Hidrasec® [cap]

Solvay Pharma [ Zuellig ]

MIMS Class : Antidiarrheals

See related Hidrasec cap information

Contents Racecadotril
Indications Cap Treatment of acute diarrhea. Powd Adjunct to oral or parenteral
rehydration in the treatment of acute watery diarrhea in infants &
childn.
Dosage Cap Adult 100 mg. Further treatment: 8 hrly until cessation of
diarrhea. Powd Childn & infants 1.5 mg/kg/dose, w/ 1 initial dose &
3 daily divided doses.
Overdosage View Hidrasec overdosage for action to be taken in the event of an
overdose.
Administration May be taken with or without food
Contraindications Powd Renal or hepatic impairment. Fructose intolerance, glucose &
galactose malabsorption syndrome or sucrase isomaltase deficiency.
Special Rehydration. Consider severe or prolonged diarrhea, maintain
Precautions feeding during diarrhea, severe vomiting, refusal of food. Childn >24
mth. Pregnancy, lactation.
Adverse Drug Drowsiness, nausea & vomiting, constipation, dizziness, headache.
Reactions View ADR Monitoring Website
Side Effects View Hidrasec side effects
Drug Interactions [Click For Detailed Information]
View more drug interactions with Hidrasec
Storage View Hidrasec storage conditions for details to ensure optimal shelf-
life.
Mechanism of View Hidrasec mechanism of action for pharmacodynamics and
Action pharmacokinetics details.
MIMS Class Antidiarrheals
ATC A07XA04 - Racecadotril ; Belongs to the class of other
Classification antidiarrheals.
Poison Schedule Rx
Presentation/Packing
Form
Hidrasec capsule
Hidrasec powder
Packing/Price Photo
Hidrasec 100 mg x 20's
Hidrasec (infant) 10 mg x 16's
Hidrasec 30 mg x 30's (P876.88)

Hidrasec® [cap]
Solvay Pharma [ Zuellig ]
MIMS Class : Antidiarrheals

See related Hidrasec cap information

Contents
Racecadotril
For the treatment of acute diarrhea.
Indications
Dosage Hidrasec should be given in conjunction with oral or parenteral
rehydration therapy in patients where dehydration has occurred or
is suspected.

Capsule: Adults: Treatment should be initiated with a single 100-

mg cap given regardless of the time. Further treatment is given
approximately 8-hourly until cessation of diarrhea.

The daily dose should not exceed 300 mg and the duration of
treatment must not exceed >7 days.

Powder: The usual daily dose is determined according to

bodyweight on the basis of 1.5 mg/kg per dose, with 1 initial dose
and 3 doses spread over the day. Children >9 years (approx >27
kg): 2 sachets/dose; 30 months - 9 years (approx 13-27 kg): 1
sachet/dose; 9-30 months (approx 9-13 kg): 2 sachets/dose; 1-9
months: 1 sachet.dose.

Children: Hidrasec is not recommended for use in children.

Elderly: An adjustment of dose is not necessary in elederly

subjectcs
Overdosage Individual 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 incident of
accidental overdosage has been reported. No specific antidote has
been identified, and management should follow recognized
procedures for overdose.
Administration May be taken with or without food
Contraindications Known hypersensitivity to racecadotril. Renal or hepatic
impairment.
Special Precautions Rehydration is the essential element of the treatment of acute
diarrhea in infants. In children >24 months, it shoud be planned
automatically. The prevention or treatment of dehydration will be
done with oral rehydration solution. It is recommended to use
solutions intended for this purpose and to follow the instructions
for reconstitution and use.

The sodium concentration should be between 30 and 60 mmol/L,

with solutions with a lower content (30 mmol/L) being reserved
for less severe dehydration. Provision of chlorine and potassium
is necessary in order to correct digestive losses. The
recommended glucosae concentration is between 74 and 110
mmol/L. The addition of hydrolyzed proteins or amino acids does
not seem to improve rehydration or the nutritional state . It is
essential to offer the child very frequent drinks, every quarter of
an hour for example. As a guideline, the proposed volume of oral
rehydratio should be equivalent to the weight loss ie, 50-100
mL/kg for dehydration of 5-10% of bodyweight.

In the case of severe or prolonged diarrhea, severe vomiting or

refusal of food, IV rehydration should be considered.

In the case of infectious diarrhea with clinical manifestations

suggesting an invasive phenomenon, use antibacterial with good
systemic diffusion.

Hidrasec 30 mg: If rehydration by rehydration solution is

prescribed, the conditions of use and the method of reconstitution
should be explained clearly and precisely.

It is not necessary to prescribe such rehydration, it is nonetheless

necessary to explain clearly the need to rehydrate the child
plentiful salty or sweetened drinks in order to make up for the
loss of fluid due to the diarrhea (the average daily ration of water
is 2 L).

Maintain feeding during period of diarrhea: Excluding certain

 product, especially fruit, green vegetables, spicy food and also
iced foods or drinks; giving preferen to grilled meat and rice;
withdrawal of milk and dairy products should be considered in
each individual case.

In the case of diabetes, take into account the quantity of sugar in

a sachet ie, about 2.899 g of sucrose per sachet of 3 g powder. If
the quantity of sucrose (source of glucose and fructose) in daily
dose of this drug >5 g/day, it should be taken into account in the
daily ration.

In the absence of any studies in these situations, Hidrasec should

not be used as treatment of first intent for acute dysentery with
blood in the stools or high fever and it should not be used in the
case of diarrhea occurring during treatment with a broad-
spectrum antibiotic.

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 embryo-fetal
development. Hidrasec should not be used in pregnancy unless
the potential benefits outweigh the risks.
Side Effects A few cases of drowsiness have been reported during clinical
trials. Nausea and vomiting, constipation, dizziness and
headaches have also been reported rarely. The side effects have
been mild, and equivalent in nature, frequency and intensity to
those reported with placebo. Post-marketing surveillance has
indicated side effects to be extremely rare in general use.
Drug Interactions No specific studies in humans have been performed.

Racecadotril does not inhibit or induce cytochrome P-450 in

animal models.

Incompatibilities: None known.

View more drug interactions for Hidrasec
Storage Store below 30°C.
Mechanism of Pharmacology: Hidrasec is an inhibitor of enkephalinase, the
Action enzyme responsible for breaking down enkephalins. It is a
selective but reversible inhibitor and protects endogenous
enkephalins which are physiologically active in the digestive
 tract.

Hidrasec has a pure intestinal antisecretory agent which has been

shown to have no effect on gastrointestinal motility. It reduces
intestinal hypersecretion of water and electrolytes caused by
cholera toxin or inflammation without affecting basal secretion.
There is therefore no effect in the normal intestine.

When given orally, enkephalinase inhibition is purely peripheral.

Racecadotril does not affect central nervous system
enkephalinase activity and has not been shown to produce
habituation or central nervous stimulant or sedative effects.

Pharmacokinetics: Racecadotril is rapidly absorbed by the oral

route. It is rapidly hydrolyzed to (RS)-N-(1-oxo-2-
(mercaptomethyl)-3-phenylpropyl) glycine, its active metabolite,
which is in turn converted into inactive metabolites which are
eliminated through the kidneys, feces and lungs.

The extent and duration of action of racecadotril depends on the

dose administered.

Activity against plasma enkephalinase starts within 30 min, with

peak activity corresponding to 75% inhibition for a dose of 100
mg, occurring 1-3 hrs after administration. The biological half-
life of racecadotril is 3 hrs. For a dose of 100 mg, the duration of
activity against plasma enkephalinase is about 8 hrs.

(RS)-N-(1-oxo-2-(mercaptomethyl)-3-phenylpropyl) glycine, the

active metabolite of racecadotril, is 90% bound to plasma
proteins, mainly albumin. Tissue distribution only affects about
1% of the administered dose.

The pharmacokinetic properties of racecadotril are not changed

by repeated administration or in elderly subjects. The
bioavailability of racecadotril is not affected by food but the peak
activity is delayed by 1½ hrs.
MIMS Class Antidiarrheals
ATC Classification A07XA04 - Racecadotril ; Belongs to the class of other
antidiarrheals.
Poison Schedule Rx
Presentation/Packing Cap 100 mg x 20's. Powd 10 mg (infant) x 16's. 30 mg (children)
x 30's.
Manufacturer: Solvay Pharma