Dissenten 2 mg - acute diarrhea treatment 15 tablets

Product Description

Dissenten helps stop diarrhea by slowing down bowel movements.

Indications

What is Dissenten used for? Dissenten is a medicine indicated for the symptomatic treatment of acute diarrhea and exacerbations of chronic diarrhea. It contains the active ingredient loperamide.

Dosage and method of use

Dissenten tablets should be taken with a little water, in the following doses and ways, keeping in mind that the medicine cannot be taken for more than two days.

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 loose (soft) stool. 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 stool normalizes and discontinue treatment in case of constipation. Caution: Do not use for more than 1 day. two days.

Children under 6 years of age: Dissenten should not be used in children under 6 years of age.

Elderly: No dose adjustment is necessary in the elderly.

Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment.

Patients with hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, Dissenten should be used with caution in these patients due to reduced first-pass metabolism.

Composition

Dissenten contains:

• the active substance loperamide hydrochloride. Each tablet contains 2 mg of loperamide hydrochloride;
• the other ingredients are magnesium stearate and microgranular cellulose.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Dissenten is contraindicated in children under 6 years of age. The drug 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 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.

Warnings

The 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 such cases, the most important countermeasure is the administration of adequate fluid and electrolyte replacement therapy. Treatment with Dissenten should be discontinued if there is no improvement in clinical symptoms within 48 hours of starting therapy, and the patient should consult their physician. AIDS patients treated with Dissenten for diarrhea should discontinue therapy at the first sign of abdominal distension. Isolated cases of constipation, with an increased risk of toxic megacolon, have been reported in patients with infectious colitis of bacterial or viral origin treated with loperamide hydrochloride. Loperamide hydrochloride is subject to extensive first-pass metabolism. Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide hydrochloride should be used with caution in these patients due to reduced first-pass metabolism. Therefore, patients with hepatic impairment should be carefully monitored for signs of central nervous system toxicity.

Pregnancy and Breastfeeding

Although there is no indication that loperamide hydrochloride has teratogenic or embryotoxic properties, the expected therapeutic benefits should be weighed against the potential risks before administering loperamide hydrochloride during pregnancy, especially during the first trimester. Therefore, if you are pregnant or are planning to become pregnant, you should consult your doctor before taking Dissenten.

Furthermore, small amounts of loperamide may appear in human breast milk. Therefore, loperamide hydrochloride is not recommended during breastfeeding.

Interactions

Non-clinical data have shown that loperamide is a substrate of P-glycoprotein. Co-administration of loperamide (a single dose of 16 mg) with quinidine or ritonavir, both inhibitors of P-glycoprotein, resulted in a 2- to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is administered at the recommended doses is unknown. Co-administration of loperamide (a single dose of 4 mg) with itraconazole, a CYP3A4 and P-glycoprotein inhibitor, resulted in a 3- to 4-fold increase in loperamide plasma 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 16 mg dose) and ketoconazole, a CYP3A4 and P-glycoprotein inhibitor, resulted in a 5-fold increase in plasma loperamide concentrations. This increase was not associated with an increase in pharmacodynamic effects, as detected 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.

Side effects

Like all medicines, Dissenten can cause side effects. You should stop taking Dissenten and consult your doctor if you experience:

• severe allergic reactions that may manifest as swelling and difficulty breathing;
• abdominal swelling associated with pain, nausea, vomiting, constipation, signs of intestinal obstruction or megacolon;
• severe skin reactions that may include blistering and peeling of the skin.

When taking this medicine, the following side effects may occur, listed by frequency:

Common (may affect up to 1 in 100 people):

• headache, dizziness;
• constipation, nausea, flatulence.

Uncommon (may affect up to 1 in 1,000 people):

• abdominal pain, especially in the upper abdomen abdominal pain, abdominal discomfort;
• dry mouth; vomiting;
• digestive problems (dyspepsia);
• skin irritation (rash).

Rare (may affect up to 1 in 10,000 people):

• swelling of the abdomen.

In addition, the following side effects have been reported (post-marketing reports), the frequency of which cannot be estimated from the available data. be established on the basis of available data:

• allergic (hypersensitivity)-type reactions, including severe ones (anaphylactic reaction, including shock and anaphylactoid reaction);
• drowsiness, loss of consciousness, mental disorders, including those associated with detachment from reality (stupor), depressed level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination making it difficult to perform certain movements; reduction in the size of the pupil, the black part of the eye (miosis); disorders indicative of a blockage of the intestine (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders that may manifest as blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), skin irritation (hives), itching;
• swelling of the face due to fluid accumulation, especially around the mouth and eyes;
• decreased need to urinate (urinary retention);
• fatigue.

Report any suspected adverse reactions via the national reporting system.

Format

Pack of 15 2 mg tablets.