Usage
Racecadotril + Saccharomyces boulardii is primarily prescribed for the treatment of acute diarrhea in adults and children over three months of age. It is particularly effective in cases of acute watery diarrhea, traveler’s diarrhea, and antibiotic-associated diarrhea.
This combination medication falls under the pharmacological classifications of antidiarrheal (Racecadotril) and probiotic (Saccharomyces boulardii).
Racecadotril acts as an enkephalinase inhibitor, reducing intestinal hypersecretion by preventing the breakdown of enkephalins. Saccharomyces boulardii, a non-pathogenic yeast, helps restore the balance of intestinal flora.
Alternate Names
There is no officially recognized alternate name for the combination product itself. However, the individual components are known by various names:
- Racecadotril: Acetorphan
- Saccharomyces boulardii: Saccharomyces cerevisiae var. boulardii, Ultra-Levure (brand name varies by region)
Several brand names exist for the combined formulation, which can differ depending on the region and manufacturer. Some of them are Racigyl-SB, Hidrasec SB, and Tiorfix SB.
How It Works
Racecadotril:
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Pharmacodynamics: Racecadotril’s antidiarrheal effect is achieved through the inhibition of enkephalinase, an enzyme that degrades enkephalins. Enkephalins are naturally occurring peptides that regulate intestinal water and electrolyte secretion. By preventing their breakdown, Racecadotril reduces the excessive secretion of water and electrolytes into the intestinal lumen, thus decreasing the fluidity and volume of stools. This mechanism is independent of opioid receptors and therefore avoids the adverse effects associated with opioid-based antidiarrheal medications.
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Pharmacokinetics: Racecadotril is rapidly absorbed following oral administration. It is metabolized into the active metabolite thiorphan, which is responsible for its enkephalinase-inhibiting action. Thiorphan is primarily eliminated via renal excretion.
Saccharomyces boulardii:
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Pharmacodynamics: Saccharomyces boulardii exerts its beneficial effects through various mechanisms, including:
- Production of enzymes that degrade bacterial toxins.
- Stimulation of the immune system within the gut.
- Enhancing nutrient absorption.
- Promoting the growth of beneficial bacteria.
- Competing with pathogenic bacteria for resources and adhesion sites.
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Pharmacokinetics: Saccharomyces boulardii is not absorbed systemically; it remains within the gastrointestinal tract and is eliminated in the feces.
Dosage
Standard Dosage
Adults:
The recommended dose of Racecadotril for adults is 100mg three times a day, taken with or without food. Saccharomyces boulardii for adults is usually dosed at 250mg twice daily. Combination products may vary.
Children:
Racecadotril dosage for children is weight-based and is usually given three times daily. The usual starting dose is 1.5 mg/kg per dose. Children weighing <9kg may receive 10mg per dose, 9-13 kg may receive 20mg per dose, and children 13-27kg may receive 30mg per dose. Children >27kg may receive 60mg per dose. Treatment is continued until two normal stools are passed. The maximum duration of treatment is generally 7 days. The recommended dosages for Saccharomyces boulardii may vary from region to region but are often the same for children and adults.
Special Cases:
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Elderly Patients: No specific dosage adjustments are typically required.
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Patients with Renal Impairment: Caution should be exercised due to limited data; dosage adjustment may be necessary. Avoid use in children with renal impairment.
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Patients with Hepatic Dysfunction: Caution should be exercised due to limited data; dosage adjustment may be necessary. Avoid use in children with hepatic impairment.
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Patients with Comorbid Conditions: Patients with diabetes should account for the sugar content in some formulations.
Clinical Use Cases
Dosage recommendations for specific clinical settings generally align with the standard dosage guidelines. Racecadotril and Saccharomyces boulardii are typically not indicated for use in clinical situations such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dosage adjustments may be necessary in patients with renal or hepatic impairment. For such individuals, a careful assessment of their condition is required, and dosage should be individualized based on their specific needs and clinical response.
Side Effects
Common Side Effects
- Headache
- Rash
- Abdominal pain
- Nausea
- Vomiting
- Flatulence
- Tonsillitis (especially in infants or children)
Rare but Serious Side Effects
- Angioedema
- Severe skin reactions (e.g., erythema nodosum, erythema multiforme)
Long-Term Effects
Data on long-term effects are limited as the medication is intended for short-term use.
Adverse Drug Reactions (ADR)
Severe skin reactions, angioedema and hypersensitivity.
Contraindications
- Hypersensitivity to Racecadotril, Saccharomyces boulardii, or any component of the formulation.
- Diarrhea associated with fever and/or bloody or purulent stools.
- Antibiotic-associated diarrhea (although the combination medication is sometimes used in this scenario, it is important to carefully assess the risks and benefits).
- History of angioedema with ACE inhibitors.
- Fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency (due to sucrose content in some formulations).
Drug Interactions
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ACE Inhibitors: Concomitant use with ACE inhibitors may increase the risk of angioedema.
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Antifungals: Antifungal medications may reduce the effectiveness of Saccharomyces boulardii.
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Antidepressants such as MAOIs, SSRIs, and tricyclic antidepressants.
Pregnancy and Breastfeeding
Racecadotril and Saccharomyces boulardii should be used during pregnancy and breastfeeding only if the potential benefits outweigh the potential risks to the fetus or infant. Consult with a specialist before considering use in these populations.
Drug Profile Summary
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Mechanism of Action: Racecadotril: Enkephalinase inhibitor, reduces intestinal hypersecretion. Saccharomyces boulardii: Probiotic, restores intestinal flora balance.
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Side Effects: Headache, rash, abdominal pain, nausea, vomiting, flatulence, tonsillitis, angioedema, severe skin reactions.
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Contraindications: Hypersensitivity, bloody/purulent diarrhea, history of angioedema with ACE inhibitors, certain metabolic disorders (fructose intolerance, etc.).
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Drug Interactions: ACE inhibitors, antifungals, antidepressants.
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Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
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Dosage: Adults: Racecadotril 100mg TID, S. boulardii 250mg BID. Children: Racecadotril 1.5 mg/kg TID (weight based). S. boulardii dosing varies.
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Monitoring Parameters: Stool frequency and consistency, hydration status, resolution of symptoms.
Popular Combinations
Racecadotril is sometimes combined with oral rehydration solutions (ORS) for the comprehensive management of acute diarrhea.
Precautions
- Monitor for signs of dehydration.
- Patients with a history of angioedema should be closely monitored.
- Use cautiously in patients with hepatic or renal impairment.
- In diabetic patients, consider the sugar content of some formulations.
- Prolonged vomiting may warrant discontinuation.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Racecadotril + Saccharomyces boulardii?
A: Adult dosing is typically Racecadotril 100mg three times daily and S. boulardii 250mg twice daily. Pediatric Racecadotril dosing is weight-based at 1.5 mg/kg three times daily. Dosage may vary based on the specific combination product. Always refer to the product’s prescribing information.
Q2: How does Racecadotril differ from loperamide in managing diarrhea?
A: Racecadotril is an antisecretory agent, while loperamide is an antimotility agent. Racecadotril reduces intestinal fluid secretion, whereas loperamide slows intestinal transit. Racecadotril is associated with a lower risk of constipation compared to loperamide.
Q3: Can Racecadotril + Saccharomyces boulardii be used in children?
A: Racecadotril can be used in children over three months of age. Saccharomyces boulardii is generally considered safe for children, but dosage should be appropriate for age and weight. Always consult the product’s information.
Q4: What are the main contraindications for this combination?
A: Contraindications include hypersensitivity, bloody/purulent diarrhea, history of angioedema with ACE inhibitors, and certain metabolic disorders (e.g., fructose intolerance).
Q5: Are there any specific drug interactions to be aware of?
A: Yes, concomitant use with ACE inhibitors can increase the risk of angioedema. Antifungal medications may reduce the efficacy of S. boulardii, and antidepressants can interact with both components.
Q6: What is the role of oral rehydration solution (ORS) in conjunction with this medication?
A: ORS remains the cornerstone of treatment for acute diarrhea. It is crucial for replacing lost fluids and electrolytes and should be used alongside Racecadotril + S. boulardii to prevent dehydration.
Q7: How long should treatment with this combination be continued?
A: Treatment should continue until two normal stools are passed, but generally not exceeding seven days.
Q8: What are the signs of dehydration to watch out for in patients with diarrhea?
A: Signs of dehydration include decreased urine output, dry mouth, increased thirst, sunken eyes, lethargy, and dizziness. In children, observe for decreased wet diapers and lack of tears when crying.
Q9: Can Racecadotril + Saccharomyces boulardii be used for chronic diarrhea?
A: No. It is specifically indicated for acute diarrhea. Chronic diarrhea requires investigation to determine the underlying cause and targeted management.
Q10: Are there any dietary recommendations during treatment?
A: Patients should maintain adequate hydration with clear fluids, like water or ORS. Avoid sugary drinks, as they can exacerbate diarrhea. It’s generally advisable to follow a bland diet to minimize gastrointestinal irritation.
