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.
A large fraction of the absorbed dose of Zimax® (Azithromycin) remains
unmetabolised. There is some metabolism in the liver mainly by Ndemethylation,
the metabolite being excreted in the bile.
The terminal elimination phase of Zimax® (Azithromycin) from the serum is
due to hepatic metabolism, biliary excretion and transintestinal passage. The
half-life of this phase is approximately 40-60 hours. The major route of
elimination is biliary excretion of the unchanged compound. Transintestinal
excretion of the unchanged drug is also an important route of elimination.
Only a small amount of the dose is excreted unchanged in the urine.
Zimax® (Azithromycin) demonstrated activity in vitro, against a wide range
of Gram-positive and Gram-negative bacteria including: Staphylococcus
aureus, Streptococcus pneumoniae, Streptococcus pyogenes (Group A) and
Azithromycin
Macrolide
Zimax®
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.
DRUG INTERACTION
Antacids: Peak serum levels but not the total extent of absorption are
reduced by aluminium – and magnesium – containing antacids in the
stomach. Azithromycin should therefore be taken at least 1 hour before or 2
hours after taking these antacids.
Ergot Derivatives: Because of the theoretical possibility of ergotism,
concomitant administration of ergot derivatives and azithromycin should be
avoided.
Digoxin & Cyclosporin: Macrolides have been known to increase the plasma
concentration of Digoxin & Cyclosporin and so caution should be exercised
while co-administration is necessary.
Anti-Histamines: A potentially life threatening interaction between
erythromycin and terfenadine or astemizole have been reported. Although
Zimax®
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