Antibiotic itself can be the

cause of Diarrhea
Any antibiotic can initiate Antibiotic Associated Diarrhea (AAD). It can be just a few hours following antibiotic
administration up to several months after its discontinuation.

It has been reported to occur in up to 30% of patients receiving antibiotics. The most severe form is Clostridium
difficile-associated diarrhea (CDAD). Consequences of AAD and CDAD include increased morbidity and mortality,
extended hospital stays & increased risk of developing colitis or toxic mega colon.

Saccharomyces boulardii, a nonpathogenic yeast, has been widely used as a probiotic

to prevent Antibiotic Associated Diarrhea (AAD).

Mechanisms by which S. boulardii exerts its action in preventing AAD & C. difficile-associated diarrhea are as follows:

Antimicrobial activities
Saccharomyces boulardii

Inhibits the growth of pathogenic bacteria and parasites

Reduces gut translocation of pathogens
Neutralizes bacterial virulence factors

Anti-inflammatory activity
Inhibits IL- 8 production induced by either IL-1b or toxin A

Antitoxin activity
Produces antitoxin enzyme proteins (54 kDa, 63 kDa,
120 kDa, IgA antitoxin A) which work against toxins
produced by C. difficile, pathogenic E. coli & Vibrio cholerae

*kDa=kilodalton

Ref.: Ther Adv Gastroenterol (2012) 5(2) 111–125

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Effective in
Antibiotic associated diarrhea
Clostridium difficile infection
Helicobacter pylori infection management

Manufactured with the

quality raw material from

EUROPE
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Significantly reduces the risk of Antibiotic Associated Diarrhea (AAD)

Study type : Total 05 Randomized-controlled trials
No. of Patients : 1076 participants (830 adults and 246 Children aged 6 months -14 years)
Drug used : S. boulardii 200 mg to 1gm or Placebo
Duration : Up to 14 days
Result :

Incidence of developing AAD during or Incidence of developing AAD during or

after antibiotic use in Adults after antibiotic use in Children

17.14% 17.32%

7.64%
3.36%
S. boulardii Group Placebo S. boulardii Group Placebo

Ref.: Aliment Pharmacol Ther 2005; 22: 365–372.

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Clostridium difficile infections (CDI) continue to persist as a leading cause of nosocomial gastrointestinal
illness. Studies have documented that CDI extends patients’ hospital stays from 4 to 36 days. S. boulardii
shows promise for C. difficile infection control.

Better efficacy in reducing recurrence of C. difficile infection in adults

No. of Patients : 124 adult patients
Drug used : S. boulardii 1000 mg per day or Placebo (all patients were on varied doses of Vancomycin
or Metronidazole)
Duration : 4 weeks
Result :

Incidence of developing recurrence of C. difficile infection

44.8%

26.3%

S. boulardii Group Placebo

Ref.: World J Gastroenterol 2010 May 14; 16(18): 2202-2222
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Carriage of Helicobacter pylori (H.pylori) is a risk factor for developing gastric lymphoma or adenocarcinoma in
later stage of life.S. boulardii induces morphologic changes in H. pylori cells consistent with cellular damage.

Shows favorable results in managing Helicobacter pylori infections

No. of Patients : 124 adult patients
Drug used : S. boulardii 1000 mg per day or Placebo (all patients were received triple therapy)
Duration : 2 weeks
Result :

H. pylori eradication Occurence of epigastric distress

71.% 43.5%

59.7% 14.5%

S. boulardii Group Placebo S. boulardii Group Placebo

Ref.: World J Gastroenterol 2010 May 14; 16(18): 2202-2222

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P r e s c r i b i n g i n f o r m a t i o n
COMPOSITION to 9 weeks.
BolardiTM 250 Capsule: Each capsule contains Saccharomyces boulardii 250 mg (Eqv. to 5 billion CFU). For diarrhea in ulcerative colitis: 250 mg of Saccharomyces boulardii three times daily.
BolardiTM 500 Capsule: Each capsule contains Saccharomyces boulardii 500 mg (Eqv. to 10 billion CFU). For treatment of infections due to Helicobacter pylori: 250 mg - 500 mg Saccharomyces boulardii twice daily
in addition to usual treatment.
PHARMACOLOGY For diarrhea in Irritable bowel syndrome (IBS): 250 mg capsule twice daily.
Saccharomyces boulardii strain survives stomach acid to colonize in the intestinal tract while acting as a For traveler's diarrhea: The recommended dosage is 250 mg capsule per day.
temporary flora to protect the beneficial organisms of the intestine. Additionally, it works with the body to Children:
re-establish the microflora, thereby helping to maintain and support healthy immunity, digestion and gut For reduction in symptoms of acute diarrhea: Children over three months are recommended to take two
health. doses of 250 mg a day for five days. Children under three months are recommended to take 125 mg twice
It shows following actions: daily for five days.
a) Anti-toxin activity: S. boulardii produces proteins which work to neutralize bacterial toxins. This may
include the toxins produced by Clostridium difficile. CONTRAINDICATION
b) Anti-microbial: S. boulardii adheres to pathogens, which decreases their adhesion to the intestinal wall It is contraindicated in patients with a history of hypersensitivity to Saccharomyces boulardii or any other
and decreases invasion of enterocytes into the body. These pathogens are then removed during bowel components of this product.
movements.
c) Enzymatic activity: In healthy adults, S. boulardii increases the enzymatic activities (lactase, alpha-gluco- PREGNANCY & LACTATION
sidase, alkaline phosphatase). The production of intestinal polyamines by S. boulardii is one of its most There is no available information about the safety of taking Saccharomyces boulardii in pregnancy and
relevant and specific mechanisms of action. The polyamines spermidine, spermine, and putrescine lactation.
enhance the expression of brush border enzymes (such as hydrolases, proteases, and transport molecules).
d) Immune Enhancement: S. boulardii helps prevent infection by stimulating the immune system along the SIDE EFFECTS
GI lining by increasing the protective antibody IgA. Saccharomyces boulardii is likely safe for most adults when taken by mouth. It can cause gas in some
e) Anti-inflammatory: S. boulardii causes a decrease in pro-inflammatory cytokines. people.

INDICATION DRUG INTERACTIONS

BolardiTM is indicated for the prevention and treatment of following conditions: Taking Saccharomyces boulardii with medications for fungal infections (e.g. fluconazole, itraconazole,
• Diarrhea associated with antibiotics terbinafine and others) can reduce the effectiveness of it.
• Traveler's diarrhea
• Recurring intestinal disease caused by Clostridium difficile STORAGE
• Side effects of treatment for Helicobacter pylori Store below 25° C, away from direct sunlight & moisture. Keep out of reach of children.
• Symptoms of acute diarrhea
• Diarrhea in infants HOW SUPPLIED
• Crohn's disease BolardiTM 250 Capsule: Each box contains 30 capsules in Alu-Alu blister pack.
• Ulcerative colitis and IBS BolardiTM 500 Capsule: Each box contains 30 capsules in Alu-Alu blister pack.

DOSAGE & ADMINISTRATION

Adult:
For diarrhea associated with the use of antibiotics: 250-500 mg of Saccharomyces boulardii two to four
times a day.
For diarrhea caused by Clostridium difficile: 1 gram of Saccharomyces boulardii daily for 4 weeks along with
antibiotic treatment.
For reduction in symptoms of acute diarrhea: 250 mg of Saccharomyces boulardii twice a day for 5 days.
For diarrhea in Crohn's disease: 250 mg of Saccharomyces boulardii three times daily has been used for up
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Significantly Shows
reduces the favorable
risk of results in
Antibiotic managing
Associated H. pylori
Can be Diarrhea Better infections
taken with efficacy in
common reducing
antibiotics recurrence of
C. difficile
infection in
adults

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