Pediatric Oral Antibiotic and Antifungal Suspensions and Liquids

Transcription

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,
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)
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.
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.
More. . .
Generic
Name
Trade Name
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.
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:
Fruity crème.
1 day12
14 days
Generics:
Bubble gum.
Fruit.
Teva: 125 mg/5 mL. Fruit gum.
Max dose: 400 mg/day;
200 mg/day is max for pharyngitis.
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
(Info is for brand
product)
Pharyngitis (≥2 yrs): 15 mg/kg/day
Skin infections (≥2yrs): 20 mg/kg/day
given once daily.
Max dose: 1 g/day.
More. . .
Generic
Name
Trade Name
Ceftibuten
Cedax
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:
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.
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.
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.
More. . .
Generic
Name
Trade Name
Clarithromycin
Biaxin
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
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.
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
(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)
Children ≥2 mos:
8 mg/kg/day based on TMP divided twice
daily.
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.
Children ≥2 mos:
Otitis media: 50 mg/kg/day erythromycin
(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.
More. . .
Generic
Name
Trade Name
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.
Neonates ≤14 days: see product labeling.
Levofloxacin
Levaquin
Penicillin VK
Veetids
(Brand no
longer
available)
Voriconazole
Vfend
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. . .
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. . .
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.
Medical Information,
Pfizer Laboratories. September 11, 2007.
12. Personal communication. Medical Communications,
Bristol Myers Squibb. September 11, 2007.
Medical Information,
Pernix Therapeutics. November 23, 2010.
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.
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
Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get Detail-Documents, like this one, on any
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Pediatric Oral Antibiotic and Antifungal Suspensions and Liquids

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