Pharmacotherapeutic Group: Antibacterial.
Pharmacology: Antibiotic action: Azithromycin has the same antimicrobial action 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.
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 are taken up into white blood cells. There is little diffusion in 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.
For 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, uncomplicated Chlamydial urethritis, cervicitis or pharyngitis. 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.
Powder for Suspension: Usual dose for children over 6 months of age for pneumonia or otitis media is 10 mg per kg on the first day, then 5 mg per kg daily for a further 4 days treatment, and the dose for pharyngitis in children aged over 2 years is 12 mg per kg daily for 5 days or as prescribed by the physician.
Typical symptoms of overdosage with Azithromycin (as monohydrate) include hearing loss, severe nausea, vomiting and diarrhea. Gastric lavage and general supportive measures are indicated.
Patients with a history of allergic or hypersensitivity reactions to azithromycin, erythromycin or any of the macrolide antibiotics.
Azithromycin should not be used in patients with hepatic impairment.
Pregnancy: Pregnancy Category B.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.
Lactation: It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to lactating women.
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 seen 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.
Antacid, carbamazepine, cimetidine, terfenadine, zidovudine, didanosine, cyclosporin, digoxin, methylprednisolone, coumarin-type oral anticoagulants, rifabutin, efavirenz, fluconazole, indinavir, nelfinavir, trimethoprim/sulfamethoxazole.
Store at temperatures not exceeding 30°C.
Shake well before use.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Azi-200 powd for susp 200 mg/5 mL
22.5 mL x 1's
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