Products

    PurAmino™

    Hypoallergenic amino acid-based formula for infants with severe cow’s milk protein and multiple food allergies or elemental diet needs

    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 make an important contribution in supporting the maintenance of adequate 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.

    Ingredients

    Ingredients: Corn syrup solids (46%), amino acids (potassium aspartate, L-leucine, L-lysine hydrochloride, L-proline, L-alanine, L-valine, L-isoleucine, L-serine, L-threonine, L-glutamine, L-tyrosine, L-aspartic acid, L-arginine, L-phenylalanine, L-histidine, L-cystine, glycine, L-tryptophan, L-methionine) (18%), high oleic sunflower oil (9%), medium chain triglycerides (MCT) oil (9%), soy oil (8%), modified tapioca starch (4%), and less than 2%: Mortierella alpina oil*, Schizochytrium sp. 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, sodium citrate, magnesium phosphate, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium chloride, 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.

    WARNING: Not for parenteral (I.V.) use.

    Nutrients

    Normal Dilution

    Per 100 kcal (5 fl oz)

    Per 100 mL

    Per 100 grams Powder (500 kcal)

    Protein equivalent, g

    2.8

    1.9

    14

    Fat, g

    5.3

    3.6

    27

    Linoleic acid, mg

    860

    580

    4300

    Carbohydrate, g

    10.6

    7.2

    53

    Water, g

    133

    90

    1.76

    Vitamins/Other Nutrients

         

    Vitamin A, IU

    300

    200

    1500

    Vitamin D, IU

    60

    41

    300

    Vitamin E, IU

    2

    1.36

    10

    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

    1.5

    Niacin, mcg

    1000

    680

    5000

    Folic acid (Folacin), mcg

    16

    10.9

    80

    Pantothenic acid, mcg

    500

    340

    2500

    Biotin, mcg

    3

    2

    15

    Vitamin C (Ascorbic acid), mg

    12

    8.2

    60

    Choline, mg

    24

    16.3

    120

    Inositol, mg

    24

    16.3

    120

    Minerals

         

    Calcium, mg

    116

    79

    580

    Phosphorus, mg

    64

    44

    320

    Magnesium, mg

    8

    5.4

    40

    Iron, mg

    1.8

    1.22

    9

    Zinc, mg

    1

    0.68

    5

    Manganese, mcg

    25

    17

    125

    Copper, mcg

    75

    51

    380

    Iodine, mcg

    15

    10.2

    75

    Selenium, mcg

    2.8

    1.9

    14

    Sodium, mg

    47

    32

    240

    Potassium, mg

    110

    75

    550

    Chloride, mg

    86

    58

    430

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

    Nutrient Density

    20 kcal/fl oz

    Protein (% Calories)

    11

    Fat (% Calories)

    47

    Carbohydrate (% Calories)

    42

    Potential Renal Solute Load (mOsm/100 kcal)8

    25

    Potential Renal Solute Load (mOsm/100 mL)8

    17.2

    Osmolality (mOsm/kg water)

    350

    Osmolarity (mOsm/L formula)

    320

    Lactose-free

    Yes

    AMINO ACID COMPOSITION

    ESSENTIAL AMINO ACIDS

    mg/100 kcal

    mg/100 g Pwd

    Histidine

    73

    360

    Isoleucine

    190

    950

    Leucine

    340

    1720

    Lysine

    220

    1120

    Methionine

    64

    320

    Cysteine

    73

    360

    Phenylalanine

    140

    700

    Tyrosine

    151

    760

    Threonine

    171

    850

    Tryptophan

    67

    340

    Valine

    210

    1060

    NONESSENTIAL AMINO ACIDS

    mg/100 kcal

    mg/100 g Pwd

    Arginine

    148

    740

    Alanine

    270

    1350

    Aspartic Acid

    560

    2800

    Glutamic Acid

    168

    830

    Glycine

    73

    360

    Proline

    280

    1390

    Serine

    171

    850

    Glutamine

    Product Forms and Ordering Information

    PURAMINO IS AVAILABLE IN POWDER

    Coding systems and reimbursement allowable rates vary by payer:

    1. Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
    2. 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
    3. Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information

    PurAmino™, Powder

    Item #: 179101​

    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

    * HCPCS application in progress.

    PRODUCT BENEFITS

    • 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% medium-chain triglycerides (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

    A deeper look at how PurAmino supports healthy development in infants with CMA

    PurAmino has the amount of DHA clinically shown to support brain and eye development2-11 *2-11

    *Studies using regular cow’s milk protein formula instead of amino acid-based formula.

    †Average amount of DHA worldwide in breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2472 women.

    Nutritionally complete, PurAmino is clinically shown to support normal growth*1

    • Weight gain from day 14 to days 30, 60, 90 and 120 was similar in both groups1
    • Study included healthy, full-term infants 1

    Clinical study

    HYPOALLERGENICITY, GROWTH AND TOLERANCE WITH AMINO ACID-BASED FORMULA AND DHA

    Insurance Assistance for PurAmino

    PurAmino Insurance Letter

    myPurAmino™ is a dedicated resource to help parents and physicians navigate insurance reimbursement. Downloading and completing this insurance letter may help parents get reimbursed. Plus, parents will receive a FREE CASE OF PURAMINO from Mead Johnson while their coverage is being evaluated.

    Contact Mead Johnson

    Contact a Mead Johnson representative to request information and samples

    Layout:
    Understanding CMA
    Review the prevalence and impact of CMA, and the additional research Mead Johnson has supported to improve outcomes...
    PurAminoTM infant formula is WIC®*-approved in 45 states
    Access your state’s medical documentation form to help your WIC infants and toddlers receive the formula they need.
    Additional products for cow’s milk allergy
    Mead Johnson has a complete portfolio for infants and toddlers with CMA and food allergies.

    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.