TRADENAME OF THE MEDICINAL PRODUCT:
QUAUTATIVE AND QUANTITATIVE COMPOSITION :
capsules. Azithromycin dihydrate 262.05 mg equivalent to 250 mg azothromycin base.
Powder for Oral Suspension: azithromycin dihydrate 209.64 mg/SmI equivialent to 200 mg/5 ml of azithromycin base
PHARMACUTICAl FORM :
Capsules: Azithromycin capsules for oral administration are available as plain white No. 0 hard gelatin capsules containing azlthromycln dihydrate equivalent to 250 mg azithromycm. The capsule tS printed m black with the Plilar logo andfor a product code ·ZTM 250.”
Powder for 0rl Suspension: Azithromycin powder for oral suspension is presented as a dry powder
which yields, on reconstitution with water, I white to off·white suspension containing the equivalent of 200 mg azithromycin per 5ml
CLINICAl PARTICULARS :
Azithromycin is indicated for infections caused by susceptible organisms:in lower respiratory tract inlections including bronchitis and pneumonia, in odontostomalological lniections in skin and soft tissue infection in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis tonsillitis(Penicillin is the usual drug 0f choice in the treatment 0f Streptococcus pyogenes pharyngitis including the prophlaxis of rheumatic fever azithromycin is
generally affective in the eradication of streptococci from the oropharynx however date establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not avaliable at present
In sexually transmitted diseases in men and women, azithromycin is indicated in the treatment 0f uncomlicated genital infection with treponema pallidum should be excluded
Posology and Method 0f Administretion :
Oral azrthromycin should be administered as a single daily dose The period 0f dosing with regard to injection is given below Administration of azithromycin capsules following asubstantial 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
For adults : for the treatment of sexually transmitted diseases caused by chlamydia trachomatis haemophilus ducreyi or susceptible neisseria gonorrhoea the dose is 1000 mg as asingle oral dose
For prophylaxis against MAC infections: In panents In’ected with the human imrrnmodeficlenty virus (HIV), the dose is 1200mg once per week.
For the treatment of DMAC infections :600 mg once day
For all other indications : in which the oral formulation is administered, the total dosage 0f 1500 mg should be given as 500 mg daily Ior 3 days.
in children : The maximum recommended total dose for any treatment Is 1500 mg lor children. With the single exception of the treatment 01 sueptcccccat pharyngitiS, the total dose in childran is 30 mg/kg which slloukl be given asa single daily ecee 01 10 mglkg daily for 3 days.
For pediatric streptococcal pharyngitis : azithromycin given as asingle dose of 10 mg/kg or 20 mg/kg for 3days
for the treatment of children with acute 0titis media : ,the recommended total dose 01 azrthromycln powder for oral suspension is 30mg/kg given as asingle dose,as a3-day rgimen(10mg!kgdaity) For children weighing less than 15 kg, azrthromyan 5USpOOSIOO should be measured as closely as posSIble. For chIlcIren wetghlllg 15 kg or more. 8ZJIhrOlTl)’Clfl suspensoon, should be adminIStered ac:coning to the guiOeprOYiOedbelow
AZITHROMYCIN SUSPENSION 30 mg/kg Total Treatment Dose :
Weight (kg) 3.Day Regimen Bottle Size (mg)
< 15 10 mglkg once daily on days 1:3 600
15-25 200 mg (5 mL) once daily on days 1·3. 600
26-35 300 mg (7.5 mL) once daily on days 1:3 900
36-45 400 mg (10 mL) once daily on days 1·3 1200
> 45 Dose as per adults. 1500
The use of this product Is contraIndicated In patients with a history 01 allergic reactions 10 azlthromyeln or any 0f the macrolide antibiotics
Pregnancy and Loctation :
Animal reproduction studies have demonstrated that azithromycin crosses the placent but have revealed no eviddence of harm to the fetus there are no date on secretion in breast milk safty for use in human preganancy and lactation has not been established azithromycin should only be used in pregnant or lactating woman where adequate alternatives are not available
Effects on Ability t0 Drive and Use Machines :
there is no evidence to suggest that azithromycin may have an effect on a patient,s ability to drive or operat machinery
Undesirable Ettacts :
Azithromycim is well tolerated with a low incidence 0f side effects
Adverse events experienced in higher than recommended dotes were Similar to those seen at normal doses in the event of 0verd0sage, general symptomatiC and supportive measuresar. are indicated as required
PHARMACOLOGICAL PROPERTIES :
Pharmacodynamic Propertlel Azithromycln is the first of asubclass of macrolide of antibiotics known as azalides and is chemically different from erythromycin chemically it is derived by insertion of anitrogen atom into the lactone ring of erythromycine a the chemical name of azithromycin is 9 deoxy -9a -aza-9a-methy 1-9a- homerythromycin a the molecular weight is 749 0
Manufactured by :
PFIZER EGYPT, S.A.E. CAIRO, A.R.E.
Under authority Plizer INC. U.S.A