Diphenoxylate And Atropine
Pronunciation: dye-fen-OX-i-late and a-TRO-peen.
- Generic name
- Diphenoxylate and Atropine
- Brand names
- Lonox, Lomotil, Dipentil, Diocalm, Diphenat, Co-phenotrope
- Drug class
- Antidiarrheal (Opioid + Anticholinergic combination)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Diphenoxylate and Atropine is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Diphenoxylate and Atropine works
Diphenoxylate is a synthetic opioid that acts on the intestinal smooth muscle to inhibit peristalsis, thereby prolonging transit time and reducing fecal volume. Atropine is an anticholinergic added in subtherapeutic doses to discourage abuse; it has minimal antidiarrheal effect at prescribed doses.
What Diphenoxylate and Atropine is used for
Diarrhea (acute, adjunctive therapy)
FDA-labeled indication is as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. The clinician database record additionally listed "Irritable Bowel Syndrome" as an indication, but this is not an FDA-labeled use for this product and has been removed from the indications list to avoid overstating approved use; any IBS-related use would be off-label and should be discussed with a prescriber. (2)
Before taking Diphenoxylate and Atropine
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to diphenoxylate or atropine, obstructive jaundice, children under 6 years, and diarrhea associated with pseudomembranous colitis or enterotoxin-producing bacteria. (Contraindication)
Tell your clinician about
(2)How to take Diphenoxylate and Atropine
- General Instructions: Take this medication exactly as prescribed by your healthcare provider. Do not take more than the recommended dose. Drink plenty of fluids to prevent dehydration.. Adult Dosing: Initial dose: 2 tablets (or 10 mL oral solution) four times daily until diarrhea is controlled. Maintenance dose: 1 tablet (or 5 mL) once or twice daily as needed. Maximum: 8 tablets (20 mg diphenoxylate; or 40 mL) per day.. Pediatric Dosing: Contraindicated under 6 years (respiratory depression risk). The FDA-labeled indication and established dosing are for patients 13 years and older; safety and efficacy for the 6-12 year age range are not established, so use in that age range should only follow specific, individualised prescriber guidance rather than a standard regimen.. Administration: Take tablets by mouth with or without food. Oral solution should be measured carefully with a dosing device.. When To Stop: If diarrhea is not controlled within 48 hours, or if you develop abdominal swelling, constipation, or signs of an allergic reaction, seek medical advice promptly; let the clinician you see advise on whether to continue or stop this medicine.. Storage: Store below 25°C (77°F), away from moisture, heat, and light. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
This medicine is generally taken after each unformed stool rather than on a fixed schedule, so a missed-dose situation is unlikely in typical use. If you are on a scheduled regimen and miss a dose, contact your healthcare provider or pharmacist for advice on what to do next. Do not take an extra dose to make up for a missed one.
Overdose
Overdose can be life-threatening, especially in children. Symptoms include severe drowsiness, slow or shallow breathing, muscle weakness, and unresponsiveness. Seek emergency medical help or call your local poison control center immediately. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Constipation
Incidence: Reported in the clinician-authored database; frequency not established
Drowsiness
Incidence: Reported in the clinician-authored database; frequency not established
Dizziness
Incidence: Reported in the clinician-authored database; frequency not established
Dry mouth
Incidence: Reported in the clinician-authored database; frequency not established
Blurred vision
Incidence: Reported in the clinician-authored database; frequency not established
Abdominal pain
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Urinary retention
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
Not for use in children under 6 years due to risk of respiratory depression and death — serious
Symptoms: Not for use in children under 6 years due to risk of respiratory depression and death. Do not use for diarrhea caused by certain infections (e.g., C. difficile). May cause drowsiness or dizziness. Risk of misuse, abuse, and dependence. Use with caution in elderly or those with liver/kidney impairment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with hypersensitivity to diphenoxylate or atropine, obstructive jaundice, children under 6 years, and diarrhea associated with pseudomembranous colitis or enterotoxin-producing bacteria. Use with caution in hepatic or renal impairment, elderly, and those with a history of substance abuse.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
FDA product labeling for this drug class carries the caution — serious
Symptoms: FDA product labeling for this drug class carries the caution: this is not an innocuous drug, and dosage recommendations should be strictly adhered to, especially in children — overdose (particularly in children) can cause life-threatening respiratory and central nervous system depression. Keep this medicine safely out of reach of children at all times.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Alcohol and other CNS depressants (barbiturates, benzodiazepines, opioids, antihistamines) | Alcohol and other central nervous system depressants can potentiate the sedative effects of this medicine, increasing drowsiness and impairment. Avoid alcohol and tell your healthcare provider about all sedating medicines you take. | (2) |
| MAO inhibitors | Combining with monoamine oxidase inhibitors (MAOIs) carries a risk of hypertensive crisis. Tell your healthcare provider about all antidepressants and other medicines you take. | (2) |
| Other sedating or anticholinergic medications and supplements | Diphenoxylate + Atropine may interact with other medications that cause drowsiness and with certain antidepressants. Inform your healthcare provider of all medicines and supplements you are taking to avoid harmful interactions. |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
No adequate, well-controlled human studies exist. Animal studies showed fertility effects only at high doses. This medicine should be used in pregnancy only if the anticipated benefit justifies the potential risk to the fetus, and only under a healthcare provider's guidance. (2)
Breastfeeding
Both diphenoxylate's active metabolite and atropine are excreted into breast milk. Breastfeeding individuals should ask their healthcare provider before use so the provider can weigh the infant-exposure risk against the clinical need. (2)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Contraindicated under 6 years (respiratory depression risk); the FDA-labeled indication and established safety/efficacy are for patients 13 years and older, so use in the 6-12 year range is not an established, standard regimen. (2)
Renal_impairment
The clinician record advises caution in hepatic or renal impairment; obstructive jaundice is a contraindication. No specific renal or hepatic dose-adjustment regimen was found in either source reviewed, so clinicians should individualise dosing and monitor closely rather than apply a standard dose in these patients. (2)
Hepatic_impairment
The clinician record advises caution in hepatic or renal impairment; obstructive jaundice is a contraindication. No specific renal or hepatic dose-adjustment regimen was found in either source reviewed, so clinicians should individualise dosing and monitor closely rather than apply a standard dose in these patients. (2)
Monitoring
(2)Storage
Store below 25°C (77°F), away from moisture, heat, and light. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Diarrhea (adjunctive therapy, 13 years and older)
Dose summary: Initial dose of 5 mg diphenoxylate (2 tablets) with 0.05 mg atropine 4 times daily, followed by a maintenance/after-each-unformed-stool dose of 2.5 mg diphenoxylate (1 tablet); maximum 20 mg diphenoxylate (8 tablets) per day. The label specifies that a lack of improvement after 10 days should prompt clinical reassessment of the diagnosis and treatment plan.
Renal context: No specific renal-impairment dosing regimen was found in either source reviewed; the clinician record advises general caution and individualised dosing in renal impairment rather than a fixed adjusted dose. (2)
Frequently asked questions
What is Diphenoxylate + Atropine used for?
It is used to treat short-term (acute) diarrhea in adults and children over 6 years old. It helps reduce the frequency and urgency of bowel movements.
How quickly does Diphenoxylate + Atropine work?
Most people notice improvement in diarrhea within 48 hours of starting treatment. If symptoms persist, consult your healthcare provider.
Can I use this medication for infectious diarrhea?
No, it should not be used for diarrhea caused by certain infections, especially those with fever or blood in the stool, as it may worsen the condition.
Is Diphenoxylate + Atropine safe for children?
It is contraindicated in children under 6 years due to the risk of serious, potentially life-threatening respiratory depression. The FDA-labeled indication and established dosing are for patients 13 years and older; safety and efficacy for children aged 6-12 have not been established, so use in that age range is a specialist decision made on a case-by-case basis, not a standard regimen.
What should I do if I experience side effects?
Mild side effects often resolve on their own. If you experience severe symptoms such as difficulty breathing, severe abdominal pain, or signs of allergic reaction, seek medical help immediately.
Can I take Diphenoxylate + Atropine with other medications?
Some medications can interact with Diphenoxylate + Atropine. Always inform your healthcare provider about all medicines and supplements you are taking.
How should I store this medication?
Store at room temperature, away from moisture and heat. Keep out of reach of children and pets.
What happens if I take too much Diphenoxylate + Atropine?
Taking too much Diphenoxylate + Atropine can lead to serious overdose symptoms, including severe constipation, abdominal distension, drowsiness, respiratory depression, and even coma. Atropine overdose symptoms like dry mouth, blurred vision, and rapid heart rate may also occur. If you suspect an overdose, seek immediate emergency medical attention. Do not induce vomiting unless advised by a healthcare professional.
Can I drink alcohol while taking Diphenoxylate + Atropine?
It is strongly advised to avoid alcohol while taking Diphenoxylate + Atropine. Both alcohol and this medication can cause central nervous system depression, leading to increased drowsiness, dizziness, and impaired coordination. Combining them can significantly amplify these effects, making activities like driving or operating machinery dangerous. Always consult your doctor or pharmacist about alcohol consumption with any medication.
Is Diphenoxylate + Atropine safe during pregnancy?
The safety of Diphenoxylate + Atropine during pregnancy has not been definitively established. It is categorized as a Pregnancy Category C drug, meaning animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. Therefore, it should only be used if the potential benefit justifies the potential risk to the fetus. Always consult your doctor before using this medication if you are pregnant or planning to become pregnant.
What is the mechanism of action of Diphenoxylate and Atropine?
Diphenoxylate is a synthetic opioid that acts on the intestinal smooth muscle to inhibit peristalsis, thereby prolonging transit time and reducing fecal volume. Atropine is an anticholinergic added in subtherapeutic doses to discourage abuse; it has minimal antidiarrheal effect at prescribed doses.
What is the generic name of Diphenoxylate And Atropine?
The generic name is Diphenoxylate and Atropine. It is sold under brand names including Lonox, Lomotil, Dipentil, Diocalm, Diphenat, Co-phenotrope.
What class of drug is Diphenoxylate and Atropine?
Diphenoxylate And Atropine is classed as: Antidiarrheal (Opioid + Anticholinergic combination).
References
- Diphenoxylate + Atropine — MedGuideGlobal Medicine RecordMedGuideGlobal clinician-authored medicine record · Global (internal) · accessed 2026-08-06 · source 1
- Diphenoxylate Hydrochloride and Atropine Sulfate Tablets — prescribing informationU.S. National Library of Medicine, DailyMed · United States · accessed 2026-08-06 · source 2
Brand names by country
Single-ingredient Diphenoxylate and Atropine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Lomotil