IMODIUM 2MG INSTANT 6 TAB

Indications

Approved Uses

Symptomatic treatment of acute diarrhea; symptomatic treatment of chronic diarrhea (e.g., associated with inflammatory bowel disease); reduction of ileostomy output.

Off-Label Uses

Chemotherapy-induced diarrhea (selected cases under specialist guidance).

Dosage & Administration

Dosing by Condition

Acute diarrhea (adults): Initial 4 mg, then 2 mg after each loose stool; maximum 8 mg/day for OTC self-treatment (some labels allow up to 16 mg/day under medical supervision depending on jurisdiction). Stop and seek care if not improved within 48 hours.
Chronic diarrhea (adults, under medical supervision): Initial 4 mg/day, then titrate to the lowest effective dose (commonly 4-8 mg/day in divided doses); maximum 16 mg/day.
Ileostomy output reduction (adults, under medical supervision): Dose individualized; typical total daily dose 4-16 mg/day in divided doses, not exceeding 16 mg/day.

Initial Dose

4mg (two 2mg tablets) as a single initial dose

Maintenance Dose

2mg after each loose stool, not exceeding 16mg per day

Maximum Dose

OTC maximum: 8 mg/day; prescription maximum: 16 mg/day.

Children's Dosage

Not for use in children under 2 years. Children 2-5 years (up to 20 kg): use liquid formulation, 1 mg three times a day on day 1, then 1 mg after each loose stool (max 3 mg/day). Children 6-8 years (20-30 kg): 2 mg twice a day on day 1, then 1 mg after each loose stool (max 4 mg/day). Children 9-12 years (>30 kg): 2 mg three times a day on day 1, then 1 mg after each loose stool (max 6 mg/day).

Dose Adjustment Notes

No renal dose adjustment is required; use caution in hepatic impairment (especially severe) due to reduced first-pass metabolism and increased risk of CNS/cardiac toxicity; do not exceed recommended doses because of serious cardiac arrhythmia risk at high doses or with interacting drugs.

How to Take

Place the orodispersible tablet on the tongue and allow it to dissolve; swallow with saliva. Water is not needed. Take 4 mg (2 tablets) initially, then 2 mg (1 tablet) after each loose stool, within the maximum daily dose.

Side Effects

Common Side Effects

Constipation, flatulence, nausea, abdominal cramping, dizziness, headache, dry mouth

Side Effect Frequency

Common (≥1%): constipation, nausea, flatulence, abdominal pain/cramps, dizziness, headache. Uncommon (0.1-1%): vomiting, dry mouth, rash/pruritus, somnolence. Rare (<0.1%): ileus (including paralytic ileus), megacolon/toxic megacolon, severe hypersensitivity/serious skin reactions; QT prolongation/torsades reported mainly with misuse/overdose or interacting drugs.

Safety & Warnings

Contraindications

Hypersensitivity to loperamide; children <2 years; acute dysentery (blood in stool and high fever); acute ulcerative colitis; bacterial enterocolitis due to invasive organisms (e.g., Salmonella, Shigella, Campylobacter); pseudomembranous colitis associated with antibiotics; and any condition where inhibition of peristalsis should be avoided (e.g., ileus/abdominal distension/constipation).

Warnings & Precautions

Do not use if blood in stool or high fever (possible dysentery/invasive infection); not a substitute for oral rehydration; stop and seek care if constipation, abdominal distension, or ileus develops; do not exceed recommended dose due to risk of serious cardiac events; use caution in hepatic impairment; if no improvement within 48 hours for acute diarrhea, seek medical advice.

Age Restriction

Contraindicated in children <2 years; for OTC self-use generally not recommended in children <12 years unless directed by a clinician (product-specific labeling may vary by country).

Driving Warning

No specific driving warning; drowsiness reported but not prominent in clinical data.

Drug Interactions

Drug Interactions

Clinically relevant interactions include P-glycoprotein inhibitors (e.g., quinidine, ritonavir) and strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, clarithromycin) and CYP2C8 inhibitors (e.g., gemfibrozil), which can increase loperamide exposure; additive risk with other QT-prolonging drugs (e.g., amiodarone, moxifloxacin) especially if loperamide is misused or overdosed.

Interaction Severity

"MAJOR: Strong P-gp inhibitors and/or CYP3A4/CYP2C8 inhibitors (e.g., quinidine, ritonavir, ketoconazole/itraconazole, gemfibrozil) especially in combination; additive risk with other QT-prolonging drugs at high exposure/overdose.
MODERATE: Other CNS depressants (may increase dizziness/sedation) and drugs causing constipation/ileus (additive GI effects)."

Food Interaction

No restriction.

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Not for use in children under 2 years. Children 2-5 years (up to 20 kg): use liquid formulation, 1 mg three times a day on day 1, then 1 mg after each loose stool (max 3 mg/day). Children 6-8 years (20-30 kg): 2 mg twice a day on day 1, then 1 mg after each loose stool (max 4 mg/day). Children 9-12 years (>30 kg): 2 mg three times a day on day 1, then 1 mg after each loose stool (max 6 mg/day).

Elderly

Standard adult dosing; ensure adequate hydration

Kidney Impairment

No adjustment needed.

Liver Impairment

No specific dose adjustment is provided; use with caution in hepatic impairment (especially severe) and monitor for CNS toxicity.

Storage & Patient Advice

Stopping the Medicine

No taper is required; stop when diarrhea resolves, and seek medical advice if symptoms persist >48 hours (or earlier if red flags such as fever, blood in stool, dehydration, or worsening abdominal pain occur).

Overdose

Overdose may cause CNS depression, miosis, constipation/ileus, urinary retention, and serious cardiac toxicity (QT prolongation, ventricular arrhythmias/Torsades); management includes activated charcoal if appropriate, naloxone (often repeated due to longer loperamide duration), continuous cardiac monitoring, and supportive care with observation (often up to 48 hours).

Patient Counseling

Let the orodispersible tablet dissolve on the tongue and swallow with saliva (no water needed). Adults: take 4 mg initially then 2 mg after each loose stool; do not exceed the product’s OTC maximum (commonly 8 mg/day) unless directed by a clinician. Stop and seek medical advice if diarrhea lasts >48 hours, or if fever, blood/mucus in stool, severe abdominal pain, or abdominal distension occurs; maintain hydration/ORS. May cause dizziness-use caution driving. Do not use in children <2 years; avoid use in suspected infectious dysentery or acute ulcerative colitis unless advised by a clinician.

Monitoring Requirements

No routine labs for short-term OTC use; monitor clinical response and hydration status, and seek care for fever, blood/mucus in stool, severe abdominal pain/distension, or symptoms >48 hours. For prolonged/supervised use, monitor for constipation/ileus and for CNS/cardiac toxicity risk in hepatic impairment or with interacting drugs.

Pharmacology

Mechanism of Action

Peripherally acting μ-opioid receptor agonist in the intestinal wall/myenteric plexus that decreases propulsive motility and intestinal secretion, increases water/electrolyte absorption, and increases anal sphincter tone with minimal CNS effect at therapeutic doses.

Duration of Effect

Approximately 4-6 hours per dose (clinical effect), with a longer elimination half-life (~9-14 hours).

Half-Life

Approximately 9-14 hours (reported ranges include ~9.1-14.4 hours; mean around ~10-11 hours).

Bioavailability

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

Metabolism

Extensive hepatic first-pass metabolism, primarily via CYP3A4 and CYP2C8; also a P-glycoprotein (P-gp) substrate.

Excretion

Elimination mainly by oxidative N-demethylation; primarily fecal (unchanged drug remains low).

Product Information

Available Dosage Forms

Orodispersible tablet (this product); also available in other markets as capsules, tablets/caplets, and oral solution/suspension.

Composition per Dose

Each orodispersible tablet: 2mg loperamide (as loperamide hydrochloride)

Generic Availability

Yes

Gi Condition

Diarrhea

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