Saccharomyces Boulardii

A07F - Antidiarrheal microorganisms ATC A07FA02

JFDA label: Floratil 200mg

Indications

Approved

Dietary supplement

Contraindications

Source: Lexicomp

OTC labeling: When used for self-medication, do not use in patients with a known hypersensitivity to Saccharomyces boulardii or any component of the formulation Absolute
patients with a central line Absolute
patients with a yeast allergy Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Gastrointestinal disorders (2)

Not Known Constipation · flatulence

General disorders and administration site conditions (1)

Not Known Thirst

Other (1)

Not Known Fungemias

Dosing

Source: Lexicomp

Probiotic: Oral: Maintain intestinal flora balance: 250 mg (1capsule or powder packet) twice daily Promote intestinal health: 500 mg (2 capsules or powder packets) twice daily for 30 days

Probiotic: Infants ≥2 months, Children, and Adolescents: Oral: Refer to adult dosing.

Refer to adult dosing.

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

Warnings & Precautions

Source: Lexicomp

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). Additionally, S. boulardii, although a nonpathogenic yeast, has been associated with case reports of fungemia in this population (Enache-Angoulvant 2005). Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage form specific issues:

Lactose

Some products may contain lactose; use with caution in patients with lactose intolerance. Special handling:

Yeast

Do not open the capsules or packets in the vicinity of patients with central lines; health care workers should always change gloves after handling product as to avoid any accidental transfer into the central line of any patient. 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.

Pregnancy & Lactation

Pregnancy

Registered Products (3)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Floratil	Tablet 200 mg	10 tab pack varies	THE ARAB DRUG STORE P.S.C	4.530
Floratil	Sachet 100 mg	20 sachet	THE ARAB DRUG STORE P.S.C	4.760
Floratil	Tablet 200 mg	30 tab pack varies	THE ARAB DRUG STORE P.S.C	10.550