Overdose of Redotil in details
No data are available for overdosage in children. However, in adults, single doses of 2 g ie, 20 times the therapeutic dose for the treatment of acute diarrhea, have been administered in clinical trials without causing any harmful effects. No incidence of accidental overdosage has been reported. No specific antidote has been identified and management should follow recognized procedures for overdose.
Redotil warnings
this medicine Paediatric: In diabetic patients, the quantity of sugar in the sachets ie, 580 mg (0.6-g sachet), 966.5 mg (1-g sachet), 1740 mg (1.8-g sachet) or 2900 mg (3-g sachet) of sucrose should be taken into account. If the quantity of sucrose (source of glucose and fructose) provided by this medicine Paediatric exceeds 5 g/day, it should be taken into account in the daily ration.
Caution should be exercised in patients with renal or hepatic failure due to lack of clinical experience in these groups.
Effects on the Ability to Drive or Operate Machinery: No adverse effects on the ability to drive or operate machinery have been identified.
Use in pregnancy & lactation: Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryofetal development. this medicine/this medicine Paediatric should not be used in pregnancy unless the potential benefits outweigh the risks.
Adequate human data on use in lactation are not available. However, animal studies have not identified any risk to lactation or the breastfed offspring.
Use in children: this medicine capsule is not recommended for use in children <15 years.
Redotil precautions
The administration of Redotil do not modify the usual rehydration regimens. It is essential for the child to drink abundant liquids.
In the event of serious or prolonged diarrhoea with important vomiting or a lack of appetite, IV rehydration should be considered.
The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea, or the presence of other severe disease. Also, Redotil has not been tested in antibiotic-associated diarrhoea. Therefore, Redotil should not be administered under these conditions.
Chronic diarrhoea has not been sufficiently studied with Redotil.
Redotil must not be administered in patients with renal or liver impairment, whatever the degree of severity, due to a lack of information on these patient populations.
Hepatic or Renal Impairment: There are no studies in infants or children with renal or hepatic impairment.
Because of possible reduced bioavailability, the product must not be administered in cases of prolonged or uncontrolled vomiting.
In patients with diabetes, it should be taken into account that each sachet contains sucrose 0.966 g (Redotil Infants) and 2.899 g (Redotil Children). If the quantity of sucrose (source of glucose and fructose) present in the daily dose of Redotil Infants and Redotil Children exceeds 5 g daily, the latter should be taken into account in the daily sugar ration.
Redotil must not be administered to infants <3 months, as there are no clinical trials in this population.
Effects on the Ability to Drive or Operate Machinery: Redotil has no or negligible influence on the ability to drive and use machines.
Fertility: Fertility studies conducted with Redotil on rats demonstrate no impact on fertility.
Use in pregnancy & lactation: There are no adequate data from the use of Redotil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo-foetal development, parturition or postnatal development. However, since no specific clinical studies are available, Redotil should not be administered to pregnant women.
There is insufficient information on the excretion of Redotil in human milk; Redotil should not be administered to breastfeeding women.
References
- DrugBank. "Racecadotril". http://www.drugbank.ca/drugs/DB11696 (accessed September 17, 2018).
- MeSH. "Protease Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
