Overview
A meperidine congener used as an antidiarrheal, usually in combination with atropine. At high doses, it acts like morphine. Its unesterified metabolite difenoxin has similar properties and is used similarly. It has little or no analgesic activity. This medication is classified as a Schedule V under the Controlled Substances Act by the Food and Drug Administration (FDA) and the DEA in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II.
Background
A meperidine congener used as an antidiarrheal, usually in combination with atropine. At high doses, it acts like morphine. Its unesterified metabolite difenoxin has similar properties and is used similarly. It has little or no analgesic activity. This medication is classified as a Schedule V under the Controlled Substances Act by the Food and Drug Administration (FDA) and the DEA in the United States when used in preparations. When diphenoxylate is used alone, it is classified as a Schedule II.
Indication
For as adjunctive therapy in the management of diarrhea
Associated Conditions
- Diarrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lohxa | 70166-630 | ORAL | 2.5 mg in 5 mL | 9/10/2019 | |
| A-S Medication Solutions | 50090-5592 | ORAL | 2.5 mg in 1 1 | 2/25/2020 | |
| Bryant Ranch Prepack | 63629-1934 | ORAL | 2.5 mg in 1 1 | 11/3/2017 | |
| Physicians Total Care, Inc. | 54868-0032 | ORAL | 2.5 mg in 1 1 | 1/25/2011 | |
| RPK Pharmaceuticals, Inc. | 53002-3401 | ORAL | 2.5 mg in 1 1 | 2/25/2020 | |
| RedPharm Drug, Inc. | 67296-1210 | ORAL | 2.5 mg in 1 1 | 1/20/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-809 | ORAL | 2.5 mg in 1 1 | 3/28/2024 | |
| Stat Rx USA | 16590-080 | ORAL | 2.5 mg in 1 1 | 3/24/2010 | |
| Dispensing Solutions, Inc. | 66336-437 | ORAL | 2.5 mg in 1 1 | 2/17/2012 | |
| RedPharm Drug, Inc. | 67296-1241 | ORAL | 2.5 mg in 1 1 | 1/20/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SUN-DIANOX TABLET | SIN09095P | TABLET | 2.5 mg | 12/20/1996 | |
| DHAMOTIL TABLET | SIN05379P | TABLET, FILM COATED | 2.5 mg | 1/29/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DHAMOTIL TAB | N/A | N/A | N/A | 3/10/1989 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LOMOTIL diphenoxylate hydrochloride 2.5 mg atropine sulfate monohydrate 0.025 mg tablet blister pack | 74475 | Medicine | A | 6/23/2000 | |
| LOMOFEN Tablets | 20437 | Proqualix Pty Ltd - in Administration | Medicine | A | 9/27/1991 |
| LOFENOXAL diphenoxylate hydrochloride 2.5 mg atropine sulfate monohydrate 0.025 mg tablet blister pack | 74476 | Medicine | A | 6/23/2000 | |
| LOMOTIL | 40188 | Proqualix Pty Ltd - in Administration | Medicine | A | 6/4/1992 |