Table 1.

Food effect studies conducted in paediatric populations.

Drug	Formulation	Dose	Age Range	Meal	Change in Parameter	Comments	Ref	Comparable Adult Data	Adult Ref
Amoxicillin	oral suspension	15 or 25 mg/kg	4 m–45 m (mean 27 months)	4oz milk or formula (Similac or Infamil)	Cmax decreased at 15mg/kg dosing Cmax unchanged at 25 mg/kg dosing AUC unchanged all doses		[42]	Adult study at 500mg dose showed no impact of food (standard breakfast)	[43]
Ampicillin	oral suspension	15 or 25 mg/kg	4 m–45 m (mean 27 months)	4oz milk or formula (Similac or Infamil)	Cmax unchanged AUC unchanged		[42]	Adult study at 500mg dose showed reduction in Cmax and AUC with food (standard breakfast)	[43]
Cefpodoxime proxetil	oral suspension	10 mg/kg	5 m–12 y	Age-appropriate meal (volume and composition)	Tmax prolonged Cmax unchanged	Cefpodoxime can be administered without regard for food	[44]	Cmax and AUC eleveated in the fed states for all meals (high protein, low protein, high fat, low fat).	[45]
Cephalexin	suspension and capsule	25 mg/kg	3–14 y	Standard hospital meal	Cmax reduced (not significant) AUC increased (not significant)	Concomitant administration of food does not substantially affect absorption	[46]	Absorption is delayed but AUC is not appreciably altered	[47]
Clarithromycin	oral suspension	7.5 mg/kg			AUC unchanged		[48]	The extent of absorption is relatively unaffected by the presence of food	[49]
Desmopressin	oral lyophilisate (MELT)	120 mg	mean age 12.7 y	Standardised meal	Cmax unchanged AUC unchanged	Bioequivalence established, even with concomitant food-intake	[50]	AUC and Cmax are reduced with food in adults (for the tablet formulation but not the MELT)	[51]
Didanosine		50 or 150 mg/m2			Cmax reduced AUC unchanged	Take in the fasted state	[52]	AUC and Cmax are substantially reduced with some formulations if taken with food	[53]
Griseofulvin	oral suspension	10 or 15 mg/kg/day	19 m–11 y (mean 4.8 y)	120 mL whole milk	Cmax increased AUC increased	Drug should be administered with whole milk or other food containing fat for optimum bioavailability	[54]	Cmax increased AUC increased	[55]
Lumefantrine	dispersible or crushed tablets (Coartem ®) with 10mL water		0.25–12.4 y	Categorised as: none; breast feeding; liquid (soup, broth); pancake; porridge or other	Cmax increased (greater increased for crushed tablet) Pancake increased the exposure to a greater extent than milk	Consumption of food at the time of dosing remains advisable	[56]	Cmax and AUC increased when given with food	[57]
6-mercaptopurine		75 mg/m2		250 mL milk and 50 g biscuits	Tmax prolonged Cmax significantly reduced AUC significantly reduced	6-MP should be taken in a fasting state to optimize drug absorption in children undergoing chemotherapy for ALL	[58]	Tmax prolonged Cmax reduced	[59]
6-mercaptopurine			4 year old child (n = 1)	Milk or fruit squash	In the presence of milk Cmax reduced AUC reduced	Child required increased dose of mercaptopurine when taken with milk	[60]	Tmax prolonged Cmax reduced	[59]
6-mercaptopurine				Breakfast (milk or yogurt plus cereal, or sandwiches)	Cmax unchanged AUC unchanged	Insufficient data for a recommendation	[61]	Tmax prolonged Cmax reduced	[59]
Methotrexate		15 mg/m2	3–15 years	Milky meal = milk, cornflakes sugar, bread and butter Or citrus meal = orange juice, fresh orange, bread, butter and jam	Milky meal: Tmax prolonged Cmax and AUC significantly reduced Citrus meal: Cmax and AUC unchanged	Methotrexate absorption is delayed by food, particularly milk. For maximum absorption methotrexate should not be taken at meal times.	[62]	Tmax prolonged AUC unchanged	[63]
Penicillin V (phenoxymethylpenicillin)	dispersed in water 23 mg/mL (Calciopen)	20 mg/kg	6 m–5 years	Breakfast	Cmax significantly reduced AUC significantly reduced	Dosing Penicillin V with food will reduce its exposure	[10]	Slight alteration in pharmacokinetics such that it is recommended to dose penicillin V in the fasted state	[64]
Penicillin V (phenoxymethylpenicillin)	Suspension		infants and children	milk	Cmax reduced AUC reduced	Dosing Penicillin V with milk will reduce its exposure	[65]	Slight alteration in pharmacokinetics such that it is recommended to dose penicillin V in the fasted state	[64]
Propylthiouracil	Not stated	100–280 mg/m2		Not stated	Tmax prolonged Cmax reduced AUC variable	Propylthiouracil administration in the fasting state is advisable	[66]	Cmax unchanged AUC unchanged	[67]
Theophylline	slow release products			Standard breakfast of cornflakes, rye bread, butter, salami and low fat milk	Effects dependent upon formulation	Food effect is dependent upon formulation. Caution advised if switching brand.	[68]	Food has substantial but variable effects on absorption from modified-release formulations in adults.	[69]
6-thioguanine	Not stated	40 mg/m2	1–16 years	Standard breakfast of cereal with milk, toast and a glass of milk	Tmax prolonged Cmax significantly reduced AUC significantly reduced	Although there is a reduction in exposure with food there was no difference in 6-TGN concentrations after 4 weeks. Taking the drug on an empty stomach may not be necessary.	[70]