RACE-F
Manufacturer Details
BESTOCHEM
Bestochem Formulations (India)Ltd
2 Mohakampur
Industrial Complex
Phase I Delhi Road
Meerut 250 002
sales@bestochem.com
Compositions:
Racecadotril 100mg capsules,
Racecadotril 15mg powder,
|
Strength
|
Rate
|
Packing Style
|
|
100mg
|
56.91
|
10s capsules
|
|
15mg
|
12.89
|
1 powder
|
List of Related Indications:
List Of Drugs:
- Racecadotril - Antidiarrheals- (Oct 2001)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
No clinically significant interactions involving interference with drug metabolism have been reported with racecadotril
Indication:
Diarrhea of bacterial and viral etiology
LIST OF DRUGS DURING 2004
Sr.No- 202
Name of the Drug- Racecadorril Sachet (10mg/30mg)
Pharmacological Classification- Anti-diarrhoeal
Date of Approval- 18-05-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2006
Sr.No- 160
Name of the Drug- Racecadotil dispersible tablet (10mg/30mg)
(new dosage form) Pharmacological Classification- For diarrheoa
Date of Approval- 15-12-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Racecadotril Anti-Diarrhoeal 10-10-2001
2.Racedoxil Dispersible Tablet 15-12-2006
10mg/30mg
New Dosage Form
For Diarrhea
3.Racedoxil Sachet 10mg/30mg 18-05-2004
Anti-diarrheal
Adverse Reaction:
Vomiting was the most frequent adverse event associated with racecadotril in 2 studies which was comparable to loperamide.
In general it is better tolerated than loperamide and caused less constipation after resolution of diarrhea than loperamide.
Other reported adverse reactions include nausea, thirst, vertigo and headache.
Contra-Indications:
Contraindications None reported
Special precautiions-
Renal insuficiency, pregnancy and lactation
Dosages/ Overdosage Etc:
Indication-
Diarrhea of bacterial and viral etiology
Dosage
Adults- 100 - 300mg t.i.d.
Children- 1.5mg/kg t.i.d.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Racecadotril is lipophilic desterified prodrug of the enkephalinase inhibitor thiorphan. Thiophan, by inhibiting the membrane bound enkephalinase enzymes increases the avilability of endogenous opioids (enkephalins). These enkephalins activate data opiod receptors in the gastrointestinal tract . This in turn leads leads to the reduction of water and electrolytes into the intestinal lumen. This is in contrast to loperamide which is a receptor agonist and hence disrupts intestinal peristasis thereby allows more time for net absorption of fluids to occur.This could lead to bacterial overgrowth, invasion by by shigela and precipitation of megacolon.
Pharmacokinetics-
Orally administered racecadotril is rapidly absorbed from the GI tract. It is hydrolysed to thiopham in peripheral tissues. It reached peak plasma concentrations of 805-1055 nmol/L in 1 hour. Racecaditril has an elimination halflife of 3 hours and 92% of the drug is excreted from the body in 24 hours.
Pregnancy and lactation:
Caution to be excrecised during use pregnacy and lactation
