ACTIVE-INGREDIENT OF AZROLID
each tablet contains : active ingrediants : azithromycin dihydrate 524.1 mg ( equivalent to 500 mg azithromycin ) .
INDICATION OF AZROLID
- azrolid is indicated for infection by susceptible organisms : in lower respiratory tract infections , including bronchitis and pneumonia , in odontostomatological infections , in skin and soft tissue infections , in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis .
- azithromycin is generally effective in the eradication of streptococci from the oropharynx , however , data establishing the efficacy of azithromycin and the subsequent preventation of rheumatic fever are not available at present .
- in sexually transmitted disease in men and women , azrolid is indicated in the treatment of chancroid due to haemophilus ducreyi , and uncomplicated genital infection due to non-multiresistant neisseria gonorrhoea , concurrent infection with treponema pallidum should be excluded .
- azithromycin is indicated either alone or in combination with rifabutin prophylaxis against mycobacterium avium-intracellulare . complex (MAC) infection , an opportunistic infection prevalent in patient with advanced human immunodeficiency virus (HIV) .
- azithromycin is indicated in combination with ethambutol for the treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection .
DOSAGE OF AZROLID
- Follow all directions given to you by your pharmacist or doctor carefully .
- They may differ from the information contained in this leaflet
- Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
- administration of azithromycin tablets following a substantial meal does not affect the biovailability .
- Thus , azithromycin tablets may be given without regard to meals .
- in adults : for the treatment of sexually transmitted disease caused by chlamydia trachomatis , haemophilus ducreyi , or susceptible neisseria gonorrhoea , the dose is 1000 mg as a single oral dose .
- for prophylaxis against MAC infections : in patients infected with human immundoeficiency virus (HIV) the dose is 1200 mg once per week . for the treatment of DMAC infections : in patients with advanced HIV infection , the recommended dose is 600 mg once a day .
- azithromycin should be administered in combination with other antimycobacterial agents that have shown in vitro activity against MAC , such as ethambutol at the approved dose .
- for all other indications in which the oral formulation is administered , the total dose of 1500 mg should be given as 500 mg daily for 3 days .
- in children : the maximum recommended total dose for any treatment is 1500 mg for children .
- with the single exception of the treatment of streptococcal pharyngitis , the total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg daily for 3 days .
- for pedoiatric streptococcal pharyngitis : azithromycin given as a single dose of 10 mg/kg or 20 mg/kg for 3 days has been shown to be effective ; however a daily dose of 500 mg must not be exceeded .
- in clinical trials comparing these two dosage regimens , similar clinical efficacy was observed but greater bacteriologic eradication was evident at the 20 mg/kg per day dose .
- however , pencillin is the drug of choice in the treatment of streptococcus pyogenes phryngitis , including prophylaxis of rheumatic fever .
- azithromycin tablets should only be administered to children weighting more than 45 kg .
- safety and efficacy for the preventation or treatment of MAC in chioldren have not been established based on pediatric pharmacokinetic data .
- a dose of 20 mg/kg would be similar to the adult dose of 1200 mg but with a higher C max .
- in the elderly : the same dosage as in adult patients is used in rthe elderly .
- in patients with renal impairment : no dose adjustment is necessary in patients with mild to moderate ( GFR 10-80 ml/min ) or severe ( GFR <10 ml/min ) renal impairment .
- in patients with hepatic impairment : the same dosage as the patients with normal hepatic function may be used in patients with mild to moderate hepatic impairment .
OVER-DOSAGE OF AZROLID
- adverse events experienced in higher than recommended doses were similar to those seen at normal doses .
- In the event of overdosage , general symptomatic and supportive measures are indicated as required .
CONTRA-INDICATION OF AZROLID
- azithromycin is contraindicated in patients with a history of cholestatic jaudice / hepatic dysfunction associated with prior use of azithromycin .
- The use of azrolid is contraindicated in patients with a history of allergic reactions to azithromycin or any of the macrolide antibiotecs
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