Treatment: symptomatic of acute diarrhea in adults

Treatment does not exempt dietary measures and rehydration if it is necessary.

The importance of rehydration by oral or intravenous rehydration should be adjusted according to the intensity of diarrhea, age and patient characteristics.

Orally.

Reserved for the adult

The initial dosage is 2 tablets.

After each non-molded saddle, one additional tablet will be administered, not to exceed 8 tablets per 24 hours.

Elderly subjects

No dosage adjustment is necessary.
Renal insufficiency

No dosage adjustment is necessary.
Hepatic impairment

Although there are no pharmacokinetic data in patients with impaired liver function, loperamide should be used with caution in these patients due to the reduction of the first pass effect (see section 4.4). And precautions for use).

ANTI-DIARRHEA, ATC code: A07, DA 03

(A: digestive system and metabolism)

· Antidiarrheal analogue structural opiates.

· Antisecretory activity by increasing the hydro-electrolyte flow of the intestinal lumen to the plasma pole of the enterocyte and reducing the reverse flow

· Slower colonic transit with increased segmental contractions

· Quick and durable effects.

· Respects bacteriological and parasitological characteristics of stools

This medication sometimes causes discrete, transient sleepiness, dizziness or fatigue.



Attention is drawn, in particular, to vehicle operators and users of certain machines, about the possible risks attached to the use of this medicinal product.
· Hypersensitivity to loperamide or to any of the constituents

· In case of acute outbreaks of ulcerative colitis,

· In cases of haemorrhagic diarrhea and / or high fever

· In patients with enterocolitis, bacterial due to an invasive bacterium such as Salmonella, Shigella or Campylobacter

Warnings

If, after 2 days of treatment, diarrhea persists, the course to be taken should be re-evaluated and the need for oral or intravenous rehydration should be considered.

Precautions for use

· Loperamide should not be used in cases of diarrhea occurring during broad-spectrum antibiotic therapy. In fact, we must fear a colitis, pseudomembranous with toxi-infection. In this case, any treatment causing fecal stasis should be avoided.


Hepatic insufficiency should be monitored in particular because of the important effect of the first pass.

The patient should be informed of the necessity of

O rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (daily ration, average adult water is 2 liters)

O: feeding the time of diarrhea

* Excluding certain intakes and particularly raw vegetables, fruits, green vegetables, dishes, spices and food or drinks

* In favor of grilled meats, rice.

This medicinal product contains lactose and is not recommended for use in patients with lactose intolerance, lactose deficiency or malabsorption syndrome, glucose or galactose (hereditary or rare diseases). Br>

Without object.

Not applicable

Symptoms

In case of overdose (including overdose related to liver failure), central nervous system depression (decreased, vigilance, somnolence, miosis, hypertonia, depression, respiratory distress, motor incoordination) urinary retention, and ileus Can be seen. Children may be more sensitive to the effects on the central nervous system

Emergency procedure, antidote

Naloxone can be used as an antidote. The duration of action of the specialty being longer than that of naloxone (1 to 3 hours), it may be necessary to renew the administration of the latter. Accordingly, the patient must be kept under medical supervision for at least 48 hours to detect any depression of the central nervous system.
Pregnancy

Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals in well conducted studies on two species. In clinical use, the use of loperamide in a limited number of pregnancies has apparently shown no malformative or fetotoxic effects to date. However, additional studies are needed to assess the consequences of exposure during pregnancy.


In case of prolonged treatment, take account of its opiate properties, which may in particular affect the digestive functions of the newborn.

Breastfeeding

The passage of loperamide in breast milk is very low, consequently, breastfeeding is possible in the case of punctual treatment by this drug.

In case of prolonged treatment, take account of its opiate properties.

Data from clinical trials

The use of loperamide oxide was evaluated in 1776 patients with acute diarrhea.

The most frequently reported adverse reactions with the use of this drug in clinical studies are constipation (1.8%) and headache (2%).

Post marketing experience

Loperamide oxide is the prodrug of loperamide. The loperamide oxide is converted to loperamide by the intestinal flora Thus, the adverse effects considered as significant for loperamide hydrochloride are included in this section as it is theoretically expected that the two active ingredients have the same Profile of tolerance even in the absence of notifications, reported for loperamide oxide.

The undesirable effects are classified by system organ and frequency by using the following convention

Very common> 1/10

Frequent:> 1/100, 1/1000; 1/10000,