Overview
Sodium polystyrene sulfonate is a medication used to treat abnormally high potassium levels. It may be taken orally or by rectum, as an enema, and functions as a potassium-binding resin in the intestines. It is also an effective topical microbicide and spermicide, inhibiting the genital transfection of, among others, HIV.
Indication
Used to treat abnormally high potassium levels.
Associated Conditions
- Hyperkalemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/08 | Not Applicable | Completed | |||
2014/02/17 | Phase 4 | Completed | |||
2013/05/31 | Phase 4 | Terminated | |||
2006/09/29 | Phase 2 | Completed | Genzyme, a Sanofi Company | ||
2005/09/20 | Phase 3 | Completed | Genzyme, a Sanofi Company | ||
2005/03/28 | Phase 3 | Completed | Genzyme, a Sanofi Company | ||
2002/04/25 | Phase 2 | Completed | Genzyme, a Sanofi Company | ||
1999/10/19 | Phase 2 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 17856-0831 | ORAL, RECTAL | 4.1 meq in 1 g | 6/10/2021 | |
| Cardinal Health 107, LLC | 55154-7353 | ORAL, RECTAL | 15 g in 60 mL | 12/26/2018 | |
| KVK-Tech, Inc. | 10702-036 | ORAL, RECTAL | 1 g in 1 g | 2/23/2024 | |
| ATLANTIC BIOLOGICALS CORP | 17856-1136 | ORAL, RECTAL | 1 g in 1 g | 9/24/2019 | |
| Bryant Ranch Prepack | 72162-1230 | ORAL, RECTAL | 4.1 meq in 1 g | 9/13/2023 | |
| PuraCap Laboratories, LLC | 24658-760 | ORAL | 4.1 meq in 1 g | 9/21/2018 | |
| Marlex Pharmaceuticals Inc | 10135-146 | ORAL, RECTAL | 4.1 meq in 1 g | 11/9/2023 | |
| Bryant Ranch Prepack | 63629-2031 | ORAL, RECTAL | 4.1 meq in 1 g | 3/8/2022 | |
| CMP Pharma, Inc. | 46287-012 | ORAL, RECTAL | 1 g in 1 g | 11/30/2017 | |
| Epic Pharma, LLC | 42806-013 | ORAL | 4.1 meq in 1 g | 9/27/2022 |
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 |
|---|---|---|---|---|---|
| PMS-SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION 94.3 mg/g | SIN06252P | POWDER, FOR SUSPENSION | 94.3 mg/g | 5/14/1991 | |
| JAMP SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION 1G/G | SIN16808P | POWDER, FOR SUSPENSION | 1g/g | 6/14/2023 | |
| PMS-SODIUM POLYSTYRENE SULFONATE SUSPENSION 15 g/60 ml | SIN06253P | SUSPENSION | 15 g/60 ml | 6/20/1991 | |
| RESINSODIO POWDER 4.95 g/5 g | SIN09521P | POWDER, FOR SUSPENSION | 4.95 g/5 g | 11/6/1997 |
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 |
|---|---|---|---|---|---|
| RESINSODIO POWDER FOR ORAL SUSPENSION 99.75G/100G | N/A | N/A | N/A | 9/7/2016 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RESONIUM A sodium polystyrene sulfonate powder bottle | 15497 | Medicine | A | 9/10/1991 | |
| CALCIUM RESONIUM calcium polystyrene sulfonate powder can | 12567 | Medicine | A | 9/10/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SPS SUSPENSION 15GM/60ML | carolina medical products company | 00722456 | Suspension - Rectal
,
Oral | 15 G / 60 ML | 12/31/1987 |
| ODAN-SODIUM POLYSTYRENE SULFONATE | odan laboratories ltd | 02473941 | Powder For Suspension - Oral
,
Rectal | 1 G / G | 10/25/2018 |
| PMS-SODIUM POLYSTYRENE SULFONATE | 02501872 | Suspension - Oral | 250 MG / ML | N/A | |
| SOLYSTAT | pendopharm division of pharmascience inc | 00769541 | Suspension - Oral | 250 MG / ML | 12/31/1989 |
| JAMP CALCIUM POLYSTYRENE SULFONATE | 02502631 | Powder For Suspension - Oral
,
Rectal | 999 MG / G | 5/2/2022 | |
| KAYEXALATE | sanofi-aventis canada inc | 02026961 | Powder For Suspension - Oral
,
Rectal | 1 G / G | 12/31/1961 |
| RESONIUM CALCIUM | sanofi-aventis canada inc | 02017741 | Powder For Solution - Oral
,
Rectal | 999 MG / G | 12/31/1979 |
| K-EXIT POUDRE | omega laboratories limited | 00765252 | Powder For Solution - Oral
,
Rectal | 100 % | 12/31/1988 |
| SOLYSTAT | pendopharm division of pharmascience inc | 00755338 | Powder For Suspension - Rectal
,
Oral | 1 G / G | 12/31/1988 |
| PMS-SODIUM POLYSTYRENE SULFONATE | 02501864 | Powder For Suspension - Oral
,
Rectal | 1 G / G | N/A |
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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