Generic Name and Formulations:
Azithromycin (as dihydrate) 250mg, 500mg, 600mg; tabs.
Indications for ZITHROMAX:
Mild-to-moderate susceptible infections including acute bacterial exacerbations of COPD, acute bacterial sinusitis, acute otitis media, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure, urethritis, cervicitis, chancroid in men. Treatment and prophylaxis of Mycobacterium avium complex (MAC) infection.
Use packets only for doses equal to 1g. COPD: 500mg once daily for 3 days; or 500mg once for 1 day, then 250mg once daily for 4 days. Sinusitis: 500mg once daily for 3 days. Community-acquired pneumonia, pharyngitis/tonsillitis, skin and skin structure: 500mg once for 1 day, then 250mg once daily for 4 days. Nongonococcal urethritis, cervicitis, chancroid: 1g as a single dose. Urethritis, cervicitis due to N. gonorrhoeae: 2g as a single dose. MAC prevention (alone or combined with rifabutin): 1200mg once weekly. MAC treatment (combined with ethambutol): 600mg once daily.
Use oral susp (not packets). Otitis media: <6mos: not established; ≥6mos: 30mg/kg as a single dose (max 1.5g); or 10mg/kg (max 500mg) once daily for 3 days; or 10mg/kg (max 500mg) once then 5mg/kg (max 250mg) per day for 4 days. Sinusitis: <6mos: not established; ≥6mos: 10mg/kg (max 500mg) once daily for 3 days. Community-acquired pneumonia: <6mos: not established; ≥6mos: 10mg/kg (max 500mg) once for 1 day, then 5mg/kg (max 250mg) once daily for 4 days. Pharyngitis/tonsillitis: <2yrs: not established; ≥2yrs: 12mg/kg (max 500mg) once daily for 5 days.
Ketolide allergy. History of cholestatic jaundice/hepatic dysfunction associated with prior use.
Pneumonia: oral treatment is for mild, community-acquired cases suitable for outpatient therapy only. Discontinue if signs/symptoms of hepatitis occur. Known QT prolongation, proarrhythmic conditions, clinically significant bradycardia: avoid. Allergic symptoms may recur after initial successful symptomatic treatment. Myasthenia gravis. Hepatic or renal impairment. Elderly. Pregnancy (Cat.B). Nursing mothers.
Avoid concomitant aluminum- or magnesium-containing antacids. Monitor with digoxin, phenytoin, warfarin. Monitor for azithromycin toxicity (eg, liver dysfunction, ototoxicity) with nelfinavir. Concomitant Class 1A (eg, quinidine, procainamide), or Class III (eg, dofetilide, amiodarone, sotalol) antiarrhythmics, or others known to prolong the QT interval: avoid.
Diarrhea, nausea, abdominal pain, vomiting, rash; hepatotoxicity, hypersensitivity reactions (eg, angioedema, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS; discontinue if occurs), torsade de pointes (esp. elderly), C. difficile associated diarrhea.
Biliary (primarily), renal.
Tabs—30; Z-Pak (6 x 250mg tabs)—3; Tri-Pak (3 x 500mg tabs)—3; Susp 100mg/5mL—15mL; 200mg/5mL—15mL, 22.5mL, 30mL; Single Dose Packets—3, 10; Inj—10
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