Presentation
Azithromycin Tablet: Each tablet contains Azithromycin Dihydrate USP 524.03 mg equivalent to Azithromycin 500 mg.
Azithromycin 250 Tablet: Each tablet contains Azithromycin Dihydrate USP 262.015 mg equivalent to Azithromycin 250 mg.
Azithromycin Dry Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin 35 ml Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.
Azithromycin injection: Each vial contains lyophilized powder of Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg, after reconstitution according to direction each ml contains Azithromycin Dihydrate USP equivalent to Azithromycin 100 mg.
Description
Azithromycin is an azalide antibiotic, a subclass of macrolide antibiotic. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin has been shown to be active against most strains in the following microorganisms, both In vitro and in clinical infections:
Gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Escherichia coli.
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Bacteroides fragilis, Legionella pneumophila, oxoplasma gondii.
Indications and Uses
Azithromycin is indicated for infections caused by susceptible organisms in-
Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis
Lower respiratory tract infections including bronchitis, acute bacterial exacerbations of chronic obstructive pulmonary
disease (COPD)
Otitis media
Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections
In diarrhea, Shigellosis
Sexually transmitted diseases, especially in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Mild or moderate typhoid due to multiple-antibacterial resistant organisms
Prophylaxis against a-hemolytic (viridans group) streptococcal bacterial endocarditis
Other infections including odontogenic infections, bartonella infections, toxoplasmosis, babesiosis
Contraindications
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivative and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
Dosage And Administration
Azithromycin tablet can be taken with or without food. Azithromycin suspension should be taken at least 1 hour before or 2 hours after meal.
Oral
Adult
For respiratory tract infections, otitis media and skin & soft tissue infections: 500 mg once daily for 3 days or an alternative to this as 500 mg once on day 1, followed by 250 mg once daily for next 4 days. For sexually transmitted diseases like genital ulcer, non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis : a single 1 gm (1000 mg) dose. For the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae : a single 2 gm (2000 mg) dose. In typhoid, 500 mg once daily for 7 days. In Cholera, a single 1 gm (1000 mg) dose. In Shigellosis, 500 mg once on day 1, followed by 250 mg once daily for next 4 days.
Children:
Age/body weight Daily dose Measuring dropper/spoon Duration
Over 6 months 10 mg/kg According to Physician's 3 days
Recommendation
15-25 kg 200 mg 1 spoonful 3 days
26-35 kg 300 mg 1.5 spoonful 3 days
36-45 kg 400 mg 2 spoonful 3 days
Elderly: same as for adults
Injection
Adults
Community-acquired pneumonia: 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 tablet to complete a 7- to 10-day course of therapy.
Pelvic inflammatory disease: 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.
Children
Use and dose must be determied by doctor. Although not currently approved by the FDA, the IV preparation has been studied in children using a dose of 10 mg/kg administered over 1 hour once daily.
Azithromycin injection should be followed by Azithromycin by the oral route as required. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
Precautions
As with any antibiotic, observation for signs of super infection with non-susceptable organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.
Side Effects
Azithromycin is well tolerated with a low incidence of side-efects. The side-effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy. Reversible elevations in liver transaminases have been observed occasionally. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although causal relationship to Azithromycin has not been established.
Use in pregnancy & lactation
Pregnancy: US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to nursing mother.
Overdosage
There are no data available on overdose with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
Commercial Pack
Azithromycin Tablet: Each box contains 2 blister strip of 3 tablets.
Azithromycin 250 Tablet: Each box contains 2 blister strip of 3 tablets.
Azithromycin Dry suspension: Bottle containing dry powder for 20 ml suspension.
Azithromycin 35 ml suspension: Bottle containing dry powder for 35 ml suspension.
Azithromycin injection: Each Pack contains 1 vial of lyophilized powder of Azithromycin USP 500 mg, 1 ampoule of 5 ml water for injection BP for dilution and a 5 ml disposable syringe and a butterfly needle.