IMODIUM 2/MG INSTANTS MELT TAB 12/TAB

Indications

Approved Uses

Symptomatic treatment of acute diarrhea; symptomatic treatment of chronic diarrhea (under medical supervision); reduction of volume of discharge from ileostomies.

Dosage & Administration

Maintenance Dose

2mg after each loose stool, not exceeding the maximum daily dose

Children's Dosage

Not for use in children under 2 years. For children 2 years and older, dosing is typically weight-based and should be determined by a physician. OTC use for children 6-11 years has specific lower maximum daily doses.

How to Take

With dry hands, remove the orodispersible tablet from the blister, place it on the tongue, allow it to dissolve, then swallow; water is not required.

Side Effects

Common Side Effects

Constipation, abdominal pain/cramps, nausea, flatulence, dizziness, headache (dry mouth and vomiting can also occur).

Side Effect Frequency

Common: constipation, nausea, flatulence, abdominal pain/cramps, dizziness, headache. Uncommon: vomiting, dry mouth, rash/urticaria, drowsiness. Rare/serious: ileus (including paralytic ileus), toxic megacolon (especially with infectious colitis/IBD), severe hypersensitivity; QT prolongation/torsades reported mainly with supratherapeutic doses/abuse or interacting drugs.

Safety & Warnings

Warnings & Precautions

Do not use with blood in stool or high fever; not a substitute for oral rehydration; stop and seek care if symptoms persist >48 hours or if constipation, abdominal distension, or ileus develops; do not exceed recommended dose due to risk of QT prolongation/Torsades/cardiac arrest/death; use caution in hepatic impairment; in AIDS patients stop if abdominal distension occurs (risk of toxic megacolon).

Age Restriction

Contraindicated in children <2 years; for the 2 mg orodispersible (Imodium Instants) product, use in children is generally not recommended unless specifically directed by a clinician (many product labels restrict OTC self-use to ≥12 years).

Drug Interactions

Drug Interactions

Major interactions: CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) and CYP2C8 inhibitors (e.g., gemfibrozil) and P-glycoprotein inhibitors (e.g., quinidine, ritonavir) can increase loperamide exposure; additive risk with other QT-prolonging drugs and in patients with cardiac risk factors.

Interaction Severity

"MAJOR: Strong P-gp and/or CYP3A4/CYP2C8 inhibitors (e.g., quinidine, ritonavir, ketoconazole/itraconazole, gemfibrozil; especially combinations) can markedly increase loperamide exposure and risk of serious cardiac arrhythmias at higher-than-recommended doses.
MODERATE: Other QT-prolonging drugs (additive risk, particularly if loperamide is misused/overdosed) and other moderate CYP/P-gp inhibitors.
MINOR: No clinically meaningful interactions expected at recommended OTC doses with most agents, but counsel to avoid exceeding dose limits."

Food Interaction

No restriction.

Special Populations

Breastfeeding

Caution

Children

Not for use in children under 2 years. For children 2 years and older, dosing is typically weight-based and should be determined by a physician. OTC use for children 6-11 years has specific lower maximum daily doses.

Elderly

Standard adult dosing; no specific adjustment required, but monitor for constipation and abdominal distension

Kidney Impairment

No adjustment needed.

Liver Impairment

No specific dose adjustment is defined, but use with caution in hepatic impairment (especially severe) and monitor closely for CNS/cardiac toxicity; avoid exceeding recommended doses.

Storage & Patient Advice

Missed Dose

For acute diarrhea (OTC), dosing is as needed after loose stools-no scheduled doses, so a “missed dose” is generally not applicable; for chronic scheduled use, take the missed dose when remembered unless close to the next dose, and do not double.

Overdose

Overdose can cause CNS depression (somnolence/stupor), miosis, respiratory depression, urinary retention, ileus, and serious cardiac toxicity (QT prolongation, Torsades de Pointes, ventricular arrhythmias, cardiac arrest); treat with supportive care, consider activated charcoal if early, and naloxone for opioid/CNS effects (repeat dosing may be needed) with cardiac monitoring.

Pharmacology

Mechanism of Action

Peripherally acting mu-opioid receptor agonist in the intestinal wall/myenteric plexus that decreases propulsive motility and intestinal secretion, increases transit time, and improves stool consistency (with minimal CNS effect at recommended doses due to P-gp efflux).

Onset of Action

Approximately 1 hour (clinical effect often within 1-3 hours).

Duration of Effect

Up to three days (not 24 hours)

Bioavailability

Very low systemic bioavailability (<1%) due to extensive first-pass metabolism and P-glycoprotein efflux.

Metabolism

Extensive hepatic first-pass metabolism, primarily via CYP3A4 and CYP2C8 (oxidative metabolism including N-demethylation).

Excretion

Excreted predominantly in feces via biliary elimination, mainly as metabolites; urinary (renal) excretion is minimal.

Protein Binding

Approximately 95% protein bound.

Product Information

Available Dosage Forms

Orodispersible tablet (instant melt), tablet/caplet, capsule, and oral solution/syrup (availability varies by country/market).

Composition per Dose

Each orodispersible tablet: 2mg loperamide hydrochloride

Generic Availability

Yes

Gi Condition

Diarrhea

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