Overview
A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)
Indication
Rifampin is indicated for the treatment of tuberculosis and tuberculosis-related mycobacterial infections. In combination with pyrazinamide and isoniazid, it is used in the initial phase of the short-course treatment of pulmonary tuberculosis.
Associated Conditions
- Cholestatic pruritus
- MRSA Infections
- Prosthetic Joint Infections
- Asymptomatic Neisseria meningitidis carrier of the nasopharynx
- Initial phase Tuberculosis
- Late phase Tuberculosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/10 | Not Applicable | Not yet recruiting | |||
2025/06/12 | Phase 1 | Not yet recruiting | |||
2025/06/11 | Phase 1 | Not yet recruiting | |||
2025/04/08 | Phase 2 | Not yet recruiting | Shandong University | ||
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2025/02/19 | Phase 1 | Completed | |||
2025/02/12 | Phase 1 | Completed | Ahon Pharmaceutical Co., Ltd. | ||
2024/11/22 | Phase 1 | Not yet recruiting | Shanghai Jiatan Pharmatech Co., Ltd | ||
2024/10/01 | Phase 1 | Completed | |||
2024/08/20 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 60687-575 | ORAL | 150 mg in 1 1 | 6/20/2023 | |
| Central Texas Community Health Centers | 76413-136 | ORAL | 150 mg in 1 1 | 12/9/2016 | |
| REMEDYREPACK INC. | 70518-2404 | ORAL | 300 mg in 1 1 | 1/18/2024 | |
| A-S Medication Solutions | 50090-0964 | ORAL | 300 mg in 1 1 | 12/5/2018 | |
| Akorn | 61748-015 | ORAL | 150 mg in 1 1 | 7/12/2022 | |
| Central Texas Community Health Centers | 76413-137 | ORAL | 300 mg in 1 1 | 12/9/2016 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9230 | INTRAVENOUS | 600 mg in 1 1 | 1/28/2022 | |
| EPIC PHARMA, LLC | 42806-799 | ORAL | 300 mg in 1 1 | 12/15/2021 | |
| Sanofi-Aventis U.S. LLC | 0068-0599 | INTRAVENOUS | 600 mg in 10 mL | 12/21/2023 | |
| Physicians Total Care, Inc. | 54868-4683 | ORAL | 300 mg in 1 1 | 8/30/2011 |
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 |
|---|---|---|---|---|---|
| RIFAREN 150 CAPSULE 150 mg | SIN00312P | CAPSULE | 150 mg | 4/21/1988 | |
| ROYCE RIFAMPICIN CAPSULE 300MG | SIN16653P | CAPSULE | 300mg | 12/7/2022 | |
| RIFAREN 300 CAPSULE 300 mg | SIN10052P | CAPSULE | 300 mg | 9/13/1998 | |
| ROYCE RIFAMPICIN CAPSULE 150MG | SIN16652P | CAPSULE | 150mg | 12/7/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rifampicin Cream | 国药准字H44025324 | 化学药品 | 乳膏剂 | 12/2/2019 | |
| Rifampicin Cream | 国药准字H34023831 | 化学药品 | 乳膏剂 | 11/19/2020 | |
| Rifampicin Tablets | 国药准字H41020131 | 化学药品 | 片剂 | 7/23/2020 | |
| Rifampicin Tablets | 国药准字H44022213 | 化学药品 | 片剂(糖衣) | 4/9/2024 | |
| Rifampicin Tablets | 国药准字H34020193 | 化学药品 | 片剂 | 2/13/2020 | |
| Rifampicin Tablets | 国药准字H33020596 | 化学药品 | 片剂 | 5/26/2020 | |
| Rifampicin Tablets | 国药准字H14021312 | 化学药品 | 片剂 | 4/10/2020 | |
| Rifampicin Tablets | 国药准字H41020803 | 化学药品 | 片剂 | 5/14/2020 | |
| Rifampicin Tablets | 国药准字H42020853 | 化学药品 | 片剂 | 9/14/2020 | |
| Rifampicin Tablets | 国药准字H64020181 | 化学药品 | 片剂 | 12/18/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| EREMFAT 150 TAB 150MG | N/A | N/A | N/A | 1/7/2005 | |
| ROUEE-RIFAMPICIN CAPSULES 300MG | N/A | N/A | N/A | 3/20/2013 | |
| RIFICIN CAP 300MG | N/A | N/A | N/A | 5/31/1984 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RIFADIN rifampicin 600mg powder for injection vial with diluent ampoule | 156919 | Medicine | A | 1/21/2009 | |
| RIMYCIN 150 rifampicin 150 mg capsule bottle | 48230 | Medicine | A | 3/10/1994 | |
| RIFADIN rifampicin 300mg capsules blister pack | 233443 | Medicine | A | 6/17/2015 | |
| Rifinah 300/150mg | 345792 | Medicine | A | 10/12/2020 | |
| Rifampicin Capsules 150mg Bulk | 404910 | Medicine | A | 2/15/2023 | |
| Rifampicin Capsules 300mg Bulk | 407545 | Medicine | A | 4/12/2023 | |
| RIFADIN rifampicin 20mg/mL oral liquid bottle | 10113 | Medicine | A | 7/8/1991 | |
| RIMYCIN 300 rifampicin 300 mg capsule bottle | 48231 | Medicine | A | 3/10/1994 | |
| RIFADIN rifampicin 150mg capsules blister pack | 233442 | Medicine | A | 6/17/2015 |
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