AZITH Tablet

In the treatment of:

Lower Respiratory Tract Infections- community acquired pneumonia, acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bronchitis due to H.influenza, M.catarrhalis, or S.pneumoniae.

Upper Respiratory Tract Infections- Ear, nose and throat infections like, tonsillitis, sinusitis, otitis media and pharyngitis.

Genitourinary Tract Infections- (including sexually transmitted diseases), urethritis, prostatitis, cervisitis.

Cervicovaginitis and salpingitis due to N.gonorrhoea and C.trachomatis, chlamydial conjunctivitis.

Skin& Soft Tissue Infections- Folliculitis, furuncles, carbuncles, impetigo, pyoderma, infected ulcer, infected dermititis, cellulitis and erysipelas due to S.aures, S.pyogenes or S.agalaqctiae.

Dosage and Administration:

AZITH tablets may be taken without regarding food. However increased tolerability has been observed when tablets are taken with food.

Mild to Moderate Lower Respiratory Tract Infections, Upper Respiratory Tract Infections and Uncomplicated Skin& Soft Tissue Infections:

Adults (>16 years of age): 500mg. as a single dose on the first day followed by 250mg. once daily on 2 days through 5 for a total dose of 1.5 gm. OR 500mg. once daily for 3 days.

Genital Ulcer Disease due to Haemophilus decreyi (chancroid), non-gonococcal urethritis and cervicitis due to chlamydia.

Adults (>16 years of age): 100mg. dose of Azithromycin.

Urethritis and Cervicitis due to Neisseria gonnorhoea.

Adults (>16 years of age): Single 200mg.dose of Azithromycin.

Children (<16 years of age): The usual dose for children is 10mg/kg of body weight, orally, once a day for 3 days. Alternatively after a 10mg/kg of body weight oral loading dose on the first day; therapy can be continued at a dose of 5mg/kg of body weight on subsequent 4 days. (The Drug is not recommended for the infants below 6 months of age).

In patients with a history of allergic reactions to Azithromycin or any other macrolide antibiotic.

Azithromycin is well tolerated with low incidence of side effects in both adults and children. The majority of side effects were gastrointestinal in origin, with diarrhoea, abdominal discomfort, nausea, vomiting and flatulence. Occasionally reversible elevations in liver transaminases have been seen. Allergic reactions lie skin rash may occur.

Alminium and Magnesium containing Antacids.

Theophylline.

Warfarin.

Digoxin.

Ergotamine of dihydroergatamine.

Triazolam.

Drugs metabolized by the cytochrome P450 system.

Pregnancy

Teratogenic Effects: Pregnancy category B. There are no adequate and well controlled studies in pregnant women. Azithromycin should be used in pregnancy only if clearly indicated.

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 nursing women.

Serious allergic reactions, including angioedema, anaphylaxis and dermatological reactions including Stevens Johnson syndrome and toxic epidermal necrolysis have been reported rarely in patients on Azithromycin therapy. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be constituted. Physicians should be aware that reappearance of allergic symptoms might occur when symptomatic therapy is discontinued. Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range i severity from mild to life threatening. Therefore it is important to consider the diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.

Azithromycin acts by binding the 50s ribosomal sub units of susceptible organisms and thus interferes with microbial protein synthesis.

Antimicrobial Activity

Gram Positive Organisms: S.aureus (beta-lactamase and non-beta-lactamase producing), S.pneumoniae, S.pyogens and other streptococcus species.

Gram Negative Organisms: H.influenza, H.ducreyi, N.gonorrhoea, N.meningitidis, M.catarrhalis, E.coli, s.typhii, B.pertussis, B.parapertusis.

Atypical Pathogens: C.pneumoniae, C.trachomatis, M.pneumoniae, U.urealyticum, L.pneumophila, M.hominis.

Anaerobic Bacteria: B.fragilis, C.perfringens, peptococcus species, peptostreptococcus species, Fusobacterium, Propionibacterium.

Others: Myobacerium ssp., T.pallidum, B.burgdoferi.