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Lactobacillus


General


Pronunciation

(lak toe ba SIL us)


Brand Names: U.S.

  • Advanced Probiotic [OTC]
  • Bacid [OTC]
  • Culturelle [OTC]
  • Dofus [OTC]
  • Flora-Q [OTC]
  • Floranex [OTC]
  • Kala [OTC]
  • Lactinex [OTC]
  • Lacto-Bifidus [OTC]
  • Lacto-Key [OTC]
  • Lacto-Pectin [OTC]
  • Lacto-TriBlend [OTC]
  • Megadophilus [OTC]
  • MoreDophilus [OTC]
  • Pedia-Lax Probiotic Yums [OTC]
  • ReZyst IM
  • Risa-Bid [OTC]
  • RisaQuad [OTC]
  • RisaQuad-2 [OTC]
  • Superdophilus [OTC]
  • Visbiome [OTC]
  • VSL #3 [OTC]
  • VSL #3-DS

Indications


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: Dietary management of an ileal pouch or ulcerative colitis.


Contraindications


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


Dosing and Administration


Dosing: Adult

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

Flora-Q: 1 capsule once 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 per day

Pouchitis: 2 to 4 packets/day

Ulcerative colitis (active): 4 to 8 packets/day

Ulcerative colitis (maintenance): 4 to 8 capsules or 1 to 2 packets per day

VSL #3: 1 to 8 packets or 2 to 8 capsules/day

VSL #3-DS: 1 to 4 packets/day


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

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

Infants: Gerber Soothe: 5 drops once daily

Infants, Children, and Adolescents:

Visbiome:

<2 years: Note: Do not use in premature infants in the NICU.

Irritable bowel syndrome or ulcerative colitis (maintenance): 1 capsule or 1/4 packet per day

Ulcerative colitis (active): 1 to 2 capsules or 1/4 to 1/2 packet per day

2 to 5 years:

Irritable bowel syndrome or ulcerative colitis (maintenance): 2 capsules or 1/2 packet per day

Ulcerative colitis (active): 2 to 4 capsules or 1/2 to 1 packet per day

6 to 11 years:

Irritable bowel syndrome: 2 capsules or 1/2 packet per day

Ulcerative colitis (active): 4 to 8 capsules or 1 to 2 packets per day

Ulcerative colitis (maintenance): 2 to 4 capsules or 1/2 to 1 packet per day

12 to 17 years:

Irritable bowel syndrome: 2 to 4 capsules or 1/2 to 1 packet per day

Ulcerative colitis (active): 8 to 16 capsules or 2 to 4 packets per day

Ulcerative colitis (maintenance): 4 to 8 capsules or 1 to 2 packets per day

Children ≥1 year and Adolescents:

Culturelle Digestive capsule: 1 capsule once daily

Culturelle Digestive Health and Culturelle Kids chewable tablet: Children ≥3 years: 1 chewable tablet once daily; may increase to twice daily to alleviate digestive distress or during travel

Culturelle Kids packet: 1 packet once daily; may increase to twice daily to alleviate digestive distress

VSL #3: 1 to 4 packets or 1 to 8 capsules/day

VSL #3 Junior: 1 to 4 packets/day

VSL #3-DS: 1 to 2 packets/day


Dosing: Renal Impairment

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


Dosing: Hepatic Impairment

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


Administration

Oral:

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.

Flora-Q: Administer with or without food.

Gerber Soothe Colic drops: Shake well before use. Drops can be given on the breast, mixed with breast milk or formula, or by spoon.

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 noncarbonated beverage.

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


Dietary Considerations

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


Storage

Store at room temperature; keep away from direct sunlight and protect from extreme heat; some preparations may need to be refrigerated; consult individual product labeling.

Visbiome: Store refrigerated at 4 ‚ °C to 8 ‚ °C (39 ‚ °F to 46 ‚ °F). May be stored at room temperature for up to 1 week.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule:

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

Culturelle: L. rhamnosus GG 10 billion colony-forming units [contains casein and whey]

Dofus: L. acidophilus and L. bifidus 10:1 ratio [beet root powder base]

Flora-Q: L. acidophilus and L. paracasei ≥8 billion colony-forming units [also contains Bifidobacterium and S. thermophilus]

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 and L. casei ≥5 billion colony-forming units [also contains Bifidobacterium lactis and citrus pectin cellulose complex]

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]

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

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 112 billion live cells [gluten free; contains lactose, milk protein; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus]

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

Caplet:

Bacid: L. acidophilus and L. bulgaricus [also contains Bifidobacterium bifidum and Streptococcus thermophilus]

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

Granules:

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]

Powder:

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: L. acidophilus 35 million and L. sporogenes 25 million

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: L. reuteri 100 million organisms

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]

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


Drug Interactions

There are no known significant interactions.


Adverse Reactions


Frequency not defined.

Gastrointestinal: Bloating (intestinal), flatulence


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.


Actions


Pharmacology

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.


Absorption

Oral: None


Distribution

Local, primarily colon


Excretion

Feces


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience flatulence. Have patient report immediately to prescriber dizziness (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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