Description loperamide (generic doc) * 15 tablets 2mgdenominazionoperoperamide doc generic 2 mg tabletary pharmacotherapeuticaporiatropussives /Eff.secondaripersensità to the active ingredient or any of the excipients. Do not use in children with age less than 2 years. Do not use primary therapy: in patients with acute dysentery, characterized by blood in stools and high fever; In patients with acute ulcerative colitis; In patients with bacterial enterocoliths caused by invasive organisms included Salmonella, Shigella and Campilobacter; In pseudomembranosa colitis patients associated with the use of extensive antibiotics. Do not use when a peristalsi inhibit should be avoided due to the possible risk of significant consequences including ileo, megacolon and toxic megacolon. The treatment must be discontinued when constipation occurs, abdominal distension oileo.posologiaadults and children of age between 6 and 17 years: the tablets must be taken with a little liquid. Acute diarrhea: the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; Subsequently 1 tablet (2 mg) after each subsequent evacuation of non-formed stools (soft). Chronic diarrhea: the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children a day; This initial dose must be adapted until 1-2 solid evacuations are obtained per day, which are generally reached with a maintenance dose of 1-6 tablets (2 mg -12mg) per day. The maximum daily dose for chronic and acute diarrhea is 8 tablets (16 mg) per day for adults; In children the dose must be correlated to body weight (3 tablets / 20 kg) but must not exceed a maximum of 8 tablets per day. Children with age to 2 years: should not be used in children with age less than 2 years. Elderly: In the elderly a dose adjustment is not necessary. Renal impairment: In patients with renal impairment, a dose adjustment is not necessary. Hepatic impairment: although pharmacokinetic data is not available in patients with hepatic impairment, it must be used with caution in these patients due to a reduced first-to-pass metabolism. It does not require a particular condition of conservation. AvvertenziThe diarrhea treatment with the Medication is only symptomatic. Each time a basic etiology can be determined, specific treatment must be administered when appropriate. In patients with diarrhea, especially in children, a depletion of fluids and electrolytes can occur. In these cases the most important countermeasure is the administration of adequate replacement therapy based on liquids and electrolytes. Do not administer in children of age between 2 and 6 years of age without prescription and medical supervision. In acute diarrhea, if you do not observe the improvement of clinical symptoms over 48 hours, the provision of the productDEve be interrupted and patients must be advised to consult your doctor. Patients suffering from AIDS treated with diarrhea drug must suspend therapy to the first signs of abdominal distension. In these patients with infectious colitis caused by viral and bacterial pathogens, treated with loperamide hydrochloride, cases of constipation with an increase in the risk of toxic megacolon risks were found. Although pharmacokinetic data on patients with hepatic impairment are not available, the medicine must be used with caution in these patients due to the reduced first passage metabolism. Patients with hepatic dysfunction must be carefully monitored for signs of toxicity to be paid by the central nervous system (SNC). This medicine contains 0.34 g of lactose for each tablet. When taken according to the recommended dosage each daily dose provides up to a maximum of 2.720 g of lactose, then patients suffering from rare problems of galactose intolerance, from lactase lapp deficits, or from glucose-galactose malabsorption should not take this Medicinal product. It is advisable to suspend the treatment with the loperamide if there is no improvement in clinical sintomatology over the 48 hours afterwards at the beginning of therapy and patients must consult their doctor. Intrainable interactions can occur with drugs with similar drug properties To those of the loperamide or drugs that can slow down the intestinal peristals (for example the anticholinergic), as the effects of the loperamide could be enhanced. The substances that accelerate gastrointestinal transit can decrease the effect. The concomitant use of cytochrome CYP450 inhibitors and p-glycoprotein inhibitors is not recommended. Non-clinical data have shown that the Loperamide is a substrate of p-glycoprotein. Concomitant administration of Loperamide (insignola dose of 16 mg) with quinidine, or ritonavir, both p-glycoprotein inhibitor, showed an increase in loperamide plasmaidella levels from 2 to 3 times. The clinical relevance of this pharmacokinetic interaction with p-glycoprotein inhibitors, when the operamide is administered at the recommended doses (from 2 to a maximum of 16 mg per day), it is not known. The administration concomitante loperamide (in a single dose of 4 mg) and the itraconazole, a cyp3a4 and p-glycoprotein inhibitor showed an increase in the plasma levels of the loperamide of 3-4 times. In the same study Ilgemfibrozil, a CYP2C8 inhibitor showed an increase in the plasma levels of the Loperamide of about 2 times. The combination of Itraconazole and Gemfibrozil has shown an increase in the peak of the plasma levels of the operamide of 4 times and an increase in total plasma exposure of 13 times. These increases were not associated with the effects on the central nervous system (SNC) as detected by psychomotor tests (for example subjective vertigo and the digit symbol substitution test). Concomitant administration of Loperamide (in singledose of 16 mg) and ketoconazole, a CYP3A4 and P-glycoprotein inhibitor showed an increase in 5-fold plasma levels. This increase was not associated with an increase of drugs pharmacodynamics as detected by pupilometry. Concomitant treatment with oral desmopressin appeared in an increase in plasma plasma desmopressin concentrations of 3 times, presumably due to a slow gastrointestinal motion. It is expected that drugs with similar pharmacological properties can possnopertically the effect of the loperamide and that the medicines that accelerate gastrointestinal transit can decrease this effect. Unspokenly adverse reactions most commonly reported in clinical conloperamide studies for the treatment of acute diarrhea were: Stipes, flatulence, headache and nausea. In clinical studies for the treatment of chronic diarrhea, the most commonly reported ADRs were: flatulence, constipation, nausea and dizziness. Frequencies Adverse reactions: very common (> = 1/10); common (> = 1/100 up to <1/10); uncommon (> = 1/1000 up to <1/100); rare (> = 1/10,000 up to <1 / 1,000); and Mail: (<1 / 10,000). Reactions AVERSE reported with the use of loperamideClorhydrate from clinical studies in adults and children of age> = 12 years.The acute. Nervous system pathologies. Municipality: headache; Uncommon: dizziness. Gastrointestinal pathologies. Municipality: constipation, nausea, flatulence; Uncommon: abdominal pain, abdominal malaise, dry mouth, pain in the upper part of the abdomen, vomiting; Rare: abdominal distension. Cute and subcutaneous fabric pathologies. Non: Rash. Chronic diarrhea. Nervous system pathologies. Municipality: dizziness; Uncommon: headache. Gastrointestinal pathologies. Municipality: constipation, nausea, flatulence; Uncommon: abdominal pain, abdominal malaise, dry mouth, dyspepsia. Loperamide hydrochloride, datédelle post-marketing adverse reactions: the process to determine post-marketing adverse loperamids of Loperamide hydrochloride did not differ between the indications of chronic and acute diarrhea or between children and adults; Thus, adverse reactions listed below represent combined indications and subject populations. Adverse reactions identified in the post-marketing period for loperamide hydrochloride are listed through the classification for systems and organs and the dictionariesomedical for regulatory activities (Medra) according to the favorite terms (PT). Immune system disorders: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), and anaphylactoid reaction. Nervous system disorders: drowsiness, loss of consciousness, amazement, depression of consciousness levels, hypertonia, and anomalous coordination. Eye pathologies: Miosi. Gastrointestinal diseases: ileo (including paralytic ileo) and megacolon (including megacolontoxic) and Glossinia. Skin and subcutaneous tissue pathologies: Bollosa eruption syndrome (including Stevens-Johnson syndrome, toxic epidermal necrolisi and multiform erythema), angioedema, urticaria, itching. Kidney and urinary pathologies: urinary retention. Systemic pathologies and conditions relating to the administration site: fatigue. Pediatric population: The safety of Loperamide hydrochloride was evaluated on 607 age patients between 10 days and 13 years who participated in 13 clinical studies controlled and non-controlled with loperamide hydrochloride used for the treatment of acute diarrhea. In general, the ADR profile in this patient’s population was similar to that observed in clinical studies with loperamide hydrochloride in adults and children of age ouger than 12 years. Report any suspicious adverse reaction through the national signaling system. Concludes and liabilities There are no indications that the operamide hydrochloride has owned teratogenic or embryotoxic properties, the therapeutic benefits predict evaluated with respect to potential risks before administering the drug during pregnancy, especially in the Course of the first quarter. Small quantities of loperamide can appear in human breast milk. Therefore it is not recommended during breastfeeding.