INDICATIONS:
Zithrin® is indicated for infections caused by susceptible organisms, in lower
respiratory tract infections including bronchitis and pneumonia, skin and soft tissue infections,
otitis media and in upper respiratory tract infections including sinusitis, pharyngitis and
tonsillitis.
Zithrin®(Azithromycin) is indicated in the treatment of uncomplicated genital infections due to
Chlamydia trachomatis.
Zithrin®(Azithromycin) is also indicated in enteric fever, diarrhoea and cholera.
DOSAGE AND ADMINISTRATION:
For Adults, Zithrin®(Azithromycin) should be given as
500mg once daily orally for 3 days or as an alternative given over 5 days with 500mg on day
1 then 250mg on days 2-5.
For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1g
given as a single dose.
For complicated enteric fever, in adults 1g of Azithromycin and in children 20mg/kg of
Azithromycin once daily for 5 days can be given.
For diarrhoea, in adults 500mg of Azithromycin and in children 10mg/kg of Azithromycin once
daily for 3 days can be given.
For cholera, in adults 1g a single dose of Azithromycin and in children 20mg/kg a single dose
of Azithromycin can be given.
Normal adult dose is recommended for elderly patients.
For children over 1 month recommended dose is 10mg/kg once daily for 3 days; or if body
weight is 15-25kg: 200 mg once daily for 3 days; body weight is 26-35kg: 300mg once daily
for 3 days, body weight is 36-45kg: 400mg once daily for 3 days. Azithromycin is also
preferred for infant below 1 month, though limited safety data are available.
As common with many other antibiotics, Zithrin® should be taken at least 1 hour before or 2
hours after meal and antacid.
CONTRAINDICATIONS:
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. Majority
of the side effects were mild to moderate in nature and of gastrointestinal in origin with
nausea, abdominal discomfort, vomiting, flatulence and diarrhoea. Allergic reactions such as
rash have occurred and there have also been rare reports of serious hypersensitivity
reactions. Reversible elevations in liver transaminases have been seen with a frequency
similarly to the comparative macrolides and penicillins used in clinical trials. Transient mild
reductions in neutrophil counts have occasionally been observed in clinical trials, although a
causal relationship to Azithromycin has not been established.
PRECAUTIONS:
As with any antibiotic, observation for signs of super infection with no
susceptible organisms, including fungi recommended. No dose adjustment is needed in
patients with renal impairment.
USE IN PREGNANCY AND LACTATION:
Animal reproduction studies have demonstrated
that Azithromycin crosses the placenta, but have revealed 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. No data on secretion
of Azithromycin in breast milk is available. So, Azithromycin should only be used in lactating
women where adequate alternatives are not available.
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