Azithromycin Monohydrate: Package Insert and Label Information
AZITHROMYCIN MONOHYDRATE- azithromycin monohydrate tablet
PD-Rx Pharmaceuticals, Inc.
1 INDICATIONS AND USAGE
Azithromycin tablets are 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. [see DOSAGE AND ADMINISTRATION ( 2)]
1.1 Adult Patients
- Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae.
- 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.
1.2 Pediatric Patients
[see USE IN SPECIFIC POPULATIONS ( 8.4) and CLINICAL STUDIES ( 14.2)]
- Acute otitis media ( >6 months of age) caused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae.
- Community-acquired pneumonia ( >6 months ofage) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae , 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.
1.3 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).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, 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.
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
[see INDICATIONS AND USAGE ( 1.1) and CLINICAL PHARMACOLOGY ( 12.3)]
|Infection*||Recommended Dose/Duration of Therapy|
|Community-acquired pneumonia 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|
|Acute bacterial exacerbations of chronic obstructive pulmonary disease||500 mg once daily for 3 days OR 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5|
|Acute bacterial sinusitis||500 mg once daily for 3 days|
|Genital ulcer disease (chancroid)||One single 1 gram dose|
|Non-gonococcal urethritis and cervicitis||One single 1 gram dose|
|Gonococcal urethritis and cervicitis||One single 2 gram dose|
|*DUE TO THE INDICATED ORGANISMS [see INDICATIONS AND USAGE ( 1.1)]|
Azithromycin tablets can be taken with or without food.
2.2 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 [see INDICATIONS AND USAGE ( 1.2)]|
|1 see dosing tables below for maximum doses evaluated by indication|
Azithromycin for oral suspension can be taken with or without food.
* Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
|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||200 mg/5 mL||Total mL per Treatment Course||Total mg per Treatment Course|
|Kg||Day 1||Days 2 to 5||Day 1||Days 2 to 5|
|5||2.5 mL; (½ tsp)||1.25 mL;(¼ tsp)||7.5 mL||150 mg|
|10||5 mL; (1tsp)||2.5 mL; (½ tsp)||15 mL||300 mg|
|20||5 mL; (1 tsp)||2.5 mL; (½ tsp)||15 mL||600 mg|
|30||7.5 mL; (1½ tsp)||3.75 mL; (¾ tsp)||22.5 mL||900 mg|
|40||10 mL; (2 tsp)||5 mL;(1 tsp)||30 mL||1200 mg|
|50 and above||12.5 mL; (2½ tsp)||6.25 mL; (1¼ tsp)||37.5 mL||1500 mg|
* Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis 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||200 mg/5 mL|
|Kg||Days 1 to 3||Days 1 to 3||Total mL per Treatment Course||Total mg per Treatment Course|
|5||2.5 mL; (1/2 tsp)||7.5 mL||150 mg|
|10||5 mL; (1 tsp)||15 mL||300 mg|
|20||5 mL (1 tsp)||15 mL||600 mg|
|30||7.5 mL (1½ tsp)||22.5 mL||900 mg|
|40||10 mL (2 tsp)||30 mL||1200 mg|
|50 and above||12.5 mL (2 ½ tsp)||37.5 mL||1500 mg|
|OTITIS MEDIA: (1-Day Regimen)|
|Dosing Calculated on 30 mg/kg as a single dose.|
|Weight||200 mg/5 mL||Total mL per Treatment Course||Total mg per Treatment Course|
|5||3.75 mL;(3/4 tsp)||3.75 mL||150 mg|
|10||7.5 mL;(1½ tsp)||7.5 mL||300 mg|
|20||15 mL;(3 tsp)||15 mL||600 mg|
|30||22.5 mL;(4½ tsp)||22.5 mL||900 mg|
|40||30 mL;(6 tsp)||30 mL||1200 mg|
|50 and above||37.5 mL;(7½ tsp)||37.5 mL||1500 mg|
The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.
The recommended dose of azithromycin for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)
|PHARYNGITIS/TONSILLITIS: (5-Day Regimen)|
|Dosing Calculated on 12 mg/kg/day for 5 days.|
|Weight||200 mg/5 mL||Total mL per Treatment Course||Total mg per Treatment Course|
|Kg||Day 1 to 5|
|8||2.5 mL; (½ tsp)||12.5 mL||500 mg|
|17||5 mL; (1 tsp)||25 mL||1000 mg|
|25||7.5 mL; (1½ tsp)||37.5 mL||1500 mg|
|33||10 mL; (2 tsp)||50 mL||2000 mg|
|40||12.5 mL; (2½ tsp)||62.5 mL||2500 mg|
Constituting instructions for azithromycin oral suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:
|Amount of water to be added||Total volume after constitution ( azithromycin content )||Azithromycin concentration after constitution|
|9 mL (300 mg)||15 mL (300 mg)||100 mg/5 mL|
|9 mL (600 mg)||15 mL (600 mg)||200 mg/5 mL|
|12 mL (900 mg)||22.5 mL (900 mg)||200 mg/5 mL|
|15 mL (1200 mg)||30 mL (1200 mg)||200 mg/5 mL|
Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.
After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.
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