Loperamide tablets 2mg №10×2

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Loperamide tabl 2mg in bl. in pack. No. 10×2
Description:
Tablets of white or almost white color, round shape, with a flat surface, with a chamfer. The main active ingredient Loperamide hydrochloride Release form: 10 tablets in a blister, 2 blisters in a pack. Dosage 2 mg in bl. in pack. No. 10×2 Special instructions Treatment of diarrhea is symptomatic. If it is possible to determine the etiology of the disease (or it is indicated that it is necessary to do this), then, if possible, specific treatment should be carried out (the drug does not replace antibacterial treatment for infectious diseases). During the treatment of diarrhea (especially in children), it is necessary to replenish the loss of fluid and electrolytes and follow a diet. With caution, the drug should be used for dehydration, elderly patients (risk of loss of fluid and electrolytes). Patients with acquired immunodeficiency syndrome taking the drug for diarrhea should stop treatment at the first signs of bloating. There are isolated case reports of toxic megacolon in AIDS patients with infectious colitis of both viral and bacterial origin while treated with loperamide. Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide should be used with caution in such patients due to a slowdown in first-pass metabolism. Patients with impaired liver function should be closely monitored in order to timely detect signs of toxic damage to the central nervous system. Loperamide should be used with caution in patients in cases of exacerbation of ulcerative colitis. Drugs that prolong transit time may lead to the development of toxic megacolon in this group of patients. Given that loperamide is well metabolized, loperamide or its metabolites are excreted in the faeces, it is usually not necessary to adjust the dose of loperamide in patients with impaired renal function. Pharmacodynamics Loperamide has antidiarrheal activity. Interacts with opiate receptors in the intestinal wall and blocks the release of acetylcholine and prostaglandin. Slows down intestinal motility and increases the time of passage of intestinal contents. The drug increases the tone of the anal sphincter, helps to retain feces and reduce the frequency of the urge to defecate. Loperamide is highly specific for the intestinal wall, reaches the systemic circulation in a limited volume, and practically does not penetrate the blood-brain barrier. The threshold of central action is much higher than the dose that has the maximum effect against diarrhea. Pharmacokinetics The action occurs quickly (1 hour after taking the tablets orally, 85% of loperamide is found in the gastrointestinal tract, 5% in the liver) and lasts 4-6 hours. The maximum concentration of loperamide in plasma is determined after 4 hours. Binding to plasma proteins – 97%. It is excreted mainly in the form of conjugates with bile and feces. The elimination half-life averages 12 hours. With renal failure, an increase in the concentration of loperamide in the blood serum is possible. Indications for use Symptomatic treatment of acute and chronic diarrhea of various origins. It can be recommended in case of “traveler’s diarrhea” with a duration of treatment up to 2 days. In case of fever or in the presence of blood in the stool, it is recommended to stop taking the drug until the causes of this phenomenon are clarified. Dosage and administration Loperamide is administered orally orally, the tablets are swallowed whole (without chewing), washed down with water. Loperamide is not intended for the initial treatment of severe diarrhea accompanied by a decrease in fluid and electrolyte levels. Particularly in children, it is desirable to compensate for this loss by prescribing parenteral or oral replacement therapy. In acute diarrhea, the initial dose for adults is 2 tablets (4 mg), for children over the age of 6 years – 1 tablet (2 mg); in the future – 1 tablet (2 mg) after each next liquid bowel movement. In chronic diarrhea, the initial dose for adults is 2 tablets (4 mg) daily, for children over the age of 6 years – 1 tablet (2 mg) daily. This dose is then adjusted so that the frequency of solid bowel movements is 1-2 times a day, which is usually achieved with a maintenance dose of 1-6 tablets (2-12 mg) per day. The maximum daily dose for acute and chronic diarrhea for adults is 8 tablets (16 mg); for children, it should be calculated based on the child’s body weight (3 tablets per 20 kg of the child’s body weight, but not more than 8 tablets). In acute diarrhea, if there is no clinical improvement within 48 hours, loperamide hydrochloride should be discontinued. Application for the treatment of elderly patients No dose adjustment is required for elderly patients. Application for impaired renal function Dose adjustment is not required for patients with impaired renal function. Use in hepatic impairment Although there are no pharmacokinetic data on the effect of loperamide in patients with hepatic impairment, the drug should be administered with caution to such patients due to a slowdown in their first-pass metabolism (see section “Appropriate safety measures for use”). Application during pregnancy and lactation Despite the lack of data on the teratogenic and embryotoxic properties of loperamide, the drug should be prescribed during pregnancy, especially in the first trimester, only if the expected therapeutic effect for the mother outweighs the potential risk to the fetus / child. Loperamide in small amounts passes into breast milk, therefore, if necessary, the use of the drug is recommended to stop breastfeeding. Interaction with other drugs Antifungal drugs. Itraconazole significantly (3-4 times) increases the peak plasma concentration of loperamide, and also lengthens the half-life of the drug. Simultaneous administration of loperamide and ketoconazole increases the serum level of loperamide by 5 times, but this does not lead to an increase in the pharmacodynamic effects of the drug. hypolipidemic agents. Simultaneous administration of loperamide and gemfibrozil doubles the concentration of loperamide in the blood and prolongs its half-life. The combination of itraconazole and gemfibrozil, when used simultaneously with loperamide, leads to an increase in the level of loperamide in the blood serum by 4 times and a 13-fold increase in the residence time of the drug in the blood serum, but these indicators do not affect the function of the central nervous system. P-glycoprotein inhibitors. Simultaneous use of loperamide (at a dose of 16 mg) together with ritonavir or quinidine can lead to an increase in plasma bioavailability of loperamide by 2-3 times. Antibacterial drugs. The use of co-trimoxazole increases the bioavailability of loperamide. Antiarrhythmic drugs. The simultaneous use of quinidine and loperamide can lead to respiratory depression. Hormones of the hypothalamus, pituitary gland, gonadotropic hormones and their antagonists. The use of desmopressin and loperamide leads to a 2-fold increase in the level of desmopressin in the blood serum due to its increased absorption in the gastrointestinal tract. In children, co-administration with drugs that have a depressant effect on the central nervous system should be avoided. Contraindications Hypersensitivity to loperamide hydrochloride or to any other component of the drug. Galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome. Do not use for primary therapy in patients with: acute dysentery, with the presence of blood in the stool and fever; acute ulcerative and pseudomembranous colitis resulting from the use of broad-spectrum antibiotics; bacterial enterocolitis caused by Salmonella, Shigella or Campylobacter, impaired liver function necessary for the metabolism of the drug, as this can lead to a relative overdose. Conditions in which there is an undesirable inhibition of peristalsis, due to the possible risk of significant complications, including intestinal obstruction, megacolon and toxic megacolon. It is necessary to immediately stop taking the drug if constipation, bloating or partial intestinal obstruction develops. The drug is contraindicated for children under the age of 6 years. Active ingredient: loperamide; 1 tablet contains loperamide hydrochloride in terms of 100% substance – 2 mg; excipients: lactose, monohydrate; potato starch; calcium stearate. Overdose Symptoms: depression of the central nervous system (stupor, incoordination, drowsiness, miosis, muscle hypertonicity, respiratory depression), urinary retention and a complex of symptoms similar to intestinal obstruction. Children are more sensitive to effects on the central nervous system due to the fact that their blood-brain barrier is not yet fully functional. Treatment: in case of an overdose of the drug, immediately introduce activated charcoal and rinse the stomach. Naloxone can be used as an antidote. Since the duration of action of loperamide hydrochloride exceeds that of naloxone (1-3 hours), repeated administration of naloxone may be required. Therefore, the patient should be closely monitored for 48 hours in order to detect signs of CNS depression. Side effects Allergic reactions: rash, urticaria, itching, angioedema, bullous rash, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis (Lyell’s syndrome), as well as severe hypersensitivity reactions, including anaphylactic shock and anaphylactoid reactions. From the digestive tract: constipation, flatulence, dry mouth, abdominal cramps and colic, abdominal pain, intestinal obstruction, nausea, vomiting, megacolon, including toxic megacolon; dyspepsia. From the urinary tract: urinary retention. From the nervous system: dizziness, headache, drowsiness, impaired coordination, loss of consciousness, depression of consciousness, tremor. From the list of the above-mentioned adverse reactions while taking the drug, symptoms characteristic of diarrheal syndrome (abdominal pain / discomfort, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, flatulence) may occur. Therefore, it is very difficult to distinguish between these symptoms and manifestations of side effects. On the part of the organs of vision: miosis. General disorders: fatigue. Storage conditions Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Buy Loperamide tablets 2mg No. 10×2 Price for Loperamide tablets 2mg No. 10×2