Overview
Picosulfuric acid is found in laxative products. Sodium picosulfate is a used to treat constipation or induce colon cleansing to prepare the large bowels before colonoscopy or surgery. The combination product containing sodium picosulfate and magnesium citrate was introduced to the Canadian market in 2005 and has been used in European countries for many years.
Background
Picosulfuric acid is found in laxative products. Sodium picosulfate is a used to treat constipation or induce colon cleansing to prepare the large bowels before colonoscopy or surgery. The combination product containing sodium picosulfate and magnesium citrate was introduced to the Canadian market in 2005 and has been used in European countries for many years.
Indication
Sodium picosulfate, in combination with magnesium oxide and anhydrous citric acid, is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older.
Associated Conditions
- Constipation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/12/03 | Phase 3 | Completed | |||
2020/10/20 | Phase 2 | UNKNOWN | |||
2019/11/06 | N/A | UNKNOWN | |||
2018/10/09 | Phase 4 | Completed | Tomas Bata Hospital, Czech Republic | ||
2017/03/08 | Phase 3 | Completed | Kaiser Clinic and Hospital | ||
2016/12/01 | Phase 2 | Completed | |||
2016/11/04 | Phase 4 | Completed | Tomas Bata Hospital, Czech Republic | ||
2014/08/08 | Phase 1 | Completed | |||
2013/12/11 | Not Applicable | Completed | |||
2013/11/14 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ferring Pharmaceuticals Inc. | 55566-6800 | ORAL | 10 mg in 175 mL | 8/31/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-874 | ORAL | 10 mg in 16.1 g | 8/11/2022 | |
| Ferring Pharmaceuticals Inc. | 55566-6700 | ORAL | 10 mg in 160 mL | 10/31/2019 |
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 |
|---|---|---|---|---|---|
| PICOPREP Powder for Oral Solution | SIN14303P | POWDER, FOR SOLUTION | 10 mg | 1/30/2013 | |
| PICO-SWIFT POWDER FOR ORAL SOLUTION | SIN17163P | POWDER, FOR SOLUTION | 10 mg | 1/16/2025 |
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 |
|---|---|---|---|---|---|
| APOHEALTH Picosulfate Prep powder for oral solution | 405192 | Medicine | A | 2/21/2023 | |
| DULCOLAX SP DROPS 7.5mg/mL sodium picosulfate oral liquid bottle | 133243 | Medicine | A | 11/27/2006 | |
| PICOSALAX powder for oral administration | 138775 | Medicine | A | 5/15/2007 | |
| Dendy Picolax Oral Powder | 54113 | Medicine | A | 12/12/1995 | |
| PREPKIT ORANGE powder for oral liquid sachet composite pack | 370153 | Medicine | A | 6/24/2021 | |
| PICOTOL Sodium Picosulfate Effervescent Powder for Oral Liquid sachet | 228217 | Medicine | A | 9/19/2014 | |
| NEO PICO ORAL DROPS sodium picosulfate 7.5 mg/mL oral liquid bottle | 355352 | Medicine | A | 2/22/2021 | |
| CONSTILIEVE ORAL DROPS sodium picosulfate 7.5 mg/mL oral liquid bottle | 468050 | Medicine | A | 11/11/2024 | |
| PICOPREP ORANGE powder for oral liquid sachet | 363537 | Medicine | A | 4/28/2021 | |
| Chemists' Own Picosulfate Prep powder for oral solution | 405094 | Medicine | A | 2/20/2023 |