ACUTE OTITIS MEDIA
 

Systemic Antibiotics for the Treatment of Acute Otitis Media in Children (newborn–12 years)

This table presents information on select antibiotics indicated for the treatment of acute otitis media and recommended doses as shown in the official labeling. This is not an inclusive list of products that carry this indication. Information on prophylaxis of chronic otitis media infections is not included. Under certain clinical conditions (eg, impaired renal or hepatic function), the dose may need to be adjusted. Only relevant children's doses and formulations are shown; some products are also available in solid dosage forms. For other doses or regimens, see product entries or consult the manufacturer. Other antibiotics may be used in clinical practice that are not included on this chart (eg, clindamycin). Otic preparations are listed in Section 6A. Pharmacological classes of the listed drugs are described on the Antibiotic Formulations chart also located in this Section. Unless stated otherwise, otitis media is generally treated for 10 to 14 days.

Generic Brand Form Strength Flavor Dose
amoxicillin* Amoxil drops 50mg/mL bubble gum

≤12 weeks: Max 30mg/kg per day in 2 divided doses every 12 hrs.

>12 weeks (<40kg): 40mg/kg per day in 3 divided doses every 8 hrs.
Or 45 mg/kg per day in 2 divided doses every 12 hours.

≥40kg: as adult.

Note: The AAP recommends 80–90 mg/kg per day in divided doses (this is not an FDA-approved dose)

susp 200mg/5mL, 250mg/5mL, 400mg/5mL bubble gum
chew tabs 200mg

cherry-banana-peppermint

400mg

cherry-banana-peppermint

amoxicillin + clavulanate
(clavulanate component in parentheses)		 Augmentin3 susp

125mg (31.25mg)/5mL1

 

250mg (62.5mg)/5mL1

 

200mg (28.5mg)/5mL2

 

400mg (57mg)/5mL2

 

banana

 

orange

 

orange-raspberry

 

orange-raspberry

<12 weeks: 30mg/kg per day (of amoxicillin) in 2 divided doses every 12 hrs (use 125mg/5mL susp).

≥12 weeks (<40kg): 45mg/kg per day (of amoxicillin) in 2 divided doses every 12 hrs (use 200 or 400mg/5mL susp or 200mg or 400mg chew tabs).
Or 40mg/kg per day (of amoxicillin) in 3 divided doses every 8 hrs (use 125 or 250mg/5mL susp, or 250mg or 500mg chew tabs).

≥40kg: 500mg every 12 hrs or 250mg three times daily.

chew tabs

125mg (31.25mg)1

 

250mg (62.5mg)1

 

200mg (28.5mg)2

 

400mg (57mg)2

 

lemon-lime

 

lemon-lime

 

cherry-banana

 

cherry-banana

ES-600 susp 600mg (42.9mg)/5mL

strawberry cream

<3 months: not recommended.

≥3 months (<40kg): 90mg/kg per day in 2 divided doses every 12 hrs.

≥40kg: use adult formulations.

clarithromycin Biaxin susp 125mg/5mL
250mg/5mL

fruit-punch

fruit-punch

<6 months: not recommended.

>6 months: 15mg/kg per day in 2 divided doses every 12 hrs.

cefaclor — susp 125mg/5mL
187mg/5mL
250mg/5mL
375mg/5mL		 strawberry
strawberry
strawberry
strawberry

<1 month: not recommended.

>1 month: 40mg/kg per day in 2 divided doses every 12 hrs, or in 3 divided doses every 8 hrs; max 1gram per day.

ceftibuten Cedax4 susp 90mg/5mL cherry

<6 months: not recommended.

>6 months: 9mg/kg (max 400mg) once daily.

cefuroxime Ceftin6 susp 125mg/5mL
250mg/5mL

tutti-frutti

tutti-frutti

<3 months: not recommended.

>3 months: 30mg/kg per day in 2 divided doses; max 1gram per day.

Children who can swallow tablets whole: one 250mg tab twice daily.

tabs 125mg
250mg		 N/A
cefprozil Cefzil susp 125mg/5mL
250mg/5mL

bubble gum

bubble gum

<6 months: not recommended.

>6 months: 30mg/kg per day in 2 divided doses every 12 hrs.

cefdinir Omnicef susp 125mg/5mL
250mg/5mL		 strawberry
strawberry

<6 months: not recommended.

>6 months: 14mg/kg every 24 hrs for 10 days or 7mg/kg every 12 hrs for 5–10 days; max 600mg per day.

trimethoprim Primsol soln 50mg/5mL bubble gum

≥6 months: 10mg/kg daily in 2 divided doses every 12 hrs

ceftriaxone Rocephin IM inj 250mg/vial
500mg/vial
1gram/vial		 N/A 50mg/kg IM once; max 1gram.
sulfamethoxazole (SMX) +
trimethoprim (TMP)		 Septra susp 200mg (SMX) +
40mg (TMP)/5mL		 cherry or grape

<2 months: contraindicated.

>2 months: 8mg/kg of TMP (40mg/kg of SMX) per day in 2 divided doses every 12 hrs for 10 days.

cefixime Suprax susp 100mg/5mL
200mg/5mL		 strawberry

<6 months: not recommended.

(<50kg) 6 months–12yrs: 8mg/kg once daily or 4mg/kg every 12 hrs.

(>50kg) >12yrs: 400mg once daily.

cefpodoxime Vantin susp 50mg/5mL
100mg/5mL

lemon-creme

lemon-creme

<2 months: not recommended.

≥2 months: 5mg/kg (max 200mg) every 12 hours for 5 days.

azithromycin Zithromax5 susp 100mg/5mL
200mg/5mL		 cherry

<6 months: not recommended.

≥6 months: 30mg/kg as a single dose (max 1.5g); or 10mg/kg (max 500mg) once daily for 3 days; or 10mg/kg (max 500mg) once then 5mg/kg (max 250mg) per day for 4 days.
NOTES

Key: drops = oral drops. susp = oral suspension (as supplied or after reconstitution). tabs = oral tablets. chew tabs = chewable tablets. IM inj = intramuscular injection.

* Indicates the drug is available under other brand names not shown here.

1 These formulations are intended to be used in three-times-daily (TID) regimens. Do not substitute plain tabs for chewable tabs.

2 These formulations are intended to be used in twice-daily regimens. Do not substitute plain tabs for chewable tabs.

3 These products should be taken with food.

4 These products should be taken 2 hrs before or 1 hr after food.

5 Give on an empty stomach (1 hour before or 2 hours after food or meals).

6 Ceftin susp and Ceftin tabs are not bioequivalent and cannot be interchanged on a mg/mg basis. Ceftin tabs can be taken without regard to meals; Ceftin susp must be taken with food.

Not an inclusive list

(Rev. 11/2009)