Each film-coated tablet contains: Azithromycin (as dihydrate) 500 mg.
Pharmacology: Antimicrobial Action: Azithromycin inhibits RNA dependent protein synthesis by binding to the 50s ribosomal subunit of susceptible bacteria. 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.
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 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 about 68 hours.
Azithromycin is a nitrogen-containing macrolide or azalide with wide spectrum of activity that has been used in the treatment of a wide variety of infections caused by susceptible organisms. In lower respiratory tract infections including bronchitis due to Haemophilus influenzae, Moraxella catarhallis, Streptococcus pneumoniae or Staphylococcus aureus and pneumonia due to Streptococcus pneumoniae or Haemophilus influenza. It is also given in the treatment of respiratory tract infections (including otitis media), in skin and soft-tissue infections, and in uncomplicated genital infections. Azithromycin may also be used for the prophylaxis, and as a component regimen in the treatment of Mycobacterium avium complex (MAC). It is used in some countries for the prophylaxis of endocarditis in at risks patients unable to take penicillin. It is also used in the management of trachoma and typhoid.
Usual adult dose: 500 mg as single dose daily for 3 days.
Initial dose: 500 mg followed by 250 mg daily for 4 days.
Uncomplicated genital infections due to Chlamydia trachomatis: 1 g as a single dose.
Uncomplicated gonorrhea: 2 g as a single dose.
Prophylaxis of disseminated MAC infections: 1.2 g once weekly.
Children over 6 months: 10 mg/kg once on the first day then 5 mg/kg for 4 days.
Over 2 years: 12 mg/kg once daily for 5 days.
Or as prescribed by the physician.
Azithromycin should not be used in patients with hepatic impairment because biliary excretion is the major route of elimination for azithromycin. It is also contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotics.
Azithromycin should not be used in patients with hepatic impairment because biliary excretion is the major route of elimination for azithromycin. It is also contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotics.
Gastrointestinal disturbances are the most frequent adverse effect 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. Pain and inflammation may occur at the site of intravenous infusions.
Concurrent administration of antacids containing aluminum or magnesium salts can reduce the rate, but not the extent, of absorption of azithromycin. Azithromycin and ergot derivatives should not be co-administered because of the theoretical possibilities of ergotism. Some of the macrolide antibiotics have been reported to impair the metabolism of Digoxin (in the gut) in some patients. Increased ribafutin toxicity has been reported in patients receiving azithromycin and ribafutin.
Store at temperatures not exceeding 30°C.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Azent FC tab 500 mg
4 × 6's (P2,640/box)