Azithromycin (Page 10 of 13)

Pediatric Patients

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

Acute Otitis Media

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5. (See chart below.)

Acute Bacterial Sinusitis

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute bacterial sinusitis is 10 mg/kg once daily for 3 days. (See chart below.)

Community-Acquired Pneumonia

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with community-acquired pneumonia is 10 mg/kg as a single dose on the first day followed by 5 mg/kg on Days 2 through 5. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS AND COMMUNITY-ACQUIRED PNEUMONIA (Age 6 months and above, see PRECAUTIONS: Pediatric Use.) 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 200 mg/5 mL Total mL Per Treatment Course Total mg Per Treatment Course
Kg Lbs. Day 1 Days 2-5 Day 1 Days 2-5
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.

5

11

2.5 mL

(1/2 tsp)

1.25 mL

(1/4 tsp)

7.5 mL

150 mg

10

22

5 mL

(1 tsp)

2.5 mL

(1/2 tsp)

15 mL

300 mg

20

44

5 mL

(1 tsp)

2.5 mL

(1/2 tsp)

15 mL

600 mg

30

66

7.5 mL

(1-1/2 tsp)

3.75 mL

(3/4 tsp)

22.5 mL

900 mg

40

88

10 mL

(2 tsp)

5 mL

(1 tsp)

30 mL

1200 mg

50

and

above

110

and

above

12.5 mL

(2-1/2 tsp)

6.25 mL

(1-1/4 tsp)

37.5 mL

1500 mg

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 Total mL per Treatment Course Total mg per Treatment Course
Kg Lbs. Day 1-3 Day 1-3
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.

5

11

2.5 mL

(1/2 tsp)

7.5 mL

150 mg

10

22

5 mL

(1 tsp)

15 mL

300 mg

20

44

5 mL

(1 tsp)

15 mL

600 mg

30

66

7.5 mL

(1-1/2 tsp)

22.5 mL

900 mg

40

88

10 mL

(2 tsp)

30 mL

1200 mg

50

and

above

110

and

above

12.5 mL

(2-1/2 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
Kg Lbs. Day 1

5

11

3.75 mL

(3/4 tsp)

3.75 mL

150 mg

10

22

7.5 mL

(1-1/2 tsp)

7.5 mL

300 mg

20

44

15 mL

(3 tsp)

15 mL

600 mg

30

66

22.5 mL

(4-1/2 tsp)

22.5 mL

900 mg

40

88

30 mL

(6 tsp)

30 mL

1200 mg

50 and

above

110 and

above

37.5 mL

(7-1/2 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, eight patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

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