Each film coated tablet contains: Azithromycin Dihydrate, USP equivalent to Azithromycin 500 mg.
Pharmacology: Antimicrobial Action: Azithromycin is less active than erythromycin against streptococci and staphylococci, but has greater activity than erythromycin in vitro against some Gram-negative organisms such as Haemophilus influenzae and Moraxella catarrhalis (Branhamella catarrhalis), as well as having activity against some of the Enterobacteriaceae such as Escherichia coli and Salmonella and Shigella spp. Azithromycin is also more active than Erythromycin against Chlamydia trachomatis and Ureaplasma urealyticum, and some opportunistic mycobacteria, including Mycobacterium avium complex. It has activity against the protozoa Toxoplasma gondii and Plasmodium falciparum.
Pharmacokinetics: Azithromycin given orally is rapidly absorbed and about 40% bioavailable. Absorption from capsules, but not tablets or suspension, is reduced by food. Peak plasma concentrations occur 2 to 3 hours after an oral dose and 1 to 2 hours after intravenous dosage. However, Azithromycin is extensively distributed into the tissues, and tissue concentrations subsequently remain much higher than those in the blood; in contrast to most other antibacterials, plasma concentrations are therefore of little value as a guide to efficacy. High concentrations are taken up into white blood cells. There is little diffusion into the CSF when the meninges are not inflamed. Data from animal studies indicate that Azithromycin are demethylated in the liver, and it is excreted in bile mainly as unchanged drug and a number of inactive metabolites have also been detected. About 6% of an oral dose (representing about 20% of the amount in the systemic circulation) is excreted in the urine. The terminal elimination half-life is about 68 hours.
Azithromycin is used for the treatment of infections from respiratory pathogen (e.g. S. pyogenes, S. pneumoniae, M. catarrhalis, C. trachomatis, Legionella sp., Mycoplasma pneumoniae, S. aureus, and H. influenzae); C. pneumoniae and M. Avium infection; uncomplicated chlamydial urethritis, cervicitis or pharyngitis; alternative drug for multi-drug resistant Salmonella typhi infection outside the Central Nervous System (CNS).
The usual oral adult dose of Azithromycin is 500 mg as a single dose daily for 3 days.
Alternatively, an initial dose of 500 mg may be followed by 250 mg daily for a further 4 days. For uncomplicated genital infections caused by Chlamydia trachomatis and for chancroid, 1 g of Azithromycin is given as a single dose.
Gastrointestinal disturbances are the most frequent adverse effect of Azithromycin but are usually mild and less frequent than with Erythromycin.
Headache, somnolence, and taste disturbance may occur. Severe hypersensitivity reactions occur rarely but may be prolonged. Thrombocytopenia and mild transient neutropenia have been rarely reported in patients receiving Azithromycin. Pain and inflammation may occur at the site of intravenous infusions particularly at high concentrations.
Store at temperatures not exceeding 30°C. Protect from light.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
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