Florastor
Florastor
Generic Name
Florastor
Mechanism
- Colonization of the gastrointestinal lumen: *S. boulardii* competes with pathogenic bacteria for adhesion sites and nutrients.
- Modulation of the host mucosal immune response: Enhances secretory IgA and downregulates pro‑inflammatory cytokines (TNF‑α, IL‑6).
- Enzymatic activity: Degrades enterotoxins from *C. difficile* and other enteropathogens.
- Improvement of tight‑junction integrity: Preserves intestinal barrier function, reducing luminal leakage of toxins and inflammatory mediators.
- Suppression of bacterial overgrowth: By producing anti‑adhesive factors, it limits overgrowth that can trigger diarrhea.
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Pharmacokinetics
| Parameter | Profile |
| Absorption | Oral capsule; bioavailability limited – yeast cells survive gastric passage but do not cross epithelium. |
| Distribution | Confined to the gastrointestinal tract; minimal systemic absorption. |
| Metabolism | Not applicable; live yeast is degraded by gut microbiota. |
| Excretion | Eliminated in feces as part of normal stool. |
| Half‑life | Colonization persists for days to weeks; no pharmacokinetic “half‑life” in systemic sense. |
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Indications
- Antibiotic‑Associated Diarrhea (AAD): Proven to shorten duration and reduce incidence.
- Traveler’s Diarrhea: Reductions in onset and severity when taken daily during travel.
- Clostridioides difficile‑Related Diarrhea: Adjunct therapy in mild‑to‑moderate cases to speed recovery and reduce recurrence.
- Inflammatory Bowel Disease Support: Off‑label use to reduce flare‑up frequency and severity in ulcerative colitis and Crohn’s disease (clinical evidence mixed).
- Post‑Operative Gut Flora Restoration: Limited data support short‑term use after abdominal surgery.
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Contraindications
- Immunocompromised states: Neutropenia, HIV (CD4 < 200 cells/µL), or immunosuppressive therapy; risk of fungemia.
- Premature or low‑birth‑weight infants: Elevated risk of invasive yeast infection; avoid until at least 36 weeks corrected gestation.
- Severe hepatic or renal impairment: No systemic absorption, but careful use is advised due to reduced clearance of potential complications.
- Allergy to yeast: Contraindicated.
- Severe bowel obstruction or sudden onset ileus: Use with caution—yeast may exacerbate luminal contents.
Warn of rare fungemia / candidemia in susceptible patients; consider monitoring serum *S. cerevisiae* if signs of sepsis appear.
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Dosing
| Population | Dose | Timing | Special Instructions |
| Adults (≥ 18 yr) | 2 capsules (≈ 250 mg *S. boulardii*) | Daily; before or with meals | Keep refrigerated (unopened), freeze‑dry at room temp after opening. |
| Children (2–12 yr) | 1 capsule (≈ 250 mg) | Daily; with or without food | Use child‑appropriate formulation if available; do not crush. |
| Infants (1–4 mo) | Contraindicated unless under close supervision | — | — |
| Pregnancy & Lactation | Judicious use; potential benefit in preventing AAD | Once daily | Counsel patient on limited data; high‑risk situations may justify use. |
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Adverse Effects
- Common
- Mild abdominal cramps
- Flatus/flatulence
- Paradoxical *diarrhea* (rare)
- Rare *oral candidiasis* when immune‑suppressed
- Serious
- Fungemia / candidemia (especially in neutropenic or immunocompromised hosts)
- Severe allergic reactions (anaphylaxis) in yeast‑allergic individuals
- Bacterial superinfection (e.g., *Clostridioides difficile* over‑growth if improperly matched timing with antibiotics)
Risk management: Evaluate patient’s immunologic status before initiating therapy; discontinue immediately if signs of sepsis arise.
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Monitoring
| Parameter | Frequency | Rationale |
| Clinical assessment | At each follow‑up visit | Track stool frequency, consistency, and infection signs |
| Viral/bacterial stool cultures | If diarrhea persists > 7 days | Differentiate AAD from other etiologies |
| Blood cultures | If patient presents with fever, chills, hypotension | Detect rare fungemia early |
| CBC | Baseline, then every 3–4 weeks in neutropenic patients | Monitor for leukopenia or pancytopenia |
| Liver and renal panels | Occasionally, if underlying hepatopathy/renal disease | Ensure no new organ dysfunction |
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Clinical Pearls
- Timing with antibiotics is key: Start *S. boulardii* within 48 hr of initiating broad‑spectrum antibiotics to prevent *intestinal dysbiosis*.
- Stop with antibiotics? No; continue *S. boulardii* throughout the full course of antibiotics and for 2–3 days afterward to maintain gut flora equilibrium.
- Paclitaxel‑induced mucositis: Adjunctive *S. boulardii* can reduce diarrhea severity in chemotherapy patients—evidence emerging but supportive.
- Shelf life: After opening, keep at ≤ 8 °C and avoid moisture; freeze‑dry powder shrinks, which can alter dosing if not adequately reconstituted.
- Drug interactions: No clinically significant interactions are known with standard pharmacopeial antibiotics; however, gentamicin nephrotoxicity can be alleviated by *S. boulardii* in some case reports.
- Use during urinary tract infections (UTIs): Anecdotal benefit in reducing recurrent cystitis among susceptible women, but data are limited.
- Storage: Place in a standard refrigerator; do not expose to freezing temperatures—this can damage yeast viability.
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• Sources: FDA label, American Academy of Pediatrics Assessment of Probiotics, Clinical Infectious Diseases 2021 meta‑analysis, UpToDate “Probiotics for preventing antibiotic‑associated diarrhea” (2023).