Your activity: 315 p.v.
your limit has been reached. plz Donate us to allow your ip full access, Email: sshnevis@outlook.com

Lactobacillus: Drug information

Lactobacillus: Drug information
(For additional information see "Lactobacillus: Patient drug information" and see "Lactobacillus: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Advanced Probiotic [OTC];
  • Bilac;
  • Culturelle Baby [OTC];
  • Culturelle [OTC];
  • DermacinRx Probisol [OTC];
  • Dialyvite Probiotic [OTC];
  • Floranex [OTC];
  • Folika Probiotic [DSC];
  • Kala [OTC];
  • Lactinex [OTC];
  • Lacto-Bifidus [OTC];
  • Lacto-Key [OTC];
  • Lacto-Pectin [OTC];
  • Lacto-TriBlend [OTC];
  • Lactojen [DSC];
  • Megadophilus [OTC];
  • MoreDophilus [OTC];
  • Pedia-Lax Probiotic Yums [OTC];
  • Probitrol [OTC];
  • Prodigen;
  • Promella in Prebiotic;
  • Promerol;
  • ReZyst IM [DSC];
  • Risa-Bid [OTC];
  • RisaQuad [OTC];
  • RisaQuad-2 [OTC];
  • Superdophilus [OTC];
  • Visbiome [OTC];
  • VSL #3 [OTC];
  • VSL #3-DS
Brand Names: Canada
  • Bacid;
  • Bio-K+;
  • Fermalac
Pharmacologic Category
  • Dietary Supplement;
  • Probiotic
Dosing: Adult
Dietary supplement/medical food

Dietary supplement/medical food: Oral: Dosing varies by manufacturer; consult product labeling.

Acidophilus products: 2 capsules 2 to 4 times daily or 1 to 2 wafers 2 to 4 times daily.

Culturelle Digestive Health capsule and chewable tablet: 1 capsule or chewable tablet once daily; may increase chewable tablet to twice daily to alleviate digestive distress or during travel.

Floranex: 4 tablets 3 to 4 times daily.

Lactinex: 1 packet or 4 tablets 3 to 4 times daily.

Visbiome:

Irritable bowel syndrome: 2 to 4 capsules or ½ to 1 packet daily.

Pouchitis: 2 to 4 packets daily.

Ulcerative colitis (active): 4 to 8 packets daily.

Ulcerative colitis (maintenance): 4 to 8 capsules or 1 to 2 packets daily.

VSL #3:

Irritable bowel syndrome: 2 to 4 capsules or ½ to 1 packet daily.

Pouchitis: 2 to 4 packets daily.

Ulcerative colitis (active): 4 to 8 packets daily.

Ulcerative colitis (maintenance): 4 to 8 capsules or 1 to 2 packets daily.

VSL #3-DS:

Pouchitis: 1 to 2 packets daily.

Ulcerative colitis (active) 2 to 4 packets daily.

Ulcerative colitis (maintenance): One-half to 1 packet daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Lactobacillus: Pediatric drug information")

Dietary supplement

Dietary supplement: Note: Product formulations and labeling for use in pediatric patients may vary among available formulations; consult product labeling.

Culturelle:

Baby Grow and Thrive Drops: Lactobacillus rhamnosus GG 400 million CFU, Bifidobacterium animalis 100 million CFU, and cholecalciferol 2 mcg/drop: Infants: Oral: 5 drops once daily.

Baby Grow and Thrive Packets: Lactobacillus rhamnosus GG 3 billion CFU, Bifidobacterium animalis 500 million CFU, and cholecalciferol 10 mcg/packet: Children ≤2 years: Oral: 1 packet once daily.

Kids Daily Probiotic Packets: Lactobacillus rhamnosus GG 5 billion CFU/packet: Children <3 years: Oral: 1 packet once or twice daily.

Kids Daily Probiotic Chewables: Lactobacillus rhamnosus GG 5 billion CFU/tablet: Children ≥3 years and Adolescents: Oral: 1 tablet once or twice daily.

Digestive Health Daily Probiotic Chewable: Lactobacillus rhamnosus GG 10 billion CFU, inulin 200 mg, and vitamin C 6 mg/tablet: Children ≥12 years and Adolescents: Oral: 1 tablet once or twice daily.

Digestive Health Daily Probiotic Capsule: Lactobacillus rhamnosus GG 10 billion CFU and inulin 200 mg/capsule: Children ≥12 years and Adolescents: Oral: 1 capsule once or twice daily.

Digestive Health Extra Strength: Lactobacillus rhamnosus GG 20 billion CFU and inulin 200 mg/capsule: Children ≥12 years and Adolescents: Oral: 1 capsule once daily.

Gerber:

Soothe Probiotic Colic Drops: Lactobacillus reuteri 20 million CFU/drop: Infants: Oral: 5 drops once daily.

Soothe Vitamin D and Probiotic Drops: Lactobacillus reuteri 20 million CFU and cholecalciferol 2 mcg/drop: Infants: Oral: 5 drops once daily.

Good Start Toddler Digestive and Immune Support Probiotic Packet: Lactobacillus reuteri 100 million CFU/packet: Children: Oral: 1 packet once daily.

Good Start Kids Digestive and Immune Support Probiotic Tablet: Lactobacillus reuteri 100 million CFU/tablet: Children ≥3 years: Oral: 1 tablet once daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Advanced Probiotic: L. acidophilus, L. casei, L. delbrueckii, and L. rhamnosus GG 10 billion live cultures [also includes Bifidobacterium lactis, and B. longum]

Bilac: L. acidophilus 17 billion colony-forming units, Bifidobacterium animalis 16 billion colony-forming units

Culturelle: L. rhamnosus GG 10 billion colony-forming units

DermacinRx Probisol: L. acidophilus and Bifidobacterium animalis

Folika Probiotic: L. acidophilus 16 billion colony-forming units [also includes Bifidobacterium lactis] [DSC]

Lacto-Key:

100: L. acidophilus 1 billion colony-forming units [milk, soy, and yeast free; rice derived]

600: L. acidophilus 6 billion colony-forming units [milk, soy, and yeast free; rice derived]

Lacto-Bifidus:

100: L. bifidus 1 billion colony-forming units [milk, soy, and yeast free; rice derived]

600: L. bifidus 6 billion colony-forming units [milk, soy, and yeast free; rice derived]

Lacto-Pectin: L. acidophilus, L. casei, L. plantarum, L. rhamnosus, Bifidobacterium breve, and B. longum 20 billion colony-forming units

Lacto-TriBlend:

100: L. acidophilus, L. bifidus, and L. bulgaricus 1 billion colony-forming units [milk, soy and yeast free; rice derived]

600: L. acidophilus, L. bifidus, and L. bulgaricus 6 billion colony-forming units [milk, soy and yeast free; rice derived]

Lactojen: L. acidophilus 20 billion colony-forming units [DSC]

Megadophilus, Superdophilus: L. acidophilus 2 billion units [available in dairy based or dairy free formulations]

Probitrol: L. acidophilus and Bifidobacterium infantis 31 billion colong-forming units [lactose free]

Prodigen: L. acidophilus 42 billion colony-forming units and Bifidobacterium lactis 39 billion colony-forming units

Promella in Prebiotic: L. acidophilus and Bifidobacterium animalis lactis 64 billion colony-forming units

Promerol: L. acidophilus and Bifidobacterium infantis 31 billion colong-forming units [lactose free]

RisaQuad: L. acidophilus and L. paracasei 8 billion colony-forming units [also includes Bifidobacterium and Streptococcus thermophilus]

RisaQuad-2: L. acidophilus and L. paracasei 16 billion colony-forming units [gluten free; also includes Bifidobacterium and Streptococcus thermophilus]

Visbiome: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus112 billion live cells [gluten free; contains lactose, milk protein]

VSL #3: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus 112 billion live cells [gluten free]

Caplet, Oral:

Risa-Bid: L. acidophilus and L. bulgaricus [also contains Bifidobacterium bifidum and Streptococcus thermophilus]

Granules:

Culturelle Baby Grow + Thrive: L. rhamnosus and Bifidobacterium animalis 3.5 billion colony-forming untis with cholecalciferol 400 IU per packet (30s) [contains sucrose]

Floranex: L. acidophilus and L. bulgaricus 100 million live cells per 1 g packet (12s) [contains milk, sodium 5 mg/packet, soy]

Lactinex: L. acidophilus and L. bulgaricus 100 million live cells per 1 g packet (12s) [gluten free; contains calcium 5 mg/packet, lactose 380 mg/packet, potassium 20 mg/packet, sodium 5 mg/packet, sucrose 34 mg/packet, whey, evaporated milk, and soy peptone]

Liquid, Oral:

Culturelle Baby Grow + Thrive: L. rhamnosus and Bifidobacterium animalis 2.5 billion colony-forming units with cholecalciferol 400 IU per 5 drops (9 mL)

Powder, Oral:

Lacto-TriBlend: L. acidophilus, L. bifidus, and L. bulgaricus 10 billion colony-forming units per ¼ teaspoon (60 g) [milk, soy, and yeast free; rice derived]

Megadophilus, Superdophilus: L. acidophilus 2 billion units per half-teaspoon (49 g, 70 g, 84 g, 126 g) [available in dairy based or dairy free (garbanzo bean) formulations]

MoreDophilus: L. acidophilus 12.4 billion units per teaspoon (30 g, 120 g) [dairy free, yeast free; soy and carrot derived]

Visbiome: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 450 billion live cells per packet (30s) [gluten free; contains lactose, milk protein; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus; lemon flavor and unflavored]

VSL #3: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 450 billion live cells per sachet (10s, 30s) [gluten free; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus; lemon cream flavor and unflavored]

VSL #3-DS: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 900 billion live cells per packet (20s,) [gluten free; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus]

Tablet, Oral:

Floranex: L. acidophilus and L. bulgaricus 1 million colony-forming units [contains lactose, nonfat dried milk, whey]

Kala: L. acidophilus 200 million units [dairy free, yeast free; soy based]

Tablet, chewable, Oral:

Dialyvite Probiotic: L. acidophilus and Bifidobacterium lactis 10 billion cells [orange cream flavor]

Lactinex: L. acidophilus and L. bulgaricus 1 million live cells [gluten free; contains calcium 5.2 mg/4 tablets, lactose 960 mg/4 tablets, potassium 20 mg/4 tablets, sodium 5.6 mg/4 tablets, and sucrose 500 sucrose/4 tablets; contains whey, evaporated milk, and soy peptone]

Pedia-Lax Probiotic Yums: L. reuteri 100 million organisms [dye free, gluten free, sugar free; contains milk protein; strawberry flavor]

ReZyst IM: L. acidophilus and Bifidobacterium 150 mg [3 billion lives cells; berry flavor] [DSC]

Wafer, Oral:

Generic: L. acidophilus 90 mg and L. bifidus 25 mg (100s) [provides 1 billion organisms/wafer at time of manufacture]

Generic Equivalent Available: US

Yes

Administration: Adult

Oral:

Note: See product-specific labeling for additional administration information.

Acidophilus products: Administer with water or milk during a meal.

Culturelle: Do not add to warm or hot foods or beverages. Capsules may be opened and mixed in a cool beverage or sprinkled onto baby food or applesauce. Mix entire contents of packet into cool food or drink until dissolved.

Floranex: May follow administration with milk, fruit juice, or water.

Lactinex: Tablets may be chewed or swallowed; may follow with milk, fruit juice, or water. Granules may be added to cereal, food, or milk.

Visbiome: Unflavored powder packet or contents of capsule may be sprinkled on cold food or into cold noncarbonated beverages. Flavored packet may be mixed with cold water or any cold noncarbonated beverage.

VSL #3, VSL #3-DS: Powder may be mixed in any cold noncarbonated beverage or mixed with any cold food such as yogurt, ice cream, or apple sauce.

Administration: Pediatric

Oral:

Granules (packet), powder, or contents of capsules may be added to or administered with cereal, food, milk, fruit juice, or water. For infants or children <3 years, contents of packets should be mixed with cool food or drink; mix until dissolved.

Infant drops: Shake well before use. Drops can be placed directly in infant's mouth, administered while on the breast, or mixed with breast milk or formula.

Use: Labeled Indications

Dietary supplement: Probiotic to promote normal bacterial flora of the intestinal tract; probiotic supplement for breastfed or partially breastfed infants experiencing excessive crying, colic, and fussiness (Gerber Soothe Colic only).

Medical food:

Visbiome: Dietary management of pouchitis, ulcerative colitis, and irritable bowel syndrome.

VSL #3 and VSL #3-DS: Dietary management of an ileal pouch or ulcerative colitis; dietary management of irritable bowel syndrome (VSL #3 only).

Medication Safety Issues
Sound-alike/look-alike issues:

Floranex may be confused with Florinef

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Contraindications

OTC labeling: When used for self-medication, do not use if sensitive to soy or milk protein (product specific).

Warnings/Precautions

Disease-related:

• Immunocompromised patients: Use dietary supplements containing live bacteria or yeast with caution in immunocompromised patients. A fatal case of GI mucormycosis caused by the mold Rhizopus oryzae has been previously reported in a premature infant administered a dietary supplement containing 3 species of live bacteria (FDA Safety Information 2014).

Dosage form specific issues:

• Interchangeability: Significant differences may exist from one preparation compared to another with respect to biologic activity and composition.

• Lactose: Some products may contain lactose; use with caution in patients with lactose intolerance.

Other warnings/precautions:

• Dietary supplement: Probiotics are classified as dietary supplements; therefore, there are no safety reviews or approved therapeutic indications by the FDA. There is no conclusive evidence to support widespread use in the treatment of diarrhea.

Warnings: Additional Pediatric Considerations

Dietary supplements containing live bacteria or yeast may be associated with a risk of invasive fungal disease in the immunocompromised. A premature neonate developed a fatal case of GI mucormycosis caused by Rhizopus oryzae; this mold was found in an unopened bottle of ABC Dophilus powder that was used to treat the infant (FDA Safety Information 2014). Case reports of Lactobacillus sepsis have also been reported in at least 5 pediatric patients (ages 18 days to 17 years) treated with Lactobacillus Rhamnosus GG (Dani 2016; Land 2005; Vahabnezhad 2013). The AAP recommends avoiding use of probiotics in pediatric patients who are seriously or chronically ill, including ill preterm neonates and patients with indwelling medical devices or IV catheters (AAP [Thomas 2010]).

Other trials evaluating the addition of probiotic formulations (various live bacteria/yeast have been reported) to infant formula have reported no adverse effects when used in healthy infants. Use with caution; Lactobacillus-containing products are considered a dietary supplement and therefore less regulated by the FDA in terms of production, safety and efficacy, and definitive data reporting in these areas are lacking.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Dietary Considerations

Some products may contain lactose, potassium, and/or sodium.

Mechanism of Action

Helps re-establish normal intestinal flora; suppresses the growth of potentially pathogenic microorganisms by producing lactic acid which favors the establishment of an aciduric flora.

Pharmacokinetics

Absorption: Oral: None

Distribution: Local, primarily colon

Excretion: Feces

Pricing: US

Capsules (Floranex One Oral)

200-250 mg (per each): $0.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Lacteol Fort (MX)


For country code abbreviations (show table)
  1. Acidophilus Chewables (Lactobacillus) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.
  2. Acidophilus with Bifidus Chewables (Lactobacillus) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.
  3. Acidophilus with Pectin Capsules (Lactobacillus) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.
  4. Culturelle Baby Grow + Thrive Probiotics + Vitamin D Drops (Lactobacillus) [prescribing information]. Cromwell CT: I-Health, Inc; 2018.
  5. Culturelle Baby Grow + Thrive Probiotic + Vitamin D Packets (Lactobacillus) [prescribing information]. Cromwell CT: I-Health, Inc; 2018.
  6. Culturelle Digestive Health Probiotic Capsules (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2015.
  7. Culturelle Digestive Health Daily Probiotic (Lactobacillus) capsules [prescribing information]. Cromwell, CT: I-Health Inc; received June 2020.
  8. Culturelle Digestive Health Probiotic Chewables (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2015.
  9. Culturelle Digestive Health Daily Probiotic Chewables (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2018.
  10. Culturelle Digestive Health Extra Strength (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2018.
  11. Culturelle Kids Probiotic Chewables (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2018.
  12. Culturelle Kids Probiotic Packets (Lactobacillus) [prescribing information]. Cromwell, CT: I-Health Inc; 2018.
  13. Culturelle Ultimate Strength Probiotic (Lactobacillus) capsules [prescribing information]. Cromwell, CT: I-Health Inc; received June 2020.
  14. Dani C, Coviello C, Corsini I, Arena F, Antonelli A, Rossolini GM. Lactobacillus sepsis and probiotic therapy in newborns: two new cases and literature review. AJP Rep. 2016;6(1):e25-29. [PubMed 26929865]
  15. Florajen Acidophilus (Lactobacillus) capsules [prescribing information]. Solon, OH: American Lifeline Inc; received April 2020.
  16. Florajen Kids (Lactobacillus) capsules [prescribing information]. Solon, OH: American Lifeline Inc; received April 2020.
  17. Florajen Women (Lactobacillus) capsules [prescribing information]. Solon, OH: American Lifeline Inc; received April 2020.
  18. Floranex (Lactobacillus) [prescribing information]. Allendale, NJ: Rising Pharmaceuticals, Inc; August 2012.
  19. Food and Drug Administration (FDA). FDA investigates presence of mucormycosis-causing mold in infant and children's probiotic supplement. Published December 10, 2014.
  20. Gerber Good Start Kids Digestive & Immune Support Probiotic (Lactobacillus) [prescribing information]. Arlington, VA: Nestle Infant Nutrition; received December 2019.
  21. Gerber Good Start Toddler Digestive & Immune Support Probiotic (Lactobacillus) [prescribing information]. Arlington, VA: Nestle Infant Nutrition; received December 2019.
  22. Gerber Soothe Colic Drops (Lactobacillus) [prescribing information]. Arlington, VA: Nestle Infant Nutrition; no date.
  23. Gerber Soothe Vitamin D & Probiotic Drops (Lactobacillus) [prescribing information]. Wilkes-Barre, PA: Nestle Infant Nutrition; no date.
  24. Goldenberg JZ, Yap C, Lytvyn L, et al. Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children. Cochrane Database Syst Rev. 2017;(12):CD006095. doi:10.1002/14651858.CD006095.pub4 [PubMed 29257353]
  25. Johnston BC, Ma SS, Goldenberg JZ, et al. Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):878-888. doi:10.7326/0003-4819-157-12-201212180-00563 [PubMed 23362517]
  26. Lactinex (Lactobacillus) granules [prescribing information]. Franklin Lakes, NJ: Becton, Dickinson and Company; July 2015.
  27. Lactojen (Lactobacillus) capsules [prescribing information]. Huntington Beach, CA: ChapmanMedicalRx; received July 2020.
  28. Land MH, Rouster-Stevens K, Woods CR, Cannon ML, Cnota J, Shetty AK. Lactobacillus sepsis associated with probiotic therapy. Pediatrics. 2005;115(1):178-181. [PubMed 15629999]
  29. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1‐e48. doi:10.1093/cid/cix1085 [PubMed 29462280]
  30. Szajewska H, Kołodziej M. Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2015;42(7):793‐801. doi:10.1111/apt.13344 [PubMed 26216624]
  31. Thomas DW, Greer FR, American Academy of Pediatrics Committee on Nutrition, American Academy of Pediatrics Section on Gastroenterology, Hepatology, and Nutrition. Probiotics and prebiotics in pediatrics. Pediatrics. 2010;126(6):1217-1231. [PubMed 21115585]
  32. US Food and Drug Administration (FDA). Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease. Accessed December 2, 2015.
  33. Vahabnezhad E, Mochon AB, Wozniak LJ, Ziring DA. Lactobacillus bacteremia associated with probiotic use in a pediatric patient with ulcerative colitis. J Clin Gastroenterol. 2013;47(5):437-439. [PubMed 23426446]
  34. Visbiome Capsules (Lactobacillus) [prescribing information]. Gaithersburg, Maryland: Exegi Pharma; Received February 2016.
  35. Visbiome Packets (Lactobacillus) [prescribing information]. Gaithersburg, Maryland: Exegi Pharma; Received February 2016.
  36. VSL #3 (Lactobacillus) [prescribing information]. Covington, LA: Alfasigma USA Inc; July 2017.
  37. VSL #3-DS (Lactobacillus) [prescribing information]. Gaithersburg, MD: Sigma-Tau Pharmaceuticals, Inc; 2012.
Topic 9541 Version 135.0