• Pregestimil®

Pregestimil®

For fat malabsorption problems.

Last Updated: Saturday, July 29, 2017

Indication: Pregestimil is 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, with attention to developmental as well as nutritional implications of such a dietary regimen.

  • Product Features
      • Hypoallergenic suitable for someone with lactose intolerance
      • 55% of the fat from MCT oil
      • Designed for infants with fat malabsorption problems
      • Ready to use is virtually isotonic
      • Has DHA and ARA, important nutrients also found in breast milk, that promote brain and eye development*,1-8
      • Available in both powder and Nursette® bottles

      Fatty Acid Nutrients*

      • DHA – 17 mg
      • ARA – 34 mg

      * Per 100 Calories

  • Nutrient Values For Various Forms
    • Nursette Bottle - 20Cal / fl oz Cal Pro Fat Carb
      Per 100mL 68 1.89g 3.8g 6.9g
      Per fl oz 20 0.56g 1.12g 2g
      Nursette Bottle - 24Cal / fl oz Cal Pro Fat Carb
      Per 100mL 81 2.3g 4.5g 8.3g
      Per fl oz 24 0.67g 1.34g 2.4g
      Powder Cal Pro Fat Carb
      Per 100g 500 14g 28g 51g
      Per Scoop (8.9g) 45 1.25g 2.5g 4.5g
  • Nutrients
    • (Normal Dilution) Per 100 Calories Per 100 grams
      20 Cal/fl oz RTU & Pwd (5 fl oz) 24 Cal/fl oz RTU (4.2 fl oz) Powder (500 Cal)
      Protein, g 2.8 2.8 14
      Fat, g 5.6 5.6 28
      Linoleic acid, mg 940 940 4700
      Carbohydrate, g 10.2 10.2 51
      Water, g 133 (RTU) 131 (Pwd) 108 2.6
      (Normal Dilution) Per 100 Calories Per 100 grams
      20 Cal/fl oz RTU & Pwd (5 fl oz) 24 Cal/fl oz RTU (4.2 fl oz) Powder (500 Cal)
      Vitamin/Other Nutrients
      Vitamin A, IU 350 350 1750
      Vitamin D, IU 50 50 250
      Vitamin E, IU 4 4 20
      Vitamin K, mcg 12 12 60
      Thiamin (Vitamin B1), mcg 80 80 400
      Riboflavin (Vitamin B2), mcg 90 90 450
      Vitamin B6, mcg 60 60 300
      Vitamin B12, mcg 0.3 0.3 1.5
      Niacin, mcg 1000 1000 5000
      Folic acid (Folacin), mcg 16 16 80
      Pantothenic acid, mcg 500 500 2500
      Biotin, mcg 3 3 15
      Vitamin C (Ascorbic acid), mg 12 12 60
      Choline, mg 24 24 120
      Inositol, mg 17 17 85
      (Normal Dilution) Per 100 Calories Per 100 grams
      20 Cal/fl oz RTU & Pwd (5 fl oz) 24 Cal/fl oz RTU (4.2 fl oz) Powder (500 Cal)
      Minerals
      Calcium, mg 94 94 470
      Phosphorus, mg 52 52 260
      Magnesium, mg 8 8 40
      Iron, mg 1.8 1.8 9
      Zinc, mg 1 1 5
      Manganese, mcg 25 25 125
      Copper, mcg 75 75 380
      Iodine, mcg 15 15 75
      Selenium, mcg 2.8 2.8 14
      Sodium, mg 47 47 240
      Potassium, mg 110 110 550
      Chloride, mg 86 86 430

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

  • Nutrient Facts
    • Nutrient Density 20 Calories/fl oz 24 Calories/fl oz
      Protein (% Calories) 11 11
      Fat (% Calories) 49 (RTU) 49 (PWD) 49
      Carbohydrate (% Calories) 40 (RTU) 40 (PWD) 40
      Potential Renal Solute Load (mOsm ⁄ 100 Calories)9 25 25
      Potential Renal Solute Load (mOsm ⁄ 100 mL)9 16.9 20
      Osmolality (mOsm ⁄ kg water) 290 (RTU) 320 (Pwd) 340
      Osmolarity (mOsm ⁄ L) 260 (RTU) 280 (Pwd) 310
      Lactose-Free Suitable for someone with lactose intolerance Suitable for someone with lactose intolerance
  • Product Forms
    • Pregestimil® is available in powder and ready-to-use liquid.

    • Item #: 036721
      Description: Powder
      Unit Size: 1 lb can
      Cal./Unit: 2240
      Prod. Yield / Unit (fl oz): 112
      Case: 6 cans per case
      Reimbursement Code: 00087–036701

    • Item #: 143301
      Description: RTU, 20 Cal
      Unit Size: 2 fl oz bottle
      Cal./Unit: 40
      Prod. Yield / Unit (fl oz): 2
      Case: 48 bottles per case
      Reimbursement Code: 00087–143341

    • Item #: 143401
      Description: RTU, 24 Cal
      Unit Size: 2 fl oz bottle
      Cal./Unit: 48
      Prod. Yield / Unit (fl oz): 2
      Case: 48 bottles per case
      Reimbursement Code: 00087–143441

      HCPCS Code

  • Composition
    • Ingredients: Powder: Corn syrup solids (42%), casein hydrolysate (from 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 (from 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 (from 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.

  • Preparation of Feedings
    • The baby's health depends on carefully following these instructions. 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 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.

      Powder

      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 following chart for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in its original can.

      To Make Water Powder Weight
      2 fl oz 2 fl oz 1 packed level scoop 8.9 g
      4 fl oz 4 fl oz 2 packed level scoops 17.8 g
      6 fl oz 6 fl oz 3 packed level scoops 26.7 g
      8 fl oz 8 fl oz 4 packed level scoops 35.6 g
      1 quart 28.5 fl oz 1 packed level household measuring cup 128 g

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

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

      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 within 1 hour or discard.

      Powder Storage (cans)

      Store cans at room temperature. After opening the can, keep it tightly covered, store in a dry area and use contents within 1 month. Do not freeze powder, and avoid excessive heat. Use by date on the bottom of the can.

      Pregestimil® does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

      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 prepare or 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 within 1 hour or discard.

      Nursette Bottle Storage

      Store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze. Use by date on carton and bottle label.

      Pregestimil does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

  • Product Characteristics
    • Fat

      The fat content in Pregestimil is 49% of total calories. The fat blend for ready to use consists of approximately:

      • 55% medium-chain triglycerides (MCT) oil
      • 35% soy oil
      • 7.5% high oleic safflower oil
      • 2.5% single-cell oil blend of docosahexaenoic acid (DHA) and arachidonic acid (ARA)

      The fat blend for powder consists of approximately:

      • 55% MCT oil
      • 25% soy oil
      • 10% corn oil
      • 7.5% high oleic safflower oil
      • 2.5% single-cell oil blend of DHA and ARA

      Medium-chain triglycerides can help assure that infants with fat malabsorption receive an adequate energy supply. Medium-chain triglycerides are more rapidly and completely hydrolyzed than long-chain triglycerides, and the resulting medium-chain fatty acids are effectively absorbed by individuals with fat malabsorption10.

      DHA and ARA

      Pregestimil has DHA and ARA, two nutrients also found in breast milk, that are important building blocks for a baby's brain and eyes1-8. The amounts of DHA in Pregestimil is similar to that found in average worldwide breast milk#,11 as well as levels specified by expert groups12-15.

      # Average level 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 2474 women.

      Protein

      Protein provides 11% of total calories in Pregestimil. The hypoallergenic protein source is extensively hydrolyzed casein that is supplemented with three amino acids—L-cystine, L-tyrosine, and L-tryptophan—to provide an appropriate balance of amino acids to the infant. The protein source provides a high percentage of free amino acids with the remainder as small peptides. The protein efficiency ratio (PER) for Pregestimil is greater than the PER for casein16. Thus, the protein in Pregestimil is of very high quality.

      Every batch of protein hydrolysate used in Pregestimil is tested for antigenicity using a procedure that detects the ability of a peptide to bind to a casein-specific antibody. The hydrolysates used in Pregestimil result in an approximately 1 million-fold reduction in antigenicity compared with unmodified casein.

      Carbohydrate

      Carbohydrate provides 40% of total calories in Pregestimil and the product is suitable for someone with lactose intolerance. In Pregestimil powder, the carbohydrate blend is 85% corn syrup solids, and 15% modified corn starch. In the ready-to-use liquid, the carbohydrate blend is 75% corn syrup solids and 25% modified corn starch. The carbohydrates in Pregestimil liquid and powder are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, is impaired17. The production of corn syrup solids and modified corn starch includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, these carbohydrate sources are hypoallergenic18.

      Vitamins and Minerals

      Pregestimil meets U.S. Food and Drug Administration requirements for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 10722.

      Calcium and Phosphorus

      Pregestimil has 94 mg calcium ⁄ 100 Calories and 52 mg phosphorus⁄100 Calories. The calcium:phosphorus ratio is about 1.8:1, which is in the range specified by the U.S. Infant Formula Act of 198019.

      Iron

      Pregestimil 20 Calories/fl oz has 12.2 mg iron/L, and Pregestimil 24 Calories/fl oz has 14.6 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula20.

      Electrolytes—Sodium, Potassium, and Chloride

      The electrolyte amounts in Pregestimil are within the ranges specified by the U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act19. The sodium, potassium, and chloride amounts are 47 mg ⁄ 100 Calories, 110 mg ⁄ 100 Calories, and 86 mg ⁄ 100 Calories, respectively.

      Osmolality/Potential Renal Solute Load

      When low osmolality is considered to be especially important, liquid Pregestimil (20 Cal/fl oz) has a lower osmolality than formula prepared from powder. The low potential renal solute load is important for helping infants with malabsorption maintain appropriate water balance.

  • Clinical Experience
    • Pregestimil was introduced in 1971, and several clinical experiences with the product are summarized below**.

      ** Studied before the addition of DHA and ARA.

      Efficacy

      Pregestimil has been clinically shown to be useful in the nutritional management of infants with fat malabsorption. A study of infants with severe diarrhea21 found that fat from Pregestimil was well absorbed. In addition, this study found that feeding Pregestimil promoted weight gain and improvements in anthropometric and biochemical measurements. Clinical studies also showed that Pregestimil promoted growth of infants with cystic fibrosis22 and infants recovering from malnutrition23. In infants with chronic liver disease, Pregestimil promoted appropriate essential fatty acid status24.

      Safety and Tolerance

      The sources of DHA and ARA in Pregestimil are well tolerated and safe. In clinical studies comparing infants fed formulas that had DHA and ARA with infants fed formulas without DHA and ARA, there were no clinically significant differences in tolerance, and the addition of DHA and ARA had no effect on the incidence of adverse events25-27. The sources of DHA and ARA in Pregestimil are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration28-29.

  • 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 (LCPUFAs) [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.

      10. Bach AC, Babayan VK. Medium-chain triglycerides: an update. Am J Clin Nutr 1982;36:950-962.

      11. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr 2007;85:1457-64.

      12. The British Nutrition Foundation. Recommendations for intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and Physiological Significance: The Report of the British Nutrition Foundation's Task Force. London: Chapman & Hall; 1992:152-163.

      13. FAO/WHO Joint Expert Consultation. Lipids in early development. In: Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United Nations and the World Health Organization. FAO Food and Nutr Pap. 1994;57:49-55.

      14. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;18:487-489.

      15. Koletzko B, Agostoni C, Carlson SE, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.

      16. Data on file, Mead Johnson Nutritionals, April 1994.

      17. Ziegler EE, Fomon SJ. Methods in infant nutrition research: balance and growth studies. Acta Paediatr Scand Suppl. 1982;299:90-96.

      18. Richardson GG, Leary L, 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.

      19. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.

      20. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Pediatrics. 1999;104:119-123.

      21. Jirapinyo P, Young C, Srimaruta N, et al. High-fat semielemental diet in the treatment of protracted diarrhea of infancy. Pediatrics. 1990;86:902-908.

      22. Data on file, Mead Johnson Nutritionals, June 1992.

      23. Cordano A, Gastanaduy AS, Graham GG. Absorption and retention from an iso-osmolal casein hydrolysate infant formula. Nutrition Research. 1988;8:1353-1362.

      24. Kaufman SS, Scrivner DJ, Murray ND, et al. Influence of Portagen and Pregestimil on essential fatty acid status in infantile liver disease. Pediatrics. 1992;89:151-154.

      25. Carlson SE, Mehra S, Kagey WJ, et al. Growth and development of term infants fed formulas with docosahexaenoic acid (DHA) from algal oil or fish oil and arachidonic acid (ARA) from fungal oil [abstract]. Pediatr Res. 1999;45:278A.

      26. Clandinin MT, Van Aerde JE, Merkel KL, et al. Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. J Pediatr. 2005;146:461-468.

      27. Wheaton DH, Castañeda YS, Hoffman DR, et al. Biosafety of docosahexaenoic acid (DHA)/arachidonic acid (ARA) enriched infant formula fed for 9 months [abstract]. J Am Coll Nutr. 2003;22:469. Abstract 56.

      28. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000041. Available at: http://www.cfsan.fda.gov/~rdb/opa-g041.html. Accessed April 19, 2007.

      29. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000080. Available at: http://www.cfsan.fda.gov/~rdb/opa-g080.html. Accessed April 19, 2007.

  • Retail Listing
    • Available at these and other fine stores:
      Wal-Mart Bruno's Schnucks
      Kroger Bashas Markets Vons
      Albertsons Buy Low Dominick's
      Safeway Shaw's Rite Aid
      HEB

      Availability varies depending on the size of the store, as all stores do not carry all of these products. Typically, the larger the store, the more likely it is that these products will be available in the store you visit. If you find one of the stores listed above does not have the product you need, please ask the store manager to order the quantity you will need on a monthly basis.

      It is possible that a specific store in one of these chains may not accept Women, Infants and Children vouchers.

      For your convenience, you can go shop online or find a retail store in your area to purchase this product.

      If you have a question or want to purchase Ready to Use Nursette® bottles (Women, Infants and Children vouchers cannot be accepted for these purchases), you can call 1-800-BABY123.

      *No endorsement of any brand or product by the USDA is implied or intended.

  • Insurance Reimbursement Request for Pregestimil®

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