Imodium Complete Relief

White, capsule-shaped tablet with vanilla odor debossed with "IMO" on one side, the other is debossed with a line between "2" and "125".
Each tablet contains: Loperamide HCl, Ph Eur. 2 mg, Simethicone, Ph. Eur 125 mg.

Loperamide + Simethicone (Imodium Complete Relief) is indicated for the control of acute diarrhea of any cause and its commonly associated symptoms. These are often attributed to "trapped wind" and include abdominal discomfort, bloating, cramping and flatulence.

Adults and pediatrics (12 years and older): Two tablets (4 mg) initially, followed by one tablet (2 mg) after every loose stool.
Not more than 4 tablets (8 mg) should be taken in a day, limited to no more than 2 days.
Pediatrics (under 12 years of age): Loperamide-Simethicone should not be used in children less than 12 years of age.
Elderly & Renal Impairment: No dosage adjustment is necessary in renal impairment.
Hepatic Impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide-Simethicone should be used with caution in such patients because of reduced first pass metabolism.
What should the patient do if they miss a dose: Continue medication based on dosage and/or consult a doctor.

Signs and Symptoms of Overdose: In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, respiratory depression), urinary retention and paralytic ileus may occur. Children may be more sensitive to CNS effects than adults.
In individuals who have intentionally ingested overdoses (reported in doses from 40 mg up to 792 mg per day) of loperamide HCl, QR interval and QRS complex prolongation and/or serious ventricular arrhythmias, including Torsade de Pointes, have been observed. Fatal cases have also been reported. Abuse, misuse and/or overdose with excessively large doses of loperamide, may unmask Brugada syndrome. Upon cessation, cases of drug withdrawal syndrome, have been observed in individuals abusing, misusing or intentionally overdosing with excessively large doses of loperamide.
What to do when the patient has taken more than the recommended dosage: In cases of overdose, ECG monitoring for QR interval prolongation should be initiated.
If CNS symptoms of overdose occur, naloxone can be given as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone may be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible CNS depression. Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center (where available) to determine the latest recommendations for the management of an overdose.

Loperamide-simethicone should not be used in children less than 12 years of age.
Loperamide-simethicone is contraindicated in patients with a known hypersensitivity to loperamide, simethicone or to any of the excipients.
Loperamide-simethicone should not be used as the primary therapy: in patients with acute dysentery, which is characterized by blood in stools and high fever; in patients with acute ulcerative colitis; in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter; in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.
Loperamide-simethicone should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon.
Loperamide-simethicone must be discontinued promptly when constipation, abdominal distension or ileus develop.

Treatment of diarrhea with loperamide-simethicone is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate.
In patients with (severe) diarrhea, fluid and electrolyte depletion may occur. In such cases the administration of appropriate fluid and electrolyte replacement should be considered.
If clinical improvement is not observed within 48 hours, the administration of loperamide-simethicone should be discontinued. Patients should be advised to consult their physician.
Patients with AIDS treated with loperamide-simethicone for diarrhea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide HCl.
This medicine must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to CNS toxicity.
Abuse and misuse, as an opioid substitute, have been described in individuals with opioid addiction.
When should the patient consult a doctor: If symptoms persist or worsen, or if new symptoms occur, stop use and consult a doctor.

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of loperamide-simethicone or loperamide HCl based on the comprehensive assessment of the available adverse event information. A causal relationship with loperamide-simethicone cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trial data: The safety of loperamide-simethicone was evaluated in 2040 patients who participated in five clinical trials. All trials were in patients with acute diarrhea with gas related discomfort and with a chewable tablet loperamide-simethicone formulation. Four trials compared loperamide-simethicone with loperamide, simethicone and placebo and one trial compared two formulations of loperamide- simethicone with placebo. Adverse reactions reported by ≥1% of loperamide-simethicone treated patients (N=618) are shown in Table 1. (See Table 1.)

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Adverse reactions reported by <1% of loperamide simethicone-treated patients in the previously mentioned clinical trial dataset are shown in Table 2. (See Tables 2 and 3.)

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Postmarketing data: Adverse reactions first identified during post marketing experience with loperamide-simethicone or loperamide HCl are included in Table 4. In the table, the frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000, <1/1,000; Very rare <1/10,000, including isolated reports.
In Table 4, adverse reactions are presented by frequency category based on spontaneous reporting rates. (See Table 4.)

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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 P-glycoprotein 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 of 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 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, presumable 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.
Since simethicone is not absorbed from the gastrointestinal tract, no relevant interactions between simethicone and other drugs are expected.

Store at temperatures not exceeding 30°C.

Antidiarrheals

A07DA53 - loperamide, combinations ; Belongs to the class of antipropulsives. Used in the treatment of diarrhea.

Non-Rx