Products

    Pregestimil®

    A hypoallergenic formula with MCT oil for infants with fat malabsorption

    Indication

    Pregestimil is an infant formula designed for infants who experience fat malabsorption and who may also be sensitive to intact proteins. Fat malabsorption or steatorrhea may be associated with cystic fibrosis, short bowel syndrome, intractable diarrhea and severe protein calorie malnutrition.

    View Long-term Usage Guidelines

    Pregestimil is designed to provide a sole source of nutrition for infants up to age 6 months, and to provide a major source of nutrition through 12 months of age. 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 chronic malabsorption disorders, Pregestimil is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of Pregestimil in the diet beyond 12 months of age may make a significant contribution to the maintenance of good nutrition in such patients and is not known to be harmful in any way. When Pregestimil is used as a milk substitute, the total calcium content of the diet should be assessed.

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

    LETTER OF MEDICAL NECESSITY FOR PREGESTIMIL

    This letter establishes a medical need for Pregestimil and might help parents get reimbursed by their insurance company

    Ingredients

    Ingredients: Powder: Corn syrup solids (42%), casein hydrolysate* (milk) (16%), medium chain triglycerides (MCT oil) (15%), modified corn starch (7%), soy oil (7%), corn oil (2%), high oleic vegetable oil (safflower or sunflower) (2%) and less than 2%: Mortierella alpina oil, Crypthecodinium cohnii oil, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium citrate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium citrate, potassium citrate, potassium chloride, potassium hydroxide, sodium selenite, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

    Ingredients: 20 Calories/fl oz Ready To Use: Water (87%), corn syrup solids (5%), casein hydrolysate* (milk) (2%), medium chain triglycerides (MCT oil) (2%) and less than 2%: modified corn starch, soy oil, high oleic vegetable oil (safflower and/or sunflower oils), Mortierella alpina oil, Crypthecodinium cohnii oil, carrageenan, vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium hydroxide, calcium phosphate, potassium phosphate, magnesium chloride, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium citrate, sodium iodide, potassium citrate, sodium selenite, potassium chloride, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

    Ingredients: 24 Calories/fl oz Ready To Use: Water (84%), corn syrup solids (6%), casein hydrolysate* (milk) (3%), medium chain triglycerides (MCT oil) (2%), soy oil (2%), modified corn starch (2%) and less than 2%: high oleic vegetable oil (safflower or sunflower oil), Mortierella alpina oil, Crypthecodinium cohnii oil, calcium phosphate, potassium citrate, calcium carbonate, magnesium chloride, potassium phosphate, calcium hydroxide, potassium chloride, sodium citrate, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, vitamin B12, thiamin hydrochloride, vitamin D3, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, carrageenan, choline chloride, inositol, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

    *Modified to be better tolerated in milk-allergic babies

    †A source of arachidonic acid (ARA).

    †A source of docosahexaenoic acid (DHA).

    POTENTIAL ALLERGENS

    Pregestimil contains milk-origin protein hydrolysate and soy ingredients. Pregestimil is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported.

    Nutrients

    (Normal Dilution)

    20 Cal/fl oz Per 100 Calories (5 fl oz) RTU

    20 Cal/fl oz Per 100 Calories (5 fl oz) Pwd

    20 Cal/fl oz Per 100 mL RTU

    20 Cal/fl oz Per 100 mL Pwd

    24 Cal/fl oz Per 100 Cals (4.2 fl oz) RTF

    24 Cal/fl oz Per 100 mL RTF

    Per 100 grams (500 Cal) Pwd

    Protein, g

    2.8

    2.8

    1.89

    1.89

    2.8

    2.3

    14

    Fat, g

    5.6

    5.6

    3.8

    3.8

    5.6

    4.5

    28

    Linoleic acid, mg

    940

    940

    640

    640

    940

    760

    4700

    Carbohydrate, g

    10.2

    10.2

    6.9

    6.9

    10.2

    8.3

    51

    Water, g

    133

    131

    90

    89

    108

    90

    2.6

    Vitamins/Other Nutrients

                 

    Vitamin A, IU

    350

    350

    240

    240

    350

    280

    1750

    Vitamin D, IU

    50

    50

    34

    34

    50

    41

    250

    Vitamin E, IU

    4

    4

    2.7

    2.7

    4

    3.2

    20

    Vitamin K, mcg

    12

    12

    8.1

    8.1

    12

    9.7

    60

    Thiamin (Vitamin B1), mcg

    80

    80

    54

    54

    80

    65

    400

    Riboflavin (Vitamin B2), mcg

    90

    90

    61

    61

    90

    73

    450

    Vitamin B6, mcg

    60

    60

    41

    41

    60

    49

    300

    Vitamin B12, mcg

    0.3

    0.3

    0.2

    0.2

    0.3

    0.24

    1.5

    Niacin, mcg

    1000

    1000

    680

    680

    1000

    810

    5000

    Folic acid (Folacin), mcg

    16

    16

    10.8

    10.8

    16

    13

    80

    Pantothenic acid, mcg

    500

    500

    340

    340

    500

    410

    2500

    Biotin, mcg

    3

    3

    2

    2

    3

    2.4

    15

    Vitamin C (Ascorbic acid), mg

    12

    12

    8.1

    8.1

    12

    9.7

    60

    Choline, mg

    24

    24

    16.2

    16.2

    24

    19.5

    120

    Inositol, mg

    17

    17

    11.5

    11.5

    17

    13.8

    85

    Minerals

                 

    Calcium, mg

    94

    94

    64

    64

    94

    76

    470

    Phosphorus, mg

    52

    52

    35

    35

    52

    42

    260

    Magnesium, mg

    8

    8

    5.4

    5.4

    8

    6.5

    40

    Iron, mg

    1.8

    1.8

    1.22

    1.22

    1.8

    1.46

    9

    Zinc, mg

    1

    1

    0.68

    0.68

    1

    0.81

    5

    Manganese, mcg

    25

    25

    16.9

    16.9

    25

    20

    125

    Copper, mcg

    75

    75

    51

    51

    75

    61

    380

    Iodine, mcg

    15

    15

    10.1

    10.1

    15

    12.2

    75

    Selenium, mcg

    2.8

    2.8

    1.89

    1.89

    2.8

    2.3

    14

    Sodium, mg

    47

    47

    32

    32

    47

    38

    240

    Potassium, mg

    110

    110

    74

    74

    110

    89

    550

    Chloride, mg

    86

    86

    58

    58

    86

    70

    430

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

    Nutrient Density

    20 Cal/fl oz Pwd

    20 Cal/fl oz Liq

    24 Cal/fl oz

    Protein (% Calories)

    11

    11

    11

    Fat (% Calories)

    49

    49

    49

    Carbohydrate (% Calories)

    40

    40

    40

    Potential Renal Solute Load (mOsm/100 Calories)9

    25

    25

    25

    Potential Renal Solute Load (mOsm/100 mL)9

    16.9

    16.9

    20

    Osmolality (mOsm/kg water)

    320

    290

    340

    Osmolarity (mOsm/L formula)

    280

    260

    310

    Lactose-free

    Yes

    Yes

    Yes

    AMINO ACID COMPOSITION

    ESSENTIAL AMINO ACIDS

    mg/100 Cal

    mg/100 g Pwd

    Histidine

    84

    420

    Isoleucine

    162

    810

    Leucine

    270

    1370

    Lysine

    240

    1180

    Methionine

    73

    360

    Cysteine

    48

    240

    Phenylalanine

    137

    690

    Tyrosine

    59

    290

    129

    640

    Tryptophan

    46

    230

    Valine

    200

    1010

    NONESSENTIAL AMINO ACIDS

    mg/100 Cal

    mg/100 g Pwd

    Arginine

    112

    560

    Alanine

    95

    480

    Aspartic Acid

    210

    1060

    Glutamic Acid

    640

    3200

    Glycine

    59

    290

    Proline

    290

    1470

    Serine

    162

    810

    Product Forms and Ordering Information

    PREGESTIMIL IS AVAILABLE IN POWDER AND READY-TO-FEED LIQUID

    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

    Pregestimil®, Powder
    Item #: 036721
    Description: Powder
    Unit Size: 1 lb can
    Calories/Unit: 2240
    Product Yield/Unit (fl oz): 112
    Case: 6 cans per case
    HCPCS Code: B4161
    NDC Format Code: 00087-0367-01

    Pregestimil®, Ready-to-Feed, 20 Cal
    Item #: 143301
    Description: RTF, 20 Cal
    Unit Size: 2 fl oz bottle
    Calories/Unit: 40
    Product Yield/Unit (fl oz): 2
    Case: 48 bottles per case
    HCPCS Code: B4161
    NDC Format Code: 00087-1433-41

    Pregestimil®, Ready-to-Feed, 24 Cal
    Item #: 143401
    Description: RTF, 24 Cal
    Unit Size: 2 fl oz bottle
    Calories/Unit: 48
    Product Yield/Unit (fl oz): 2
    Case: 48 bottles per case
    HCPCS Code: B4161
    NDC Format Code: 00087-1434-41

    PRODUCT BENEFITS

    Pregestimil contains 55% of the fat from MCT oil, which is easily absorbed by babies with some GI problems

    • Designed for infants with fat malabsorption problems and who may also be sensitive to intact proteins
    • Hypoallergenic protein source (extensively hydrolyzed casein)

    Has DHA and ARA, important nutrients also found in breast milk, that support brain and eye development1-8

    Available in both powder and Nursette® bottles

    • Ready-to-feed formula is virtually isotonic

    Additional product features:

    • Lactose-free

    Contact Mead Johnson

    Contact a Mead Johnson representative to request information and samples

    Layout:
    Help parents receive supplemental nutrition approved formulas
    Special Supplemental Nutrition Program for Women, Infants, and Children
    Additional special needs products
    Mead Johnson offers a range of products for infants, children and adults with special medical needs.

    References

    1. Birch EE, Hoffman DR, Uauy R, 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. Fomon SJ, Ziegler EE. Renal solute and potential renal solute load in infancy. J Pediatr. 1999;134:11-14