DOTRIL – Antidiarrheal

  • Generic Name: Racecadotril
  • Dosage Strength: Oral 30 mg
  • Dosage Form: Granules for Suspension

Formulation

Each 30 mg sachet contains:

Racecadotril Ph.Eur ………………. 30 mg

Sucrose BP ………………………….. 2939.50 mg

Excipients …………………………… q.s.

Indications

Complementary symptomatic treatment of acute diarrhea in infants (older than 3 months) and in children together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible.

If causal treatment is possible, racecadotril can be administered as a complementary treatment.

Additional Info

DOSAGE AND ADMINISTRATION:

Racecadotril sachets are administered via the oral route, together with oral rehydration.

Racecadotril sachets 30 mg is intended for children =13 kg.

The recommended dose is determined according to body weight: l.S mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals.

In infants less than 9 kg: one 10 mg sachet 3 times daily.

In infants from 9 kg to< 13 kg: two 10 mg sachets 3 times daily.

In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily.

In children of more than 27 kg: two 30 mg sachets 3 times daily.

The duration of treatment in the clinical trials with children was 5 days.

​Treatment should be continued until two normal stools are recorded.

Treatment should not exceed 7 days. Long-term treatment with racecadotril is not recommended.

There are no clinical trials in infants under 3 months of age.

The granules can be added to food or dispersed in a small amount of water (e.g. a teaspoon), mixed well and should be administered immediately.

STORAGE:

Store at temperatures not exceeding 30°C.

AVAILABILITY:

Paper/Polyethylene/Aluminium/Polyethylene sachets.

Box of 30’s x 30 mg sachet

Shelf life

2 years.

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