Symptomatic treatment of acute and chronic diarrhea of various origins. Reduction in the amount of faecal fluid after ileostomy and colostomy.
Composition:
1 tabl contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulphate. The product contains lactose and sucrose.
Action:
A drug that inhibits intestinal peristalsis. Diphenoxylate is a morphine analogue without analgesia. As a result of interaction with opioid receptors in the intestinal wall, diphenoxylate reduces the cholinergic effect. Diphenoxylate reduces peristalsis of the small intestine and colon and prolongs intestinal transit time. Atropine - a competitive antagonist of acetylcholine - is present in the composition of the tablet in an amount just below the therapeutic (subtherapeutic) threshold. It reduces intestinal motility and enteric secretion.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients. Children under 4 years old (in young children, especially below 2 years of age, the range between therapeutic and toxic doses is very narrow and drug intolerance may occur). Do not use this medicine to treat diarrhea caused by bacteria that produce enterotoxins (eg toxicogenic bacteriaEscherichia coli, bacteria of the genusSalmonella andShigella). Do not use the preparation as the main medicine in the treatment of acute dysentery, which is characterized by the presence of blood in the stool and high fever. Do not use this medicine to treat acute phase of ulcerative colitis or pseudomembranous colitis caused by broad-spectrum antibiotics. Patients who are contraindicated in the use of anticholinergics (eg in the case of narrow-angle glaucoma, prostate hyperplasia, giant colon, stenosis of the subareosal tract, myasthenia gravis, tachycardia, bronchial asthma in children). Severe cirrhosis of the liver. Acute and cholestatic hepatitis. The drug should not be used to treat mechanical jaundice. Situations when avoiding inhibition of intestinal motility (eg, sub-terminal states); treatment should be discontinued immediately if abdominal distension or permeable obstruction occurs.
Precautions:
In acute diarrhea, if the improvement does not occur within 48 hours, the preparation should be discontinued. Patients with diarrhea, especially in children, may lose fluid and electrolytes. In such cases, the most important is the replenishment of fluids and electrolytes. In the case of severe dehydration or electrolyte imbalance, administration should be discontinued until adequate fluid and electrolyte replacement commences, as suppression of peristaltic intestinal activity may result in fluid retention in the intestines, exacerbating the state of dehydration and electrolyte imbalance. Young children may be particularly susceptible to diphenoxylate (respiratory suppression) and atropine sulfate. In children over 4 years, the preparation should only be used under strict medical supervision. In the case of liver dysfunction, patients should remain under strict medical supervision due to the possibility of toxic effects of the preparation on the nervous system. There have been reports of dependence on the preparation (administered at very high doses, exceeding 125 tablets per day), so be especially careful when giving it to people addicted to medication. The product contains atropine, which was added to the active substance - diphenoxylate to prevent abuse of the preparation. There have been reports of anticholinergic side effects following the recommended posology. The product contains sucrose - should not be used in patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase intolerance (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
Due to the lack of adequate data, the preparation can be used during pregnancy only if the expected benefits of treatment for the mother, outweigh the risk to the fetus. Do not use the product when breastfeeding.
Orally. Dosage depends on the patient's age and severity of symptoms.Acute diarrhea. If the symptoms can not be controlled within 48 hours after the start of treatment, further treatment is unlikely to produce the desired effect.Adults: 1-2 tabl. 3 times a day. In severe cases, exceptionally, the dose can be increased to a maximum of 2 tablets. 4 times a day. In most patients, this dose is used until the number of stools is normalized. When this happens, the dose can be reduced depending on your individual needs. In case of mild diarrhea, it is enough to use 1 tablet. 2 times a day, in the morning and in the evening, before a meal.Children and youth. Children 4-8 years: 1 tabl. Three times a day; children 9-12 years: 1 tabl. 4 times a day; 13-16 year olds: 2 tabl. 3 times a day.Chronic diarrhea. Adults. Generally, it is recommended to give 1 tabl. 2 times a day. If the symptoms of chronic diarrhea do not disappear within 10 days despite the maximum dose - 2 tabl. 4 times a day, you should not expect a beneficial effect of treatment.Children and youth. Children 4-8 years: 1 tabl. Three times a day; children 9-12 years: 1 tabl. 4 times a day; 13-16 year olds: 2 tabl. 3 times a day.
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