Overview
Loperamide is an anti-diarrheal agent that is available as various over-the-counter products for treating diarrhea. The drug was first synthesized in 1969 and used medically in 1976. It is a highly lipophilic synthetic phenylpiperidine opioid that is structurally similar to opiate receptor agonists such as diphenoxylate and haloperidol. Due to pharmacological properties, loperamide has been misused and abused to self-manage opioid withdrawal symptoms and to induce euphoria. However, loperamide is associated with a risk for experiencing a range of adverse effects, often life-threatening, if taking for non-therapeutic reasons or at doses higher than the recommended dose.
Background
Loperamide is an anti-diarrheal agent that is available as various over-the-counter products for treating diarrhea. The drug was first synthesized in 1969 and used medically in 1976. It is a highly lipophilic synthetic phenylpiperidine opioid that is structurally similar to opiate receptor agonists such as diphenoxylate and haloperidol. Due to pharmacological properties, loperamide has been misused and abused to self-manage opioid withdrawal symptoms and to induce euphoria. However, loperamide is associated with a risk for experiencing a range of adverse effects, often life-threatening, if taking for non-therapeutic reasons or at doses higher than the recommended dose.
Indication
Loperamide is indicated for the relief of diarrhea, including Travelers’ Diarrhea. As an off-label use, it is often used to manage chemotherapy-related diarrhea.
Associated Conditions
- Diarrhea
- Traveler's Diarrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/22 | Not Applicable | Recruiting | |||
2023/01/10 | Phase 4 | Recruiting | Henry M. Jackson Foundation for the Advancement of Military Medicine | ||
2022/09/06 | Phase 1 | Recruiting | |||
2022/08/30 | Phase 2 | Active, not recruiting | MedSIR | ||
2022/02/23 | Phase 1 | Completed | |||
2022/02/23 | Phase 2 | Active, not recruiting | |||
2021/03/30 | Phase 1 | Completed | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | ||
2021/02/03 | Phase 2 | UNKNOWN | |||
2020/04/29 | Phase 2 | Completed | |||
2020/03/19 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wal-Mart Stores Inc | 49035-695 | ORAL | 1 mg in 7.5 mL | 6/19/2025 | |
| American Health Packaging | 60687-229 | ORAL | 2 mg in 1 1 | 2/16/2024 | |
| Bryant Ranch Prepack | 71335-2061 | ORAL | 2 mg in 1 1 | 5/24/2023 | |
| Physicians Total Care, Inc. | 54868-2118 | ORAL | 2 mg in 1 1 | 9/18/2012 | |
| Amerisource Bergen | 46122-620 | ORAL | 2 mg in 1 1 | 4/8/2025 | |
| REMEDYREPACK INC. | 70518-3413 | ORAL | 2 mg in 1 1 | 1/10/2024 | |
| allphamed Pharbil Arzneimittel GmbH | 60468-005 | ORAL | 2 mg in 1 1 | 2/22/2023 | |
| A-S Medication Solutions | 50090-6208 | ORAL | 2 mg in 1 1 | 10/7/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2257 | ORAL | 2 mg in 1 1 | 1/20/2022 | |
| STAT Rx USA LLC | 16590-423 | ORAL | 2 mg in 1 1 | 10/12/2012 |
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 |
|---|---|---|---|---|---|
| IMODIUM CAPSULE 2 mg | SIN06212P | CAPSULE | 2 mg | 5/8/1991 | |
| COLODIUM CAPSULE 2 mg | SIN08031P | CAPSULE | 2.00MG | 2/23/1995 | |
| DIATROL SYRUP 1 mg/5 ml | SIN05600P | SYRUP | 1 mg/5 ml | 3/27/1991 | |
| ABYDIUM CAPSULES 2MG | SIN16450P | CAPSULE | 2.00 mg | 3/24/2022 | |
| DIATROL CAPSULE 2 mg | SIN07107P | CAPSULE | 2 mg | 7/10/1992 | |
| LORAMIDE CAPSULE 2 mg | SIN09217P | CAPSULE | 2 mg | 2/20/1997 | |
| LOPERAX CAPSULE 2 mg | SIN05595P | CAPSULE | 2 mg | 3/27/1991 | |
| LOPERAMIL TABLET 2 mg | SIN07812P | TABLET, FILM COATED | 2 mg | 8/1/1994 | |
| LORPA SYRUP 1mg/5ml | SIN06525P | SYRUP | 1.05 mg/5 ml | 8/29/1991 | |
| ELDOPER CAPSULE 2 mg | SIN09601P | CAPSULE | 2 mg | 1/6/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Loperamide Hydrochloride Granules | 国药准字H20010004 | 化学药品 | 颗粒剂 | 6/15/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H19994079 | 化学药品 | 胶囊剂 | 5/25/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H20003231 | 化学药品 | 胶囊剂 | 6/5/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H20013165 | 化学药品 | 胶囊剂 | 4/15/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H10910085 | 化学药品 | 胶囊剂 | 5/28/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H31021810 | 化学药品 | 胶囊剂 | 3/23/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H19983095 | 化学药品 | 胶囊剂 | 2/26/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H31021088 | 化学药品 | 胶囊剂 | 11/26/2019 | |
| Loperamide Hydrochloride Capsules | 国药准字H20003271 | 化学药品 | 胶囊剂 | 6/12/2020 | |
| Loperamide Hydrochloride Capsules | 国药准字H10900068 | 化学药品 | 胶囊剂 | 4/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PERA SYRUP 2MG/5ML | N/A | N/A | N/A | 4/3/1995 | |
| SANPO CAP 2MG | N/A | N/A | N/A | 4/17/2002 | |
| TEDIUM CAP 2MG | N/A | N/A | N/A | 3/15/2008 | |
| HAWKPERMIDE TAB 2MG | N/A | N/A | N/A | 10/14/2007 | |
| WILLIPO LOPERAMIDE HYDROCHLORIDE TABLETS 2MG | N/A | N/A | N/A | 2/7/2022 | |
| VACONTIL TAB 2MG | N/A | N/A | N/A | 3/20/1998 | |
| LIDERIUM CAP 2MG | N/A | N/A | N/A | 11/12/1982 |