Azithromycin (azithromycin)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Azithromycin is an azalide antibiotic, a subclass of macrolide antibiotics.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Generic name: azithromycin
Pronunciation: (ay-ZITH-roe-MYE-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Azithromycin
Indications
The following indications are listed for Azithromycin:
- Acute Bacterial Otitis Media
- Acute Exacerbation Of Obstructive Chronic Bronchitis By M. Catarrhalis
- Acute Exacerbation Of Obstructive Chronic Bronchitis By Streptococcus Pneumoniae
- Acute Exacerbation Of Obstructive Chronic Bronchitis Due To H. Flu
- Acute Gonococcal Cervicitis
- Acute Gonococcal Urethritis
- Acute Haemophilus Influenzae Bacterial Sinusitis
- Acute Moraxella Catarrhalis Bacterial Sinusitis
- Acute Streptococcus Pneumoniae Bacterial Sinusitis
- Chancroid
- Chlamydia Cervicitis
- Chlamydia Trachomatis Pelvic Inflammatory Disease
- Chlamydia Trachomatis Urethritis
- Chlamydial Pneumonia
- Chronic Bronchitis With Bacterial Exacerbation
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Pneumonia
- Moraxella Catarrhalis Acute Otitis Media
- Mycoplasma Hominis Pelvic Inflammatory Disease
- Mycoplasmal Pneumonia
- Pelvic Inflammatory Disease With Neisseria Gonorrhea
- Pharyngitis Due To Streptococcus Pyogenes
- Pneumococcal Acute Otitis Media
- Pneumococcal Pneumonia
- Skin And Skin Structure Streptococcus Agalactiae Infection
- Skin And Skin Structure Streptococcus Pyogenes Infection
- Staphylococcus Aureus Skin And Skin Structure Infection
- Tonsillitis Due To Streptococcus Pyogenes
Also known as: Acute Bacterial Exacerbation Of Chronic Bronchitis, Acute Cervical Gonococcal Infection, Acute Cervical Gonorrhea, Acute Cervical Infection Due To Neisseria Gonorrhoeae, Acute Exacerbation Of Obstructive Chronic Bronchitis By B. Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Branhamella Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Moraxella Catarrhalis, Acute Exacerbation Of Obstructive Chronic Bronchitis By Neisseria Catarrhalis, Acute H. Influenzae Exacerbation Of Obstructive Chronic Bronchitis, Acute Otitis Media Due To Diplococcus Pneumoniae, Acute Otitis Media Due To Fraenkel's Pneumococcus, Acute Otitis Media Due To H. Flu, Acute Otitis Media Due To Haemophilus Influenzae, Acute Otitis Media Due To Hemophilus Influenzae, Acute Otitis Media Due To Influenza Bacillus, Acute Otitis Media Due To Moraxella Catarrhalis, Acute Otitis Media Due To Pfeiffer's Bacillus, Acute Otitis Media Due To Pneumococcus, Acute Otitis Media Due To Pneumonococcus, Acute Otitis Media Due To Streptococcus Pneumoniae, Acute Sinusitis Due To B. Catarrhalis, Acute Sinusitis Due To Branhamella Catarrhalis, Acute Sinusitis Due To Diplococcus Pneumoniae, Acute Sinusitis Due To Fraenkel's Pneumococcus, Acute Sinusitis Due To Fraenkel's Pneumonococcus, Acute Sinusitis Due To H. Flu, Acute Sinusitis Due To H. Influenzae, Acute Sinusitis Due To Haemophilus Influenzae, Acute Sinusitis Due To Hemophilus Influenzae, Acute Sinusitis Due To Influenza Bacillus, Acute Sinusitis Due To M. Catarrhalis, Acute Sinusitis Due To Moraxella Catarrhalis, Acute Sinusitis Due To Neisseria Catarrhalis, Acute Sinusitis Due To Pfeiffer's Bacillus, Acute Sinusitis Due To Pneumococcus, Acute Sinusitis Due To Streptococcus Pneumoniae, Acute Sinusitis From Fraenkel-Weichselbaum Pneumococcus, Acute Urethral Gonococcal Infection, Acute Urethral Gonorrhea, Acute Urethral Infection Due To Neisseria Gonorrhoeae, Bacterial Exacerbation Of Chronic Bronchitis, Bacterial Otitis Media, Cervicitis Due To Chlamydia Trachomatis, Chancroidal Ulcer, Eaton Agent Pneumonia, Epidemic Sore Throat, Fraenkel-Weichselbaum Pneumococcus Acute Otitis Media, H. Flu Pneumonia, H. Influenzae Pneumonia, Hemophilus Influenzae Pneumonia, Infection Of The Lungs Due To Chlamydia, Influenza Bacillus Pneumonia, Ngu Due To Chlamydia Trachomatis, Nongonococcal Urethritis Due To Chlamydia Trachomatis, Pelvic Inflammatory Disease Due To Chlamydia Trachomatis, Pelvic Inflammatory Disease Due To Mycoplasma Hominis, Pelvic Inflammatory Disease Due To Neisseria Gonorrhea, Pfeiffer's Bacillus Pneumonia, Pharyngitis Due To Group A Beta-Hemolytic Streptococci, Pharyngitis Due To Streptococcus Epidemicus, Pid Due To Chlamydia Trachomatis, Pid Due To Mycoplasma Hominis, Pneumonia Due To Haemophilus Influenzae, Pneumonia Due To Streptococcus Pneumoniae, Primary Atypical Pneumonia, Septic Sore Throat, Skin & Skin Soft Tissue Streptococcus Pyogenes Infection, Skin And Skin Soft Tissue Infection Due To S. Agalactiae, Skin And Skin Soft Tissue S. Agalactiae Infection, Skin And Skin Soft Tissue Staphylococcus Aureus Infection, Streptococcal Pharyngitis, Streptococcus Pyogenes Tonsillitis, Trachelitis Due To Chlamydia Trachomatis, Urethritis Due To Chlamydia Trachomatis, Venereal Ulcer.
Dosing
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Dosage of azithromycin, which is commercially available for oral and IV use as the dihydrate, is expressed in terms of anhydrous azithromycin.
Two 250-mg tablets of azithromycin are bioequivalent to one 500-mg tablet. The extended-release oral suspension is not bioequivalent to and is not interchangeable with the conventional oral suspension or tablets.
Dosage adjustment is not necessary in patients with renal impairment (glomerular filtration rate 80 mL/minute or less). However, data are limited regarding use of azithromycin in patients with severe renal impairment (glomerular filtration rate less than 10 mL/minute) and the manufacturer states that the drug should be used with caution in these patients.
The pharmacokinetics of azithromycin in patients with hepatic impairment have not been established. The manufacturer states that data are insufficient to make dosage recommendations for patients with hepatic impairment and azithromycin should be used with caution in such patients since the drug is eliminated principally via the liver. Based on results of a limited study in patients with impaired hepatic function, some clinicians state that dosage adjustments are not necessary in patients with class A or B liver cirrhosis.
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Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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No enhanced messaging available.
Reproduction studies in rats and mice using azithromycin dosages up to 200 mg/kg daily (approximately equivalent on a mg/m2 basis to 4 and 2 times, respectively, the human daily oral azithromycin dosage of 500 mg; to 2 or 1 times, respectively, the 1.2-g weekly dosage used for prevention of M. avium complex infection; or 3.3 or 1.7 times, respectively, the 600-mg daily oral dosage used for the treatment of M. avium complex) have not revealed evidence of harm to the fetus. However, there are no adequate and controlled studies to date using azithromycin in pregnant women, and the drug should be used during pregnancy only when clearly needed.
Preliminary data indicate that azithromycin may be safe and effective in the treatment of chlamydial infections in pregnant women; however, there are insufficient data to recommend routine use of the drug during pregnancy. (See Chlamydial Infections: Urogenital Chlamydial Infections, in Uses.) Azithromycin is considered the drug of choice for Mycobacterium avium complex (MAC) prophylaxis in HIV-infected pregnant women. (See Mycobacterium Avium Complex (MAC) infections: Prevention of Disseminated MAC Infection, in Uses.)
Azithromycin has been detected in human milk. The drug should be used with caution in nursing women.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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