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ZITHROMAX® (azithromycin dihydrate) Dosage and Administration

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
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
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 disease500 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 sinusitis500 mg once daily for 3 days
Genital ulcer disease (chancroid)One single 1 gram dose
Non-gonococcal urethritis and cervicitisOne single 1 gram dose
Gonococcal urethritis and cervicitisOne single 2 gram dose

ZITHROMAX tablets can be taken with or without food.

2.2 Pediatric Patients1

Infection*Recommended Dose/Duration of Therapy
1 see dosing tables below for maximum doses evaluated by indication
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
Acute otitis media30 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 sinusitis10 mg/kg once daily for 3 days.
Community-acquired pneumonia10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis12 mg/kg once daily for 5 days.

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

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8.4)])
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.
Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDay 1Days 2–5Day 1Days 2–5
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
52.5 mL; (½ tsp)1.25 mL;(¼ tsp)7.5 mL150 mg
105 mL; (1tsp)2.5 mL; (½ tsp)15 mL300 mg
205 mL; (1 tsp)2.5 mL; (½ tsp)15 mL600 mg
307.5 mL; (1½ tsp)3.75 mL; (¾ tsp)22.5 mL900 mg
4010 mL; (2 tsp)5 mL; (1 tsp)30 mL1200 mg
50 and above12.5 mL; (2½ tsp)6.25 mL; (1¼ tsp)37.5 mL1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDays 1–3Days 1–3
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
52.5 mL; (1/2 tsp)7.5 mL150 mg
105 mL; (1 tsp)15 mL300 mg
205 mL (1 tsp)15 mL600 mg
307.5 mL (1½ tsp)22.5 mL900 mg
4010 mL (2 tsp)30 mL1200 mg
50 and above12.5 mL (2 ½ tsp)37.5 mL1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
Kg1-Day Regimen
53.75 mL;(3/4 tsp)3.75 mL150 mg
107.5 mL;(1½ tsp)7.5 mL300 mg
2015 mL;(3 tsp)15 mL600 mg
3022.5 mL;(4½ tsp)22.5 mL900 mg
4030 mL;(6 tsp)30 mL1200 mg
50 and above37.5 mL;(7½ tsp)37.5 mL1500 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.

Pharyngitis/Tonsillitis: The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8.4)])
Based on Body Weight

PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDay 1–5
82.5 mL; (½ tsp)12.5 mL500 mg
175 mL; (1 tsp)25 mL1000 mg
257.5 mL; (1½ tsp)37.5 mL1500 mg
3310 mL; (2 tsp)50 mL2000 mg
4012.5 mL; (2½ tsp)62.5 mL2500 mg

Constituting instructions for ZITHROMAX 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 addedTotal 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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