Zithrodose 100 mg

Anti-infective
Product

Zithrodose

Active

Azithromycin Dihydrate 104.8 mg equivalent to 100 mg Azithromycin base

Category
Anti-infective
Indication

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHRODOSE (azithromycin) and other antibacterial drugs, ZITHRODOSE (azithromycin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

ZITHRODOSE (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications.

1.Adult Patients

Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenza, Moraxella catarrhalis, or Streptococcus pneumonia.

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae.

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.

Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.

Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

2.Pediatric Patients

Acute otitis media (>6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.

Pharyngitis/tonsillitis (> 2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

3.Limitations of Use

Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

patients with cystic fibrosis

patients with nosocomial infections

patients with known or suspected bacteremia

patients requiring hospitalization

elderly or debilitated patients, or

Patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).

Dose

Pediatric Patients

Infection* Recommended Dose/Duration of Therapy
Acute otitis media 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 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 Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis 12 mg/kg once daily for 5 days.
*DUE TO THE INDICATED ORGANISMS

ZITHRODOSE for oral suspension can be taken with or without food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITYACQUIRED PNEUMONIA (Age 6 months and above, Based on Body Weight

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight 100 mg/5 mL Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1 Days 2-5
5 11 2.5 mL; (½ tsp) 1.25 mL;(¼ tsp) 7.5 mL 150 mg
10 22 5 mL; (1tsp) 2.5 mL; (½ tsp) 15 mL 300 mg

* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight 100 mg/5 mL

Days 1-3

 Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1 Days 2-5
5 11 2.5 mL; (½ tsp) 1.25 mL;(¼ tsp) 7.5 mL 150 mg
10 22 5 mL; (1tsp) 2.5 mL; (½ tsp) 15 mL 300 mg

Adults

Zithrodose should be taken as a single 2 g dose. Zithrodose provides a full course of antibacterial therapy in a single oral dose. It is recommended that Zithrodose be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

2.2 Pediatric patients

For pediatric patients 6 months and older, Zithrodose should be taken as a single dose of 60 mg/kg (equivalent to 27 mg/lb) body weight. The Zithrodose dose in mL is equivalent to the child’s weight in lb (1 mL/lb dose, see Table 1 below), for a body weight of less than 75 lb (34 kg). It is recommended that Zithrodose be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).

Pediatric patients weighing 75 lb (34 kg) or more should receive the adult dose (2 g).

Table 1. Zithrodose Pediatric Dosage Guidelines: 1-dose regimen
Dosing Calculated on 1 mL/lb, Dose 1 mL of Suspension for every 1 lb of Body Weight for Children <75 lb (34 kg)*
Weight 1 mL/lb Dose
Lb Kg Dose Volume
(mg) (ml)
*To ensure accurate dosing, a dosing spoon, medicine syringe, or cup is recommended.
10 5 270 10
15 7 405 15
20 9 540 20
25 11 675 25
30 14 810 30
35 16 945 35
40 18 1080 30
45 20 1215 45
50 23 1350 50
55 25 1485 55
60 27 1620 60
65 30 1755 65
70 32 1890 70
<_75 34 2000 Consume entire contents of bottle