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Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and paediatric patient populations vary in these indications.
Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Acute Bacterial Sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Community-acquired Pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/Tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated Skin and Skin Structure Infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.
Urethritis and Cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital Ulcer Disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Acute Otitis Media (patients >6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Community-acquired Pneumonia (patients >6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/Tonsillitis (patients >2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Note: Azithromycin is not the substance of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. For this and for the prophylaxis of acute rheumatic fever, penicillin is the treatment of first choice.
| Infection* | Recommended Dose/Duration of Therapy |
|---|---|
| Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) | 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2 through 5. |
| Acute bacterial exacerbations of chronic obstructive pulmonary disease | 500 mg q.d. × 3 days OR 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2 through 5. |
| Acute bacterial sinusitis | 500 mg q.d. × 3 days |
| Genital ulcer disease (chancroid) | One single 1 gm dose |
| Non-gonoccocal urethritis and cervicitis | One single 1 gm dose |
| Gonococcal urethritis and cervicitis | One single 2 gm dose |
* Due to the indicated organisms
No dosage adjustment is recommended for patients with mild-to-moderate renal impairment (GFR 30–80 ml/min). The mean AUC0–120 was similar in subjects with GFR at 10–80 mL/min compared with subjects with normal renal function, whereas it increased by 35% in subjects with GFR <10 mL/min compared with subjects with normal renal function. Caution should be exercised when azithromycin is administered to subjects with severe renal impairment (GFR <10 ml/min).
Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease.
The same dosage as in adult patients is used in the elderly. Since elderly patients can be patients with ongoing pro-arrhythmic conditions, particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes.
| Age | Indications | 1-day Regimen | 3-day Regimen | 5-day Regimen |
|---|---|---|---|---|
| 6 months and above | Acute otitis media | 30 mg/kg single dose | 10 mg/kg once daily | Day 1: 10 mg/kg single dose Days 2–5: 5 mg/kg/day |
| Acute bacterial sinusitis | 10 mg/kg once daily | Day 1: 10 mg/kg single dose Days 2–5: 5 mg/kg/day | ||
| Community- acquired pneumonia/ Acute bronchitis | 10 mg/kg once daily | Day 1: 10 mg/kg single dose Days 2–5: 5 mg/kg/day | ||
| 6 months to 1 year | Pharyngitis/ Tonsillitis | -- | 10 mg/kg once daily | |
| From 1 year to 2 years | -- | 10 or 20 mg/kg with max. daily dose of 500 mg | ||
| 2 years and above | -- | 10 or 20 mg/kg with max. daily dose of 500 mg | 12 mg/kg once daily | |
| Adolescents and older children (weighing above 45 kg) | Uncomplicated genital infections | A single 1 gm dose | ||
| Children above 45 kg weight | All the above given indications | As per adult dosage | ||
Effectiveness of the 1-day regimen in paediatric patients with community-acquired pneumonia and acute bacterial sinusitis has not been established. The safety of redosing azithromycin in paediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established.
AZIMAX tablets can be taken with or without food.
Adverse events experienced in higher than recommended doses were similar to those seen at normal doses, particularly nausea, diarrhoea and vomiting. In the event of overdose, administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated as required.
Store at room temperature. Protect from moisture
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