Hidrasec 100mg 10 capsules
Hidrasec is a medicine that contains racecadotril as the active ingredient. It is indicated for the treatment of the symptoms of acute nonspecific diarrhea in adults.
Hidrasec is a medicine that contains racecadotril as the active ingredient. It is indicated for the treatment of the symptoms of acute nonspecific diarrhea in adults.
Hidrasec (100 Mg 10 Capsules)
Racecadotril
Hidrasec is a medicine that contains racecadotril as the active ingredient.
It is indicated for the treatment of the symptoms of acute nonspecific diarrhea in adults.
You must talk to a doctor if you do not feel better or if you feel worse after 2 days.
ACTION AND MECHANISM
Intestinal antisecretory antidiarrheal. Racecadotril is a prodrug of thiorphan, a true active metabolite, which is formed by hydrolysis. Thiorphan is a selective inhibitor of plasma enkephalinase, a membrane peptidase responsible for the degradation of natural enkephalins.
The inhibitory effect on enkephalinase translates at the level of the intestinal mucosa into a sustained effect of enkephalins on delta-type opioid receptors, involved in the regulation of intestinal water and electrolyte reabsorption. The sustained action of enkephalins on these receptors is responsible for the intestinal antisecretory effect of water and electrolytes, neutralizing the hypersecretion induced by various agents, both chemical and biological.
The inhibition of peripheral enkephalinase leads to an increase in the permanence of enkephalins, with the consequent regulatory effect of intestinal secretion.
It does not appear that racecadotril significantly affects basal secretion, nor does it modify intestinal transit time. The action is exclusively peripheral (only 1% of the dose of racecadotril is distributed in the tissues), without significant effects on the central nervous system.
After oral administration, the inhibitory effect of enkephalinase begins to manifest itself within 30 minutes, reaching maximum activity after two hours. With oral doses of 1.5 mg / kg, the maximum enzyme inhibition level is around 90%. The inhibitory effect is significantly maintained for around eight hours.
PHARMACOKINETICS
- Absorption: It is a prodrug, which after oral administration is completely hydrolyzed in peripheral tissues to thiorphan (active metabolite). Orally, racecadotril is rapidly absorbed. The activity on plasma enkephalinase appears as early as 30 min.
The duration and extent of the effect of racecadotril are a function of the administered dose. The peak of activity on plasma enkephalinase is observed approximately 2 hours after administration and corresponds to an inhibition of 90% with the dose of 1.5 mg / Kg. The duration of inhibitory activity on plasma enkephalinase is approximately 8 hours.
Food: Bioavailability is unchanged if administered with food, but peak activity is delayed by approximately 1 hour and a half
- Distribution: only 1% of the administered dose is distributed in the tissues. 90% of the active metabolite of racecadotril, ((RS) -N- (1-oxo-2- (mercaptomethyl) -3-phenylpropyl) glycine), is bound to plasma proteins, mainly albumin.
- Metabolism: It is rapidly hydrolyzed to ((RS) -N- (1-oxo-2- (mercaptomethyl) -3-phenylpropyl) glycine), the active metabolite, which in turn is transformed into inactive metabolites which are eliminated by renal, fecal and pulmonary route.
- Elimination: The half-life is approximately 3 hours.
The pharmacokinetic properties of racecadotril do not change with repeated administration or in the elderly.
INDICATIONS
"NO MEDICAL PRESCRIPTION (HIDRASEC)":
- Symptomatic treatment of nonspecific acute [DIARRHEA] in adults.
POSOLOGY
Orally:
- Adults and the elderly: 100 mg initially, whatever the time of day; subsequently, 100 mg / 8 h, preferably before main meals.
- Duration of treatment: should be maintained until 2 normal stools occur.
* Without a prescription (Hidrasec): the treatment will be complementary to the dietary measures and should not last more than 48 hours.
DOSAGE IN KIDNEY INSUFFICIENCY
Sufficient clinical experience is lacking.
DOSAGE IN LIVER INSUFFICIENCY
Sufficient clinical experience is lacking.
CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients.
- Enteroinvasive diarrhea, characterized by fever and blood in the stools.
- Diarrhea caused by antibiotic therapy.
PRECAUTIONS
For severe or prolonged diarrhea with significant vomiting or reluctance, intravenous rehydration should be considered.
In case of diarrhea with clinical manifestations suggesting an infectious etiology, antibacterial agents with good systemic diffusion should be administered.
- It should not be used in cases of kidney or liver failure due to the lack of data in these populations.
PRECAUTIONS RELATING TO EXCIPIENTS
- This medicine contains lactose. Patients with hereditary [LACTOSE INTOLERANCE] or galactose, Lapp's lactase deficiency, or glucose or galactose malabsorption should not take this medicine.
ADVICE TO THE PATIENT
- Treatment with Hidrasec will be discontinued when clinical improvement is not observed within 48 h or if fever appears. The doctor should be consulted in these cases.
SPECIAL WARNINGS
- The administration of racecadotril does not modify the usual rehydration guidelines.
- It has not been sufficiently studied in chronic diarrhea. Racecadotril has not been studied in diarrhea caused by antibiotics.
- Treatment with Hidrasec will be discontinued when clinical improvement is not observed within 48 h or if fever appears. Patients should be informed that they should consult their doctor in these cases.
- Since the treatment of diarrhea with Hidrasec is only symptomatic, whenever possible, it should be treated based on its cause.
INTERACTIONS
- Butylhioscine: in rodents, high doses (10 - 20 mg / kg orally) have caused a slight enhancement of the effects of butylhioscine on gastrointestinal transit.
- Phenytoin: in rodents a slight enhancement of the anticonvulsant action has been observed.
PREGNANCY
Animal safety : Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, fertility, embryo-fetal development, parturition or postnatal development.
Safety in humans : There are no adequate and well-controlled studies in humans. Racecadotril should not be administered to pregnant women.
Effects on Fertility : Studies with racecadotril in rats showed no impact on fertility.
LACTATION
Due to the lack of data on the passage of racecadotril into human milk, it should not be administered to women during lactation.
ADVERSE REACTIONS
Side effects reported in clinical trials occurred with an incidence similar to placebo. The most frequent were:
- Gastrointestinal: [VOMITING] (5%), [CONSTIPATION] (<1%).
- Others: [FEVER] (1.3%).
- Dermatological: rarely, [EXANTEMATIC ERUPTIONS]. Unknown frequency: [ERYTHEMA MULTIFORME], tongue swelling, face swelling, angioedema, urticaria, erythema nodosum, papular rash.
- Nervous system: Common: [HEADACHE]. Rarely, [VERTIGO].
OVERDOSE
- No cases of overdose have been described.
- Doses greater than 2 g in a single dose, the equivalent of 20 times the therapeutic dose, have been administered in adults, without any adverse effects being observed.
Naloxone reverses the antidiarrheal effects of racecadotril.