Hidrasec Infants 10 mg Granules

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