Radola100 mg

Radola is indicated for the symptomatic treatment of acute diarrhea in adults and infants/children (from about 3 months of age), used as an adjunct to oral rehydration therapy (ORT), which remains the essential primary treatment for fluid and electrolyte loss.

• Established use: Acute (non-bloody, non-persistent) diarrhea of presumed infectious or functional origin, in combination with appropriate oral or intravenous rehydration.
• Mechanism-based rationale: Radola reduces intestinal hypersecretion of water and electrolytes without slowing gut motility, distinguishing it from opioid-derived antimotility antidiarrheals such as loperamide.
• Not established: Radola is not indicated for chronic diarrhea, diarrhea due to invasive bacterial infection with systemic symptoms, or as a substitute for rehydration therapy.

Each formulation of Racecadotril contains racecadotril as the active ingredient. It is commonly available as:

• Capsules containing 100 mg of Racecadotril (for adults and adolescents).
• Granules for oral suspension containing 10 mg or 30 mg per sachet of Racecadotril (for infants and children, weight-based dosing).

Formulations also contain standard pharmaceutical excipients appropriate to the dosage form.

Radola is an orally active antisecretory antidiarrheal agent that acts as an enkephalinase (neutral endopeptidase) inhibitor. It is a prodrug that is rapidly converted to its active metabolite, thiorphan, after oral administration.

Unlike opioid-receptor-based antidiarrheal agents, Radola acts purely on intestinal fluid secretion and does not affect gastrointestinal motility or transit time, which is associated with a lower risk of constipation and abdominal distension.

Radola belongs to the therapeutic class of antidiarrheal agents, specifically classified as an enkephalinase (neutral endopeptidase) inhibitor with antisecretory action.

Racecadotril is a prodrug rapidly hydrolyzed to its active metabolite, thiorphan, which inhibits enkephalinase (membrane neutral endopeptidase), an enzyme responsible for degrading endogenous enkephalins in the intestinal wall.

By protecting enkephalins from degradation, Racecadotril prolongs their physiological action on intestinal opioid receptors, reducing the hypersecretion of water and electrolytes into the intestinal lumen that occurs during acute diarrhea. It has a purely antisecretory effect without altering basal intestinal secretion, transit time, or motility, and without clinically significant central nervous system effects at recommended doses (limited CNS penetration).

Onset of action of Racecadotril is rapid (within about 30 minutes), and its antisecretory effect is not associated with rebound constipation on discontinuation.

Radola capsules should be swallowed whole with water, preferably before meals.

For infants and young children, the contents of a Radola granule sachet should be dispersed in water or mixed into food or a baby bottle immediately before administration, and given right away (see Reconstitution).

Oral rehydration solution should be continued alongside Radola, and fluid/electrolyte replacement should never be interrupted.

Radola has a low potential for clinically significant drug interactions, as it acts locally in the intestine with minimal systemic enzyme induction or inhibition (it is not a significant inhibitor or inducer of hepatic cytochrome P450 enzymes).

• No clinically significant interaction has been established between Radola and commonly co-administered medicines when used as directed for acute diarrhea.
• As a general precaution, Radola should not be combined with other antidiarrheal agents (e.g., loperamide) unless directed by a physician, since the combined effect on bowel function has not been systematically studied.
• Inform your physician of all other medicines being taken concurrently so an individualized safety assessment can be made.

Radola is generally well tolerated. Because it does not slow intestinal motility, it is not typically associated with the constipation or abdominal distension seen with opioid-based antidiarrheals.

• Common: Mild skin reactions (rash), headache.
• Uncommon/Rare: Vomiting, constipation.
• Rare but serious: Angioedema (swelling of the face, lips, tongue, or throat) and other hypersensitivity reactions, including urticaria and, very rarely, severe skin reactions — seek immediate medical attention if these occur.

Patients should stop Radola and seek urgent medical care if signs of a severe allergic reaction develop.

Data on the use of Radola during pregnancy are limited. As a precaution, Radola should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

It is not known whether Radola or its active metabolite passes into breast milk. Because data are limited, a decision to use Radola while breastfeeding should be made in consultation with a physician, weighing benefits against potential risk to the infant.

Radola does not replace oral or intravenous rehydration therapy, which remains the cornerstone of managing acute diarrhea, particularly in infants, young children, and the elderly, where dehydration — not the diarrhea itself — is the primary danger.

• If diarrhea persists beyond a few days (generally more than 7 days in adults, or sooner in infants/young children), or is accompanied by fever, blood or mucus in the stool, or signs of dehydration, discontinue Radola and seek prompt medical evaluation for an underlying cause.
• Use with caution in patients with severe renal or hepatic impairment, as clinical experience in these populations is limited; see Use in Special Populations.
• Discontinue Radola immediately if any sign of allergic reaction (rash, swelling, difficulty breathing) occurs; see Side Effects.
• Radola is not recommended for use as sole therapy without concurrent rehydration.

Limited data are available on overdose with Radola; clinical experience with doses several times the recommended dose has not shown specific toxicity, but caution is warranted.

In case of a suspected overdose of Radola, seek immediate medical attention or contact a poison control center. Treatment should be symptomatic and supportive; there is no specific antidote.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children. Once a sachet of granules is reconstituted, use immediately and discard any unused portion.

Pediatric: Radola granules for oral suspension are used in infants from about 3 months of age and in children, with dosing based on body weight (see Dosage). Safety and efficacy in infants below 3 months of age have not been established.

Elderly: No dose adjustment is generally required; clinical experience supports standard adult dosing of Radola, with the same precautions regarding rehydration.

Renal impairment: Data are limited; use Radola with caution as there is no established dose-adjustment recommendation.

Hepatic impairment: Data are limited; use Radola with caution as there is no established dose-adjustment recommendation.

Treatment with Radola should continue only until acute diarrhea resolves (typically evidenced by two consecutive normal stools), and should generally not exceed 7 days. If diarrhea has not improved or has worsened after a few days, medical reassessment is needed rather than continuing Radola indefinitely.

For the pediatric granule formulation, the contents of one sachet of Radola should be dispersed just before use in a small amount of water, or mixed into a baby bottle or soft food (avoid very hot liquids). The reconstituted dose of Radola should be administered immediately and should not be stored for later use.

Antidiarrheals; Enkephalinase (neutral endopeptidase) inhibitors

Racecadotril acts as a prodrug converted to thiorphan, which inhibits intestinal enkephalinase, thereby preserving endogenous enkephalins that reduce intestinal fluid and electrolyte hypersecretion (see Pharmacology for full mechanistic detail). Unlike antimotility agents, this antisecretory action of Racecadotril is achieved without altering gut transit time.

Radola granules for oral suspension are used in infants and children from about 3 months of age, dosed according to body weight (see Dosage). Safety and efficacy of Radola in infants younger than 3 months have not been established, and it should not be used in this age group without medical advice.

Radola should always be used together with oral rehydration therapy in children, as dehydration is the principal risk in pediatric acute diarrhea. Caregivers should seek medical care promptly if a child shows signs of dehydration, high fever, blood in the stool, or if diarrhea does not improve.