Formulation
Each film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin …………….. 500 mg
Each film-coated tablet contains:
Azithromycin Dihydrate USP
Eq. to Azithromycin …………….. 500 mg
Azithromycin is indicated for the following bacterial infections induced by micro-organisms susceptible to azithromycin:
RECOMMENDED DOSE:
Posology:
Azithromycin should be given as a single daily dose. Duration of the treatment for the different infection diseases is given below.
Children and adolescents with a body weight above 45 kg, adults and the elderly:
The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg) can be administered in a period of 5 days, 500 mg on the first day and 250 mg on day 2 to 5.
In the case of uncomplicated Chlamydia trachomatis urethritis and cervicitis, the dosage is 1000 mg as a single oral dose.
Children and adolescents with a body weight below 45 kg:
Azithromycin tablets are not suitable for patients under 45 kg body weight. Other dosage forms are available for this group of patients.
Elderly patients:
For elderly patients the same dose as for adults can be applied. Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes.
Patients with renal impairment:
Dose adjustment is not required in patients with mild to moderate renal impairment (GFR 10-80 ml/min).
Patients with hepatic impairment:
Dose adjustment is not required for patients with mild to moderate hepatic dysfunction.
MODE OF ADMINISTRATION:
Oral Administration
The tablets can be taken with or without food.
The tablets should be taken with 1/2 glass of water.
STORAGE CONDITION:
Store at temperatures not exceeding 30°C. Protect from light and moisture.
Keep out of reach of children.
AVAILABILITY:
Alu PVC Blister Pack x 3’s (Box of 1’s)
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