Azilide (Azithromycin)

• Composition :
  Each tablet contains: Azithromycin 100/250/500mg and suspension 100 mg/5 mL and 200 mg/5 mL
• Indications :
  For the treatment in mild to moderate susceptible infection including RTI, uncomplicated skin/skin structure, non gonococcal urethritis, cervicitis
• Pharmacodynamics :
  Themode of action of azithromycin is inhibition of protein synthesis in bacteria by binding to the 50s ribosomal subunit and preventing translocation of peptides
• Dosage and administration :
  Adults: Community-acquired pneumonia (mild severity) Pharyngitis/tonsillitis (second line therapy) Skin/skin structure (uncomplicated): 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.Non-gonoccocal urethritis and cervicitis :One single 1 gram dose Pediatric Patients- Acute otitis media: 30 mg/kg as a single dose or10 mg/kg once daily for 3 days or10 mg/kg as a single dose on Day1 followed by 5 mg/kg/day onDays 2 through 5; Acute bacterial sinusitis: 10 mg/kg once daily for 3 days; Community-acquired pneumonia: 10 mg/kg as a single dose on Day1 followed by 5 mg/kg once dailyon Days 2 through 5; Pharyngitis/tonsillitis: 12 mg/kg once daily for 5 days
• Contraindications :
  The use of this product is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
• Precautions and warnings :
  Serious (including fatal) allergic and skin reactions: Discontinue Azithromycin if reaction occurs. Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity may occur.Prolongation of QT interval and cases of torsades de pointes have beenreported. This risk which can be fatal should be considered in patientswith certain cardiovascular disorders including known QT prolongationor history torsades de pointes, those with proarrhythmic conditions, andwith other drugs that prolong the QT interval. Clostridium difficile-Associated Diarrhea: Evaluate patients if diarrheaoccurs. May exacerbate muscle weakness in persons withmyasthenia gravis
• Use in pregnancy, lactation & pediatrics :
  Teratogenic Effects: Pregnancy Category B.There are, however, no adequate and well-controlled studies in pregnant women. Because animalreproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearlyneeded. It is not known whether azithromycin is excreted in human milk.Caution should be exercised whenazithromycin is administered to a nursing woman.Safety and effectiveness in the treatment of pediatric patients less than 6 months of age have not been established
• Drug interactions :
  Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations.Co-administration with efavirenz, or fluconazole had a modest effect on the pharmacokinetics of azithromycin
• Adverse reactions :
  most common treatment-related side effects arediarrhea, abdominal pain, vomiting, nausea and rash
• Therapy Area :
  Anti-Bacterials