ZITHROMAX® TABLET, SUSPENSION Dosage and Administration

(azithromycin dihydrate TABLET, SUSPENSION)

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 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

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 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.

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 Course
Total 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.

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

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.

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.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
Kg1-Day Regimen

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.

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

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 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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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 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

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 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.

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 Course
Total 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.

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

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.

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.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
Kg1-Day Regimen

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.

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

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 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.

Medication Guide

Health Professional Information

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