Pregestimil®

For fat malabsorption problems.

Last Updated: Wednesday, December 13, 2017 - 19:00

Description/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.

Long-Term Usage: 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.

Product Features:

  • Hypoallergenic protein source (extensively hydrolyzed casein)
  • 55% of the fat from medium-chain triglycerides (MCT) oil
  • Designed for infants with fat malabsorption problems
  • Ready to use is virtually isotonic
  • DHA and ARA, important nutrients also found in breast milk, that promote brain and eye development1-8
  • Available in both powder and Nursette® bottles
  • Lactose-free
  • Nutrients
    • (Normal Dilution)

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

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

      20 Cal/fl oz Per 100 mL RTU

      20 Cal/fl oz Per 100 mL Powder

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

      24 Cal/fl oz Per 100 mL RTU

      Per 100 grams Powder (500 Cal)

      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 Facts
    • 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)

      280

      260

      310

      Lactose-free

      Yes

      Yes

      Yes

  • Product Forms

      Pregestimil is available in powder and ready-to-use liquid.

      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: Pregestimil®
      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
    • Product: Pregestimil
      Item #: 143301
      Description: RTU, 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
    • Product: Pregestimil
      Item #: 143401
      Description: RTU, 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
  • Composition
    • 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, 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 and soy. Pregestimil is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported.

  • Amino Acid Composition
    • ESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Histidine84420
      Isoleucine162810
      Leucine2701370
      Lysine2401180
      Methionine73360
      Cysteine48240
      Phenylalanine137690
      Tyrosine59290
      Threonine129640
      Tryptophan46230
      Valine2001010
      NONESSENTIAL AMINO ACIDS
      mg/100 Calmg/100 g Pwd
      Arginine112560
      Alanine95480
      Aspartic Acid2101060
      Glutamic Acid6403200
      Glycine59290
      Proline2901470
      Serine162810
      Tyrosine59290
      Threonine129640
      Tryptophan46230
      Valine2001010
  • 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, 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 its original can.

      Pregestimil

      To Make*

      Water

      Powder

      Weight

      2 fl oz bottle

      2 fl oz

      1 PACKED level scoop

      8.9 g

      4 fl oz bottle

      4 fl oz

      2 PACKED level scoops

      17.8 g

      8 fl oz bottle

      8 fl oz

      4 PACKED level scoops

      35.6 g

      * Each scoop adds about 0.2 fl oz to the amount of prepared formula.

    • Nursette<sup>®</sup> Bottles

      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. Discuss with parents which formula is appropriate for the baby.

      2 fl oz Nursette® Bottles

      1. Inspect each bottle for signs of damage.
      2. Wash hands thoroughly with soap and water before preparing bottle for feeding.
      3. SHAKE BOTTLE WELL and remove cap.
      4. Attach nipple unit (not included).

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

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

  • 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.
  • Consumer Reviews
  • Letter of Medical Necessity Pregestimil®

    Insurance companies are not required to cover exempt infant formulas or 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.