CV: QT interval prolongation, CARDIOVASCULAR DEATH, chest pain, hypotension, palpitations, TORSADES DE POINTES.
Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), photosensitivity, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.
EENT: ototoxicity.
F and E: hyperkalemia.
GI: abdominal pain, diarrhea, nausea, ↑ liver enzymes, cholestatic jaundice, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), dyspepsia, flatulence, HEPATOTOXICITY, melena, oral candidiasis, pyloric stenosis.
GU: nephritis, vaginitis.
Hemat: anemia, leukopenia, thrombocytopenia.
Neuro: dizziness, drowsiness, fatigue, headache, seizures.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).
Most Respiratory and Skin Infections
- PO (Adults): 500 mg on 1st day, then 250 mg/day for 4 more days (total dose of 1.5 g); Acute bacterial sinusitis: 500 mg once daily for 3 days.
- PO (Children ≥ 6 mo): Pneumonia/Pertussis: 10 mg/kg (not to exceed 500 mg/dose) on 1st day, then 5 mg/kg once daily (not to exceed 250 mg/dose) for 4 more days. Pharyngitis/tonsilitis: 12 mg/kg once daily for 5 days (not to exceed 500 mg/dose); Acute bacterial sinusitis: 10 mg/kg once daily for 3 days.
- PO (Neonates): Pertussis, treatment and post-exposure prophylaxis: 10 mg/kg once daily for 5 days.
Otitis Media
- PO (Children ≥6 mo): 30 mg/kg single dose (not to exceed 1500 mg/dose) or 10 mg/kg once daily (not to exceed 500 mg/dose) for 3 days or 10 mg/kg (not to exceed 500 mg/dose) on 1st day, then 5 mg/kg once daily (not to exceed 250 mg/dose) for 4 more days.
Acute Bacterial Exacerbations of Chronic Bronchitis
- PO (Adults): 500 mg on 1st day, then 250 mg once daily for 4 more days (total dose of 1.5 g) or 500 mg once daily for 3 days.
Community-Acquired Pneumonia
- IV, PO (Adults): More severe: 500 mg IV every 24 hr for at least 2 doses, then 500 mg PO every 24 hr for a total of 710 days; Less severe: 500 mg PO, then 250 mg/day PO for 4 more days.
- PO (Children >6 mo): 10 mg/kg on 1st day, then 5 mg/kg once daily for 4 more days.
Pelvic Inflammatory Disease
- IV, PO (Adults): 500 mg IV every 24 hr for 12 days, then 250 mg PO every 24 hr for a total of 7 days.
Endocarditis Prophylaxis
- PO (Adults): 500 mg 1 hr before procedure.
- PO (Children): 15 mg/kg 1 hr before procedure.
Nongonococcal Urethritis, Cervicitis, Chancroid, Chlamydia
- PO (Adults): Single 1-g dose.
- PO (Children): Chancroid: Single 20-mg/kg dose (not to exceed 1000 mg/dose). Urethritis or cervicitis: Single 10-mg/kg dose (not >1000 mg/dose).
Gonorrhea
- PO (Adults): Single 2-g dose.
Prevention of Disseminated MAC Infection
- PO (Adults): 1.2 g once weekly (alone or with rifabutin).
- PO (Children): 5 mg/kg once daily (not >250 mg/dose) or 20 mg/kg (not >1200 mg/dose) once weekly (alone or with rifabutin).
Cystic Fibrosis
- PO (Children ≥6 yrs, ≥40 kg): 500 mg every Monday, Wednesday, and Friday.
- PO (Children ≥6 yrs, 25 kg to <40 kg): 250 mg every Monday, Wednesday, and Friday.
Therapeutic Classification: agents for atypical mycobacterium, anti-infectives
Pharmacologic Classification: macrolides
Absorption: Rapidly absorbed (40%) after oral administration. IV administration results in complete bioavailability.
Distribution: Widely distributed to body tissues and fluids. Intracellular and tissue levels exceed those in serum; low CSF levels.
Protein Binding: 751%.
Metabolism/Excretion: Mostly excreted unchanged in bile; 4.5% excreted unchanged in urine.
Half-life: 1114 hr after single dose; 24 days after several doses.