COMPOSITION
Zimax® 500 Tablet : Each film coated tablet contains Azithromycin USP
500 mg as Azithromycin Dihydrate USP.
Zimax® Capsule : Each capsule contains Azithromycin USP 250 mg as
Azithromycin Dihydrate USP.
Zimax® Dry Powder for Suspension: When reconstituted, each 5 ml
suspension contains Azithromycin USP 200 mg as
Azithromycin Dihydrate USP.
PHARMACOLOGY
Zimax® (Azithromycin) is an azalide antibiotic, subclass of the macrolide
class of antibiotics.
Zimax® (Azithromycin) acts by binding to the 50S ribosomal subunit of
susceptible organisms and thus interferes with microbial protein synthesis.
Following oral administration in humans, Zimax® (Azithromycin) is rapidly
absorbed and widely distributed throughout the body ; bioavailability is
approximately 37%. The time taken to peak plasma levels is 2-3 hours.
However, kinetic studies have shown markedly higher Zimax®
(Azithromycin) levels in tissue than in plasma or serum indicating that the
drug is higher tissue bound, resulting in rapid distribution into tissues and
high concentration within cells. Concentrations in target tissues such as
lung, tonsil and prostate exceed the MIC90 for likely pathogens after a single
dose of 500 mg.
MACROLIDES
other Streptococcal species ; Haemophilus influenzae and parainfluenzae ;
Moraxella catarrhalis ; anaerobes including Bacteroides fragilis, Escherichia
coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi,
Haemophilus ducreyi, Neisseria gonorrhoeae and Chlamydia trachomatis.
Zimax® (Azithromycin) also demonstrates activity in vitro against Legionella
pneumophila, Mycoplasma pneumoniae and hominis; Campylobacter spp.,
Toxoplasma gondii and Treponema pallidum.
INDICATION
Zimax® (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, Zimax® (Azithromycin)
is indicated in the treatment of non-gonococcal urethritis and cervicitis due
to Chlamydia trachomatis.
MACROLIDES
Azithromycin on children under 6 months of age. For children with body
weight 15-25 kg (3-7 years), the dose is 200 mg once daily for 3 days; for
body weight 26-35 kg (8-11 years), the dose is 300 mg once daily for 3 days;
for body weight 36-45 kg (12-14 years), the dose is 400 mg once daily for 3
days. For body weights over 45 kg, normal adult dosage is recommended.
CONTRAINDICATION AND PRECAUTION
Azithromycin is contra-indicated in patients with a known hypersensitivity to
azithromycin or any of the macrolide antibiotics. Because of the theoretical
possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.
As the liver is the principal route of excretion of azithromycin
it should not be used in patients with hepatic disease.
Avoid concomitant administration with terfenadine or astemizole.
Precaution should be taken in patients with more severe renal impairment.
SIDE EFFECT
Zimax® (Azithromycin) is well tolerated with a low incidence of side-effects.
The side-effects include nausea, vomiting, abdominal discomfort
(pain/cramps), flatulence, diarrhoea, 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.
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