Frequently Asked Questions:
Visbiome Extra Strength

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General Questions

  • What is the most important information I should know about Visbiome Extra Strength?

    • Visbiome Extra Strength is a medical food intended for the dietary management of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE).
    • This product should not be used in premature infants in the Neonatal Intensive Care Unit (NICU) setting.
  • What is Visbiome Extra Strength?

    • Visbiome Extra Strength is a high potency probiotic medical food, containing 8 strains of live bacteria in a concentration of 900 billion bacteria per packet. 
    • The De Simone Formulation in Visbiome Extra Strength has been the subject of over 60 published clinical trials in human subjects, with extensive clinical research in the dietary management of of dysbiosis associated with irritable bowel syndrome (IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE).
    • Visbiome Extra Strength is a medical food intended for use under the supervision of a healthcare provider.
  • How should I store Visbiome Extra Strength?

    • Visbiome should be stored under refrigeration.
    • Store at (39-46°F, 4-8°C). Do not freeze.
    • Visbiome can be stored at room temperature for up to one week without adversely affecting potency.
  • What ingredients are in Visbiome Extra Strength?

    • Primary Ingredients – Lactobacillus acidophilus DSM24735TM, Lactobacillus plantarum DSM24730TM, Lactobacillus paracasei DSM24733TM,Lactobacillus delbrueckii subsp. bulgaricus* DSM24734TM, Streptococcus thermophilus DSM24731TM, Bifidobacterium longum‡ DSM24736TM, Bifidobacterium breve DSM24732TM, Bifidobacterium infantis‡ DSM24737TM
    • Extra Strength Powder Inactive Ingredients – maltose and silicon dioxide
    • * Recently reclassified as L. helveticus
    • ‡ Recently reclassified as B. lactis
  • Is Visbiome Extra Strength an FDA approved Drug?

    • Visbiome Extra Strength is a medical food as defined by the Orphan Drug Act and additional FDA regulations. Visbiome Extra Strength is not an FDA approved Drug.
  • Do I need a prescription to buy Visbiome Extra Strength?

    • Yes, Visbiome Extra Strength is a medical food which is dispensed by prescription.
  • Gluten, Halal, Kosher, and Dairy Status

    • Visbiome Extra Strength is gluten-free, Halal certified, and Kosher.
    • Contains milk. Visbiome Extra Strength may contain trace amounts of lactose (less than 0.1g per 100g) and dehydrated skim milk or milk protein (casein and beta-lacto globulin of less than 2mg/kg).
  • Does Visbiome Extra Strength contain cornstarch?

    • Visbiome Extra Strength does not contain cornstarch.
  • What is the difference between Visbiome and Visbiome Extra Strength?

    • Visbiome is available in powder and capsule format with 450 billion bacteria and 112.5 billion bacteria per dose respectively.
    • Visbiome Extra Strength contains a higher concentration of bacteria (900 billion bacteria per dose) and is dispensed with a healthcare provider's prescription.
    • The products contain the same bacteria in the same concentrations and proportions.
  • Should Visbiome be taken with or without food? What time of day should I take Visbiome?

    • Probiotics are often recommended to be consumed in the morning on an empty stomach. However, there is not a recommended time of day to take Visbiome, so you may wish to follow your personal preference and consult with your healthcare provider when making this determination.
  • Where is Visbiome Extra Strength manufactured?

    • Visbiome is manufactured in the United States.
  • Is Visbiome Extra Strength reimbursed by insurance?

    • Visbiome Extra Strength may be covered by some insurance providers and managed care organizations. Please consult with your insurance provider or managed care organization.
    • Customers who do not receive insurance coverage or do not wish to seek coverage may purchase Visbiome Extra Strength directly from ExeGi at a discounted price with a healthcare provider's prescription.

 

Safety

  • Does Visbiome Extra Strength have any drug Interactions?

    • Certain strains contained in Visbiome Extra Strength may be inactivated by some types of antibiotics. Preferably, do not consume Visbiome within 4 hours after taking antibiotics.
    • Visbiome may be consumed concomitantly with rifaximin (antibiotic) and/or lactulose in the dietary management of dysbiosis associated with hepatic encephalopathy.
  • What should I tell my doctor before receiving Visbiome Extra Strength?

    • Before receiving Visbiome Extra Strength you should tell your doctor if you:
    • Are on antibiotics.
    • Are pregnant or lactating.
  • What are the possible side effects of Visbiome Extra Strength?

    • You may experience bloating during the first few days after starting Visbiome Extra Strength as your intestinal microflora changes. If this occurs, you may need to reduce daily consumption to allow for adjustment. Please consult with your physician if you experience bloating.
  • Does Visbiome Extra Strength contain milk or dairy ingredients?

    • Contains milk. Visbiome Extra Strength may contain trace amounts of lactose (less than 0.1g per 100g) and dehydrated skim milk or milk protein (casein and beta-lacto globulin of less than 2mg/kg).

 

Ordering and Shipping

  • How do I order Visbiome Extra Strength?

    • Visbiome Extra Strength is a medical food which is dispensed only by prescription.
    • Visbiome Extra Strength can be special ordered through most pharmacies or ordered directly through ExeGi Direct. Visit www.Visbiome.com to Request Authorization. Your doctor can FAX your prescription to 866-612-7817.
  • Why is Visbiome Extra Strength stored cold?

    • Visbiome Extra Strength is shipped and stored cold to prevent elevated temperature exposure which could inactivate some of the live bacterial strains.
    • Visbiome Extra Strength is stable at room temperature for up to one week without adversely affecting potency
  • What if my product arrives at room temperature?

    • Visbiome Extra Strength is shipped with frozen ice packs to ensure it is maintained at temperatures at or below 80° F. Your product may arrive at or around room temperature, depending on ambient conditions.
    • Provided that Visbiome Extra Strength does not arrive hot (greater than 80° F) and is not exposed to room temperature for more than a week, it will maintain potency.
    • Please call customer service if you believe your product has been exposed to excessive heat at 844-FIT-GUTS (348-4887).
  • Do pharmacies stock Visbiome Extra Strength?

    • Yes, some pharmacies do stock Visbiome Extra Strength, but most will require 2-3 days to special order the product from local wholesalers.
    • Please provide the following product code to your pharmacist:
    • Visbiome Extra Strength 30 Pack-69355-0516-01
    • Visbiome Extra Strength may also be purchased directly though ExeGi Direct. Visit www.Visbiome.com to Request Authorization. Your doctor can FAX your prescription to 866-612-7817.
  • What are the shipping options?

    • When ordering Visbiome Extra Strength online at www.Visbiome.com through our Direct Purchase Program, the following options are available:
    • $7.50 standard 2-Day shipping applies for orders placed Monday-Wednesday before 2:30pm ET excluding holidays
    • $25.00 Overnight Delivery applies for orders placed Monday-Thursday before 2:30pm ET excluding holidays
    • $50.00 Saturday Delivery applies for orders placed on Friday before 2:30pm ET excluding holidays
  • What are the NHRIC Codes for Visbiome Extra Strength and Visbiome?

    • Visbiome Extra Strength 30 Pack – 69355-0516-01
    • Visbiome 30 Pack – 69355-0412-01
    • Visbiome 30 Pack Unflavored – 69355-0412-02
    • Visbiome Capsules 60 Count – 69355-0412-03

 

Dosing and Dietary Management with Visbiome

  • Why does VisbiomeTM Extra Strength contain 8 strains of bacteria?

    • The strains contained in Visbiome Extra Strength have been selected not only for their specific individual characteristics, but also for their synergistic activities. They work as a close team to perform what single strains or other combinations of strains may not do.
  • What is a medical food and why is Visbiome Extra Strength a medical food?

    • The Orphan Drug Act defines “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation” [21 U.S.C. § 360ee(b)(3)]. The regulation in 21 C.F.R. 101.9(j)(8) sets forth additional criteria that a medical food must meet.
    • This proprietary formulation has been extensively studied in these target patient populations based on their unique dietary needs. The evaluation of the distinct nutritional requirement of these patient populations, and the role of the Visbiome Extra Strength formulation in addressing these needs, has been extensively characterized and evaluated by independent medical evaluation.
  • How should I take Visbiome Extra Strength?

    • Consult with your healthcare provider and take Visbiome Extra Strength exactly as instructed.
    • Visbiome Extra Strength can be mixed with 3-6 oz of any cold, non-carbonated beverage, and consumed.
    • Stir contents until mixed and promptly drink all content (mixture may settle on bottom of glass over time).
    • Alternatively, Visbiome Extra Strength can be mixed with cold food such as yogurt or applesauce.
    • You may add Visbiome Extra Strength into any cold, non-carbonated smoothie. It is best to add Visbiome toward the end of the blending cycle.
    • Consult with your healthcare provider before altering daily consumption of Visbiome Extra Strength.
    • You may experience bloating during the first few days after starting Visbiome Extra Strength as your intestinal microflora changes. If this occurs, you may need to reduce daily consumption to allow for adjustment. Please consult with your healthcare provider if you experience bloating.
  • How long can Visbiome Extra Strength be used?

    • Consult with your healthcare provider.
  • How long does it take Visbiome Extra Strength to work?

    • Approximately 1-2 weeks. Consult with your healthcare provider.
  • How much Visbiome Extra Strength should I consume?

    • Clinical trials have been conducted using Visbiome Extra Strength in varying amounts in the dietary management of of dysbiosis associated with irritable bowel syndrome(IBS), ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE).
    • Please consult with your physician for recommended daily intake of Visbiome Extra Strength.
    • Visbiome Extra Strength - Adult Recommended Daily Intake – Consult with your physician
    • For the Dietary Management of Packets Per Day (900 Billion Bacteria)
      Irritable Bowel Syndrome ¼-1 (225-900 billion)
      Ulcerative Colitis (maintenance) ½-1 (450-900 billion
      Pouchitis 1-2 (900-1800 billion)
      Active Ulcerative Colitis (flaring) 2-4 (1800-3600 billion)

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