single dose.1 182 183 191 242 371 Because of concerns regarding rapid emergence of macrolide resistance, do not use lower dosage and use only when necessary.242 371 (See Gonorrhea under Uses).

Granuloma Inguinale (Donovanosis)
Oral

1 g once weekly for at least 3 weeks or until all lesions have healed completely;221 242 consider adding IV aminoglycoside (e.g., 1 mg/kg of gentamicin IV every 8 hours) in HIV-infected individuals or if improvement is not evident within the first few days of treatment.242 Despite effective anti-infective therapy, relapse may occur 6–18 months later.242

Leptospirosis
Oral

1 g as a single dose on day 1 followed by 500 mg once daily for 2 days.363 Alternatively, 15 mg/kg daily in 2 divided doses for 7 days has been used.365

Lyme Disease
Early Localized or Early Disseminated Lyme Disease
Oral

500 mg once daily for 7–10 days.288 Macrolides generally less effective than first-line agents; monitor closely to ensure resolution of clinical manifestations.288

Mycobacterium avium Complex (MAC) Infections
Primary Prevention of MAC in Adults with Advanced HIV Infection
Oral

1.2 g once weekly.10 233 234 Usually given alone, but has been given in conjunction with rifabutin.10 233 234

ATS, IDSA, and others recommend initiating primary prophylaxis if CD4+ T-cell count is <50/mm3.233 234 May be discontinued if there is immune recovery in response to antiretroviral therapy with an increase in CD4+ T-cell count to >100/mm3 sustained for ≥3 months.233 234 Reinitiate prophylaxis if CD4+ T-cell count decreases to <50–100/mm3.233 234

Treatment of Disseminated MAC in HIV-infected Adults
Oral

Manufacturer recommends 600 mg once daily in conjunction with ethambutol (15 mg/kg daily), with or without an additional antimycobacterial.10

ATS, CDC, NIH, and IDSA recommend 500–600 mg once daily in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily).233 308

Prevention of MAC Recurrence in HIV-infected Adults
Oral

500–600 mg once daily in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily) recommended by CDC, NIH, and IDSA.234 308

Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adults.233 234 Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 sustained for ≥6 months.233 234 Reinitiate prophylaxis if CD4+ T-cell count decreases to <100/mm3.233

Initial Treatment of Pulmonary MAC Infections (Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains
Oral

500–600 mg 3 times weekly in conjunction with ethambutol (25 mg/kg 3 times weekly) and rifampin (600 mg 3 times weekly) recommended by ATS and IDSA.233 Continue until patient has been culture negative on treatment for 1 year.233

Intermittent (3-times-weekly) regimen is not recommended for those with cavitary or moderate or severe disease or those who have been previously treated.233

Initial Treatment of Pulmonary MAC Infections (Fibrocavitary or Severe Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains
Oral

250–300 mg once daily in conjunction with ethambutol (15 mg/kg once daily) and either rifampin (450–600 mg once daily) or rifabutin (150–300 mg once daily) recommended by ATS and IDSA.233 Continue until patient has been culture negative on treatment for 1 year.233 Consideration can be given to including amikacin or streptomycin 3 times weekly during the first 2–3 months of treatment for extensive disease, especially fibrocavitary disease, or when previous therapy has failed.233

Mycobacterium abscessus Infections
Oral

250 mg daily in conjunction with parenteral amikacin, cefoxitin, or imipenem.233 Duration of therapy should be at least 4 months for serious infections; a duration of 6 months is recommended for bone infections.233

Neisseria meningitidis Infections
Elimination of Nasopharyngeal Carrier State
Oral

500 mg as a single dose.346 349

Pelvic Inflammatory Disease
IV, then Oral

500 mg IV once daily for 1–2 days, followed by 250 mg orally once daily to complete 7 days of therapy.196 If anaerobic bacteria are suspected, an anti-infective active against anaerobes should also be used.196

Pertussis
Treatment or Postexposure Prophylaxis of Pertussis
Oral

500 mg once on day 1, then 250 mg once daily on days 2–5 recommended by CDC and AAP.203 334

Postexposure prophylaxis regimen is the same as the treatment regimen.203 334 When used for postexposure prophylaxis, initiate within 3 weeks of exposure or onset of cough in the index patient.203 334

Scrub Typhus
Oral

500 mg as a single dose.362 364 Alternatively, 1 g as a single dose on day 1, then 500 mg once daily for 2 days.363

Syphilis
Treatment of Primary or Secondary Syphilis in Penicillin-allergic Patients
Oral

2 g as a single dose;242 293 308 close follow-up is essential since efficacy not well documented.8 242 293 308

Toxoplasmosis
Oral

900–1200 mg once daily in conjunction with pyrimethamine and leucovorin recommended by CDC, NIH, and IDSA.308

Continue acute treatment for ≥6 weeks;308 longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.308

Typhoid Fever and Other Salmonella Infections
Oral

1 g once daily for 5 days.323 Alternatively, 8–10 mg/kg (up to 500 mg) once daily for 7 days.332 361

Prevention of Bacterial Endocarditis
Patients Undergoing Certain Dental or Respiratory Tract Procedures
Oral

500 mg as a single dose given 30–60 minutes prior to the procedure.201

Prophylaxis in Sexual Assault Victims
Oral

1 g as a single dose in conjunction with IM ceftriaxone and oral metronidazole.242

Special Populations

Hepatic Impairment

Manufacturer states dosage recommendations not available.1 10 196 302 Some clinicians state dosage adjustments not necessary in patients with class A or B liver cirrhosis.173

Use caution;1 3 10 196 210 211 pharmacokinetics in hepatic impairment not completely established.1 10 196

Renal Impairment

Dosage adjustment not necessary.1 10 196 302

Use caution in severe renal impairment (GFR <10 mL/minute) because of limited data.1 10 196 302

Geriatric Patients

Dosage adjustments not usually necessary in geriatric patients with normal renal and hepatic function receiving conventional or extended-release formulations.1 10 70 202 302

Cautions for Azithromycin

Contraindications

  • Known hypersensitivity to azithromycin, erythromycin, any macrolide, or any ketolide.1 10 196 302

Warnings/Precautions

Warnings

Severe Pneumonia

Should not be used orally for treatment of moderate to severe pneumonia or when there are risk factors that make oral therapy inappropriate (e.g., cystic fibrosis, nosocomial infection, known or suspected bacteremia, illness requiring hospitalization, geriatric or debilitated status, immunodeficiency or functional asplenia or other underlying conditions that may compromise ability to respond to treatment).1 10

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 10 196 302 Institute appropriate therapy if superinfection occurs.1 10 196

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 10 196 302 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including azithromycin, and may range in severity from mild diarrhea to fatal colitis.1 10 196 302 Hyper toxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1 10 196 302

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 10 196 302 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1 10 263 264 265 266 267 302

If CDAD is suspected or confirmed, azithromycin may need to be discontinued.1 10 196 263 264 265 266 267 302 Some mild cases may respond to discontinuance alone.263 264 265 266 267 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 10 196 263 264 265 266 267 302

Sensitivity Reactions

Hypersensitivity and Dermatologic Reactions

Serious allergic and dermatologic reactions (e.g., angioedema, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have occurred.1 10 196 302 Fatalities reported.1 10 196 302

If a hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1 10 196 302

Despite initially successful symptomatic management of allergic reactions, symptoms have recurred soon after symptomatic treatment was discontinued; the relationship between these episodes and the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown.1 10 196 302

General Precautions

Cardiac Effects

Prolonged cardiac repolarization and QT interval with risk of cardiac arrhythmia and torsades de pointes reported with some macrolides.1 10 196 302 Possibility of such effects with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.1 10 196 302

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of azithromycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1 10 196 302

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 10 196 302 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1 10 196 302

Because S. pyogenes (group A β-hemolytic streptococci) resistant to azithromycin have been reported, in vitro susceptibility tests should be performed when the drug is used for treatment of pharyngitis and tonsillitis.1

Sodium Content

Conventional tablets: Each 250- or 500-mg tablet contains 0.9 or 1.8 mg of sodium, respectively,1 and each 600 mg tablet contains 2.1 mg of sodium.10

Conventional oral suspension: Each 5 mL containing 100 or 200 mg of azithromycin contains 3.7 or 7.4 mg of sodium, respectively.1 The single-dose 1-g oral suspension contains 37 mg of sodium per package.10

Extended-release oral suspension: 2-g dose contains 148 mg (6.43 mEq) of sodium.302

IV infusion: Each vial contains 114 mg (4.96 mEq) of sodium.196 (See Geriatric Use under Cautions.)

Specific Populations

Pregnancy

Category B.1 10 196 302

Lactation

Distributed into milk; 144 use with caution.1 10 196 302

Pediatric Use

Conventional tablets and oral suspension: Safety and efficacy not established for treatment of pharyngitis and tonsillitis in children <2 years of age1 or for treatment of AOM in children <6 months of age.1

Conventional tablets and oral suspension: Safety and efficacy of oral azithromycin not established for treatment of acute maxillary sinusitis in children <6 months of age.1 Use for sinusitis in those ≥6 months of age is supported by evidence from adequate and well-controlled studies in adults, similar pathophysiology of acute sinusitis in adults and pediatric patients, and studies of AOM in pediatric patients.1

Conventional tablets and oral suspension: Safety and efficacy of oral azithromycin not established for treatment of acute community-acquired pneumonia in children <6 months of age.1 Safety and efficacy for pneumonia caused by C. pneumoniae or M. pneumoniae were documented in pediatric trials; although safety and efficacy for pneumonia caused by H. influenzae or S. pneumoniae were not documented in pediatric trials, use for infections caused by these bacteria is supported by evidence from adequate and well-controlled studies in adults.1

Extended-release oral suspension: Safety and efficacy not established in pediatric patients.302

IV azithromycin: Safety and efficacy not established in children or adolescents <16 years of age.196

Manufacturer states that safety and efficacy of azithromycin not established for prevention or treatment of MAC infection in HIV-infected pediatric patients,10 but some experts recommend use of the drug for HIV-infected infants and children.234

Adverse effects reported in pediatric patients are similar to those reported in adults and generally involve the GI tract.1 10 Treatment-related reversible hearing impairment reported in some HIV-infected children receiving the drug for treatment of opportunistic infections.10

Geriatric Use

No overall differences in safety and efficacy of oral azithromycin in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.1 10 302

When used in a dosage >300 mg daily for a mean of 207 days for the treatment of various opportunistic infections (including MAC) in adults 65–94 years of age, adverse effect profile generally was similar to that in younger adults, except for a higher incidence of adverse GI effects and reversible hearing impairment.10

No overall differences in safety of IV azithromycin in those ≥65 years of age compared with younger adults; similar decreases in clinical response were noted with increasing age in both azithromycin- and comparator-treated patients.196

Azithromycin preparations contain sodium.1 10 196 302 (See Sodium Content under Cautions.) Patients receiving the usual IV dosage will receive 114 mg (4.96 mEq) of sodium per dose.196 Geriatric patients may respond to salt loading with blunted natriuresis,196 and the total sodium content from dietary and nondietary sources may be clinically important with regard to such diseases as congestive heart failure.196

Hepatic Impairment

Use caution.1 10 196 302

Pharmacokinetics not studied in hepatic impairment, but the drug is principally eliminated by the liver.1 10 196

Renal Impairment

Because of limited data, use caution if GFR <10 mL/minute.1 10 196 302

Clearance is decreased in severe renal impairment.1 10 196 (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Adverse GI effects, including diarrhea/loose stools, nausea, vomiting, abdominal pain.1 3 10 108 110 132 155 196 210 211 302 Adverse GI effects occur more frequently with single-dose regimens (1 or 2 g) than multiple-dose regimens.1 10

Adverse effects reported with long-term azithromycin used for prevention of MAC infection are similar to those reported with short-term dosage regimens but also included reversible hearing impairment.10

Local reactions (pain, inflammation) with IV administration.196

Interactions for Azithromycin

Does not appear to have an effect on CYP isoenzymes.65 67 162 211

Many drug interactions reported with other macrolides (e.g., erythromycin, clarithromycin) have not been reported to date with azithromycin.1 10 132 162 196 211

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Although pharmacokinetic interactions with substrates, inhibitors, or inducers of CYP isoenzymes have been reported with other macrolides (e.g., clarithromycin), they have not been reported to date with azithromycin.1 10 65 67 162 196 211 Azithromycin appears to have no effect on the CYP isoenzyme system and interactions mediated by this enzyme system would not be expected to occur.162 211 However, the possibility that such drug interactions may occur cannot be ruled out.1 10 196 211

Specific Drugs

Drug

Interaction

Comments

Albendazole

Increased peak plasma concentration and AUC of azithromycin when azithromycin, albendazole, and ivermectin given concomitantly355

Effect on azithromycin not considered clinically important355

Antacids (aluminum- and magnesium-containing)

Conventional tablets or oral suspension: Decreased azithromycin plasma concentrations; AUC unaffected1 10 146

Extended-release oral suspension: Rate and extent of azithromycin absorption not affected302

Conventional tablets or oral suspension: Simultaneous administration with aluminum- or magnesium-containing antacids not recommended1 10

Extended-release oral suspension: May be taken without regard to aluminum- or magnesium-containing antacids302

Anticoagulants, oral

Does not appear to affect PT response to a single warfarin dose;1 10 196 increased anticoagulant effects reported rarely with azithromycin192 and also reported with other macrolides1 10 196

Monitor PT carefully when used with warfarin1 10 196 302

Antimycobacterials, rifamycins (rifabutin)

Modest effect on rifabutin pharmacokinetics1 10 196

No dosage adjustment recommended1 196 302

Atazanavir

Clinically important pharmacokinetic interactions not expected299

Benzodiazepines (midazolam, triazolam)

Modest effect on pharmacokinetics of midazolam or triazolam;1 196 decreased clearance of triazolam and increased pharmacologic effect reported with other macrolides10

No dosage adjustment recommended1 10 196 302

Carbamazepine

Modest effect on pharmacokinetics of carbamazepine;1 196 147 148 increased carbamazepine concentrations reported with other macrolides10

No dosage adjustment recommended;1 196 302 monitor closely10

Cetirizine

Modest effect on pharmacokinetics of cetirizine1 196

No dosage adjustment recommended1 196 302

Chloroquine

No clinically important pharmacokinetic interactions between chloroquine and azithromycin338

In vitro evidence of additive to synergistic effects against P. falciparum, including multidrug-resistant strains339 357

Cimetidine

No effect on azithromycin absorption if cimetidine given 2 hours prior to azithromycin 1 10 146

Co-trimoxazole

Modest effect on pharmacokinetics of co-trimoxazole;1 10 no clinically important effect on pharmacokinetics of azithromycin

No dosage adjustment recommended1 196 302

Cyclosporine

No interaction studies with azithromycin; 1 10 196 increased cyclosporine concentrations reported with other macrolides 1 10 196

Monitor carefully1 10 196

Didanosine

Modest or no effect on pharmacokinetics of didanosine1 10 196

No dosage adjustment recommended1 196 302

Digoxin

No interaction studies with azithromycin; 1 10 196 increased digoxin concentrations reported with other macrolides1 10 196

Monitor carefully1 10 196

Efavirenz

Modest or no effect on efavirenz and azithromycin pharmacokinetics1 10 196

No dosage adjustment recommended1 196 302

Ergot alkaloids (ergotamine, dihydroergotamine)

No interaction studies with azithromycin;1 10 196 acute ergot toxicity (severe peripheral vasospasm and dysesthesia)reported with other macrolides1 10 196

Monitor carefully1 10 196

Fluconazole

Modest or no effect on pharmacokinetics of azithromycin and fluconazole 1 10 196

No dosage adjustment recommended1 196 302

Hexobarbital

No interaction studies with azithromycin; 10 196 increased hexobarbital concentrations reported with other macrolides 10 196

Monitor carefully10 196

HMG-CoA reductase inhibitors (atorvastatin)

Modest effect on pharmacokinetics of atorvastatin1 196

Rhabdomyolysis reported with lovastatin229

No dosage adjustment recommended;1 196 302 monitor closely229

Indinavir

Modest or no effect on pharmacokinetics of indinavir1 10 196

No dosage adjustment recommended1 196 302

Ivermectin

Increased peak plasma concentrations and AUC of azithromycin and ivermectin when azithromycin, ivermectin, and albendazole given concomitantly355

Effect on azithromycin not considered clinically important; additional study needed regarding effect on pharmacokinetics of ivermectin355

Lopinavir

Clinically important pharmacokinetic interactions not expected300

Nelfinavir

Decreased AUC of nelfinavir and its M8 metabolite; increased plasma concentrations and AUC of azithromycin10 196

No dosage adjustment recommended;10 196 302 closely monitor for adverse effects of azithromycin (e.g., liver enzyme abnormalities, hearing impairment)10 196 302

Phenytoin

No interaction studies with azithromycin;1 10 196 increased phenytoin concentrations reported with other macrolides1 10 196

Monitor carefully1 10 196

Pimozide

Potential increased pimozide plasma concentrations and risk of prolonged QT interval and serious cardiac arrhythmias reported with other macrolides243 244 245

Manufacturer of pimozide states concomitant use contraindicated245

Quinine

In vitro evidence of additive to synergistic effects against P. falciparum, including multidrug-resistant strains339 340 357

Sildenafil

Modest effect on sildenafil pharmacokinetics1 196

No dosage adjustment recommended1 196 302

Theophylline

Modest or no effect on theophylline pharmacokinetics;1 10 196 increased theophylline concentrations have been reported with other macrolides10

No dosage adjustment recommended;1 196 302 closely monitor theophylline concentrations10

Zidovudine

Modest effect on zidovudine pharmacokinetics1 10 196

No dosage adjustment recommended1 10 196 302

Azithromycin Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from GI tract.1 65 66 67 68 211

Conventional tablets or oral suspension: Absolute oral bioavailability is 34–52%.10 66 67 68 131 163 170 196 200 Peak serum concentrations attained about 2 hours after an oral dose.1

Extended-release oral suspension: Bioavailability is approximately 83% of that reported with conventional oral suspension.302 Peak serum concentrations attained a median of 5 hours (range: 2–8 hours) after an oral dose (about 2.5 hours later than that reported with conventional oral suspension).302

Extended-release oral suspension not bioequivalent to conventional oral suspension or tablets.302

A single 500-mg conventional tablet is bioequivalent to two 250-mg conventional tablets.1

Food

Conventional tablets or oral suspension: Food may increase peak plasma concentrations and rate of absorption, but does not change extent of absorption (AUC).1 10 170

Extended-release oral suspension: Administration with high-fat or standard meal increases mean peak concentrations by 115 or 119%, respectively, and increases AUC by 23 or 12%, respectively, compared with administration in the fasted state.302

Distribution

Extent

Distributed into most tissues and fluids following oral or IV administration, including skin, lungs, sputum, tonsils, and cervix.1 10 65 66 67 68 71 131 163 164 196 Tissue concentrations generally exceed plasma concentrations by at least 10- to 100-fold.1 10 65 66 67 84 163 164

Only low concentrations detected in CSF in the presence of noninflamed meninges.1 10 196

Crosses the placenta and is distributed into cord blood and amniotic fluid.368 369

Distributed into milk.144

Plasma Protein Binding

51% at plasma azithromycin concentration of 0.02 mcg/mL; 7% at concentration of 2 mcg/mL.1 10 65 66 67 131 163 196

Elimination

Metabolism

At least 10 microbiologically inactive metabolites identified.65 66 67 210 211

Elimination Route

Biliary excretion as unchanged drug is a major route of elimination.1 10 196 Excreted in feces principally as unchanged drug.65 66 67 68 163 210 211

Only a small portion (approximately 6%) of a dose excreted in urine as unchanged drug.1 10 66 67 131 163 196 211 251

Half-life

Conventional tablets or oral suspension: Terminal serum half-life averages 68–72 hours.1 10 131 163 196 198

Extended-release oral suspension: Terminal serum half-life averages 59 hours.302

The prolonged terminal half-life apparently occurs because of extensive uptake and subsequent release from tissues.1

Tissue half-life averages 1–4 days;65 66 67 131 half-life in peripheral leukocytes averages 34–57 hours.10

Special Populations

Pharmacokinetics of conventional oral preparations in men 65–85 years of age similar to that in younger adults.1 10 70 Peak plasma concentrations of conventional oral preparations may be 30–50% higher in geriatric women compared with younger adults, but clinically important accumulation does not occur.1 10 Pharmacokinetics of extended-release oral suspension not evaluated in geriatric patients.302

Pharmacokinetics in hepatic impairment not fully established.1 196 302 In patients with moderate hepatic impairment, mean residence time prolonged, but other pharmacokinetic parameters (clearance, volume of distribution, AUC) similar to those in healthy individuals.163 173 211

Compared with adults with normal renal function, peak plasma concentrations and AUC are increased by 5.1 and 4.2%, respectively, in adults with GFR 10–80 mL/minute and by 61 and 35%, respectively, in adults with severe renal impairment (GFR <10 mL/minute).1 10 196

Stability

Storage

Oral

Conventional Powder For Suspension

Single-dose packets: 5–30°C.10 Use oral solution immediately after reconstitution.10

Multiple-dose bottles: <30°C.1 Following reconstitution, 5–30°C and use within 10 days; discard when full dosing is completed.1

Conventional Tablets

15–30°C.1 10

Extended-release Microspheres For Suspension

Single-dose bottle: ≤30°C.302 Following reconstitution, store in original bottle at 25°C (may be exposed to 15–30°C) and consume within 12 hours.302 Do not refrigerate or freeze reconstituted suspension.302

Parenteral

Powder for Infusion

Following reconstitution and dilution, store at room temperature (≤30°C) for 24 hours or refrigerate at 5°C for 7 days.196

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

For dilution of reconstituted azithromycin injection:

Compatible

Dextrose 5% in Ringer’s injection, lactated196 HID

Dextrose 5% in sodium chloride 0.3196 or 0.45%196 HID

Dextrose 5% in sodium chloride 0.45% with 20 mEq KCl196

Dextrose 5% in water196 HID

Normosol M in dextrose 5%196 HID

Normosol R in dextrose 5%196 HID

Ringer’s injection, lactated196 HID

Sodium chloride 0.45 or 0.9%196 HID

Drug Compatibility
Admixture CompatibilityHID

Incompatible

Ciprofloxacin

Y-Site CompatibilityHID

Compatible

Bivalirudin

Caspofungin acetate

Ceftaroline fosamil

Dexmedetomidine HCl

Diphenhydramine HCl

Dolasetron mesylate

Doripenem

Droperidol

Hetastarch in lactated electrolyte injection (Hextend)

Ondansetron HCl

Telavancin HCl

Tigecycline

Incompatible

Amikacin sulfate

Aztreonam

Cefotaxime sodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Ciprofloxacin

Clindamycin phosphate

Famotidine

Fentanyl citrate

Furosemide

Gentamicin sulfate

Imipenem-cilastatin sodium

Ketorolac tromethamine

Levofloxacin

Morphine sulfate

Piperacillin sodium-tazobactam sodium

Potassium chloride

Ticarcillin disodium-clavulanate potassium

Tobramycin sulfate

Actions and Spectrum

  • An azalide macrolide with a broader spectrum of activity than other macrolides (erythromycin, clarithromycin).3 65 163 198 204 207 209 210 211 212

  • Usually bacteriostatic, but may be bactericidal against some organisms at high concentrations.3 18 29 163 211 212 216

  • Like other macrolide antibacterials, inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal subunits.1 3 10 29 163 164 167 196 211 216

  • Spectrum of activity includes many gram-positive and -negative aerobic and anaerobic bacteria and some other organisms (e.g., Mycobacterium, Chlamydia, Mycoplasma avium complex [MAC]).1 3 5 10 29 33 34 39 40 41 89 163 164 166 167 168 169 196 206 210 211 214

  • More active than erythromycin or clarithromycin against gram-negative bacteria; activity comparable to erythromycin against gram-positive bacteria.3 29 163 164 204 207 210 250

  • Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus,1 10 196 S. pneumoniae,1 10 196 S. pyogenes (group A β-hemolytic streptococci),1 10 and S. agalactiae (group B streptococci).1 10 Also active in vitro against some other streptococci (e.g., groups C, F, and G streptococci, viridans streptococci).1 Enterococci (e.g., Enterococcus faecalis) and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.1 10

  • Gram-negative aerobes: Active in vitro and in clinical infections against Haemophilus influenzae,1 10 196 H. ducreyi,1 Moraxella catarrhalis,1 10 196 and Neisseria gonorrhoeae.1 196 Also active in vitro against N. meningitidis346 348 and some strains of Bordetella pertussis1 and Legionella pneumophila.1 196

  • Other organisms: Active in vitro and in clinical infections against C. pneumoniae,1 196 C. trachomatis,1 10 196 M. pneumoniae,1 196 and M. hominis.196 Also active against MAC,3 5 10 11 39 40 41 89 111 165 166 167 168 169 Borrelia burgdorferi,3 10 26 46 47 88 210 211 Toxoplasma gondii,48 49 50 51 52 212 Plasmodium falciparum,340 357 Orientia tsutsugamushi (formerly Rickettsia tsutsugamushi),366 Rickettsia conorii,367 R. typhi,367 and Coxiella burnettii.367

  • Streptococci and staphylococci resistant to erythromycin usually are cross-resistant to azithromycin.1 10 29 163 196 207 210 212 213

  • Complete cross-resistance occurs between azithromycin and clarithromycin in MAC.10

Advice to Patients

  • Advise patients that antibacterials (including azithromycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1 10 196 302

  • Importance of completing full course of therapy, even if feeling better after a few days.1 10 196 302

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with azithromycin or other antibacterials in the future.1 10 196 302

  • Conventional tablets or oral suspension can be taken without regard to meals.1 10 Extended-release oral suspension should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal).302

  • Importance of not taking aluminum- or magnesium-containing antacids at the same time as conventional tablets or oral suspension.1 10 Extended-release oral suspension can be taken without regard to aluminum- or magnesium-containing antacids.302

  • Advise patients taking the extended-release oral suspension about the importance of contacting their clinician for additional treatment if they vomit within the first hour after taking the dose.302

  • Importance of discontinuing azithromycin and informing clinician if an allergic reaction occurs.1 10 196 302

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 10 196 302 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1 10 196 302

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.10

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.10

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Azithromycin Dihydrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension

100 mg (of anhydrous azithromycin) per 5 mL*

Azithromycin for Suspension

Zithromax

Pfizer

200 mg (of anhydrous azithromycin) per 5 mL*

Azithromycin for Suspension

Zithromax

Pfizer

1 g (of anhydrous azithromycin) per packet*

Azithromycin for Suspension

Zithromax Single Dose Packets

Pfizer

For suspension, extended-release

2 g (of anhydrous azithromycin)

Zmax

Pfizer

Tablets, film-coated

250 mg (of anhydrous azithromycin)*

Azithromycin Tablets

Azithromycin Tablets (available as a 5-day mnemonic pack of 6 tablets)

Zithromax

Pfizer

Zithromax Z-Paks (available as a 5-day mnemonic pack of 6 tablets)

Pfizer

500 mg (of anhydrous azithromycin)*

Azithromycin Tablets

Azithromycin Tablets (available as a 3-day mnemonic pack of 3 tablets)

Zithromax

Pfizer

Zithromax Tri-Paks (available as a 3-day mnemonic pack of 3 tablets)

Pfizer

600 mg (of anhydrous azithromycin)*

Azithromycin Tablets

Zithromax

Pfizer

Parenteral

For injection, for IV infusion only

500 mg (of anhydrous azithromycin)*

Azithromycin for Injection

Zithromax

Pfizer

2.5 g (of anhydrous azithromycin)*

Azithromycin for Injection

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Azithromycin 200MG/5ML Suspension (TEVA PHARMACEUTICALS USA): 15/$32.99 or 30/$62.97

Azithromycin 250MG Tablets (SANDOZ): 30/$98.99 or 90/$285.99

Azithromycin 500MG Tablets (SANDOZ): 30/$439.98 or 90/$1,230.97

Azithromycin 600MG Tablets (SANDOZ): 30/$399.94 or 90/$999.92

Zithromax 1GM Packet (PFIZER U.S.): 3/$127.99 or 9/$365.97

Zithromax 100MG/5ML Suspension (PFIZER U.S.): 15/$49.99 or 45/$139.97

Zithromax 200MG/5ML Suspension (PFIZER U.S.): 15/$53.99 or 45/$149.96

Zithromax 200MG/5ML Suspension (PFIZER U.S.): 30/$55.99 or 90/$154.97

Zithromax 250MG Tablets (PFIZER U.S.): 30/$346.00 or 90/$915.92

Zithromax 500MG Tablets (PFIZER U.S.): 30/$675.99 or 90/$1,926.01

Zithromax 600MG Tablets (PFIZER U.S.): 30/$721.18 or 90/$2,051.26

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 18, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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2. Pfizer Pharmaceuticals Group, New York, NY: Personal communication.

3. Piscitelli SC, Danziger LH, Rodvold KA. Clarithromycin and azithromycin: new macrolide antibiotics. Clin Pharm. 1992; 11:137-52. [IDIS 290145] [PubMed 1312921]

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10. Pfizer Labs. Zithromax (azithromycin) tablets (600 mg) and for oral suspension (1 g) prescribing information. New York, NY; 2007 Aug.

11. Havlir DV, Dubé MP, Sattler FR et al for the California Collaborative Treatment Group. Prophylaxis against disseminated Mycobacterium avium complex with weekly azithromycin, daily rifabutin, or both. N Engl J Med. 1996; 335:392-8. [IDIS 369567] [PubMed 8676932]

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17. Dunkin KT, Jones S, Howard AJ. The in-vitro activity of CP-62,993 against Haemophilus influenzae, Branhamella catarrhalis, staphylococci and streptococci. J Antimicrob Chemother. 1988; 21:405-11. [PubMed 2837451]

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39. Naik S, Ruck R. In vitro activities of several new macrolide antibiotics against Mycobacterium avium complex. Antimicrob Agents Chemother. 1989; 33:1614-6. [PubMed 2817858]

40. Yew WW, Piddock LJV, Li MSK et al. In-vitro activity of quinolones and macrolides against mycobacteria. J Antimicrob Chemother. 1994; 34:343-51. [IDIS 336427] [PubMed 7829409]

41. Perronne C, Gikas A, Truffot-Pernot C et al. Activities of sparfloxacin, azithromycin, temafloxacin, and rifapentine compared with that of clarithromycin against multiplication of Mycobacterium avium complex within human macrophages. Antimicrob Agents Chemother. 1991; 35:1356-9. [PubMed 1656860]

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45. Heifets L, Mor N, Vanderkolk J. Mycobacterium avium strains resistant to clarithromycin and azithromycin. Antimicrob Agents Chemother. 1994; 38:635. [IDIS 326458] [PubMed 8031406]

46. Preac-Mursic V, Wilske B, Schierz G et al. Comparative antimicrobial activity of the new macrolides against Borrelia burgdorferi. Eur J Clin Microbiol Infect Dis. 1989; 8:651-3. [PubMed 2550233]

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48. Chang HR, Pechère JCF. In vitro effects of four macrolides (roxithromycin, spiramycin, azithromycin [CP-62,993], and A-56268) on Toxoplasma gondii. Antimicrob Agents Chemother. 1988; 32:524-9. [IDIS 242426] [PubMed 2837140]

49. Derouin F, Chastang C. Activity in vitro against Toxoplasma gondii of azithromycin and clarithromycin alone and with pyrimethamine. J Antimicrob Chemother. 1990; 25:708-11. [PubMed 2161824]

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71. Gladue RP, Bright GM, Isaacson RE et al. In vitro and in vivo uptake of azithromycin (CP-62,993) by phagocytic cells: possible mechanism of delivery and release at sites of infection. Antimicrob Agents Chemother. 1989; 33:277-82. [PubMed 2543276]

72. Bonnet M, Van der Auwera P. In vitro and in vivo intraleukocytic accumulation of azithromycin (CP-62,993) and its influence on ex vivo leukocyte chemiluminescence. Antimicrob Agents Chemother. 1992; 36:1302-9. [PubMed 1329619]

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