Treatment of AOM caused by H. influenzae, M. catarrhalis, or S. pneumoniae.
Not a drug of first choice; considered an alternative for patients with type I penicillinhypersensitivity. 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.
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. 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.
CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice; oral cephalosporins and oral macrolides are considered alternatives. Amoxicillin sometimes used instead of penicillin V, especially for young children.
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. (See Selection and Use of Anti-infectives under Cautions),
GI Infections
Treatment of symptomatic enteric infections caused by Campylobacter jejuni†. Recommended by CDC, NIH, IDSA, AAP, and others as a drug of choice for empiric treatment.
Treatment of cryptosporidiosis† in HIV-infected adults, adolescents, or children. Anti-infectives may suppress the infection, but none found to reliably eradicate Cryptosporidium. 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.
Treatment of shigellosis† caused by susceptible strains of Shigella dysenteriae, S. boydii, S. flexneri, or S. sonnei. Usual drugs of choice are fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin); alternatives are azithromycin, ampicillin, ceftriaxone, or co-trimoxazole. Because of increasing resistance, select anti-infective based on susceptibility patterns of locally circulating Shigella.
Treatment of travelers’ diarrhea†. Generally self-limited and may resolve within 3–4 days without anti-infective treatment; 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. Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually recommended. 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.
Treatment of severe diarrhea caused by enterotoxigenic Escherichia coli† (ETEC). ETEC diarrhea generally is of moderate severity and self-limited, but may be severe. 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.
Treatment of dysentery caused by enteroinvasive E. coli† (EIEC). 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.
Treatment of diarrhea associated with enteroaggregative E. coli† (EAEC). A drug of choice, especially in children with severe or persistent illness.
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.
Respiratory Tract Infections
Treatment of acute bacterial sinusitis caused by susceptible Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) caused by H. influenzae, M. catarrhalis, or S. pneumoniae.
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.
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.
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). Do not use a macrolide alone for empiric treatment of CAP in hospitalized patients.
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. 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.
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. 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).
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.
Treatment of infections caused by L. pneumophila (Legionnaires' disease). Drugs of choice are macrolides (usually azithromycin) or fluoroquinolones with or without rifampin.
Treatment and postexposure prophylaxis of pertussis† caused by Bordetella pertussis. (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).
Babesiosis
Treatment of babesiosis† caused by Babesia microti.
Regimens of choice for babesiosis are atovaquone in conjunction with azithromycin or quinine in conjunction with clindamycin. The clindamycin and quinine regimen may be preferred for severe babesiosis; 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. Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), substantial hemolysis, or compromised renal, hepatic, or pulmonary function.
Bartonella Infections
Treatment of infections caused by B. henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosishepatitis). 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. Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome. Optimum regimens have not been identified; some clinicians recommend azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.
Treatment of bacteremia caused by Bartonella quintana†; used in conjunction with ceftriaxone. Optimum anti-infective regimens have not been identified.
Chancroid
Treatment of chancroid (genital ulcers caused by Haemophilus ducreyi).
CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin for treatment of chancroid.
Safety and efficacy of azithromycin established in men (not women), but has been effective for and is recommended by CDC for treatment of chancroid in women†.
HIV-infected patients and uncircumcised males may not respond to treatment as well as those who are HIV-negative or circumcised. CDC recommends that single-dose azithromycin or ceftriaxone regimens be used in HIV patients only if follow-up can be ensured.
Chlamydial Infections
Treatment of uncomplicated urethritis or cervicitis caused by C. trachomatis. CDC and others recommend azithromycin or doxycycline as drug of choice for nongonococcal urethritis (NGU) or cervicitis. 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.
A drug of choice for presumptive treatment of coexisting chlamydial infection in patients being treated for gonorrhea.
A drug of choice for treatment of urogenital chlamydial infections in pregnant women.
Treatment of ocular trachoma† caused by C. trachomatis. A drug of choice; recommended for use in mass treatment programs.
Treatment of chlamydial pneumonia in infants or chlamydial conjunctivitis in neonates (ophthalmia neonatorum caused by C. trachomatis).
Alternative to tetracyclines for treatment of psittacosis† caused by Chlamydophila psittaci (formerly Chlamydia psittaci), especially in children <8 years of age who should not receive tetracyclines.
Treatment of lymphogranuloma venereum caused by C. trachomatis. 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.
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; efficacy not proven to date.
Cholera
Treatment of cholera† caused by Vibrio cholerae 01 or 0139.
A tetracycline or, alternatively, a fluoroquinolone or co-trimoxazole generally used for treatment of cholera in conjunction with fluid and electrolyte replacement therapy. 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.
Gonorrhea
Treatment of uncomplicated urethritis or cervicitis caused by susceptible Neisseria gonorrhoeae.
Not recommended for routine treatment of gonorrhea. 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). Although azithromycin is effective, CDC recommends the drug be used only when necessary because of concerns related to emerging resistance to macrolides.
Granuloma Inguinale (Donovanosis)
Alternative for treatment of granuloma inguinale† (donovanosis) caused by Klebsiella granulomatis (formerly Calymmatobacterium granulomatis). CDC recommends doxycycline as the drug of choice and azithromycin, ciprofloxacin, erythromycin, or co-trimoxazole as alternatives.
Leptospirosis
Alternative for treatment of leptospirosis caused by Leptospira†. Penicillin G is drug of choice for severe infections; tetracyclines (usually doxycycline) or ceftriaxone are recommended as alternatives for less severe infections. Azithromycin also has been effective.
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. 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; macrolides generally have been less effective than first-line agents.
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. Should not be used alone as monotherapy for treatment of malaria.
Although further study is needed, has been used for treatment or prevention of P. vivax malaria†. When used for treatment, the rate of resolution of parasitemia reported for azithromycin was considerably slower than that reported for chloroquine.
Mycobacterium avium Complex (MAC) Infections
Primary prevention (primary prophylaxis) of disseminated MAC infection in adults, adolescents, and children† with advanced HIV infection. Recommended as a drug of choice for primary prevention of MAC in HIV-infected patients; usually used alone but has been used in conjunction with rifabutin.
Treatment of disseminated MAC disease, including in HIV-infected adults, adolescents, and children. ATS, IDSA, CDC, NIH, and others recommend a regimen of clarithromycin (or azithromycin) and ethambutol with or without rifabutin. 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.
Prevention of recurrence (secondary prophylaxis) of disseminated MAC infection in HIV-infected adults, adolescents, and children†. ATS, CDC, NIH, and IDSA recommend a macrolide (clarithromycin or azithromycin) given with ethambutol (with or without rifabutin).
Treatment of pulmonary MAC infections† in conjunction with other antimycobacterials. 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. 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. 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.
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.
Mycobacterium abscessus, M. kansasii, and M. marinum Infections
Treatment of infections caused by M. abscessus†. 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); surgery usually indicated for extensive disease, abscess formation, and when drug therapy is difficult. This multiple-drug regimen also has been used in the treatment of M. abscessuslung disease; anti-infectives may control symptoms and disease progression, but generally cannot produce long-term sputum conversion. 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.
Treatment of rifampin-resistant M. kansasii† infections in conjunction with other antimycobacterials. 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.
Treatment of M. marinum† infections. 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.
Neisseria meningitidis Infections
Elimination of nasopharyngeal carriage of N. meningitidis†.
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. Although further study is needed, CDC suggests azithromycin can be used as an alternative in areas where ciprofloxacin-resistant N. meningitidis have been reported (e.g., Minnesota, North Dakota).
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. If anaerobic bacteria are suspected, an anti-infective active against anaerobes should be used in conjunction with azithromycin. Although azithromycin is not included in CDC's recommended or alternative regimens for treatment of PID, CDC states a regimen of amoxicillin and clavulanic acid, azithromycin, and metronidazole has demonstrated short-term clinical cure when used in outpatients.
Pertussis
Treatment of pertussis† caused by Bordetella pertussis and postexposure prophylaxis of pertussis† in household and other close contacts of an individual with pertussis.
Macrolides (azithromycin, clarithromycin, erythromycin) are the drugs of choice. Although erythromycin traditionally has been considered the drug of choice for treatment and postexposure prophylaxis of pertussis, 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.
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; co-trimoxazole is an alternative for those ≥2 months of age when a macrolide cannot be used. 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.
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. 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.
All household and other close contacts of an individual with suspected pertussis should receive anti-infective postexposure prophylaxis, regardless of age or vaccination status. 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). In addition, all close contacts who are unvaccinated or incompletely vaccinated against pertussis should receive age-appropriate vaccination with a preparation containing pertussis antigens.
Scrub Typhus
Alternative for treatment of scrub typhus caused by Orientia tsutsugamushi (formerly Rickettsia tsutsugamushi). Drug of choice usually is doxycycline; alternatives are chloramphenicol or a fluoroquinolone. 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).
Syphilis
Alternative for treatment of primary, secondary, or early latent syphilis in nonpregnant adults and adolescents hypersensitive to penicillin†.
Penicillin G is drug of choice for treatment of all stages of syphilis, 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.
Use with caution and with close follow-up; efficacy not well documented (especially in HIV-infected individuals) and resistance and treatment failures reported.
Toxoplasmosis
Treatment of infections caused by Toxoplasma gondii, including toxoplasmic encephalitis† in HIV-infected patients and ocular toxoplasmosis†; usually used in conjunction with pyrimethamine.
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). 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; this regimen has not been evaluated in children.
Typhoid Fever and Other Salmonella Infections
Treatment of uncomplicated typhoid fever† caused by susceptible Salmonella. 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.
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).
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.
Prophylaxis in Sexual Assault Victims
Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction with IM ceftriaxone and oral metronidazole.
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