Detail-Document #231107 −This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER November 2007 ~ Volume 23 ~ Number 231107 Pediatric Oral Antibiotic and Antifungal Suspensions and Liquids (Full Update November 2010; information for U.S. products) Generic Name Trade Name Recommended Dosea,c,g Amoxicillin Amoxil (Brand no longer available) Children ≤3 mos: 30 mg/kg/day divided twice daily. Can be left at room temp up to…a,b,f 14 days If refrigerated, can be kept up to…a,b,f 14 days Refrigeration preferred but not required; improves taste. Children >3 mos: 20-40 mg/kg/day divided three times daily OR 25-45 mg/kg/day divided twice daily. High-dose for otitis media (2 mos to 12 yrs): 80 to 90 mg/kg/day divided twice daily.1 Flavor Generics: Dava: 125 mg/5 mL, 250 mg/5 mL. Bubble gum. Sandoz: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Fruit. Teva: 125 mg/5 mL, 250 mg/5 mL. Mixed berry. 200 mg/5 mL, 400 mg/5 mL. Pink fruit gum. Westward: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Tutti frutti. High-dose for sinusitis (>1 yr): 90 mg/kg/day divided twice daily.2 Amoxicillin/ clavulanate Augmentin (125 mg/5 mL and 250 mg/5 mL) Augmentin BID (200 mg/5 mL and 400 mg/5 mL) (Brand no longer available) Can give WITHOUT REGARD to meals. Children <3 mos: 30 mg/kg/day divided twice daily (use 125 mg/5 mL). Children ≥3 mos: Otitis media, sinusitis, lower respiratory infections, severe infections: 45 mg/kg/day divided twice daily (use 200 mg/5 mL or 400 mg/5 mL) OR 40 mg/kg/day divided three times daily (use 125 mg/5 mL or 250 mg/5 mL). Less severe infections: 25 mg/kg/day or 20 mg/kg/day, respectively. Do not leave at room temp. 10 days 125 mg/5 mL. Banana; tastes good.3 250 mg/5 mL. Orange. Generics: Sandoz: 200 mg/5 mL, 400 mg/5 mL. Caramel orange raspberry. Teva: 200 mg/5 mL, 400 mg/5 mL. Orange-raspberry; tastes bad.3 Westward: 200 mg/5 mL, 400 mg/5 mL. Orange. Take at start of meal to minimize GI irritation. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 2 of 8) Generic Name Trade Name Amoxicillin/ clavulanate, high-dose Augmentin ES-600 (Brand no longer available) Recommended Dosea,c,g Not FDA-approved for infants <3 mos or adults/children ≥40 kg. Can be left at room temp up to…a,b,f If refrigerated, can be kept up to…a,b,f Flavor No data4 10 days Generics: Ranbaxy: 600 mg/5 mL. Strawberry. Sandoz: 600 mg/5 mL. Raspberry. Teva: 600 mg/5 mL. Orange. Westward: 600 mg/5 mL. Orange. 10 days 10 days 100 mg/5 mL, 200 mg/5 mL. Cherry-vanilla-banana; tastes good.5,6 Generics: Teva: 100 mg/5 mL, 200 mg/5 mL. Cherry. 10 days7,8 14 days 250 mg/5 mL, 500 mg/5 mL. Orange-pineapple. Generics: Lupin: 250 mg/5 mL, 500 mg/5 mL. Pineapple orange. Otitis media (2 mos to 12 yrs) or sinusitis (>1 yr): 90 mg/kg/day divided twice daily.1,2 Take at start of meal to minimize GI irritation. Azithromycin Zithromax Otitis media (≥6 mos): 30 mg/kg single dose OR 10 mg/kg/day once daily for 3 days OR 10 mg/kg (up to 500 mg) on day one, then 5 mg/kg (up to 250 mg) once daily for 4 days. Community-acquired pneumonia (≥2yrs): 10 mg/kg (up to 500 mg) on day one, then 5 mg/kg (up to 250 mg) once daily for 4 days. Pharyngitis (≥2yrs): 12 mg/kg (up to 500 mg) once daily for 5 days. Can give WITHOUT REGARD to meals. Cefadroxil Duricef (Brand no longer available) Pharyngitis, otitis media, impetigo: 30 mg/kg/day divided once or twice daily. Divide dose twice daily for UTI, or other skin infections. Max dose: 2 g/day. Can give WITHOUT REGARD to meals. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 3 of 8) Generic Name Trade Name Recommended Dosea,c,g Cefdinir Omnicef (Brand no longer available) Children ≥6 mos: Pharyngitis, otitis media, sinusitis: 14 mg/kg/day divided twice daily or once daily. Can be left at room temp up to…a,b,f 10 days If refrigerated, can be kept up to…a,b,f 10 days; but may be hard to pour accurate dose.9 (No data for Lupin product) Skin infections: 14 mg/kg/day divided twice daily. Flavor 250 mg/5 mL. Strawberry; tastes good.10 Generics: Lupin, Sandoz: 125 mg/5 mL, 250 mg/5 mL. Strawberry. Teva: 125 mg/5 mL, 250 mg/5 mL. Cherry. Max dose: 600 mg/day. Can give WITHOUT REGARD to meals. Cefpodoxime proxetil Vantin (Brand no longer available) Children ≥2 mos: Otitis media, pharyngitis, sinusitis: 10 mg/kg/day divided twice daily. No data11 14 days Generics: Sandoz: 50 mg/5 mL, 100 mg/5 mL. Fruity crème. 1 day12 14 days Generics: Lupin: 125 mg/5 mL, 250 mg/5 mL. Bubble gum. Sandoz: 125 mg/5 mL, 250 mg/5 mL. Fruit. Teva: 125 mg/5 mL. Fruit gum. Max dose: 400 mg/day; 200 mg/day is max for pharyngitis. Can give WITHOUT REGARD to meals. Cefprozil Cefzil (Brand no longer available) Otitis media (≥6 mos): 30 mg/kg/day divided twice daily. Sinusitis (≥6 mos): 15-30 mg/kg/day divided twice daily. (Info is for brand product) Pharyngitis (≥2 yrs): 15 mg/kg/day divided twice daily. Skin infections (≥2yrs): 20 mg/kg/day given once daily. Max dose: 1 g/day. Can give WITHOUT REGARD to meals. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 4 of 8) Generic Name Trade Name Ceftibuten Cedax Recommended Dosea,c,g Pharyngitis, otitis media: 9 mg/kg once daily on EMPTY STOMACH. Can be left at room temp up to…a,b,f If refrigerated, can be kept up to…a,b,f Flavor No data13 14 days 90 mg/5 mL. Cherry. No stability data due to product reformulation, Aug 2004.14 10 days 125 mg/5 mL, 250 mg/5 mL. Tutti-frutti; tastes bad.15,16 Can cause metallic aftertaste.17 The manufacturer advises against using any flavoring systems with Ceftin suspension.d,14 1 day18 14 days Generics: Lupin: 125 mg/5 mL, 250 mg/5 mL. Strawberry. Teva: 125 mg/5 mL, 250 mg/5 mL. Mixed fruit. 14 days 14 days 250 mg/5 mL, 500 mg/5 mL. Strawberry. Max dose: 400 mg/day. Cefuroxime axetil Ceftin Children ≥3 mos: Pharyngitis: 20 mg/kg/day up to 500 mg/day divided twice daily. Sinusitis, otitis media, impetigo: 30 mg/kg/day up to 1 g/day divided twice daily. Take WITH FOOD. Cephalexin Keflex (Brand no longer available) 25-50 mg/kg/day divided four times daily. Can give twice daily for pharyngitis in children >1 yr or for skin infections. Max dose: 100 mg/kg/day. Can give WITHOUT REGARD to meals. Ciprofloxacin Cipro Complicated UTI or pyelonephritis (≥1 yr): 10-20 mg/kg/dose, up to 750 mg/dose, given twice daily. Inhalational anthrax (post-exposure): 15 mg/kg/dose, up to 500 mg/dose, given twice daily. Can give WITHOUT REGARD to meals. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 5 of 8) Generic Name Trade Name Clarithromycin Biaxin Recommended Dosea,c,g 15 mg/kg/day divided twice daily. Can be left at room temp up to…a,b,f If refrigerated, can be kept up to…a,b,f Do not refrigerate due to thickening and increased bitterness of taste.11 14 days To avoid thickening, do not refrigerate. No stability concerns. Does not require refrigeration. Generics: Hi-Tech: 200 mg-40 mg/5 mL. Cherry. Qualitest: 200 mg-40 mg/5 mL. Cherry. Teva: 200 mg-40 mg/5 mL. Cherry. E.E.S. 200 and E.E.S. 400 liquids: 14 days (Refrigerate prior to dispensing to preserve taste) EryPed: 35 days E.E.S. granules: 10 days E.E.S. granules: Cherry. E.E.S. 200 liquid: Fruit. E.E.S. 400 liquid: Orange. EryPed 200 granules: Fruit. EryPed 400 granules: Banana. 1 day19 14 days Can give WITHOUT REGARD to meals. Cleocin Pediatric Serious infections: 8-12 mg/kg/day divided three to four times daily. 250 mg/5 mL. Fruit punch; tastes relatively bad.15 Can taste gritty or cause metallic aftertaste. Generics: Dava: 125 mg/5 mL, 250 mg/5 mL. Fruit. Sandoz: 125 mg/5 mL, 250 mg/5 mL. Fruit. 75 mg/5 mL. Cherry. Generics: Paddock: 75 mg/5 mL. Cherry. 14 days Max dose: 1 g/day. Clindamycin palmitate Flavor Severe infections: 13-25 mg/kg/day divided three to four times daily. (For otitis media-see footnote “e”). Cotrimoxazole TMP-SMX Erythromycin ethylsuccinate Erythromycin ethylsuccinate/ sulfisoxazole Sulfatrim (Brand no longer available) E.E.S. granules, E.E.S. 200, and E.E.S. 400 liquids, EryPed 200 and EryPed 400 granules Pediazole (Brand no longer available) Can give WITHOUT REGARD to meals. Children ≥2 mos: 8 mg/kg/day based on TMP divided twice daily. Can give WITHOUT REGARD to meals. Usual dose: 30-50 mg/kg/day divided two to four times daily. More severe infections: 100 mg/kg/day divided two to four times daily. Use a pediatric dosing reference for neonates. Can give WITHOUT REGARD to meals. Children ≥2 mos: Otitis media: 50 mg/kg/day erythromycin divided three to four times daily. (Info is for brand product) (Granules: Abbott will address room temp stability on an individual basis) Generics: Duramed: 200 mg-600 mg/5 mL. Cherry. Can give WITHOUT REGARD to meals. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 6 of 8) Generic Name Trade Name Recommended Dosea,c,g Fluconazole Diflucan Children should be dosed according to corresponding adult doses. 3 mg/kg/day for a recommended adult dose of 100 mg daily, 6 mg/kg/day for a recommended adult dose of 200 mg daily, and 12 mg/kg/day for a recommended adult dose of 400 mg daily. Can be left at room temp up to…a,b,f If refrigerated, can be kept up to…a,b,f Flavor 14 days 14 days 10 mg/mL, 40 mg/mL. Orange. Generics: Greenstone: 10 mg/mL, 40 mg/mL. Orange. Roxane: 10 mg/mL, 40 mg/mL. Orange. Teva: 10 mg/mL, 40 mg/mL. Orange. No stability concerns. Does not need refrigeration. 25 mg/mL oral solution. Bubble gum. Not certain, but less than 5 days.7 14 days Generics: Teva: 125 mg/5 mL, 250 mg/5 mL. Cherry. Do not refrigerate. 200 mg/5 mL. Orange. Max dose: 600 mg/day. Neonates ≤14 days: see product labeling. Levofloxacin Levaquin Penicillin VK Veetids (Brand no longer available) Voriconazole Vfend Can give WITHOUT REGARD to meals. Not indicated for individuals <18 yrs. Give ONE HOUR BEFORE or TWO HOURS AFTER meals. 25-50 mg/kg/day, divided three to four times daily. Max dose: 3 g/day. Give ONE HOUR BEFORE or TWO HOURS AFTER meals. Not indicated for children <12 yrs. Give ONE HOUR BEFORE or ONE HOUR AFTER meals. (No data for Teva product) 14 days a The following product labeling was used for the above chart: Amoxicillin (Sandoz; February 2007), Augmentin (September 2009), Amoxicillin clavulanate 600 mg/5 mL (Sandoz; March 2007), Zithromax (January 2009), Cefadroxil (Lupin; November 2007), Cefdinir (Teva; June 2009), Cefpodoxime (Sandoz; September 2008), Cefprozil (Teva; September 2007), Cedax (April 2010), Ceftin (January 2010), Cephalexin (Teva; January 2010), Cipro (October 2008), Biaxin (August 2009), Cleocin Pediatric (January 2008), TMP-SMX (Teva; May 2008), E.E.S. (June 2009), EryPed (November 2008), Erythromycin ethylsuccinate sulfisoxazole (Duramed; March 2007), Diflucan (April 2010), Levaquin (April 2010), Penicillin VK (Teva; June 2007), Vfend (March 2010). b Stability data are the same for listed generic products unless otherwise noted. Manufacturers for all generic products listed were contacted and typically did not have stability information for storage conditions outside of those indicated by the package insert. c Check product information or dosing reference for complete dosing information. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 7 of 8) d The manufacturer has received product quality complaints concerning Ceftin suspension “thickening” and becoming difficult to pour after reconstitution. At this time, it is unclear what may cause Ceftin suspension to thicken, although the manufacturer advises against using any flavoring systems with Ceftin suspension.14 e Per the American Academy of Pediatrics, the dose of clindamycin for penicillin-resistant S. pneumoniae (otitis media infection) is 30 to 40 mg/kg/day in three divided doses.1 f For patients who store medication in a way that deviates from published storage guidelines, contact the manufacturer for guidance. Published refrigerated storage times and room temperature storage times are not generally considered to be sequential. g For premature infants, check a pediatric dosing reference for dosing information. The pediatric doses in this chart are intended to be used only for patients who are full-term neonates or older. Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and Internet links in this article were current as of the date of publication. More. . . Copyright © 2007 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com (Detail-Document #231107: Page 8 of 8) References 1. American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics 2004;113:1451-65. 2. American Academy of Pediatrics. Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical practice guidelines: management of sinusitis. Pediatrics 2001:108;798808. 3. Angelilli ML, Toscani M, Matsui DM, Rieder MJ. Palatability of oral antibiotics among children in an urban primary care center. Arch Pediatr Adolesc Med 2000;154:267-70. 4. Personal communication. Medical information, GlaxoSmithKline. September 11, 2007. 5. Matsui D, Lim R, Tschen T, et al. Assessment of the palatability of β-lactamase resistant antibiotics in children. Arch Pediatr Adolesc Med 1997;151:599602. 6. Green M. Appropriate principles in the use of antibiotics in children. Clin Pediatr 1997;36:207-8. 7. Trissel LA. Stability of Compounded Formulations. 3rd ed. Washington, DC: American Pharmaceutical Association, 2005. 8. Nahata MC, Jackson DS. Stability of cefadroxil in reconstituted suspension under refrigeration and room temperature. Am J Hosp Pharm 1991;48:9923. 9. Personal communication. Pharmaceutical Information, Abbott Laboratories. September 11, 2007. 10. Powers JL, Gooch WM, Oddo LP. Comparison of the palatability of the oral suspension of cefdinir vs. amoxicillin/clavulanate potassium, cefprozil and azithromycin in pediatric patients. Pediatr Infect Dis J 2000;19:S174-80. 11. Personal communication. Medical Information, Pfizer Laboratories. September 11, 2007. 12. Personal communication. Medical Communications, Bristol Myers Squibb. September 11, 2007. 13. Personal communication. Medical Information, Pernix Therapeutics. November 23, 2010. 14. Personal communication. Medical Information. GlaxoSmithKline. November 12, 2010. 15. Steele RW, Thomas MP, Begue RE. Compliance issues related to the selection of antibiotic suspensions for children. Pediatr Infect Dis J 2001;20:1-5. 16. Steele RW, Thomas MP, Begue RE, Despinasse BP. Selection of pediatric antibiotic suspensions: Taste and cost factors. Infect Med 1999;16:197-200. 17. Harrison CJ. Rational selection of antimicrobials for pediatric upper respiratory infections. Pediatr Infect Dis J 1995;14:S121-9. 18. Sylvestri MF, Makoid MC, Cox BE. Stability of cephalexin monohydrate suspension in polypropylene oral syringes. Am J Hosp Pharm 1988;45:1353-6. 19. Personal communication. Consumer Relations, Ross Laboratories. October 27, 2003. Project Leaders in preparation of this DetailDocument: Jill Allen, Pharm.D., BCPS (original 2003 version), Stacy A. Hester, R.Ph., BCPS (update October 2007, November 2010). Cite this Detail-Document as follows: Pediatric oral antibiotic and antifungal suspensions and liquids. Pharmacist’s Letter/Prescriber’s Letter 2007;23(11):231107. (Full update November 2010.) Evidence and Advice You Can Trust… 3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Copyright © 2007 by Therapeutic Research Center Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get Detail-Documents, like this one, on any topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com