Version May 2024
The FDA has issued a Dear Healthcare Provider letter to provide safety information on the use of probiotics in preterm infants. The letter warns health care providers that preterm or very low birthweight infants given probiotics are at risk of invasive, potentially fatal disease caused by bacteria or fungi in the probiotics. The letter also includes a reminder that the FDA has not approved any probiotic product for use as a drug or biological product in infants and that the American Academy of Pediatrics does not support the routine, universal administration of probiotics to this vulnerable population. Even though unapproved, unlicensed probiotics are sold to treat or prevent diseases or conditions in infants, including to reduce the risk of necrotizing enterocolitis in preterm infants. The FDA also reminds health care providers who administer probiotics containing live bacteria or yeast to treat, mitigate, cure, or prevent a disease or condition that they are required to submit an Investigational New Drug Application to the agency.
Further information can be found at https://content.govdelivery.com/accounts/USFDA/bulletins/3735e07 and https://www.fda.gov/media/172606/download?attachment=&utm_medium=email&utm_source=govdelivery
Probiotic: Oral:
Maintain intestinal flora balance: 250 mg (1 capsule or powder packet) twice daily.
Promote intestinal health: 500 mg (2 capsules or powder packets) twice daily for 30 days.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Probiotic: Infants ≥2 months, Children, and Adolescents: Oral: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Gastrointestinal: Constipation, flatulence
Miscellaneous: Thirst
Postmarketing and/or case reports: Fungemias
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; patients with a yeast allergy; patients with a central line (including central venous catheters and peripherally inserted central catheters); patients in acute care settings, especially those with open arterial and venous access required (such as a Vascath, Permcath, or AV fistula); pre- or post-organ or bone marrow transplant; patients considered severely immunocompromised or critically ill.
Disease-related concerns
• Immunocompromised patients: Avoid use of dietary supplements containing live bacteria or yeast 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).
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, oral:
Florastor: 250 mg [contains lactose 32.5 mg/capsule, magnesium 2.85 mg/capsule; provides 5 billion live cells]
Generic: 250 mg
Powder, oral:
Florastor Kids: 250 mg/packet (10s) [contains lactose 32.5 mg/packet, magnesium 2.85 mg/packet; tutti frutti flavor; provides 5 billion live cells]
No
Capsules (Saccharomyces boulardii Oral)
250 mg (per each): $0.84 - $0.94
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.
Administer with or without food. Do not mix in any carbonated, very hot (above 122°F), or alcohol-containing beverages or foods. Capsules may be swallowed whole or opened and the contents emptied onto the tongue or over semisolid food. Empty powder from an opened capsule or a powder packet on tongue (followed by 120 mL water or juice), sprinkle over semisolid food (eg, applesauce, yogurt), or dissolve in liquid (eg, water, juice, milk or formula) and administered immediately.
Oral: Administer with or without food. Do not mix in any carbonated, very hot (above 122°F), or alcohol-containing beverages or foods. Capsules may be swallowed whole or opened and the contents emptied onto the tongue or over semisolid food. Empty powder from an opened capsule or a powder packet on tongue (followed by 120 mL water or juice), sprinkle over semisolid food (eg, applesauce, yogurt), or dissolve in liquid (eg, water, juice, milk, or formula) and administer immediately.
Dietary supplement: Probiotic to promote normal bacterial flora of the intestinal tract
Florastor may be confused with Florinef
Codex: Brand name for saccharomyces boulardii [Italy], but also the brand name for acetaminophen/codeine [Brazil]
Codex [Italy] may be confused with Cedax brand name for ceftibuten [U.S. and multiple international markets]; Clobex brand name for clobetasol [US, Canada, and multiple international markets]
Precosa [Finland, Norway, Sweden] may be confused with Precose brand name for acarbose [US]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antifungal Agents (Systemic and Oral [Non-Absorbable]): May diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Some products may contain lactose.
S. boulardii, a nonpathogenic live yeast probiotic, acts as temporary flora to help re-establish the normal gastrointestinal microflora. May also modulate the immune system by inducing cytokines and suppress pathogenic bacteria growth.
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