VSL#3 Capsules By VSL Pharmaceuticals Overview & Drug Interactions
Check For Interactions With VSL#3 Capsules
Supplement: VSL#3 Capsules by VSL Pharmaceuticals
VSL#3 Capsules Label Images
This product contains
Below is a list of the 'active' ingredients listed on the supplement label for this product.
For a list of 'other ingredients', such as fillers, please see the 'Label Information' section on this page.
Eight Strains Of Lactic Acid Bacteria
| Ingredient Group | Blend |
|---|---|
| Category | blend |
-
Streptococcus thermophilus
Ingredient Group Streptococcus Thermophilus Category bacteria
Bifidobacterium breve
Ingredient Group Bifidobacterium breve Category bacteria
Bifidobacterium longum
Ingredient Group Bifidobacterium longum Category bacteria
Bifidobacterium infantis
Ingredient Group Bifidobacterium infantis Category bacteria
Lactobacillus acidophilus
Description:Lactobacillus acidophilus is a type of lactic acid-producing bacteria that is commonly found in the human gut, as well as in other areas of the body such as the mouth and vagina. L. acidophilus can also be found in fermented foods such as yogurt and kefir. It is commonly utilized in probiotic dietary supplements as it is considered a "friendly" or "beneficial" bacteria because it helps to maintain the balance of microorganisms in the body, and is purported to help improve digestion and boost the immune system. Some studies have suggested that L. acidophilus may also have a role in preventing and treating certain conditions such as diarrhea, vaginal yeast infections, and eczema.
See More Information Regarding Lactobacillus Acidophilus
Ingredient Group Lactobacillus acidophilus Category bacteria
Lactobacillus plantarum
Ingredient Group Lactobacillus plantarum Category bacteria
Lactobacillus paracasei
Ingredient Group Lactobacillus paracasei Category bacteria
Lactobacillus delbrueckii subsp. bulgaricus
Ingredient Group Lactobacillus delbrueckii bulgaricus Category bacteria
Microcrystalline Cellulose
| Ingredient Group | Cellulose |
|---|---|
| Category | other |
Stearic Acid
| Ingredient Group | Stearic Acid |
|---|---|
| Category | fatty acid |
Magnesium Stearate
Magnesium is a mineral that is essential for the proper functioning of the body. It plays a role in many important physiological processes, including the contraction and relaxation of muscles, the transmission of nerve impulses, and the regulation of blood pressure. Magnesium is found in a variety of foods, including leafy green vegetables, nuts, and grains, and it is also available as a dietary supplement. There are several different forms of magnesium that are available as supplements, all of which can be used to prevent deficiency. Additionally, magnesium is purported to have several different health benefits, such as improving sleep, reducing muscle cramps, reducing anxiety, and preventing or treating migraines. Although magnesium is essential for health, magnesium-containing foods and supplements can interact with some prescription medications if used at the same time.
See More Information Regarding Magnesium| Ingredient Group | Magnesium stearate |
|---|---|
| Category | other |
Vegetable Capsule
| Ingredient Group | capsule |
|---|---|
| Category | other |
- Hydroxypropyl Methylcellulose
Silicon Dioxide
Silicon, atomic number 14, is the second most abundant element on Earth, after oxygen. It is present in the human body in small amounts (such as in the skin, hair, and nails) and is considered a trace mineral in that regard. Dietary sources of silicon include oats, barley, rice, and some fruits/vegetables. Silicon is a popular dietary supplement, often consumed in the form of silica, which is a chemical compound made up of silicon and oxygen, or as silicic acid (also known as orthosilicic acid). Another common form of silicon utilized is Choline-stabilized orthosilicic acid (ch-OSA), which is the active ingredient in the popular product Biosil. Silicon is used for its purported effects to improve the health and appearance of the skin, hair, and nails. It has also historically been used for other health conditions, such as osteoporosis, cardiovascular disease, and cognitive decline.
See More Information Regarding Silicon| Ingredient Group | Silicon |
|---|---|
| Category | mineral |
Drugs that interact with VSL#3 Capsules by VSL Pharmaceuticals
Below is a list of drug interactions for each ingredient in this supplement product. Please note that a supplement product may contain more than one ingredient that has interactions.
Label Information
Supplement Facts:
| Daily Value (DV) Target Group(s): | Adults and children 4 or more years of age |
|---|---|
| Minimum serving Sizes: |
2 Capsule(s)
|
| Maximum serving Sizes: |
8 Capsule(s)
|
| UPC/BARCODE | 745749017819 |
| Ingredient | Amount per Serving | Group | % DV, Adults & children 4+ years |
|---|---|---|---|
| Eight Strains Of Lactic Acid Bacteria |
0 NP
|
Blend |
|
| Streptococcus thermophilus |
0 NP
|
Streptococcus Thermophilus |
|
| Bifidobacterium breve |
0 NP
|
Bifidobacterium breve |
|
| Bifidobacterium longum |
0 NP
|
Bifidobacterium longum |
|
| Bifidobacterium infantis |
0 NP
|
Bifidobacterium infantis |
|
| Lactobacillus acidophilus |
0 NP
|
Lactobacillus acidophilus |
|
| Lactobacillus plantarum |
0 NP
|
Lactobacillus plantarum |
|
| Lactobacillus paracasei |
0 NP
|
Lactobacillus paracasei |
|
| Lactobacillus delbrueckii subsp. bulgaricus |
0 NP
|
Lactobacillus delbrueckii bulgaricus |
|
| Microcrystalline Cellulose |
0 NP
|
Cellulose |
|
| Stearic Acid |
0 NP
|
Stearic Acid |
|
| Magnesium Stearate |
0 NP
|
Magnesium stearate |
|
| Vegetable Capsule |
0 NP
|
capsule |
|
| Silicon Dioxide |
0 NP
|
Silicon |
|
| Other Ingredients: |
|---|
Label Statments:
| Brand IP Statement(s) |
- The living shield
- Description: VSL#3 capsules are a medical food which is intended for the dietary management of irritable bowel syndrome (IBS) and ulcerative colitis (UC). VSL#3 is a probiotic consisting of 8 strains of live freeze-dried lactic acid bacteria.
- VSL#3 and The Living Shield are trademarks of VSL Pharmaceuticals, Inc. US Patent # US RE 40,023E and other Patents Pending.
2012.
- As a medical food VSL#3 is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships.
- VSL#3 Capsules are intended for use only by IBS or UC patients under the care of a physician.
- Clinical Experience
VSL#3 Capsules (reported as VSL#3) has been the subject of extensive clinical research in the dietary management of IBS or UC. The consumption of VSL#3 has been shown to be effective in the management of gas and bloating associated with IBS in two placebo-controlled randomized trials conducted at the Mayo Clinic.1,2 In one study, the consumption of VSL#3 reduced bloating by 39% in patients with diarrhea-predominant IBS.1 In the same study, fecal urgency scores showed a trend toward reduction vs placebo. In a second study, the consumption of VSL#3 reduced flatulence (gas) by 25% vs placebo.2 In both IBS studies the consumption of VSL#3 was well tolerated with no adverse events reported. In a study evaluating the efficacy of VSL#3 consumption in UC patients intolerant or allergic to 5-ASA, 75% of patients maintained remission for 12 months.5
|
|---|---|
| General Statements |
- A medical food for the dietary management of irritable bowel syndrome or ulcerative colitis that is intended to be used under the supervision of a physician
- Made in the USA.
- All rights reserved.
- The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized. 6-9 Several studies demonstrate that patients with IBS or UC may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with normal individuals.10-15 Hence, IBS and UC patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of extremely high levels of probiotic bacteria, which cannot be achieved simply by modification of the normal diet, is needed to maintain adequate and balanced colonization in the gastrointestinal tract in these patients. Patients with IBS or UC may therefore benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract.
- Safety
Probiotics have generally been associated with a long history of safe use.16-18 In fact, many probiotic species are integral to the production of fermented foods and have been consumed safely as part of these foods for millennia. 18 Furthermore, many bifidobacteria and lactobacilli species are normal, nonpathogenic inhabitants of the human gastrointestinal tract, oral cavity, skin, and vagina. 9,19-21 While, theoretically, probiotic species may act as opportunistic pathogens, epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible. 22,23 In the available literature, documented cases of infection attributable to probiotic treatment are extremely rare and limited to a few individual case reports. 24-27 Each strain of probiotic bacteria is nonpathogenic and nontoxigenic. An independent panel of food safety experts concluded that VSL#3 is Generally Recognized As Safe (GRAS) for medical food use
- How Supplied
VSL#3 Capsules is supplied as an encapsulated powder.
- References: 1. Kim HJ, Camilleri M, McKinzie S, et al. A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2003; 17:895-904. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, Minn.
2. Kim HJ, Vazquez Roque MI, Camilleri M, et al. A randomized controlled trial of a probiotic combination VSL# 3® and placebo in irritable bowel syndrome with bloating. Neurogastroenterol Motil. 2005;17:1-10. The sponsored research clinical trials were conducted at the Mayo Clinic College of Medicine, Rochester, Minn.
3. Bibiloni R, Fedorak RN, et al. VSL#3 probiotic-mixture induces remission in patients with active ulcerative colitis. Am J Gastroenterol. 2005;100:1539-1546.
4. Venturi A, et al. Impact on the composition of the faecal flora by a new probiotic preparation: Preliminary data on maintenance treatment of patients with ulcerative colitis. Aliment Pharmacol Ther. 1999; 13(8):1103-1108.
5. Tursi A, et al. Low-dose balsalazide plus high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis. Med Sci Monit. 2004;10:126-131.
6. Holzapfel WH, et al. Overview of gut flora and probiotics. Int J Food Microbiol. 1998;41(2):85-101.
7. McNaught CE, MacFie J. Probiotics in clinical practice: A critical review of the evidence. Nutr Res. 2001; 21(1&2):343-353.
8. Heller F, Duchmann R. Intestinal flora and mucosal immune responses. Int J Med Microbiol. 2003; 293(1):77-86.
9. Sanders ME. Probiotics: Considerations for human health. Nutr Rev. 2003;61(3):91-99.
10. Fabia R, et al. Impairment of bacterial flora in human ulcerative colitis and experimental colitis in the rat. Digestion. 1993;54(4):248-255.
11. Ruseler-van Embden JG, et al. Inability of Lactobacillus Casei strain GG, L. Acidophilus, and Bifidobacterium bifidum to degrade intestinal mucus glycoproteins. Scand J Gastroenterol. 30(7):675-680.
12. Bullock, et al. Comparative composition of bacteria in the human intestinal microflora during remission and active ulcerative colitis. Curr Issues Intest Microbiol. 2004;5:59-64.
13. Balsari, et al. The faecal microbial population in the irritable bowel syndrome. Microbiologica. 1982; 5(3):185-194.
14. Madden, Hunter. A review of the role of the gut microflora in irritable bowel syndrome and the effects of probiotics. Br J Nutr 2002;88(Suppl.1):S67-S72.
15. Malinen, et al. Analysis of the fecal microbiota of irritable bowel syndrome patients and health controls with real-time PCR. Am J Gastroenterol 100(2):373-382.
16. Saarela M, et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human orogastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002;14:233-240.
17. Borriello, et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780.
18. Horowitz S. Promoting gut health with probiotics. Living medicines for treating digestive disorders. Altern Complement Ther. 2003;9(5):219-224.
19. Reuter G. The Lactobacillus and Bifidobacterium microflora of the human intestine: Composition and succession. Curr Issues Intest Microbiol. 2001;2(2):43-53.
20. Mountzouris K, et al. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002;87(5):405-420.
21. Borriello, et al. Safety of probiotics that contain lactobacilli or bifidobacteria. Clin Infect Dis. 2003; 36(6):775-780.
22. Saxelin M, et al. Lactobacilli and bacteremia in southern Finland, 1989-1992. Clin Infect Dis. 1996a; 22(3):564-566.
23. Saarela M, et al. Safety aspects of Lactobacillus and Bifidobacterium species originating from human orogastrointestinal tract or from probiotic products. Microb Ecol Health Dis. 2002;14:233-240.
24. Oggioni MR, et al. Recurrent septicemia in an immunocompromised patient due to probiotic strains of Bacillus subtilis. J Clin Microbiol. 1998;36(1):325-328.
25. Mackay AD, et al. Lactobacillus endocarditis caused by a probiotic organism. Clin Microbiol Infect. 1999;5 (5):290-292.
26. Rautio M, et al. Liver abscess due to a Lactobacillus rhamnosus strain indistinguishable from L. rhamnosus strain GG. Clin Infect Dis. 1999;28(5):1159-1160.
27. Marteau PR. Probiotics in clinical conditions. Clin Rev Allergy Immunol. 2002;22(3):255-273.
- Product of USA.
- 2011 Sigma-Tau Pharmaceuticals, Inc. All rights reserved.
|
| Formula |
- 112.5 billion live lactic acid bacteria per capsule
- Each serving (2 capsules) contains at least 225 billion lyophilized lactic acid bacteria.
- Product may contain trace amounts of dairy ingredients at very low levels.
- Kosher/Halal Status
VSL#3 is kosher and halal certified.
- Ingredients: Lactic acid bacteria, microcrystalline cellulose, stearic acid, silicon dioxide, magnesium stearate, and vegetable capsule (hydroxypropyl methylcellulose).
- Kosher/Halal Status VSL#3 is kosher and halal certified.
|
| Suggested/Recommended/Usage/Directions |
- Directions: Consume 2-8 capsules daily or as directed by your physician.
- Recommended Daily Intake
1 serving = 2 capsules containing 225 billion bacteria
For Dietary Management Of Capsules Per Day
Irritable Bowel Syndrome1,2 2-4 (225-450 billion)
Ulcerative Colitis3-5 4-8 (450-900 billion)
|
| Precautions |
- Do not use if bottle seal is broken or damaged.
- Adjustment of the intestinal flora can take a few days or weeks; it may take up to one month for the colonization of the gut to become optimally stable.
- Some dairy ingredients are used in the culture medium but are removed during manufacturing. Product may contain trace amounts of dairy ingredients at very low levels.
- Drug Interactions
Avoid taking with antibiotics. Some antibiotics may inactivate certain strains of bacterium in VSL#3.
- Side Effects
Mild abdominal bloating has been reported in the first few days of consuming VSL#3.
- Precautions
Please keep this product out of reach of children.
- Pregnant or lactating women should consult with a physician or healthcare professional before using this or any other medical food product.
- Dairy Status
Some dairy ingredients are used in the culture medium but are removed during manufacturing. There might be trace amounts at very low levels. For this reason VSL#3 is not defined as a dairy-free product but as a non-dairy product.
|
| Storage |
- Storage
VSL#3 Capsules should be refrigerated (39-46(0)F, 4-8(0)C). If stored under refrigeration, the product is guaranteed through “Best if used by” date. VSL#3 Capsules can be stored at room temperature for up to one week without adversely affecting potency of bacteria.
|
| Formulation |
- Gluten Status
VSL#3 is gluten-free
|
| General |
- V1038 03/11
|
Brand Information
See all products by this brand
| Manufactured for | |
|---|---|
| Name | Sigma-Tau Pharmaceuticals |
| State | Gaithersburg |
| Country | MD |
| ZipCode | 20878 |
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DISCLAIMER: Currently this does not check for drug-drug interactions. This is not an all-inclusive comprehensive list of potential interactions and is for informational purposes only. Not all interactions are known or well-reported in the scientific literature, and new interactions are continually being reported. Input is needed from a qualified healthcare provider including a pharmacist before starting any therapy. Application of clinical judgment is necessary.
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