Description Loperamide Transient acute diarrhea Viatris 12 oral lyophilisats
Symptomatic treatment of acute and chronic diarrhea.
The treatment does not dispense with dietary measures and rehydration if it is necessary.
The extent of rehydration by oral or intravenous rehydration solution must be adapted according to the intensity of the diarrhea, the age and the particularities of the patient (associated diseases, ...).
Dosage and method of administration Loperamide Transient acute diarrhea Viatris
Dosage
Reserved for adults and children over 8 years of age.
Acute diarrhea:
The initial dosage is 2 capsules in adults and one capsule in children.
After each unformed stool, an additional capsule will be administered, without exceeding
8 capsules per 24 hours in adults, and 6 capsules per 24 hours in children.
Chronic diarrhea :
1 to 3 capsules per day in adults.
1 to 2 capsules per day in children.
Mode of administration : Oral.
Capsules should be taken with a glass of water.
Contraindications Loperamide Transient acute diarrhea Viatris
- Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1.
- Children under 8 years of age.
- Loperamide hydrochloride should not be used as first-line treatment in cases of
- acute dysentery characterized by the presence of blood in the stool and high fever
fever,
- acute attacks of ulcerative colitis,
- bacterial enterocolitis due to invasive bacteria such as Salmonella, Shigella or
Campylobacter,
- pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
- Loperamide hydrochloride should not be used when inhibition of peristalsis must be avoided because of the risk of significant sequelae including ileus, megacolon and colectasis. Treatment should be discontinued promptly if constipation, abdominal distension or ileus develops.
Special warnings and precautions for use
Treatment of diarrhea with loperamide hydrochloride is symptomatic only.
Whenever the etiology of the diarrhea can be determined, specific treatment should be instituted whenever possible.
Dehydration and electrolyte loss may occur in patients with diarrhea, especially in children. In this case, the administration of adequate fluids and electrolytes is essential.
The patient should be informed of the need to :
- rehydrate with abundant drinks, salty or sweet, to compensate for fluid losses due to diarrhea (the average daily water intake of an adult is 2 liters),
- eat during the time of the diarrhea,
o by avoiding certain foods, especially milk, raw vegetables, fruits, green vegetables, spicy dishes and iced foods or drinks
o by giving preference to grilled meats and rice.
In case of acute diarrhea, if the diarrhea persists after 2 days of treatment, the patient should be advised to stop taking this medication and to consult a doctor.
The course of action should be reassessed and the need for oral or intravenous rehydration should be considered.
Patients infected with Human Immunodeficiency Virus (HIV) and treated for diarrhea with loperamide hydrochloride should discontinue treatment at the first sign of abdominal distension. Isolated cases of obstinate constipation have been reported with an increased risk of colectasis in HIV-infected patients with bacterial and viral infectious colitis treated with loperamide hydrochloride.
Although pharmacokinetic data are not available in patients with hepatic impairment, loperamide hydrochloride should be used with caution in these patients due to the reduced first-pass effect. Patients with hepatic impairment should be closely monitored for signs of central nervous system toxicity.
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