Palatability of Oral Antibiotics Among Children in an Urban Primary Care Center

Angelilli, Mary Lu; Toscani, Michael; Matsui, Doreen; Rieder, Michael J.

doi:10.1001/archpedi.154.3.267

Cited by 63 publications

(47 citation statements)

References 7 publications

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“…The taste of the famciclovir pediatric formulation was evaluated immediately after swallowing the study medication and then 2 to 5 min later using a modified, five-point facial hedonic scale (1,16). Patients of Ն5 years of age were asked to complete the questionnaire themselves, while parents/legal guardians completed the questionnaire for patients 1 to Ͻ5 years of age and for older patients if necessary.…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics and Safety of Famciclovir in Children with Herpes Simplex or Varicella-Zoster Virus Infection

Sáez-Llorens

Yogev

Arguedas

et al. 2009

Antimicrob Agents Chemother

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Two multicenter, open-label, single-arm, two-phase studies evaluated single-dose pharmacokinetics and single-and multiple-dose safety of a pediatric oral famciclovir formulation (prodrug of penciclovir) in children aged 1 to 12 years with suspicion or evidence of herpes simplex virus (HSV) or varicella-zoster virus (VZV) infection. Pooled pharmacokinetic data were generated after single doses in 51 participants (ϳ12.5 mg/kg of body weight [BW] for children weighing <40 kg and 500 mg for children weighing >40 kg). The average systemic exposure to penciclovir was similar (6-to 12-year-olds) or slightly lower (1-to <6-year-olds) than that in adults receiving a 500-mg dose of famciclovir (historical data). The apparent clearance of penciclovir increased with BW in a nonlinear manner, proportional to BW 0.696 . An eight-step weight-based dosing regimen was developed to optimize exposure in smaller children and was used in the 7-day multiple-dose safety phases of both studies, which enrolled 100 patients with confirmed/suspected viral infections. Twenty-six of 47 (55.3%) HSV-infected patients who received famciclovir twice a day and 24 of 53 (45.3%) VZV-infected patients who received famciclovir three times a day experienced at least one adverse event. Most adverse events were gastrointestinal in nature. Exploratory analysis following 7-day famciclovir dosing regimen showed resolution of symptoms in most children with active HSV (19/21 [90.5%]) or VZV disease (49/53 [92.5%]). Famciclovir formulation (sprinkle capsules in OraSweet) was acceptable to participants/caregivers. In summary, we present a weight-adjusted dosing schedule for children that achieves systemic exposures similar to those for adults given the 500-mg dose.Intravenous and high-dose oral acyclovir has been the gold standard for many children requiring treatment and/or prevention of herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections (3,14,15,25). However, intravenous acyclovir requires hospitalization, and oral acyclovir has limited bioavailability, necessitating frequent dosing, and may not provide maximum therapeutic benefit especially in immunocompromised hosts requiring higher plasma drug levels (22). It is therefore desirable to identify more pharmacokinetically appealing therapies for children with conditions caused by HSV or VZV infections. Alternative therapies for treating herpesvirus infections have become available over the last decade, including valacyclovir and famciclovir (5, 18), but only acyclovir is currently approved for pediatric use in many countries.Penciclovir, a nucleoside analogue, possesses potent in vitro antiviral activity against HSV types 1 and 2 and VZV (21). Famciclovir, the oral prodrug of penciclovir, is currently approved for the treatment of herpes zoster and herpes labialis, treatment or suppression of genital herpes in immunocompetent adult patients, and treatment of HSV infections and herpes zoster in immunocompromised adults. Although pharmacokinetic and safety data for famciclovir have been rep...

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Section: Methodsmentioning

confidence: 99%

Pharmacokinetics and Safety of Famciclovir in Children with Herpes Simplex or Varicella-Zoster Virus Infection

Sáez-Llorens

Yogev

Arguedas

et al. 2009

Antimicrob Agents Chemother

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“…Immediately after each ORS was consumed, children rated taste by marking a point on a 100-mm visual analog scale with facial hedonic features (Figure 3). [15][16][17][18] Between tastings, the children consumed 2 unsalted crackers (Premium Plus; Kraft Canada Inc, Don Mills, Ontario) followed by 3 to 5 oz of water to remove any residual taste 15,17,19 and then waited an additional 5 minutes before tasting the next ORS. After consuming the final ORS, participants were asked which ORS tasted best.…”

Section: Interventionmentioning

confidence: 99%

Assessing the Palatability of Oral Rehydration Solutions in School-aged Children

Freedman¹,

Cho²,

Boutis³

et al. 2010

Arch Pediatr Adolesc Med

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Setting: Emergency department of a tertiary care pediatric hospital.Participants: Sixty-six children aged 5 to 10 years with concerns unrelated to the gastrointestinal tract.Intervention: Each participant consumed as much of each solution as they desired during a 15-minute period.Main Outcome Measures: The primary outcome was each child's rating of taste as measured on a 100-mm visual analog scale (worst taste, 0 mm; best taste, 100 mm). Secondary outcome measures were volume consumed, willingness to consume each liquid again, and the most favored liquid. Results:All enrolled patients completed all 3 study periods. A significant carryover effect was detected for taste scores (P=.03), which were significantly different with and without adjustment for the carryover effect (PϽ.001). Unadjusted values were 65 mm for Pedialyte, 58 mm for Pediatric Electrolyte, and 23 mm for Enfalyte. Differences in mean volume consumed were not significant (Enfalyte, 15 mL; Pediatric Electrolyte, 17 mL; and Pedialyte, 22 mL [P=.44]). The proportion of children who would drink each solution in the future varied significantly between Enfalyte and Pediatric Electrolyte (odds ratio, 0.22; 95% confidence interval, 0.11-0.46) and between Enfalyte and Pedialyte (0.38; 0.25-0.57). There were differences in the identification of the best-tasting solution, with Pedialyte selected by 35 of 66 children (53%), Pediatric Electrolyte by 26 of 66 children (39%), and Enfalyte by 5 of 66 children (8%) (PϽ.001). Conclusion:Sucralose-sweetened oral rehydration solutions (Pedialyte and Pediatric Electrolyte) were significantly more palatable than was a comparable ricebased solution (Enfalyte).

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“…Moreover, pediatric acceptability studies are not among the criteria used to define generic drugs. Many double-blind trials of antibiotics have included taste evaluations [1,2,5,6,8,9,[12][13][14][15][16][17][18][20][21][22]. In contrast, few such studies have been conducted in regular medical settings, and even fewer have concerned generics [4,23].…”

mentioning

confidence: 99%

Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients

et al. 2008

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This observational study was designed to evaluate the acceptability of oral antibiotics (including generics) commonly prescribed to children by community practitioners in France. Between February and July 2006, the parents of 953 children enrolled by 46 pediatricians completed a questionnaire, including a taste assessment based on representations of five facial expressions. The proportions of "satisfactory" taste judgments showed a significant difference between amoxicillin-clavulanate reference product and its generics (77.9% vs. 65%, p = 0.01). The amoxicillin-clavulanate generics were more likely than the reference product to be spat out at least once (28.7% vs. 19%, p = 0.05). The full treatment course was taken by 91.7% and 82.3% of children prescribed the amoxicillin-clavulanate reference product and its generics, respectively (p = 0.02). The proportions of "satisfactory" taste judgments showed no significant difference between amoxicillin reference product and generics (64.3% vs. 72.5%, p = 0.3). The amoxicillin generics were not different from the reference product to be spat out at least once (8.6% vs. 14.3%, p = 0.2). The full treatment course was taken by 90.7% and 94.6% of children prescribed the amoxicillin reference product and its generics, respectively (p = 0.3). This study suggests the role of the active substance in the taste, and calls for the evaluation of palatability of future drugs (generics and references) before granting of the marketing authorization, particularly for active substances of poor taste; this palatability plays a significant role in the compliance of the treatment, notably in children. Poor compliance increases the risk of therapeutic failures and the emergence of resistance.

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Palatability of Oral Antibiotics Among Children in an Urban Primary Care Center

Abstract: The cefixime preparation was most commonly rated as best tasting by children.

Cited by 63 publications

References 7 publications

Pharmacokinetics and Safety of Famciclovir in Children with Herpes Simplex or Varicella-Zoster Virus Infection

Pharmacokinetics and Safety of Famciclovir in Children with Herpes Simplex or Varicella-Zoster Virus Infection

Assessing the Palatability of Oral Rehydration Solutions in School-aged Children

Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients

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