Imotil Plus Tablet

Imotil Plus Tablet is used for: Diarrhea with Flatulence

Diarrhea/Flatulence After each loose bowel movement: 2 tablets once initially, then 1 tab/dose with each subsequent loose stool up to 4 tab/day

Diarrhea/Flatulence <6 years: Safety and efficacy not established 6-8 years: 1 tablet once initially, then one-half tablet/dose, up to 2 tablets/day 9-12 years: 1 tablet once initially, then one-half tablet/dose, up to 3 tablets/day > 12 years: After each loose bowel movement: 2 tablets once initially, then 1 tab/dose with each subsequent loose stool up to 4 tab/day

Since the majority of loperamide is metabolized, and metabolites or the unchanged drug is excreted in the feces, dose adjustments in patients with a kidney disorder are not required.

Should be taken by mouth and can be taken at any time of day. The caplets should be taken with a full (250 mL) glass of water. The chewable tablets should be chewed fully and then swallowed. Drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea. Take only on an empty stomach (1 hour before or 2 hours after a meal).

Hypersensitivity, bloody diarrhea, high fever, infectious diarrhea, pseudomembranous colitis Patients in whom constipation must be avoided Abdominal pain without diarrhea Avoid use as primary therapy with acute dysentery (bloody stools and high fever, acute ulcerative colitis, bacterial enterocolitis [caused by Salmonella, Shigella, and Campylobacter), pseudomembranous colitis associated with antibiotic use) Age <2 years

Chewable tab should be chewed thoroughly before swallowing loperamide May cause drowsiness or dizziness, which may impair physical abilities to operate heavy machinery or tasks requiring mental alertness Ask healthcare professional if mucus present in stool or history of abnormal heart rhythm Hypersensitivity reactions reported, including anaphylaxis, rash, urticaria, and rare cases of Steven’s Johnson syndrome or toxic epidermal necrolysis Discontinue if no improvement seen within 48 hr in patients with acute diarrhea, symptoms worsen, or abdominal swelling or bulging develops Discontinue promptly if constipation, abdominal pain or distention, blood in stool, or ileus develops; do not use when peristalsis inhibition should be avoided (ie, due to potential for ileus, megacolon, or toxic megacolon) Discontinue therapy if symptoms of abdominal distention occur in patients with AIDS; cases of toxic megacolon reported with infectious colitis, resulting from viral or bacterial pathogens Taking more than directed can cause serious heart problems or death Use with caution in patients with hepatic impairment due to reduced first-pass metabolism; monitor for signs of CNS toxicity Use of higher than recommended doses or abuse of loperamide can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes, or other ventricular arrhythmias, syncope, and cardiac arrest; in cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects simethicone Can cause false-negative gastric guaiac test

Pregnancy category: B (loperamide); C (simethicone) Lactation: Unknown if distributed in to breast milk, use caution Pregnant or breastfeeding patients should seek advice of health professional

Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with Pglycoprotein inhibitors, when loperamide is given at recommended dosages, is unknown. The concomitant administration of loperamide (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P glycoprotein, resulted in a 3 to 4 fold increase in loperamide plasma concentrations. In the same study a CYP2C8 inhibitor, gemfibrozil, increased loperamide by approximately 2 fold. The combination of itraconazole and gemfibrozil resulted in a 4 fold increase in peak plasma levels of loperamide 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 (i.e., subjective drowsiness and the Digit Symbol Substitution Test). The concomitant administration of loperamide (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5 fold increase in loperamide plasma 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 of desmopressin plasma concentrations, presumably due to slower gastrointestinal motility. It is expected that drugs with similar pharmacological properties may potentiate loperamide’s effect and that drugs that accelerate gastrointestinal transit may decrease its effect. Contraindicated (0) Serious (39) amisulpride anagrelide artemether artemether/lumefantrine asenapine asenapine transdermal bedaquiline buprenorphine buprenorphine buccal buprenorphine subdermal implant buprenorphine transdermal buprenorphine, long-acting injection ceritinib chloroquine citalopram clarithromycin clozapine crizotinib desflurane eluxadoline entrectinib erdafitinib eribulin fentanyl fentanyl intranasal fentanyl transdermal fentanyl transmucosal fexinidazole givinostat infigratinib (DSC) isoflurane lasmiditan lefamulin oxaliplatin quinidine sevoflurane sotorasib tepotinib tetrabenazine

Side effects of Loperamide + Simethicone : Frequency Not Defined Dizziness Fatigue Headache Abdominal pain Dry mouth Nausea Diarrhea Vomiting Pancreatitis

Slows intestinal motility by direct effects on circular & longitudinal muscle (loperamide); changes surface tension of gas bubbles, causing collapse of foam bubbles, thus allow easier passage (simethicone)

Imotil Plus 2 mg + 125 mg Tablet manufactured by Square Pharmaceuticals PLC.. Its generic name is Loperamide + Simethicone. Imotil Plus is availble in Bangladesh. Farmaco BD drug index information on Imotil Plus Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.