Overview
Clidinium is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. It inhibits muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites. It is used for the treatment of peptic ulcer disease and also to help relieve abdominal or stomach spasms or cramps due to colicky abdominal pain, diverticulitis, and irritable bowel syndrome.
Indication
For the treatment of peptic ulcer disease and also to help relieve abdominal or stomach spasms or cramps due to colicky abdominal pain, diverticulitis, and irritable bowel syndrome. In combination with chlordiazepoxide, clidinium is indicated to control emotional and somatic factors in gastrointestinal disorders, and is used as adjunctive therapy in the treatment of peptic ulcer, irritable bowel syndrome and acute enterocolitis.
Associated Conditions
- Irritable Bowel Syndrome (IBS)
- Peptic Ulcer Disease
- Acute Enterocolitis
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 |
|---|---|---|---|---|---|
| Sunrise Pharmaceutical, Inc. | 11534-197 | ORAL | 2.5 mg in 1 1 | 8/8/2022 | |
| Marlex Pharmaceuticals Inc | 10135-622 | ORAL | 2.5 mg in 1 1 | 6/28/2016 | |
| Alembic Pharmaceuticals Inc. | 62332-744 | ORAL | 2.5 mg in 1 1 | 10/5/2023 | |
| Chartwell RX, LLC | 62135-696 | ORAL | 2.5 mg in 1 1 | 10/5/2023 | |
| A-S Medication Solutions | 50090-0131 | ORAL | 2.5 mg in 1 1 | 12/3/2018 | |
| Misemer Pharmaceuticals, Inc | 0276-0500 | ORAL | 2.5 1 in 1 1 | 12/31/2020 | |
| Bryant Ranch Prepack | 71335-9764 | ORAL | 2.5 mg in 1 1 | 8/15/2023 | |
| Bryant Ranch Prepack | 63629-2373 | ORAL | 2.5 mg in 1 1 | 6/24/2022 | |
| Micro Labs Limited | 42571-381 | ORAL | 2.5 mg in 1 1 | 4/26/2023 | |
| Amneal Pharmaceuticals NY LLC | 60219-1677 | ORAL | 2.5 mg in 1 1 | 2/28/2023 |
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 |
|---|---|---|---|---|---|
| CHLOBAX TABLET | SIN08651P | TABLET, SUGAR COATED | 2.5 mg | 4/19/1996 | |
| AA PHARMA CHLORAX CAPSULE | SIN03049P | CAPSULE | 2.5 mg | 6/7/1989 |
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CHLORAX | aa pharma inc | 00618454 | Capsule - Oral | 2.5 MG | 12/31/1984 |
| PRO CHLORAX | PRO DOC LIMITEE | 00636223 | Capsule - Oral | 2.5 MG | 12/31/1984 |
| NU-CHLORAX CAPSULES USP | nu-pharm inc | 02239110 | Capsule - Oral | 2.5 MG / CAP | N/A |
| CORIUM CAP | icn canada ltd. | 00391077 | Capsule - Oral | 2.5 MG / CAP | 12/31/1978 |
| LIBRAX | bausch health, canada inc. | 00115630 | Capsule - Oral | 2.5 MG | 12/31/1961 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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