Azi-500

Azi-500

azithromycin

Manufacturer:

InnoGen Pharmaceuticals

Distributor:

InnoGen Pharmaceuticals
Full Prescribing Info
Contents
Azithromycin monohydrate.
Description
Each Film-Coated Tablet contains: Azithromycin (as monohydrate) 500 mg.
Azithromycin is a nitrogen-containing macrolide or azalide with actions and uses similar to those of erythromycin. It is used in the treatment of a wide variety of infections caused by susceptible organisms.
Action
Pharmacology: Pharmacokinetics: Following oral administration about 40% of a dose of azithromycin is bioavailable. Absorption from the capsule formulation, but not the tablet formulation, is reduced by food. Peak plasma concentrations are achieved 2 to 3 hours after a dose, but azithromycin is extensively distributed to 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. Small amounts of azithromycin are demethylated in the liver, and it is excreted in bile as unchanged drug and metabolites. 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 probably in excess of 40 hours.
Microbiology: Antimicrobial Action: Azithromycin has the same antimicrobial actions as erythromycin, only, azithromycin is less active than erythromycin against streptococci and staphylococci, but has greater activity than erythromycin in vitro against some Gram-negative pathogens 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 some opportunistic mycobacteria, including Mycobacterium avium complex. It has activity against the protozoa Toxoplasma gondii and Plasmodium falciparum.
Indications/Uses
Azithromycin is used in the treatment of bronchitis, severe campylobacter enteritis, chancroid diphtheria, legionnaire's disease and other Legionella infections, neonatal conjunctivitis, pertussis, pneumonia (mycoplasmal and other atypical pneumonias as well as streptococcal), sinusitis and combined with neomycin, for the prophylaxis of surgical infection in patients undergoing bowel surgery. STI due to Chlamydia trachomatis & uncomplicated genital infections due to non-multiresistant Neisseria gonorrhea.
Azithromycin may also be used as a component of regimens in the treatment of Mycobacterium avium complex (MAC) infections and may be used for prophylaxis.
Dosage/Direction for Use
Usual dose is 1 tablet 500 mg once daily for 3 days or as prescribed by the physician.
Special Precautions
Azithromycin should not be used in patients with hepatic impairment.
Adverse Reactions
The most common adverse effects with azithromycin are gastrointestinal disturbances but are usually mild and less frequent than with erythromycin. Transient elevations of liver enzyme values have been reported and, rarely, cholestatic jaundice. Rashes, headache and dizziness may occur. Severe hypersensitivity reactions occur rarely but may be prolonged. Transient alterations in neutrophil counts have been seen in patients receiving azithromycin.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Macrolides
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Azi-500 FC tab 500 mg
Packing/Price
3's (P115/film-coated tab)
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