azithromycin
Regulatory sources consulted
Approved indications
- Respiratory infections, otitis media, skin infections, and urethritis or cervicitis due to Chlamydia trachomatis caused by susceptible organisms. It includes uncomplicated gonococcal urethritis or cervicitis when supported by the label and susceptibility.
Contraindications
Absolute
- Hypersensitivity to azithromycin, erythromycin, other macrolides, or ketolides; history of azithromycin-associated cholestatic jaundice or hepatic dysfunction.
Clinical warnings
- It may prolong QT and cause torsades de pointes; avoid with prolonged QT, hypokalemia or hypomagnesemia, significant bradycardia, and other QT-prolonging drugs. — CIMA/AEMPS, ficha técnica 65600
- Major warning · It may cause cholestatic hepatitis, hepatic necrosis, or liver failure; discontinue if signs of hepatic dysfunction develop. — CIMA/AEMPS, ficha técnica 65600
- Major warning · Clostridioides difficile-associated diarrhea and colitis may occur during or after treatment; assess significant diarrhea and discontinue if confirmed. — CIMA/AEMPS, ficha técnica 65600
- Major warning · It may exacerbate myasthenia gravis or trigger a myasthenic syndrome; discontinue if weakness worsens. — CIMA/AEMPS, ficha técnica 65600
Drug interactions
- ModerateAluminum- or magnesium-containing antacids
Mechanism: They reduce peak concentration when given simultaneously.
Recommendation: Do not administer simultaneously; separate doses.
CIMA/AEMPS, ficha técnica 65600
- HighQT-prolonging drugs
Mechanism: Effects on repolarization may be additive.
Recommendation: Avoid the combination or monitor ECG and electrolytes.
CIMA/AEMPS, ficha técnica 65600
- HighWarfarin and coumarin anticoagulants
Mechanism: It may increase anticoagulant effect and prothrombin time.
Recommendation: Monitor prothrombin time/INR during and after treatment.
CIMA/AEMPS, ficha técnica 65600
Adverse events
Common (≥1%)
Nausea, abdominal pain, diarrhea, and vomiting
Rare but serious
Anaphylaxis, severe hepatotoxicity, ventricular arrhythmia, and severe skin reactions
Pregnancy and lactation
It may be used during pregnancy only when clearly needed. It passes into milk; consider temporary interruption or infant monitoring according to the situation.
Recent literature (PubMed)
Community-acquired pneumonia (CAP) results in approximately 1.4 million emergency department visits, 740 000 hospitalizations, and 41 000 deaths in the US annually. Community-acquired pneumonia can be diagnosed in a patient with 2 or more signs (eg, temperature >38 °C or ≤36 °C; leukocyte count <4000/μL or >10 000/μL) or symptoms (eg, new or increased cough or dyspnea) of pneumonia in conjunction with consistent radiographic findings (eg, air space density) without an alternative explanation. Up to 10% of patients with CAP are hospitalized; of those, up to 1 in 5 require intensive care. Older adults (≥65 years) and those with underlying lung disease, smoking, or immune suppression are at highest risk for CAP and complications of CAP, including sepsis, acute respiratory distress syndrome, and death. Only 38% of patients hospitalized with CAP have a pathogen identified. Of those patients, up to 40% have viruses identified as the likely cause of CAP, with Streptococcus pneumoniae identified in approximately 15% of patients with an identified etiology of the pneumonia. All patients with CAP should be tested for COVID-19 and influenza when these viruses are common in the community because their diagnosis may affect treatment (eg, antiviral therapy) and infection prevention strategies. If test results for influenza and COVID-19 are negative or when the pathogens are not likely etiologies, patients can be treated empirically to cover the most likely bacterial pathogens. When selecting empirical antibacterial therapy, clinicians should consider disease severity and evaluate the likelihood of a bacterial infection-or resistant infection-and risk of harm from overuse of antibacterial drugs. Hospitalized patients without risk factors for resistant bacteria can be treated with β-lactam/macrolide combination therapy, such as ceftriaxone combined with azithromycin, for a minimum of 3 days. Systemic corticosteroid administration within 24 hours of development of severe CAP may red
Cystic fibrosis, a genetic disorder defined by variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, affects more than 30 000 individuals in the US and approximately 89 000 worldwide. Absent or decreased function of the CFTR protein is associated with multiorgan dysfunction and shortened life expectancy. CFTR is an anion channel in the apical membrane of epithelial cells. Loss of function leads to obstructed exocrine glands. Of people with cystic fibrosis in the US, approximately 85.5% have the gene variant F508del. Manifestations of cystic fibrosis in patients with the F508del gene variant begin in infancy with steatorrhea, poor weight gain, and respiratory symptoms (coughing, wheezing). As people with cystic fibrosis age, chronic respiratory bacterial infections cause loss of lung function and bronchiectasis. With the availability of universal newborn screening in multiple countries including the US, many people with cystic fibrosis are asymptomatic at diagnosis. With multidisciplinary care teams that included dietitians, respiratory therapists, and social workers, treatment of cystic fibrosis can slow disease progression. Median survival has improved from 36.3 years (95% CI, 35.1-37.9) in 2006 to 53.1 years (95% CI, 51.6-54.7) in 2021. Pulmonary therapies for patients with cystic fibrosis consist of mucolytics (eg, dornase alfa), anti-inflammatories (eg, azithromycin), and antibiotics (such as tobramycin delivered by a nebulizer). Four small molecular therapies, termed CFTR modulators, that facilitate CFTR production and/or function have received regulatory approval. Examples are ivacaftor and elexacaftor-tezacaftor-ivacaftor. For example, in patients with 1 F508del variant, the combination of ivacaftor, tezacaftor, and elexacaftor improved lung function from -0.2% in the placebo group to 13.6% (difference, 13.8%; 95% CI, 12.1%-15.4%) and decreased the annualized estimated rate of pulmonary exacerbations from 0.98 to 0.37 (rate ratio, 0
Group A beta-hemolytic streptococcal pharyngitis is a common infection responsible for more than 6 million office visits in the United States annually. Only 10% of adults seeking care for a sore throat have group A beta-hemolytic streptococcal pharyngitis; however, 60% or more are prescribed antibiotics. Guidelines recommend using clinical decision rules to assess the risk of group A beta-hemolytic streptococcal infection, followed by rapid antigen testing if a diagnosis is unclear, before prescribing antibiotics. Fever, tonsillar exudate, cervical lymphadenitis, and patient ages of 3 to 15 years increase clinical suspicion. A cough is more suggestive of a viral etiology. The limited history used in these decision rules is amenable to virtual visits. After a negative rapid antigen test result, a throat culture is recommended in children and adolescents. Penicillin and amoxicillin are first-line antibiotics, with a recommended course of 10 days; first-generation cephalosporins are recommended for patients with nonanaphylactic allergies to penicillin. There is significant resistance to azithromycin and clarithromycin in some parts of the United States. Steroids are not recommended for symptomatic treatment. Patients with worsening symptoms after appropriate antibiotic initiation or with symptoms lasting 5 days after the start of treatment should be reevaluated. Tonsillectomy is rarely recommended as a preventive measure: seven episodes of streptococcal pharyngitis in 1 year, five episodes in each of the past 2 years, or three episodes in each of the past 3 years are commonly used thresholds for considering surgery.
Non-cystic fibrosis (CF) bronchiectasis is a chronic lung condition caused by permanent bronchial dilatation and inflammation and is characterized by daily cough, sputum, and recurrent exacerbations. Approximately 500 000 people in the US have non-CF bronchiectasis. Non-CF bronchiectasis may be associated with prior pneumonia, infection with nontuberculous mycobacteria or tuberculosis, genetic conditions (eg, α1-antitrypsin deficiency, primary ciliary dyskinesia), autoimmune diseases (eg, rheumatoid arthritis, inflammatory bowel disease), allergic bronchopulmonary aspergillosis, and immunodeficiency syndromes (eg, common variable immunodeficiency). Up to 38% of cases are idiopathic. According to US data, conditions associated with non-CF bronchiectasis include gastroesophageal reflux disease (47%), asthma (29%), and chronic obstructive pulmonary disease (20%). The prevalence of non-CF bronchiectasis increases substantially with age (7 per 100 000 in individuals 18-34 years vs 812 per 100 000 in those ≥75 years) and is more common in women than men (180 vs 95 per 100 000). Diagnosis is confirmed with noncontrast chest computed tomography showing dilated airways and often airway thickening and mucus plugging. Initial diagnostic evaluation involves blood testing (complete blood cell count with differential); immunoglobulin quantification testing (IgG, IgA, IgE, and IgM); sputum cultures for bacteria, mycobacteria, and fungi; and prebronchodilator and postbronchodilator spirometry. Treatment includes airway clearance techniques; nebulization of saline to loosen tenacious secretions; and regular exercise, participation in pulmonary rehabilitation, or both. Inhaled bronchodilators (β-agonists and antimuscarinic agents) and inhaled corticosteroids are indicated for patients with bronchiectasis who have asthma or chronic obstructive pulmonary disease. Exacerbations of bronchiectasis, which typically present with increased cough and sputum and worsened fatigue, are associate
Acne is one of the most common dermatological conditions to affect women of childbearing age, so it is important to consider the safety of long-term acne treatments on women who could become pregnant. In this review article, we clarify what management options are available to treat acne during pregnancy. Topical treatments, typically first-line for acne, such as azelaic acid, clindamycin, erythromycin, metronidazole, benzoyl peroxide, salicylic acid, dapsone, and retinoids, were reviewed. Systemic treatments, such as zinc supplements, cephalexin, cefadroxil, amoxicillin, azithromycin, erythromycin, and corticosteroids, typically second-line for acne, were also reviewed. Alternative treatments such as light therapy and cosmetic procedures were also evaluated. Due to recommendation of sunscreen utilization during acne treatments, sunscreen usage during pregnancy was also assessed. Management of acne during unplanned pregnancy was discussed in further detail regarding safety and adverse effects. Through summarized tables and examples of studies demonstrating safety and efficacy of treatments, the following is a resource for providers and patients to utilize for management of acne during pregnancy.