LACTOJEN- lactobacillus acidophilus capsule

Lactojen by

Drug Labeling and Warnings

Lactojen by is a Other medication manufactured, distributed, or labeled by Chapmanmedicalrx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM:

Probiotic for Immune Support

Lactojen capsules is an orally administered prescription of lactobacillus acidophilus for immune system support. It is a high-potency prescription under the supervision of a licensed healthcare provider for patients who have inadequate nutritional supplement from their diet, and for patients who need additional clinical dietary supplementation in stressful conditions. Lactojen probiotic re-establishes and maintains the intestinal homeostasis for optimal health.

SUPPLEMENT FACTS
Serving Size: 1 Capsule
Serving per container: 30
Amount per Serving	%DV ‡
Lactobacillus acidophilus	20 billion live CFU's; at time of expiration ‡
‡  % Daily value not established.  Under proper storage under refrigeration.

Other Ingredients: Maltodextrin and gelatin capsules

DESCRIPTION:

Commensal bacteria are part of the normal flora of the intestine. They derive food from the human host without hurting the host. In contrast, pathogenic microorganisms invade the intestine and cause harm to the human host. In clinical studies, probiotic Lactobacillus acidophilus has been shown to support the immune system 1-7. In Galdeano et. al, the intestine is a microbiome of bacteria, viruses, fungi, and protozoa. The activity and the composition of these microorganisms affect the immune system and thus, the health of its human host. Adhesion of Lactobacillus acidophilus to the intestinal epithelium stimulates the production of mucins, tight junction proteins, Goblet cells and Panel cells, which results in reinforcement of the intestinal walls. Orally administered probiotic Lactobacillus acidophilus also competes with harmful pathogens for nutrients by blocking their adhesion to intestinal epithelium. Additionally, Lactobacillus acidophilus interacts with the intestinal epithelial cells to increase the production of IgA cells in the intestine, bronchus, and mammary glands. IgA is the principal immunoglobulin at the mucosal membrane of the epithelium. IgA is an important first line of defense of the immune system from invasion of pathogenic microorganisms. Probiotic Lactobacillus acidophilus also activates the innate immune response by stimulating macrophages, dendritic cells, regulatory T-cells and the release of cytokine IL-10, protecting the host from pathogenic-microorganisms-induced inflammation and their associated diseases and illnesses 8-24.

1. Lactobacillus acidophilus stimulates the production of mucins, enhancing the epithelial layer of the intestinal wall. Mucins are glycosylated proteins produced by the intestinal epithelial cells.
2. Increased probiotic Lactobacillus acidophilus adhesion to the epithelial intestinal mucosa, inhibiting adhesion of other pathogenic microorganisms to the epithelium to cause diseases and illnesses.
3. Competition with other pathogenic microorganisms for nutrients.
4. Production of an antimicrobial substance from Lactobacillus acidophilus to inhibit other pathogenic microorganisms.
5. Stimulation of the Innate Immune System: macrophages, dendritic cells, and T-cells 1-7.

PRECAUTIONS AND WARNINGS:

Lactojen should be used under the supervision of a licensed healthcare provider. Consult with your doctor if you are pregnant, nursing, have any medical conditions, or take any other medications.

Avoid if you have hypersensitivity to any of the ingredients.

Store in the refrigerator: 2°C – 8°C (35°F – 46°F).

Keep out of reach of children.

Do not use if seal under cap is broken or missing.

DOSAGE AND ADMINISTRATION:

For adults, take one capsule orally daily, preferably with a meal, or as directed by a licensed healthcare provider.

PACKAGE LABEL DISPLAY PANEL:

Lactojen capsules are supplied in a child-resistant bottle of 30 count (73730-0101-30).

REFERENCES:

1. Carolina Maldonado Galdeano, Silvia Ines Cazorla, Jose Maria Lemme Dumit, Eva Velez Gabriela Perdigon: Beneficial Effects of Probiotic Consumption on the Immune System. Annals of Nutrition & Metabolism 2019; 74:115-124.
2. Hooper LV, Littman DR, Macpherson AJ: Interactions Between the Microbiota and the Immune System. Science 2012: 336: 1268-1273.
3. Galdeano CM, Perdigon G: The Probiotic Bacterium Lactobacillus Casei Induces Activation of Gut Mucosa Immune System Through Innate Immunity. Clinical & Vaccine Immunology 2006; 13: 219-226.
4. Lemme-Dumit JM, Polti MA, Perdigon G, et al: Probiotic Bacteria Cell Walls Stimulate the Activity of Intestinal Epithelial Cells and Macrophage Functionality. Beneficial Microbes 2018; 9:153-164.
5. Mack DR, Ahrne S, Hyde L, et al: Extracellular MUC3 Mucin Secretion Follows Adherence of Lactobacillus Strains to Intestinal Epithelial Cells In Vitro. Gut 2003; 52, 827-833.
6. Bermudez-Brito M, Plaza-Diaz J, Munoz-Quezada S, et al: Probiotic Mechanisms of Action. Annals of Nutrition and Metabolism 2012; 61:160-174.
7. George Kerry R, Patra JK, Gouda S, et al: Benefaction of Probiotics for Human Health: A Review. Journal of Food and Drug Analysis 2018; 26:927-939.
8. Galdeano CM, Perdigon G: Role of Viability of Probiotic Strains in Their Persistence in the Gut and In the Mucosal Immune Stimulation. Journal of Applied Microbiology 2004; 97: 673-681.
9. Wan ML, Forsythe SJ, El-Nezani H: Probiotics Interaction with Foodborne Pathogens: A Potential Alternative to Antibiotics and Future Challenges. Critical Review in Food Science and Nutrition 2018: 1-14.
10. De Moreno de LeBlan A, Chaves S, Carmuega E, et al: Effect of Long-Term Continuous Consumption of Fermented Milk Containing Probiotic Bacteria on Mucosal Immunity and The Activity of Peritoneal Macrophages. Immunobiology 2008; 213: 97-108.
11. He J, Zhang F, Han Y: Effect of Probiotics on Lipid Profiles and Blood Pressure in Patients with Type 2 Diabetes: A Meta-Analysis of RCTs. Medicine (Baltimore) 2017; 96: e9166.
12. Torres S, Fabersani E, Marquez A, et al: Adipose Tissue Inflammation and Metabolic Syndrome. The Proactive Role of Probiotics. European Journal of Nutrition 2019: 58(1): 27-43.
13. Ettinger Gm MacDonald K, Reid G el al: The Influence of the Human Microbiome and Probiotics on Cardiovascular Health. Gut Microbes 2014; 5: 719-728.
14. Swami O, Shah NJ: Role of Probiotics in Diabetes: A Review of Their Rationale and Efficacy. European Medical Journal of Diabetes 2017; 5: 104-110.
15. De Moreno del Lablanc A, Perdigon G: Probiotics in the Defense and Metabolic Balance of the Organism: The Application of Probiotic Fermented Milks in Cancer and Intestinal Inflammation. Proceeding of the Nutrition Society 2010; 69: 421-428.
16. Russo F, Linsalata M, Orlando M: Probiotics Against Neoplastic Transformation of Gastric Mucosa: Effects on Cell Proliferation and Polyamine Metabolism. World Journal of Gastroenterology 2014; 20: 13258-13272.
17. Rosa Krajmalnik-Brown, Zehra-Esra IIhan, Dae-Wook Kang, John K. Dibaise: Effects of Gut Microbes on Nutrient Absorption and Energy Regulation. Nutrition in Clinical Practice 2012; 27, No. 2: 201-214.
18. Park MS, Kwon B, Ku S, et al: The Efficacy of Bifidobacterium Longum BORI and Lactobacclus acidophilus AD031 Probiotic Treatment in Infants with Rotavirus Infection. Nutrients 2017; 9: pii: E887.
19. Hungin AP, Mulligan C, Pot B; European Society of Primary Care Gastroenterology, et al: Systematic Review: Probiotics in the Management of Lower Gastrointestinal Symptoms in Clinical Practice- An Evidence-based International Guide. Alimentary Pharmacology & Therapeutics 2013; 38: 864-886.
20. Furrie E, Macfarlane S, Kennedy A, et al: Symbiotic Therapy (Bifidobacterium Longum/Synergy 1) Initiates Resolution of Inflammation in Patients with Active Ulcerative Colitis: A Randomised Controlled Pilot Trial. Gut 2005; 54: 242-249.
21. Li J, Sung CY, Lee N, et al: Probiotics Modulate Gun Microbiota Suppresses Hepatocellular Carcinoma Growth in Mice. Proceedings of the National Academy of Sciences USA 2016; 113: E1306-E1315.
22. Verhoeven V, Renard N, Makar A, et al: Probiotics Enhance the Clearance of Human Papillomavirus-Related Cervical Lesions: A Prospective Controlled Pilot Study. European Journal of Cancer Prevention 2013, 22: 46-51.
23. Hao Q, Lu Z, Dong BR, et al: Probiotics for Preventing Acute Upper Respiratory Tract Infections. Cochrane Database Systematic Review 2015; CD006895.
24. Barbieri N, Herrera M, Salva S, et al: Lactobacillus Rhamnosus CRL1505 Nasal Administration Improves Recovery of T-cell Mediated Immunity Against Pneumococcal Infection in Malnourished Mice. Beneficial Microbes 2017; 30: 393-405.

PRECAUTIONS

Probiotic Immune Support

20 Billion Live CFU's

RX Only

KEEP IN REFRIGERATOR

30 Capsules

Do not freeze.

LABELER:

Manufactured for:

ChapmanMedicalRx

Huntington Beach, CA 92647

INGREDIENTS AND APPEARANCE

LACTOJEN 
lactobacillus acidophilus capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:73730-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5)	LACTOBACILLUS ACIDOPHILUS	20000000000 [CFU]

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GELATIN (UNII: 2G86QN327L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:73730-101-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/17/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	20 mm
scoring	1

Labeler - Chapmanmedicalrx (113156706)

Establishment
Name	Address	ID/FEI	Business Operations
Chapmanmedicalrx		113156706	manufacture(73730-101)