Azithromycin | Prescribing Information

Azithromycin is an antibiotic medication used for the treatment of several bacterial infections. This includes middle ear infections, strep throat, pneumonia, traveler’s diarrhea, and certain other intestinal infections. Along with other medications, it may also be used for malaria. It can be taken by mouth or intravenously.

Azithromycin was discovered in 1980 by the Croatian pharmaceutical company Pliva and approved for medical use under the brand name Sumamed in 1988. It is on the World Health Organization’s List of Essential Medicines. The World Health Organization classifies it as critically important for human medicine. It is available as a generic medication and is sold under many trade names worldwide. In 2020, it was the 68th most commonly prescribed medication in the United States, with more than 10 million prescriptions.


Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.


Azithromycin is acid-stable and can therefore be taken orally with no need for protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. The time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin’s half-life allows a large single dose to be administered and yet maintains bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half-life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drugs from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over a week, approximately 6% of the administered dose appears as an unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin is active against most isolates of the following microorganisms, both in vitro and in clinical infections:

  • Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
  • Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
  • Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, and Beta-lactamase production should not affect azithromycin activity.
  • Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C, F, G), Viridans group streptococci
  • Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
  • Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia


Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for the next 2 days may also be given.


  • 10 mg/kg body weight once daily for 3 days for children over 6 months
  • 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
  • 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
  • In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

  • 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and following clinical response.
  • The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and following clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
  • The safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.


Reconstitution procedure of suspension-

  • Step 01: Shake the bottle well to loosen the powder.
  • Step 02: Add boiled and cooled water up to the watermark on the bottle label.
  • Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.


Antacid: In patients receiving azithromycin and antacids, azithromycin should be taken at least 1 hour before or 2 hours after the antacid. Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite.

Cyclosporin: Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin. In the absence of conclusive data from pharmacokinetic studies or clinical data investigating potential interactions between azithromycin and cyclosporine, caution should be exercised before co-administration of these two drugs. If coadministration is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.

Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant azithromycin and digoxin the possibility of raised digoxin levels should be borne in mind and digoxin levels monitored.

Ergot derivatives: Because of the theoretical possibility of ergotism, azithromycin, and ergot derivatives should not be co-administered.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.

Theophylline: There is no evidence of any pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. In general, however, theophylline levels should be monitored.

Warfarin: In a pharmacodynamic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Azithromycin and warfarin may be co-administered, but monitoring of the prothrombin time should be continued as routinely performed.

Terfenadine: Azithromycin did not affect the pharmacokinetics of terfenadine administered at the recommended dose of 60 mg every 12 hours. The addition of azithromycin did not result in any significant changes in cardiac repolarisation (QTc interval) measured during the steady state dosing of terfenadine.


Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

Side Effects:

Azithromycin is well tolerated with a low incidence of side effects. Most side effects observed were mild to moderate in severity. The majority of side effects were gastrointestinal in origin with nausea, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhea, and loose stools being occasionally observed. Allergic reactions such as rash or photosensitivity have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Rarely, cases of cholestatic jaundice have been observed. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to azithromycin has not been established. Hearing impairment: In investigational studies where higher doses were used for prolonged periods, reversible hearing impairment was seen in some patients.

Pregnancy & Lactation:

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Precautions & Warnings:

As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic edema and anaphylaxis, have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a long period of observation and treatment.

Use in Special Populations

Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance >40 ml/min), but there are no data regarding azithromycin in patients with more severe renal impairment, thus caution should be exercised in using azithromycin in these patients.

Use in hepatic impairment: As the liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.

Effects on ability to drive and use machines: There is no evidence to suggest that azithromycin may affect a patient’s ability to drive or operate machinery.

Overdose Effects:

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting, and diarrhea. Gastric lavage and general supportive measures are indicated.

Storage Conditions:

  • Store in a cool & dry place below 30°C.
  • Protect from light & moisture.
  • Keep out of reach of children.


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