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Acute Otitis Media Treatments

October 20, 2009

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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
		chew tabs	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.
cefuroxime	Ceftin⁶	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)

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