Dissenten anti-diarrhea -10 tablets

Product Description

Symptomatic treatment of diarrhea.

Indications

Dissenten antidiarrhea is indicated for the symptomatic treatment of acute diarrhea.

Composition

Active ingredients

Benzalkonium chloride 0.2 g.

Excipients

Lemon essence 1.0 g Color E 104 0.01 mg Deionized water to 100 g.

Directions for use and Dosage

Adults and children aged between 6 and 17 years The initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; then 1 tablet (2 mg) after each subsequent evacuation of loose (soft) stools.
The maximum daily dose for adults is 8 tablets (16 mg).
For children, the dose should be related to body weight (3 tablets/20 kg) but should not exceed a maximum of 8 tablets per day.
Reduce the dose when stools normalize and discontinue treatment in case of constipation.
Caution: do not use for more than two days.
The tablets should be taken with a little liquid. Children under 6 years of age Dissenten antidiarrhea should not be used in children under 6 years of age.
No dose adjustment is necessary in the elderly.
Renal impairment No dose adjustment is necessary in patients with renal impairment. Hepatic impairment Although no pharmacokinetic data are available in patients with hepatic impairment, Dissenten antidiarrhea should be used with caution in these patients due to reduced first-pass metabolism.

Warnings

Treatment of diarrhea with loperamide hydrochloride is only symptomatic.
Whenever an underlying etiology can be determined, specific treatment should be administered when appropriate.
Fluid and electrolyte depletion may occur in patients with diarrhea, especially in children.
In these cases, the most important countermeasure is the administration of adequate fluid and electrolyte replacement therapy.
Treatment with Dissenten antidiarrhea should be discontinued if there is no improvement in clinical symptoms within 48 hours of starting therapy and the patient should consult their doctor.
AIDS patients treated with Dissenten antidiarrhea for diarrhea should discontinue therapy at the first signs of abdominal distension. Isolated cases of constipation with an increased risk of toxic megacolon have been observed in these patients with infectious colitis of bacterial or viral origin treated with loperamide hydrochloride. Loperamide hydrochloride is subject to extensive first-pass metabolism. The drug should be used with caution in patients with hepatic insufficiency as it may lead to relative overdose with CNS toxicity.
In children between 6 and 12 years of age, Dissenten antidiarrhea should be used only under medical supervision.
Cardiac events, including QT prolongation and torsade de pointes, have been reported in association with overdose. Some cases have had a fatal outcome.
Patients should not exceed the recommended dose and/or prolong the duration of therapy.

Contraindications and side effects

Hypersensitivity to the active substance or to any of the excipients.
Dissenten antidiarrhea is contraindicated in children under 6 years of age.
Dissenten antidiarrhea should not be used as primary therapy: in patients with acute dysentery, characterized by blood in the stool and high fever, in patients with acute ulcerative colitis, in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics, in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter.
In general, the use of Dissenten antidiarrhea is contraindicated in all cases where inhibition of peristalsis must be avoided due to the possible risk of significant consequences such as ileus, megacolon and toxic megacolon.
If constipation, abdominal distension or ileus occur, discontinue treatment immediately.

Interactions

Non-clinical data have shown that loperamide is a substrate of P-glycoprotein.
Concomitant administration of loperamide (single dose of 16 mg) with quinidine or ritonavir, both inhibitors of P-glycoprotein, has shown a 2- to 3-fold increase in plasma levels of loperamide. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is administered at the recommended doses, is unknown.
Concomitant administration of loperamide (a single 4 mg dose) and itraconazole, a CYP3A4 and P-glycoprotein inhibitor, resulted in a 3- to 4-fold increase in plasma loperamide concentrations. In the same study, gemfibrozil, a CYP2C8 inhibitor, increased plasma loperamide concentrations approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak plasma loperamide levels and a 13-fold increase in total plasma exposure. These increases were not associated with central nervous system (CNS) effects, as measured by psychomotor tests (e.g., subjective drowsiness and the Digit Symbol Substitution Test).
Concomitant administration of loperamide (a single dose of 16 mg) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in plasma loperamide concentrations. This increase was not associated with increased pharmacodynamic effects, as measured by pupillometry. Concomitant treatment with oral desmopressin resulted in a 3-fold increase in plasma desmopressin concentrations, presumably due to a slowing of gastrointestinal motility. Treatment with substances with similar pharmacological properties may potentiate the effect of loperamide, and drugs that accelerate intestinal transit may decrease its effect. Concomitant use of CYP 450 inhibitors is not recommended.

Overdose

Symptoms In case of overdose, including that caused by hepatic dysfunction, CNS depression (stupor, impaired coordination, drowsiness, miosis, muscle hypertonia, respiratory depression), urinary retention, and ileus may occur.
Cardiac events such as QT prolongation, torsade de pointes, other serious ventricular arrhythmias, cardiac arrest, and syncope have been observed in patients who have ingested excessive doses of loperamide hydrochloride (see section 4.4).
Fatal cases have also been reported.
Children may be more sensitive than adults to the effects of a loperamide overdose. Therefore, it is recommended to keep the product out of their reach because it may cause serious side effects. Accidental ingestion, especially in children under 4 years of age, may cause constipation and central nervous system depression with drowsiness and slowed breathing. In this case, the child should be kept under careful observation for 48 hours.
Treatment: Measures in case of overdose: gastric lavage, induction of vomiting, enema, or administration of laxatives. If symptoms of overdose occur, naloxone may be administered as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone may be indicated. Therefore, the patient must be carefully monitored for at least 48 hours to detect any worsening of central nervous system depression.

Pregnancy and breastfeeding

Administration of Dissenten antidiarrhea is not recommended during pregnancy and breastfeeding.
Pregnant or breastfeeding women should therefore consult their doctor for appropriate treatment.

Storage

No special storage precautions.

Format

10 tablets.