Overview
Cholestyramine or colestyramine is a bile acid sequestrant. Bile acid sequestrants are polymeric compounds which serve as ion exchange resins. Cholestyramine resin is quite hydrophilic, but insoluble in water.
Indication
Indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Also for the relief of pruritus associated with partial biliary obstruction.
Associated Conditions
- Atherosclerosis
- Primary Hypercholesterolemia
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/27 | Early Phase 1 | Recruiting | |||
2024/11/20 | Phase 4 | Active, not recruiting | |||
2024/11/15 | Not Applicable | Active, not recruiting | Aydin Adnan Menderes University | ||
2024/06/12 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2023/11/21 | Phase 3 | Recruiting | |||
2023/11/18 | Phase 4 | Not yet recruiting | |||
2023/09/25 | Phase 4 | Not yet recruiting | |||
2023/08/01 | Not Applicable | Recruiting | |||
2023/06/08 | Phase 1 | Completed | |||
2022/10/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ajanta Pharma USA Inc. | 27241-134 | ORAL | 4 g in 9 g | 11/23/2021 | |
| Par Pharmaceutical, Inc. | 49884-936 | ORAL | 4 g in 9 g | 9/17/2018 | |
| Zydus Lifesciences Limited | 70771-1105 | ORAL | 4 g in 9 g | 1/9/2024 | |
| EPIC PHARMA, LLC | 42806-271 | ORAL | 4 g in 5.7 g | 11/8/2023 | |
| Ascend Laboratories, LLC | 67877-422 | ORAL | 4 g in 5.718 g | 10/20/2021 | |
| EPIC PHARMA, LLC | 42806-266 | ORAL | 4 g in 9 g | 12/27/2023 | |
| EPIC PHARMA, LLC | 42806-269 | ORAL | 4 g in 5.7 g | 12/15/2021 | |
| Bryant Ranch Prepack | 72162-1834 | ORAL | 4 g in 8.780 g | 3/8/2024 | |
| Chartwell RX, LLC | 62135-937 | ORAL | 4 g in 5.7 g | 1/9/2023 | |
| Bryant Ranch Prepack | 63629-2162 | ORAL | 4 g in 5 g | 7/26/2022 |
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-CHOLESTYRAMINE POWDER | SIN07426P | POWDER | 4.00 g | 5/12/1993 | |
| RESINCOLESTIRAMINA POWDER | SIN06583P | POWDER | 4 g/sachet | 9/27/1991 |
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 |
|---|---|---|---|---|---|
| RESINCOLESTIRAMINA COLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G | N/A | N/A | N/A | 5/25/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| QUESTRAN LITE 4G powder sachet | 11971 | Medicine | A | 8/13/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CHOLESTYRAMINE | sorres pharma inc | 02236969 | Powder For Suspension - Oral | 4 G / 5 G | 2/17/1998 |
| PHL-CHOLESTYRAMINE POWDER 210G/CAN | pharmel inc | 02259249 | Powder For Suspension - Oral | 4 G / 5 G | 12/6/2004 |
| PHL-CHOLESTYRAMINE POWDER FOR SUSPENSION 400GM/CAN | pharmel inc | 02259257 | Powder For Suspension - Oral | 400 G / CAN | 12/6/2004 |
| NOVO-CHOLAMINE - PWR 4G/DOSE | novopharm limited | 02139189 | Suspension
,
Powder - Oral | 4 G / DOSE | 12/31/1995 |
| NOVO-CHOLAMINE LIGHT - PWR 4G/DOSE | novopharm limited | 02139197 | Powder
,
Suspension - Oral | 4 G / DOSE | 12/31/1995 |
| QUESTRAN PWR 378GM/CAN | bristol labs division of bristol-myers squibb | 00634093 | Powder For Solution - Oral | 4 G / PCK | 12/31/1985 |
| PHL-CHOLESTYRAMINE REGULAR - 378G TIN | pharmel inc | 02237133 | Powder For Suspension - Oral | 4 G / 9 G | 2/17/1998 |
| QUESTRAN LIGHT PWS 4GM/PCK | bristol labs division of bristol-myers squibb | 01918486 | Powder For Solution - Oral | 4 G / PCK | 12/31/1991 |
| PMS-CHOLESTYRAMINE | 02458373 | Powder For Suspension - Oral | 4 G / SACHET | N/A | |
| PMS-CHOLESTYRAMINE REGULAR POWDER -4/9G DOSE | 02207745 | Powder - Oral | 4 G / 9 G | 12/31/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| EFENSOL 3 g POLVO PARA SUSPENSION ORAL | Lazlo International S.A. | 56701 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| RESINCOLESTIRAMINA 4 g POLVO PARA SUSPENSION ORAL | Laboratorios Rubio S.A. | 49340 | POLVO PARA SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
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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