ACTIVE-INGREDIENT OF ZISROCIN SUSP
Powder for oral suspension contains : Azithromycin dihydrate 104.8 mg/5 ml equivalent to 100 mg/ 5mll of azithromycin base.
INDICATION OF ZISROCIN SUSP
- Azithromycin is indicated for infection caused by susceptible organisms in lower respiratory tract infection including bronchitis and pneumonia.
- in odonotomatological infections, in Skin and soft tissue infections, in acute otitis media and in Upper respiratory tract infections including sinusitis and pharyngitis/ tonsilitis.
- ( penicillin is the usual drug of choice in the treatment of streptococcus pyogenes pharyngitis including the prophylaxis of rheumatic fever.
- Azithromycin is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of azithromycin and the subsequent prevention of reheumatic fever are not available at present.
- In sexually transmited diseases in men and women, Zithrokan is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis.
- It is also indicated in the treatment of chancroid due to Haemophilus ducreyi, and uncomplicated genital infection due to non-multi resistant Neisseria gonorrhoea; concurrent infection with Treponema pallidum should be excluded.
- Azithromycin is indicated , either alone or in combination with rifabutin, for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infectio, an opportunistic infection prevalent in patients 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 ZISROCIN SUSP
- 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 : –
- ZISROCIN (Azithromycin) is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
- Sexually transmitted Diseases: Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
- ZISROCIN, at the recommended dose, should not be relied upon to treat gonorrhea or syphilis.
- Antimicrobial agents used in high doses for short periods of time to treate non-gonococcal urthritis may mask or delay the symptoms of incubating gonorrhea or syphilis.
- All patients with sexually-transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate cultures for gonorrhea performed at the time of diagnosis.
- Appropriate antimicrobial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
- Appropriate culture and susceptibility tests should performed before treatment to determine the causative organism and its susceptible to azithromycin.
- Therapy with ZISROCIN may be initiated before results of these tests are known; once the results become available , antimicrobial therapy should be adjusted accordingly.
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZISROCIN(azithromycin) and other antibacterial drugs, ZISROCIN (Azithromycin) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- When culture and susceptibillity information are available, they should be considered in selecting or modifying antibacterial therapy.
- In the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
- Oral Azithromycin should be administered as a single daily dose.
- The period of dosing with regard to infection is given below:
- Administration of Azithromycin capsules following a substantial meal reduces bioavailability by at least 50 % therefore, in common with many other antibiotics, each dose of the capsules should be taken at least 1 hour before or 2 hours after food.
- In adults: for the treatment of sexually transmitted disease caused by Chlamydia trachomatis, Haemophilus ducreyi , or susceptible Neisseria gonorrhea, the dose is 1000 mg as a single oral dose.
- For prophylaxis against MAC infections: in patients infected with human immunodeficiency 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 antimicrobial agents that have shown in vitro activity against MAC, such as ethambutol at the approved dose.
- For all other infections in which the oral formulation is administered, the total dose of 1500 should be given as 500 mg 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.
- In the Elderly: the same dosage as in adult patient is used in the 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 .
- ( see special warnings and precaution for use).
- 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 ( see special warnings and precaution for use).
OVER-DOSAGE OF ZISROCIN SUSP
- 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 ZISROCIN SUSP
- ZISROCIN is contraindicated in patients with a history of allergic reactions to azithromycin , erythromycin, or any of the macrolide or ketolide antibiotics.
- ZISROCIN is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of ZISROCIN.
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