PurAmino

Hypoallergenic amino acid—based formula.

Last Updated: Sunday, December 17, 2017 - 19:00

Description/Indication

PurAmino is a 20 Cal/fl oz, iron-fortified, hypoallergenic, amino acid-based infant formula for the dietary management of infants with severe cow’s milk protein allergy, not effectively managed by an extensively hydrolyzed formula. PurAmino is also indicated for the dietary management of infants 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.

Long-Term Usage: PurAmino is designed to provide a sole source of nutrition for infants up to age 6 months and provide a major source of nutrition through 24 months of age, when indicated. Normally, in feeding infants, gradual introduction of solid foods after 4–6 months of age is an important developmental as well as nutritional step. In cases of severe and multiple food allergies or intolerances, PurAmino is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of PurAmino in the diet beyond 24 months of age may make a significant contribution to maintenance of good nutrition in such patients.

When PurAmino is used as a milk substitute, the total calcium content of the diet should be assessed.

Extended use of PurAmino (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis.

Product Features:

  • Hypoallergenic, 100% free amino acids as nitrogen source:
    • 100% of infants fed PurAmino had no allergic reactions/ adverse events1
    • 2.8 g protein equivalent/100 Calories
  • Formulated with 33% MCT oil to help facilitate fat absorption
  • Nutritionally complete:
    • Can be sole source of nutrition up to age 6 months
    • Can be major source of nutrition through 24 months
    • Dietary reference intakes include a recommendation for fiber for >12 months of age
  • DHA and ARA, important nutrients also found in breast milk that promote brain and eye development2-7
  • Lactose-free
  • Demonstrated to support normal growth in healthy infants1
  • Kosher, Halal
  • Nutrients
    • (Normal Dilution)

      Per 100 Calories (5 fl oz)

      Per 100 mL

      Per 100 grams Powder (500 Cal)

      Protein equivalent, g

      2.8

      1.89

      13.9

      Fat, g

      5.3

      3.6

      26

      Linoleic acid, mg

      860

      580

      4300

      Carbohydrate, g

      10.6

      7.2

      53

      Water, g

      133

      90

      1.82

      Vitamins/Other Nutrients

      Vitamin A, IU

      300

      200

      1490

      Vitamin D, IU

      50

      34

      250

      Vitamin E, IU

      2

      1.35

      9.9

      Vitamin K, mcg

      9

      6.1

      45

      Thiamin (Vitamin B1), mcg

      80

      54

      400

      Riboflavin (Vitamin B2), mcg

      90

      61

      450

      Vitamin B6, mcg

      60

      41

      300

      Vitamin B12, mcg

      0.3

      0.2

      1.49

      Niacin, mcg

      1000

      680

      5000

      Folic acid (Folacin), mcg

      16

      10.8

      80

      Pantothenic acid, mcg

      500

      340

      2500

      Biotin, mcg

      3

      2

      14.9

      Vitamin C (Ascorbic acid), mg

      12

      8.1

      60

      Choline, mg

      24

      16.2

      119

      Inositol, mg

      17

      11.5

      85

      Minerals

      Calcium, mg

      94

      64

      470

      Phosphorus, mg

      52

      35

      260

      Magnesium, mg

      11

      7.4

      55

      Iron, mg

      1.8

      1.22

      9

      Zinc, mg

      1

      0.68

      5

      Manganese, mcg

      25

      16.9

      124

      Copper, mcg

      75

      51

      370

      Iodine, mcg

      15

      10.1

      75

      Selenium, mcg

      2.8

      1.89

      13.9

      Sodium, mg

      47

      32

      230

      Potassium, mg

      110

      74

      550

      Chloride, mg

      86

      58

      430

      Product nutrient values and ingredients are subject to change. Please see product label for current information.

  • Nutrient Facts
    • Nutrient Density

      20 Calories/fl oz

      Protein (% Calories)

      11

      Fat (% Calories)

      47

      Carbohydrate (% Calories)

      42

      Potential Renal Solute Load (mOsm/100 Calories)8

      25

      Potential Renal Solute Load (mOsm/100 mL)8

      16.9

      Osmolality (mOsm/kg water)

      350

      Osmolarity (mOsm/L)

      320

      Lactose-free

      Yes

  • Product Forms

      PurAmino is available in powder.

      When using this information, please note the following:

      Coding systems and reimbursement allowable rates vary by payer:

      • Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
      • Medicaid systems vary by state; some use HCPCS while others use NDC format code or systems of their own—contact your state provider for more information
      • Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information


    • Product: PurAmino
      Item #: 129023
      Description: Powder
      Unit Size: 14.1 oz can (400 g)
      Calories/Unit: 1960
      Product Yield/Unit (fl oz): 98
      Case: 4 cans per case
      HCPCS Code: B4161
      NDC Format Code: 00087-5104-80
  • Composition
    • Ingredients: Corn syrup solids (48%), amino acids (L-aspartic acid, L-leucine, L-proline, L-lysine hydrochloride, L-alanine, monosodium glutamate, L-valine, L-isoleucine, L-threonine, L-serine, L-tyrosine, L-arginine, L-phenylalanine, glycine, L-histidine, L-cystine, L-tryptophan, L-methionine) (18%), 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 docosahexaenoic acid (DHA).

  • Potential Allergens
    • PurAmino contains soy oil. PurAmino is hypoallergenic.

  • Amino Acid Composition
    • ESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Histidine73360
      Isoleucine190950
      Leucine3401710
      Lysine2201110
      Methionine64320
      Cysteine73360
      Phenylalanine140700
      Tyrosine151750
      Threonine171850
      Tryptophan67330
      Valine2101060
      NONESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Arginine148740
      Alanine2701350
      Aspartic Acid5602800
      Glutamic Acid168830
      Glycine73360
      Proline2801390
      Serine171850
      Tyrosine151750
      Threonine171850
      Tryptophan67330
      Valine2101060
  • Preparation of Feedings
    • Powder

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.

      Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.

      WARNING: Do not use a microwave oven to warm formula. Serious burns may result.

      Refer to the product label for the most accurate information.

      Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use formula within 1 hour or discard.

      1. Wash hands thoroughly with soap and water before preparing formula.
      2. Pour the desired amount of water into the bottle. Add powder.
      3. Cap bottle and SHAKE WELL.

      Use the charts below for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in it's original can.

      For every 1 fl oz of water, add 1 unpacked level scoop of powder (4.5 g). Each scoop adds about 0.1 fl oz to the amount of prepared formula. For example, adding 3 unpacked level scoops of powder to 3 fl oz of water will make about 3.3 fl oz of formula.

      PurAmino

      Water

      Powder

      For every

      1 fl oz

      add 1 unpacked level scoop (4.5 g)

  • References
      1. Burks W, Jones SM, Berseth CL, et al. Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid. J Pediatr 2008;153:266-271.
      2. 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.
      3. 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.
      4. 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.
      5. 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.
      6. 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.
      7. 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.
      8. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
  • Consumer Reviews
  • Letter of Medical Necessity for PurAmino

    Insurance companies are not required to cover this product, but some do. This letter establishes a medical need for the product and might help get your patients' insurance company to reimburse them for the product.