Racetril 100-MG Capsule

Racetril is indicated as an adjunct to rehydration therapy for the symptomatic treatment of acute secretory diarrhea.

Racecadotril is a prodrug that needs to be hydrolysed to its active metabolite thiorphan. Thiorphan is an inhibitor of enkephalinase. Enkephalinase is a cell membrane peptidase located in various tissues, notably in the epithelium of the small intestine. This enzyme hydrolyses or breaks down the exogenous peptides and endogenous peptides (enkephalins). Racecadotril protects enkephalins from enzymatic degradation thereby prolonging their action at enkephalinergic synapses in the small intestine and reducing water and electrolytes hypersecretion. Racecadotril exerts rapid antidiarrheal action, without modifying the duration of intestinal transit. Racecadotril does not produce abdominal distension.

Adults: One capsule initially regardless of the time of the day; then one capsule 3 times daily (preferable before food) untill diarrhea stops.

Children (3 months to 18 years): Racecadotril is suitable for children over 3 months of age. Recommended dose is 1.5 mg/kg body weight.

• If body weight less than 9 kg: 10 mg 3 times daily.
• If body weight 9-13 kg: 20 mg 3 times daily.
• If body weight 13-27 kg: 30 mg 3 times daily.
• If body weight over 30 kg: 60 mg 3 times daily.

Maximum duration of treatment is 7 days.

How to use sachet:

• Dissolve the powder in 20 ml pure water
• Stir well
• After dissolving the powder drink full suspension immediately

No interactions with other active substances have been described in humans to date. In humans, joint treatment with Racetril and Loperamide or Nifuroxazide does not modify the kinetics of Racetril.

Racecadotril is contraindicated in patients who have shown hypersensitivity to its components.

Headache, rash and erythema.

Due to a lack of clinical data, Racecadotril should not be administered to pregnant or breastfeeding women.

The administration of Racetril does not modify the usual rehydration regimens. There are limited data in patients with renal or hepatic impairment. So these patients should be treated with caution.

No cases of overdose have been reported. In adults, single doses above 2 g which is equivalent to 20 times the therapeutic dose, have been administered, and no harmful effects have been described.

Anti-diarrhoeal

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.