Radola

• Acute Diarrhea:
• Treatment of acute secretory diarrhea in adults and children, including diarrhea caused by infections and other etiologies.
• Traveler’s Diarrhea:
• Adjunctive therapy to reduce stool output and duration in travelers experiencing diarrhea.
• Off-label Uses:
• Management of chronic diarrhea in selected cases under medical supervision.

• Adults:
• 100 mg orally three times daily (every 8 hours).
• Pediatrics:
• Dose based on weight, commonly 1.5 mg/kg per dose, administered three times daily. Pediatric formulations may vary.
• Elderly:
• No dosage adjustment generally necessary; monitor for comorbidities.
• Renal Impairment:
• No specific dose adjustments recommended; caution in severe impairment.
• Hepatic Impairment:
• Use with caution; no clear dose adjustment guidelines.
• Route:
• Oral administration, preferably before meals.
• Duration:
• Typically 3 to 7 days, or until symptom resolution.

Racecadotril is a prodrug metabolized to thiorphan, an enkephalinase inhibitor. By inhibiting enkephalinase, it prevents degradation of endogenous enkephalins in the gut, leading to increased activation of δ-opioid receptors on intestinal epithelial cells. This activation reduces secretion of water and electrolytes into the intestinal lumen, thereby decreasing stool volume without affecting gastrointestinal motility.

• Absorption: Rapid oral absorption of racecadotril.
• Distribution: Active metabolite thiorphan is widely distributed; plasma protein binding approximately 70%.
• Metabolism: Rapid hydrolysis of racecadotril to thiorphan by plasma esterases; further hepatic metabolism occurs.
• Elimination: Primarily renal excretion of metabolites; half-life of thiorphan approximately 3 hours.
• Onset: Clinical effect seen within 1 hour of administration.

• Pregnancy:
• Limited data available; use only if potential benefits outweigh risks.
• Lactation:
• Safety during breastfeeding not well established; use with caution.

• Antisecretory agent
• Enkephalinase inhibitor
• Antidiarrheal agent (non-opioid)

• Known hypersensitivity to racecadotril or formulation excipients.
• Acute diarrhea with high fever or blood in stools indicating invasive infection.
• Severe dehydration requiring immediate medical attention.

• Not recommended as sole treatment for invasive bacterial diarrhea.
• Ensure adequate hydration and electrolyte balance.
• Use cautiously in severe hepatic or renal impairment.
• Monitor for allergic reactions or hypersensitivity.

Common:

• Headache
• Rash
• Flatulence
• Mild constipation

Rare:

• Severe allergic reactions (e.g., angioedema, Stevens-Johnson syndrome—extremely rare).

• No major clinically significant drug interactions identified.
• No CYP450 enzyme involvement reported.
• Caution with concurrent use of other antidiarrheal agents.

• Recognized as a safe and effective antisecretory agent for acute diarrhea treatment.
• Recommended alongside oral rehydration therapy to reduce stool volume and duration.
• Increasing use in pediatric populations with established dosing guidelines.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in tightly closed containers.
• Do not freeze.