AZILIDE® (Azithromycin)

About Geneith Pharm

Dosage forms:
Tablets:  250/500mg
Oral suspension:  100/200mg                                                    
Composition:
Each film coated tablet contains:
Azithromycin USP equivalent to anhydrous azithromycin 250/500mg

Each 5ml contains:
Azithromycin USP equivalent to anhydrous azithromycin 100/200mg.
Pharmacology and indications:
Azilide is a macrolide antibiotic effective against aerobic gram-positive and gram-negative micro organisms. It acts by binding to the 50s ribosomal submit of susceptible microorganisms and thus interferes with microbial protein synthesis, nucleic acid synthesis is not affected.

The drug is indicated for:

  • Acute bacterial exacerbation of chronic obstructive pulmonary disease.
  • Community acquired pneumonia
  • Pharyngitis/tonsillitis
  • Uncomplicated skin and skin structure infections.
  • Urethritis and cervicitis
  • Genital ulcer disease
  • Acute Otitis media.

Contraindications:
Azilide is contraindicated in patients with known hypersensitivity to Azithromycin or any other macrolide antibiotics.
Side effects/Adverse reactions:
In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug.
They include Nausea, vomiting, diarrhoea, abdominal pain. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely.
Precautions:
Azilide should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy.

  • Azilide is principally eliminated via the liver, so caution should be excercised when the drug is administered to patients with impaired hepatic function.
  • Caution should be applied when prescribing azilide in patients with renal impairment.

Use in pregnancy and lactation:
Azilide should be used in pregnancy and lactation only if clearly needed.
Drug interactions
Concurrent use of macrolides and theophylline has been associated with increases in the serum concentration of Theophylline.
Drugs metabolized by the cytochrone P450 system- elevations of serum carbamazepine, terfenadine cyclosporine, hexobarbital and phenytoin levels. Aluminium and magnesium – containing antacids reduced the rate but not the extent of absorption of Azithromycin.
Azithromycin with Digoxin – elerated digoxin levels. It also decreases the clearance of triazolam.
Dosage and administration:
Azilide should be given at least 1 hour before or 2 hours after a meal.
For the treatment of mild to moderate acute bacterial exacerbations of chronic obstructive pulmonary disease, community acquired pneumonia, pharyngitis/tonsillitis and uncomplicated skin infections, 500mg as a single dose on the first day followed by 250mg once daily on days 2 through 5.
For treatment of genital ulcer, a single 1g dose for treatment of urethritis and cervicitis, a single 2g dose.
Children:
Acute Otitis media and Community acquired Pneumonia:
Azithromycin for oral suspension 10mg/kg as a single dose on the first day (not to exceed 500mg/day) followed by 5mg/kg on days 2 through 5 (not to exceed 250mg/day)
Pharyngitis/Tonsillitis:   12mg/kg once a day for 5 days not to exceed 500mg/day.