Single Dose Zithromax (Azithromycin for Oral Suspension)
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Single Dose Zithromax Oral Suspension (30 mg/kg) is indicated for AOM in children 6 months and older due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Single Dose Zithromax oral suspension provides efficacy comparable with 20 doses of Augmentin® (amoxicillin/clavulanate potassium) in one dose. In a randomized, double-blind, double-dummy, multicenter study, a group of 321 children with AOM, aged 6 months to 12 years, received Zithromax oral suspension (30 mg/kg on day 1) or Augmentin oral suspension (45 mg/kg in equal doses for 10 days). Among 321 children evaluable at the end of therapy (day 12-16), Zithromax and Augmentin showed comparable overall clinical success* rates at the end of therapy, day 12-16 (87% and 88%, respectively), as well as at test of cure, day 28-32 (75% and 75%, respectively). Zithromax also demonstrated comparable efficacy to Augmentin in the subset of children aged 6 months to 2 years, both at the end of therapy, day 12-16 (78% and 80%, respectively), and at test of cure, day 28-32 (64% and 57%, respectively).
In a noncomparative clinical and microbiologic trial, 240 evaluable children aged 6 months to 12 years with culture-positive AOM received a single dose of Zithromax oral suspension (30 mg/kg on day 1), and bacteriologic response rate by pathogen was assessed at the end of therapy (day 10). The results demonstrated favorable response rates against key AOM pathogens at day 10 as well as day 24-28: Streptococcus pneumoniae (92% and 88%, respectively), Haemophilus influenzae (71% and 64%, respectively), and Moraxella catarrhalis (100% and 100%, respectively).
Zithromax has unique pharmacokinetics for efficacy in AOM. White blood cells act as delivery systems, taking Zithromax to the site of infection. Zithromax concentrates more highly in neutrophils and monocytes than in serum and is taken directly to the site of infection.† Infection-site concentrations of Zithromax decline very slowly, remaining at therapeutic levels several days posttherapy. This persistence at the site of infection allows for its uniquely convenient dosing regimen.
Single dose Zithromax at 30 mg/kg offers a tolerability profile that compares favorably with that of Augmentin‡ with overall incidence rates of adverse events of 16.8% and 22.5%, respectively. The incidence of vomiting and diarrhea was also comparable between Zithromax and Augmentin (4.0% and 4.0%, and 6.4% and 12.7%, respectively). The rates of discontinuation due to treatment-related adverse events were 2.3% (n=4) in Zithromax patients and 4.0% (n=7) in Augmentin patients.
Zithromax is contraindicated in patients with known hypersensitivity to any macrolide antibiotic. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy for the allergic reaction is discontinued.
Pseudomembranous colitis has been reported with nearly all antibacterial agents. It is important to consider this diagnosis in patients who present with diarrhea.
*Clinical success was defined as cure + improvement.
†High tissue concentrations should not be interpreted to be quantitatively related to efficacy.
‡The most common side effects of Single Dose Zithromax are diarrhea/loose stools (4.3%), vomiting (4.9%), abdominal pain (1.4%), rash (1.0%), and nausea (1.0%).
Single Dose Zithromax (Azithromycin for Oral Suspension)
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