ZITHMAC – Antibacterial (Macrolide)

  • Generic Name: Azithromycin
  • Dosage Strength: 500 mg
  • Dosage Form: Film-Coated Tablet

Formulation

Each film-coated tablet contains:

Azithromycin Dihydrate USP

Eq. to Azithromycin …………….. 500 mg

Indications

Azithromycin is indicated for the following bacterial infections induced by micro-organisms susceptible to azithromycin:

  •  Acute bacterial sinusitis (adequately diagnosed)
  •  Acute bacterial otitis media (adequately diagnosed)
  •  Pharyngitis, tonsillitis
  •  Acute exacerbation of chronic bronchitis (adequately diagnosed)
  •  Mild to moderately severe community acquired pneumonia
  •  Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas
  •  Uncomplicated Chlamydiatrachomatis urethritis and cervicitis

Additional Info

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)