Usage
- This combination medication is primarily prescribed for the treatment of acute diarrhea, particularly in children. It is also used to reduce the duration and severity of rotavirus diarrhea, manage antibiotic-associated diarrhea, and prevent traveler’s diarrhea. Other potential uses include irritable bowel syndrome (IBS-D) and H. pylori infection-related diarrhea.
- Pharmacological Classification: Antidiarrheal, Probiotic, Antisecretory.
- Mechanism of Action: This combination works through a multi-pronged approach. Racecadotril acts as an antisecretory agent by inhibiting enkephalinase, an enzyme responsible for breaking down enkephalins. This leads to increased enkephalin levels, which decrease the secretion of water and electrolytes into the intestines, thus reducing stool volume and frequency. Lactobacillus and Saccharomyces boulardii are probiotics that help restore the balance of beneficial gut bacteria, which can be disrupted by infections or antibiotic use. Saccharomyces boulardii, a yeast probiotic, additionally inhibits the growth of harmful bacteria and their toxins while supporting the intestinal immune system.
Alternate Names
While there isn’t a universally recognized alternate name for this specific combination, it’s important to be aware of regional variations and brand names. The individual components are sometimes referred to as:
- Lactobacillus: Lactic acid bacillus.
- Saccharomyces boulardii: S. boulardii, Yeast probiotic.
- Racecadotril: Acetorphan (INN).
Brand Names: Some examples of brand names for this combination include DD Norm, Reflora-R, Bactospore-S, Orobact R, Racelon Pro, and Enuff Extra. Note that brand names can vary by region.
How It Works
- Pharmacodynamics: Racecadotril reduces intestinal fluid secretion without affecting bowel transit time. The probiotics, Lactobacillus and Saccharomyces boulardii, work by restoring the natural gut flora and inhibiting the growth of pathogenic bacteria. S. boulardii also produces proteases that degrade bacterial toxins, strengthens the intestinal immune response, and promotes production of beneficial short-chain fatty acids.
- Pharmacokinetics: Racecadotril is rapidly absorbed after oral administration. It is metabolized to the active metabolite thiorphan, which is primarily eliminated through renal excretion. Information on the specific pharmacokinetics of the combined formulation with probiotics is limited. Probiotics generally exert their effects locally in the gut and are not systemically absorbed in significant amounts.
- Mode of Action: Racecadotril inhibits enkephalinase in the intestinal mucosa. Lactobacillus and Saccharomyces boulardii compete with pathogenic bacteria for nutrients and adhesion sites in the gut. S. boulardii exerts anti-inflammatory effects, enhances gut barrier function, and produces polyamines that support intestinal cell growth and repair.
- Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Racecadotril is a selective inhibitor of enkephalinase. The probiotics do not have specific receptor binding or enzyme inhibition properties relevant to their antidiarrheal effect.
- Elimination Pathways: Racecadotril’s active metabolite, thiorphan, is primarily excreted in the urine. Probiotics are eliminated through the feces.
Dosage
Standard Dosage
Dosage is dependent on the specific formulation and the age of the patient. Always consult the prescribing information for the particular brand being used. General guidelines are as follows:
Adults: The recommended dose varies based on the brand but is usually within the range of 100mg Racecadotril, 250-500mg Saccharomyces boulardii and 100 million-1 billion CFU of Lactobacillus, one to three times a day. The dose may be adjusted based on the severity of diarrhea.
Special Cases:
- Elderly Patients: Dosage adjustments are not typically necessary unless there is renal or hepatic impairment.
- Patients with Renal Impairment: Caution is advised, and dose adjustments may be necessary based on the degree of impairment. Consult a healthcare professional.
- Patients with Hepatic Dysfunction: Caution is advised. Dosage adjustments may be needed. Consult a healthcare professional.
- Patients with Comorbid Conditions: Consider potential interactions with other medications and underlying health conditions. Patients with diabetes should use caution, as some products may contain lactose or maltodextrin.
Clinical Use Cases
Dosage in specific clinical settings should be determined by the treating physician based on the patient’s condition and the product’s prescribing information. This combination is not typically used in situations like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dosage modifications might be needed for patients with renal or hepatic dysfunction, metabolic disorders, or other underlying medical conditions. Always consider patient-specific factors and consult a healthcare professional for personalized dosage recommendations.
Side Effects
Common Side Effects:
- Headache
- Rash
- Abdominal discomfort
- Nausea
- Vomiting
- Flatulence
- Bloating
Rare but Serious Side Effects:
- Allergic reactions (e.g., hives, difficulty breathing, swelling of face, lips, tongue, or throat)
- Signs of infection (e.g., persistent cough, high fever, chills)
- Angioedema (Sudden swelling of the face, mouth, tongue or throat which may cause difficulty in breathing or swallowing).
Long-Term Effects:
No specific long-term adverse effects have been reported, but long-term use of probiotics should be monitored.
Contraindications
- Hypersensitivity to any component of the medication.
- Patients with bloody stools or high fever.
- Severe kidney or liver disease.
- Immunocompromised individuals.
- Patients with central venous catheters.
Drug Interactions
- Antifungals (e.g., fluconazole, itraconazole)
- Antidepressants (e.g., phenelzine, fluoxetine, amitriptyline)
- Immunosuppressants (e.g., cyclosporine, tacrolimus)
- Antibiotics
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been fully established. Consult a doctor before use.
Drug Profile Summary
- Mechanism of Action: Racecadotril inhibits enkephalinase, reducing intestinal fluid secretion; probiotics restore gut flora and inhibit pathogens.
- Side Effects: Headache, rash, abdominal discomfort, nausea, vomiting, flatulence, bloating.
- Contraindications: Hypersensitivity, bloody stools/high fever, severe kidney/liver disease, immunocompromised state.
- Drug Interactions: Antifungals, antidepressants, immunosuppressants, antibiotics.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: Varies by product and age; see product information.
- Monitoring Parameters: Stool frequency and consistency, hydration status.
Popular Combinations
This medication is usually used independently for diarrhea. Combination use with other antidiarrheals should be avoided without specific physician guidance. Oral rehydration solutions (ORS) should be administered to prevent dehydration.
Precautions
- General Precautions: Assess for allergies, metabolic disorders, and organ dysfunction.
- Pregnant Women: Consult a doctor before using.
- Breastfeeding Mothers: Consult a doctor before using.
- Children & Elderly: Follow specific age-related dosing guidelines and consult a healthcare professional for children under 3 months and elderly patients with renal or hepatic impairment.
- Lifestyle Considerations: Avoid alcohol while using this medicine. Avoid driving if you experience dizziness or drowsiness after taking the medicine.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Lactobacillus + Racecadotril + Saccharomyces boulardii?
A: The dosage varies depending on factors such as age, the specific product being used, and the severity of diarrhea. Consult a healthcare professional or refer to the specific product’s prescribing information for dosage recommendations.
Q2: How should this medication be administered?
A: This combination is available in various oral forms like sachets, capsules, and suspensions. Sachets are usually dissolved in water or milk before ingestion. Consult the product instructions for specific administration details.
Q3: How long does it take for this medication to work?
A: Treatment should continue until normal stool consistency is achieved. If diarrhea persists beyond 7 days, consult a doctor.
Q4: Can I take this medication with other antidiarrheal drugs?
A: No, avoid combining this medication with other antidiarrheal medications unless advised by a doctor, as it may interfere with treatment or lead to adverse effects.
Q5: Can I give this to my child who has a neurological disorder?
A: Consult a pediatrician before giving this medication to a child with a neurological disorder, especially if the child is under 2 years old, as the medication could potentially cross the underdeveloped blood-brain barrier and cause side effects.
Q6: Can I take this medicine if I have diabetes?
A: Consult your doctor before taking this medicine if you have diabetes. Some formulations might contain lactose or maltodextrin.
Q7: Does this combination rehydrate the body?
A: While it reduces fluid loss, this medication does not rehydrate. Administer oral rehydration solutions (ORS) along with this medication for rehydration.
Q8: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.
Q9: What should I do if I experience severe side effects?
A: Discontinue use and seek immediate medical attention if you experience severe side effects like allergic reactions, signs of infection, or worsening of symptoms.
