Overview
Butylscopolamine is a peripherally acting antimuscarinic, anticholinergic agent. It is used to treat pain and discomfort caused by abdominal cramps, menstrual cramps, or other spasmodic activity in the digestive system. It is also effective at preventing bladder spasms. It is not a pain medication in the normal sense, since it does not directly affect pain, but rather works to prevent painful cramps and spasms from occurring. It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system.
Indication
Used to treat abdmoninal cramping and pain .
Associated Conditions
- Gastrointestinal spastic and hypermotility disorders
- Infantile Hypertrophic Pyloric Stenosis
- Menstrual Distress (Dysmenorrhea)
- Muscle Spasms
- Pain
- Primary Dysmenorrhoea
- Stiffness of the Urinary Tract
- Acute biliary spasm
- Acute gastrointestinal spasms
- Acute genitourinary spasms
- Genitourinary smooth muscle spasm
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/28 | Not Applicable | Recruiting | |||
2023/02/09 | Phase 3 | Recruiting | Oslo University Hospital | ||
2022/12/07 | Phase 3 | Not yet recruiting | EMS | ||
2021/02/11 | Not Applicable | Active, not recruiting | |||
2020/04/16 | Phase 4 | Completed | National University of Malaysia | ||
2019/05/23 | Phase 3 | Completed | Oslo University Hospital | ||
2017/07/21 | Not Applicable | UNKNOWN | |||
2017/02/16 | Phase 4 | Completed | |||
2016/07/07 | Phase 4 | Completed | Ahmed M Maged, MD | ||
2016/04/01 | Not Applicable | UNKNOWN | Xijing Hospital of Digestive Diseases |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| HYOSCINE BUTYLBROMIDE TABLET 10 mg | SIN03553P | TABLET, FILM COATED | 10 mg | 7/4/1989 | |
| DHACOPAN TABLET 10 mg | SIN02575P | TABLET, FILM COATED | 10 mg | 4/22/1989 | |
| COSPAN INJ. 20 mg/ml | SIN03683P | INJECTION | 20 mg/ml | 9/18/1989 | |
| COPAN INJECTION 20 mg/ml | SIN10096P | INJECTION | 20 mg/ml | 9/23/1998 | |
| DHACOPAN SYRUP 5 mg/5 ml | SIN03115P | SYRUP | 5mg | 5/31/1989 | |
| SPASMOLIV TABLET 10 mg | SIN03082P | TABLET, FILM COATED | 10 mg | 6/6/1989 | |
| BUSCOPAN TABLET 10 mg | SIN03574P | TABLET, SUGAR COATED | 10 mg | 7/4/1989 |
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 |
|---|---|---|---|---|---|
| BUSCOPAN TAB 10MG | N/A | N/A | N/A | 12/8/1978 | |
| SCOPOLAMINE-BUTYL BROMIDE TAB 10MG | N/A | N/A | N/A | 6/24/1980 | |
| DIVIDOL TABLETS 10MG | N/A | N/A | N/A | 7/8/2020 | |
| UNIGAN TAB | N/A | N/A | N/A | 11/27/1998 | |
| BUSCOPAN INJ 20MG/ML | N/A | N/A | N/A | 12/8/1978 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BUSCOPAN | sanofi consumer health inc | 00363839 | Solution - Subcutaneous
,
Intravenous
,
Intramuscular | 20 MG / ML | 12/31/1976 |
| HYOSCINE BUTYLBROMIDE INJECTION BP | omega laboratories limited | 02508419 | Solution - Subcutaneous
,
Intravenous
,
Intramuscular | 20 MG / ML | 6/4/2024 |
| HYOSCINE BUTYLBROMIDE INJECTION | 02229868 | Solution - Subcutaneous
,
Intramuscular
,
Intravenous | 20 MG / ML | 8/21/1997 | |
| BUSCOPAN | sanofi consumer health inc | 00363812 | Tablet - Oral | 10 MG | 12/31/1976 |
| ACCEL-HYOSCINE | accel pharma inc | 02512335 | Tablet - Oral | 10 MG | 8/19/2021 |
| BUSCOPAN SUP 10MG | boehringer ingelheim (canada) ltd ltee | 00363820 | Suppository - Rectal | 10 MG / SUP | 12/31/1976 |
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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