Last reviewed · How we verify
loperamide-simethicone
Loperamide-simethicone combines an antimotility agent that slows intestinal movement with an anti-gas agent that reduces bloating and flatulence.
Loperamide-simethicone combines an antimotility agent that slows intestinal movement with an anti-gas agent that reduces bloating and flatulence. Used for Acute diarrhea with associated gas, bloating, and abdominal discomfort.
At a glance
| Generic name | loperamide-simethicone |
|---|---|
| Also known as | Imodium |
| Sponsor | Johnson & Johnson Consumer and Personal Products Worldwide |
| Drug class | Antidiarrheal combination agent |
| Target | Mu-opioid receptor (loperamide component); antifoaming agent (simethicone component) |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Loperamide is a mu-opioid receptor agonist that decreases intestinal peristalsis and increases absorption of water and electrolytes, thereby reducing diarrhea. Simethicone is a silicone-based antifoaming agent that breaks up gas bubbles in the gastrointestinal tract, reducing abdominal discomfort and bloating. Together, they provide dual symptomatic relief for diarrhea accompanied by gas-related discomfort.
Approved indications
- Acute diarrhea with associated gas, bloating, and abdominal discomfort
Common side effects
- Constipation
- Abdominal pain
- Nausea
- Dizziness
Key clinical trials
- A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers (PHASE1)
- Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation (PHASE4)
- Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence (PHASE3)
- A Comparison of Three Medications to Treat Diarrhea in Adults. (PHASE4)
- Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea (PHASE4)
- Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: