Hypoallergenic amino acid-based Medical Food.
Last Updated: Wednesday, December 23, 2015
Indication: PurAmino™ Toddler is an iron-fortified, hypoallergenic, amino acid-based toddler medical food for the dietary management of toddlers with severe cow's milk protein allergy, not effectively managed by an extensively hydrolyzed formula. PurAmino Toddler is also indicated for the dietary management of toddlers with multiple food protein allergies. It may also be suitable for conditions requiring an elemental diet such as protein maldigestion, malabsorption, short bowel syndrome, and eosinophilic esophagitis.
PurAmino Toddler is designed to provide a major source of nutrition for toddlers age 1 year and up. In cases of severe and multiple food allergies or intolerances, PurAmino Toddler is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of PurAmino Toddler in the diet may make a significant contribution to maintenance of good nutrition in such patients.
When PurAmino Toddler is used as a milk substitute, the total calcium content of the diet should be assessed.
Extended use of PurAmino Toddler (or other toddler formulas) is most appropriately monitored by physicians and nutritionists on a case-by-case basis, with attention to developmental as well as nutritional implications of such a dietary regimen.
|(Normal Dilution)||Per 100 KCal||Per 100 g. PWD|
|Linoleic acid, mg||860||4300|
|Linolenic acid, mg||80||400|
|(Normal Dilution)||Per 100 KCal||Per 100 g. PWD|
|Vitamin A, IU||300||1490|
|Vitamin D, IU||50||250|
|Vitamin E, IU||2||9.9|
|Vitamin K, mcg||9||45|
|Thiamin (Vitamin B1), mcg||80||400|
|Riboflavin (Vitamin B2), mcg||90||450|
|Vitamin B6, mcg||60||300|
|Vitamin B12, mcg||0.3||1.49|
|Folic acid (Folacin), mcg||16||80|
|Pantothenic acid, mcg||500||2500|
|Vitamin C (Ascorbic acid), mg||12||60|
|(Normal Dilution)||Per 100 KCal||Per 100 g. PWD|
|Nutrient Density||30 Calories/fl oz|
|Protein (% Calories)||11|
|Fat (% Calories)||47|
|Carbohydrate (% Calories)||42|
|Potential Renal Solute Load (mOsm/100 Calories)7||25|
|Potential Renal Solute Load (mOsm/100 mL)7||25|
|Osmolality (mOsm/kg water)||Not Available|
|Osmolarity (mOsm/L)||Not Available|
|Lactose-Free||Suitable for someone with lactose intolerance|
Item #: 157301
Unit Size: 14.1 oz can (400 g)
Prod. Yield/Unit (fl oz): 66
Case: 4 cans per case
Reimbursement Code: 00087-511732
Ingredients: Corn syrup solids (49%), amino acids (L-aspartic acid, L-leucine, L-lysine hydrochloride, L-proline, L-alanine, L-valine, monosodium glutamate, L-isoleucine, L-serine, L-threonine, L-tyrosine, L-arginine, L-phenylalanine, glycine, L-cystine, L-histidine, L-tryptophan, L-methionine) (17%), high oleic sunflower oil (10%), medium chain triglycerides (MCT) oil (9%), soy oil (8%), modified tapioca starch (3%), and less than 2%: Mortierella alpina oil*, Crypthecodinium cohnii oil†, choline chloride, inositol, ascorbic acid, niacinamide, calcium pantothenate, riboflavin, thiamin hydrochloride, vitamin B6 hydrochloride, vitamin D3, folic acid, vitamin K1, biotin, taurine, vitamin E acetate, L-carnitine, vitamin A palmitate, vitamin B12, calcium phosphate, potassium citrate, calcium citrate, sodium citrate, potassium chloride, calcium hydroxide, magnesium phosphate, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite.
* A source of arachidonic acid (ARA) † A source of docosahexanoic acid (DHA)
PurAmino™ Toddler contains soy oil. PurAmino Toddler is hypoallergenic.
Your medical professional will provide the correct amount of powder to mix with water for consumption‡. It is important to follow the directions below.
Measure the correct amount of water into a suitable container for mixing. Then add the required amount of PurAmino Toddler powder. Mix until well blended.
Consume the prepared beverage immediately or cover and refrigerate. Use within 48 hours of preparation. Mix before drinking.
‡ If instructed to use the scoop in the can to make 30 Cal/fl oz feedings.
For every 1 fl oz water, 1 unpacked level scoop of powder (7.2 g) will make approximately 1.2 fl oz of prepared formula. Add 5 unpacked level scoops (36 g) of powder to 5 fl oz water to make 6 fl oz of prepared product. Add 7 unpacked level scoops (50.4 g) to 7 fl oz of water to make 8.4 fl oz of prepared product. Store DRY scoop in this can.
WARNING: Do not use a microwave oven to warm product. Serious burns may result.
Powder Storage: Store cans at room temperature. After opening can, keep tightly covered, store in a dry area and use contents within 1 month. Do not freeze powder and avoid excessive heat.
WARNING: Not for parenteral (I.V.) use.
USE BY DATE ON CAN END.
The fat content in PurAmino™ Toddler is 47% of total calories. The fat blend consists of approximately:
DHA and ARA
PurAmino Toddler has DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes1–6,8–10.
Protein provides 11% of total calories in PurAmino Toddler. The protein source is an amino acid premix composed of 100% free amino acids in the following amounts:
|Amino Acid||mg Per 100 Calories||mg Per 100 Grams|
|Amino Acid||mg Per 100 Calories||mg Per 100 Grams|
Carbohydrate provides 42% of total calories in PurAmino Toddler and the product is suitable for someone with lactose intolerance. The carbohydrate blend is corn syrup solids and modified tapioca starch. The carbohydrates in PurAmino Toddler are readily digested12 and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, may be an issue. The production of corn syrup solids includes filtration and purification procedures that remove protein, the allergenic component of corn. Therefore, carbohydrate source is considered hypoallergenic13.
Vitamins and Minerals
PurAmino Toddler has vitamins and minerals to help support growth and development.
Calcium and Phosphorus
PurAmino Toddler has calcium and phosphorus for growing toddlers. PurAmino Toddler has 94 mg calcium/100 Calories and 52 mg phosphorus/100 Calories.
PurAmino Toddler has 18.2 mg iron/L Iron helps support growth and development
Electrolytes—Sodium, Potassium, and Chloride
The sodium, potassium, and chloride levels are 47 mg/100 Calories, 110 mg/100 Calories, and 86 mg/100 Calories, respectively.
Cow's milk protein allergy occurs in approximately 2%–3% of infants14. Many healthcare professionals use an extensively hydrolyzed protein formula for the dietary management of cow's milk protein allergy. However, up to 10% of infants with severe cow's milk or food protein allergies develop specific IgE against extensively hydrolyzed casein or whey protein and may require a special formula made of free amino acids. Several of the studies using amino acid–based formulas are summarized below.
Elimination of milk and other foods from a child's diet as part of the management of milk protein allergy and/or multiple food protein allergies may impact growth and overall nutritional status15. Therefore, it is not surprising that the key criteria for assessing the safety and efficacy of a hypoallergenic formula are weight gain and height increases. In this regard, there are a number of clinical studies demonstrating that amino acid–based formulas can both improve compromised growth in infants and young children with severe cow's milk protein allergy and/or multiple food protein allergies and continue to support their growth when used for a short period or long term15-20.
Safety and Efficacy
There are several clinical trials demonstrating the safety and efficacy of reduced antigenic dietary products. However, adverse responses to these cow's milk substitutes may continue to persist in some highly allergic infants. Incidence allergic responses to hydrolyzed formulas, including extensively hydrolyzed formulas, has been reported over the past few years21,22.
In contrast to the residual allergenicity of partial and extensively hydrolyzed formulas, formulas based on free amino acid solutions are designed to contain no intact proteins or peptides23,24. As a result, there is substantial clinical evidence demonstrating the efficacy of amino acid–based formulas in these situations.
Skin Health and Digestive Health
In the dietary management of cow's milk protein allergy, benefits in skin health as well as digestive health are often seen. Atopic dermatitis is common in infants with cow's milk allergy. It has been reported that about one third of infants with severe atopic dermatitis have clinical reactivity to food proteins, including cow's milk and soy proteins25. There have been several clinical studies evaluating the efficacy of amino acid-based formulas in improving skin health as a result of continued allergenicity to cow's milk formula and extensively hydrolyzed proteins15,18,23,26. The SCORAD (SCORing Atopic Dermatitis) has been shown to decrease as dietary management with an amino acid-based formula is continued18.
Digestive issues are common in infants with an allergy to cow's milk protein or extensively hydrolyzed protein formulas. Multiple food protein allergies have been implicated as one of the causes of persistent child distress. It is well known that dietary antigens are capable of provoking gastroduodenal inflammations and hypermotility in hypersensitivity reactions. A number of clinical studies demonstrate the efficacy of amino acid-based formulas for improved GI health in infants and children allergic to cow's milk protein and extensively hydrolyzed protein formulas17,19,23,26-29.
Multiple Food Allergies
Studies suggest that many children who are allergic to cow's milk protein may develop an allergy to a large variety of other foods, such as eggs, wheat, peanuts, soy and even protein hydrolysates. This scenario is typically defined as “multiple intolerances” to dietary proteins in children and may affect 5%–8% of children during the first three years of life17,20,26,29. According to Latcham et al30, "recently there have been increasing reports of multiply-sensitized infants, often despite exclusive breastfeeding.” In the initial studies of Hill et al19, some patients with cow's milk allergy also had adverse reactions to soy milk or casein hydrolysates. Many were also intolerant to other foods (ie, multiple food proteins). A delay in the diagnosis and initiation of appropriate dietary management could sustain and/or worsen these multiple allergies. Clinical studies by Ammar et al17, Hill et al19 and Latcham et al30 add to the growing body of evidence demonstrating the potential benefits of using an amino acid-based formula for the dietary management of infants with multiple food allergies. PurAmino Toddler is a hypoallergenic formula for patients with severe cow's milk allergy and multiple food allergies.
Malabsorption and Maldigestion
Conditions resulting in maldigestion and malabsorption can be problematic for maintaining or achieving appropriate nutrient status and potentially have additional effects such as gastrointestinal issues, changes in stool patterns, and ultimately impact growth and development. Clinicians may often recommend use of an elemental formula to help promote absorption of essential nutrients. Indeed, studies in infants and children with chronic diarrhea suggest that use of an elemental formula may be beneficial. Antonson and colleagues examined the effects of an amino acid-based formula with MCT oil on 27 infants <12 months of age with chronic diarrhea, with improvements in growth and gastrointestinal issues reported31,32.
Short Bowel Syndrome
Elemental diets may also be considered for patients with short bowel syndrome. While some cases are congenital, short bowel syndrome is typically a result of intestinal resection, in which parts of the small and/or large intestine are removed due to disease or trauma33. Bowel resection reduces the absorptive surface area of the gut, which can lead to maldigestion and malabsorption. Thus, strategies for improving nutrient digestion and absorption are necessary to promote growth and development. Protein hydrolysate or amino acid-based formulas are often used in the dietary management of infants and children with short bowel syndrome33-35. In terms of the lipid requirements, it has been suggested that a mixture of both medium-chain and long-chain triglycerides is needed in patients with short bowel syndrome34,36. Due to the malabsorption that occurs, MCTs are particularly important as they are easily and quickly absorbed; however, long-chain triglycerides are still needed as they are key for stimulating trophic effects in the intestine as well as meeting essential fatty acid requirements33,36.
Indeed, studies suggest amino acid-based formulas may be beneficial. Using a retrospective chart review of children with short bowel syndrome, Andorsky and colleagues noted that use of an amino-acid based formula was associated with a shorter duration of parenteral nutrition use45. Similarly, Bines and colleagues conducted a small study of infants and children with short bowel syndrome who had a feeding intolerance to hydrolyzed formulas, noting that feeding tolerance improved within 1 month and patients were weaned from parenteral nutrition within 15 months27.
In addition to the conditions described above, elemental formulas are also commonly used in patients with eosinophilic esophagitis. Dietary recommendations include food eliminations based on allergy testing or use of an amino acid-based elemental formula in infants and children38. Indeed, studies conducted by Liacouras et al39, Markowitz et al40, and Kelly et al41 suggest that elemental formulas improve gastrointestinal issues and esophageal histology in infants and children.
Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long–chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570–580.
Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18–month old infants receiving dietary long–chain polyunsaturated fatty acids [abstract]. FASEB J. 2003;17:A727–A728. Abstract 445.1.
Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast–fed term infants weaned to formula with or without long–chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669–677.
Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long–chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540–553.
Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long–chain polyunsaturated fatty acid–supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871–879.
Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long–chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197–203.
Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11–14.
Birch EE, Hoffman DR, Uauy RD, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201–209.
Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long–chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174–181.
Birch EE, Garfield S, Castañeda YS, et al. Visual acuity and cognitive outcomes at 4 years of age in a double–blind, randomized trial of long–chain polyunsaturated fatty acid–supplemented infant formula. Early Hum Dev. 2007;83:279–284.
Data on File, Mead Johnson Nutritionals. May, 1998.
Ziegler EE, Fomon SJ. Methods in infant nutrition research: balance and growth studies. Acta Paediatr Scand Suppl. 1982;299:90–96.
Richardson GG, Leary HL, Halsey JF. Allergenicity of corn–derived carbohydrate ingredients for use in infant formulas [abstract]. Presentation at American College of Allergists 5th International Food Allergy Symposium. October 15–18, 1984.
Høst A, Koletzko B, Dreborg S, et al. Dietary products used in infants for treatment and prevention of food allergy. Joint statement of the European Society for Paediatric Allergology and Clinical Immunology (ESPACI) Committee on Hypoallergenic Formulas and the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child. 1999;81:80–84.
Niggemann B, Schnabel D, Grüters A, et al. Influence of dietary intervention on serum growth factors in infants with atopic dermatitis and cow's milk allergy—a pilot study. Allergo J. 2002;11:48–53.
Isolauri E, Sütas Y, Mäkinen–Kiljunen S, et al. Efficacy and safety of hydrolyzed cow milk and amino acid–derived formulas in infants with cow milk allergy. J Pediatr. 1995;127:550–557.
Ammar F, de Boissieu D, Dupont C. Allergy to protein hydrolysates: concerning 30 cases. Arch Pediatr. 1999;6:837–843.
Kanny G, Moneret–Vautrin DA, Flabbee J, et al. Value of a formula based on amino acids in the treatment of allergy to the proteins of cow's milk and the syndrome of multiple food allergies. Allergie et Immunologie. 2002;34:82–84.
Hill DJ, Heine RG, Cameron DJ, et al. The natural history of intolerance to soy and extensively hydrolyzed formula in infants with multiple food protein intolerance. J Pediatr. 1999;135:118–121.
Sicherer SH, Noone SA, Koerner CB, et al. Hypoallergenicity and efficacy of an amino acid–based formula in children with cow's milk and multiple food hypersensitivities. J Pediatr. 2001;138:688–693.
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Leung TF, Ma KC, Cheung LT, et al. A randomized, single–blind and crossover study of an amino acid–based milk formula in treating young children with atopic dermatitis. Pediatr Allergy Immunol. 2004;15:558–561.
Hill DJ, Cameron DJ, Francis DE, et al. Challenge confirmation of late–onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance. J Allergy Clin Immunol. 1995;96:386–394.
Bines J, Francis D, Hill D. Reducing parenteral requirement in children with short bowel syndrome: impact of an amino acid–based complete infant formula. J Pediatr Gastroenterol Nutr. 1998;26:123–128.
Vanderhoof JA, Murray ND, Kaufman SS, et al. Intolerance to protein hydrolysate infant formulas: an underrecognized cause of gastrointestinal symptoms in infants. J Pediatr. 1997;131:741–744.
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Antonson DL, Murray ND, Oliva-Hemker MM, et al. Nutritional management of infants with chronic diarrhea fed a free amino acid-based medical food. J Pediatr Gastrroenterol Nutr. 2002;35:443:A110.
Saavedra JM, Mattis LE, Chao C, et al. Use of an amino acid (AA)-based formula for the management of chronic diarrhea in children. Pediatr Res. 2000;47:168A:987.
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Andorsky DJ, Lund DP, Lillehei CW, et al. Nutritional and other postoperative management of neonates with short bowel syndrome correlates with clinical outcomes. J Pediatr. 2001;139:27-33.
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Liacouras CA, Spergel JM, Ruchelli E, et al. Eosinophilic esophagitis: a 10-year experience in 381 children. Clin Gastroenterol Hepatol. 2005;3:1198-1206.
Markowitz JE, Spergel JM, Ruchelli E, et al. Elemental diet is an effective treatment for eosinophilic esophagitis in children and adolescents. Am J Gastroenterol. 2003;98:777-782.
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