Uses
Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Source: US FDA prescribing information
Fixed-dose combination
Atropine and Diphenoxylate
Also known as atropine sulfate, diphenoxylate hydrochloride
Available on requestControlled substance
- Presentations
- 3
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Atropine and Diphenoxylate is a fixed-dose combination of an anticholinergic, an antidiarrheal and a cholinergic muscarinic antagonist indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. MedsAcross supplies Atropine and Diphenoxylate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Anticholinergic, Antidiarrheal, Cholinergic Muscarinic Antagonist, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists
- US FDA first approval
- 15 September 1960
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Oral solution
- Fixed-dose combination of
- Atropine, Diphenoxylate
- Identifiers
- RxCUI 594040Q5137497
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
Management of Diarrhea in Patients 13 Years of Age and Older Diphenoxylate hydrochloride and atropine sulfate is recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate. The use of diphenoxylate hydrochloride and atropine sulfate should be accompanied by appropriate fluid and electrolyte therapy, when indicated. If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate until appropriate corrective therapy has been indicated.
Source: US FDA prescribing information
Contraindications
Diphenoxylate hydrochloride and atropine sulfate is contraindicated in: • Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression. • Patients with diarrhea associated with pseudomembranous enterocolitis ( Clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis. • Patients with known hypersensitivity to diphenoxylate or atropine. • Patients with obstructive jaundice.
Source: US FDA prescribing information
Warnings and precautions
Respiratory and/or CNS Depression in Pediatric Patients Less Than 6 Years of Age Cases of severe respiratory depression and coma, leading to permanent brain damage or death have been reported in patients less than 6 years of age who received diphenoxylate hydrochloride and atropine sulfate. Diphenoxylate hydrochloride and atropine sulfate is contraindicated in patients less than 6 years of age due to these risks. Anticholinergic and Opioid-Toxicities Toxicities associated with the atropine and diphenoxylate components of diphenoxylate hydrochloride and atropine sulfate have been reported. The initial presenting symptoms may be delayed by up to 30 hours due to prolonged gastric emptying time induced by diphenoxylate hydrochloride.
Source: US FDA prescribing information
Side effects
The following serious adverse reactions are described elsewhere in labeling: • Respiratory and/or CNS depression • Anticholinergic and opioid-toxicities, including atroponism • Dehydration and electrolyte imbalance • GI Complications in patients with infectious diarrhea • Toxic megacolon in patients with acute ulcerative colitis At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate, the following other adverse reactions have been reported, they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort…
Source: US FDA prescribing information
Interactions
Alcohol Alcohol may increase the CNS depressant effects of diphenoxylate hydrochloride and atropine sulfate and may cause drowsiness. Avoid concomitant use of diphenoxylate hydrochloride and atropine sulfate with alcohol. Other Drugs that Cause CNS Depression The concurrent use of diphenoxylate hydrochloride and atropine sulfate with other drugs that cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, muscle relaxants), may potentiate the effects of diphenoxylate hydrochloride and atropine sulfate. Either diphenoxylate hydrochloride and atropine sulfate or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions.
Source: US FDA prescribing information
Storage
Store below 25°C (77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
3 presentations of Atropine and Diphenoxylate, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Atropine and Diphenoxylate 0.025 mg/2.5 mg tabletOralGeneric name | Atropine and Diphenoxylate | — | US FDA | Available on request |
| Atropine and Diphenoxylate 0.025 mg/2.5 mg per 5 mL oral solutionOralGeneric name | Atropine and Diphenoxylate | — | US FDA | Available on request |
| Lomotil 0.025 mg/2.5 mg tabletOral | Atropine and Diphenoxylate | Pfizer Laboratories | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 15 September 1960 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Atropine and Diphenoxylate available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Atropine and Diphenoxylate and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Atropine and Diphenoxylate have?
The catalogue lists 1 brand names for Atropine and Diphenoxylate, including Lomotil.
Is Atropine and Diphenoxylate approved by the US FDA?
Yes. The US FDA first approved Atropine and Diphenoxylate on 15 September 1960, according to Drugs@FDA.
Does Atropine and Diphenoxylate need cold chain shipping?
No listed presentation of Atropine and Diphenoxylate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
References
- Diphenoxylate Hydrochloride and Atropine Sulfate prescribing information (Mylan Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 23 February 2026
Request Atropine and Diphenoxylate for export supply
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