Dosing & Uses
ADULT AND PEDIATRICS
Community-acquired Pneumonia
Indicated for treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5 OR
500 mg IV qDay x 2 days, followed by 500 mg PO qDay to complete a 7- to 10-day course of therapy
Pharyngitis or Tonsillitis
Indicated for treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative therapy in individuals who cannot use first-line therapy
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Uncomplicated Skin/Skin Structure
Indicated for treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae
500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Chronic Obstructive Pulmonary Disease
Indicated for treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
500 mg PO qDay for 3 days OR
Alternatively, 500 mg PO x 1 dose on Day 1, followed by 250 mg PO qDay on Days 2-5
Mycobacterial Infections
Prophylaxis of disseminated Mycobacterium avium complex (MAC) disease
- Indicated alone or in combination with rifabutin for prevention of disseminated MAC disease in persons with advanced HIV infection
- 1200 mg PO once weekly
Treatment of disseminated MAC disease
- Indicated in combination with ethambutol for treatment of disseminated MAC infections in persons with advanced HIV infection
- 600 mg PO qDay plus ethambutol
Acute Bacterial Sinusitis
Indicated for treatment of acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
500 mg PO qDay x 3 days
Genital Ulcer Disease (Chancroid)
Indicated for treatment of genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Efficacy of chancroid treatment in women not established
1 gram PO x 1 dose
Non-gonococcal or Gonococcal Urethritis and Cervicitis
Indicated for treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae
Non-gonococcal: 1 gram PO x 1 dose
Gonococcal: 2 grams PO x 1 dose
Pelvic Inflammatory Disease
Indicated for treatment of pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial IV therapy
If anaerobic microorganisms are suspected of contributing to the infection, administer an antimicrobial agent with anaerobic activity in combination with azithromycin
500 mg IV qDay x 1-2 days, followed by 250 mg PO qDay to complete a 7-day course of therapy
Use only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin
Limitations of use
-
Do not use in patients with pneumonia who may be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
- Patients with cystic fibrosis
- Patients with nosocomial infections
- Patients with known or suspected bacteremia
- Patients requiring hospitalization
- Elderly or debilitated patients
- Patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia)
dverse Effects
>10%
High single dose therapy
- Diarrhea (52.8%)
- Nausea (32.6%)
- Abdominal pain (27%)
- Loose stool (19.1%)
1-10%
Elevated ALT, AST, creatinine (4-6%)
Elevated LDH, bilirubin (1-3%)
Community-acquired pneumonia
- Pain at injection site (6.5%)
- Diarrhea (4.3%)
- Nausea (3.9%)
- Local inflammation (3.1%)
- Abdominal pain (2.7%)
- Vomiting (1.4%)
Pelvic inflammatory disease
- Diarrhea (8.5%)
- Nausea (6.6%)
- Vaginitis (2.8%)
- Abdominal pain (1.9%)
- Anorexia (1.9%)
- Rash and pruritus (1.9%)
<1%
Dyspepsia
Flatulence
Mucositis
Oral Moniliasis
Gastritis
Headache
Somnolence
Bronchospasm
Taste perversion
Leukopenia
Neutropenia
Decreased platelet count
Elevated serum alkaline phosphatase
Postmarketing Reports
Allergic: Arthralgia, edema, urticaria and angioedema
Cardiovascular: Arrhythmias (eg, ventricular tachycardia), hypotension, QT prolongation, torsades de pointes, and cardiovascular death
Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and reports of tongue discoloration
General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis (including fatalities).
Genitourinary: Interstitial nephritis and acute renal failure and vaginitis
Hematopoietic: Thrombocytopenia
Liver/biliary: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure
Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope
Psychiatric: Aggressive reaction and anxiety
Skin/appendages: Pruritus, serious skin reactions including, erythema multiforme, AGEP, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS
Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss
Pregnancy & Lactation
Pregnancy
Available data on use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area
Lactation
Present in human milk
Non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin
No data available on the effects of azithromycin on milk production
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition
Clinical considerations
- Advise women to monitor the breastfed infant for diarrhea, vomiting, or rash
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.