Registered Kenya · PPB

HIDRASEC ADULTS 100 MG

RACECADOTRIL

H2014/CTD1399/073 100 MG RACECADOTRIL PER CAPSULE INN generic

What it does

Racecadotril is a medication used to treat acute diarrhea, helping to reduce the number of watery stools.

Commonly used for: acute diarrhea, watery stools

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2014/CTD1399/073
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
RACECADOTRIL
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Imperial Managed Solutions
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
JW8Q+7R3, kutch Rd, Mlolongo, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:56:22 · updated 2026-07-26 11:46:55

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Racecadotril is a medication used to treat acute diarrhea, helping to reduce the number of watery stools.

What it treats

  • acute diarrhea
  • watery stools

How it works

It works by reducing the amount of fluid in the intestines, which helps to decrease diarrhea.

Who it's for

Racecadotril is suitable for adults and children experiencing sudden diarrhea.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Racecadotril

BNF-referenced

Racecadotril is an antidiarrheal medication that acts as an enkephalinase inhibitor. It is primarily used in the symptomatic treatment of acute diarrhea, reducing the volume and frequency of stools without affecting intestinal motility. Unlike loperamide, racecadotril does not inhibit peristalsis but acts by enhancing the body’s natural defenses against diarrhea.

Indications

  • Acute diarrhea
  • Symptomatic treatment of diarrheal episodes

Dosage

Children: For children aged 3 months to 12 years, the dose is typically 1.5 mg/kg/day in divided doses. For children aged 12 years and older, the adult dosing regimen may be applied. Refer to the BNF for Children for detailed dosing guidelines.

Adults: The usual adult dose is 100 mg three times daily for up to 7 days. The treatment should be continued until diarrhea resolves.

Mechanism of action

Racecadotril is a prodrug that is converted to its active form, thiorphan, which inhibits the enzyme enkephalinase. This inhibition increases the levels of endogenous enkephalins in the gut, leading to a reduction in excessive intestinal secretions and an increase in absorption of fluids and electrolytes, thereby alleviating diarrhea.

Pharmacodynamics

Racecadotril has a rapid onset of action, with its effects seen within 1 hour of administration. It selectively targets enkephalinase and has minimal impact on gut motility, making it effective for treating acute diarrhea without the risk of constipation associated with other antidiarrheal agents.

Pharmacokinetics

After oral administration, racecadotril is rapidly absorbed and its active metabolite, thiorphan, reaches peak plasma concentrations in approximately 1 hour. The elimination half-life is around 3 hours, and it is primarily excreted through urine. The drug does not significantly alter the pharmacokinetics of other medications.

Adverse effects

  • abdominal pain
  • nausea
  • vomiting
  • headache
  • dizziness
  • constipation

Interactions

  • CNS depressants may enhance sedative effects
  • Antidiarrheal agents may mask underlying conditions

Precautions

  • Use with caution in patients with a history of gastrointestinal obstruction
  • Monitor for signs of dehydration in patients with diarrhea
  • Not recommended for use in children under 12 years

Pregnancy

Racecadotril should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as safety has not been established.

Breast-feeding

Lactating mothers should use racecadotril with caution; it is not known whether racecadotril is excreted in human milk.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Capsules
  • Oral suspension
  • Tablets
BNF for Children 2019-2020 p.73 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Racecadotril

PubChem CID 107751

Molecular formula: C21H23NO4S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.