Roxithromycin
- Generic Name
- Roxithromycin
- Drug Type
- Small Molecule
- Chemical Formula
- C41H76N2O15
- CAS Number
- 80214-83-1
- Unique Ingredient Identifier
- 21KOF230FA
Overview
Roxithromycin is a semi-synthethic macrolide antibiotic that is structurally and pharmacologically similar to erythromycin, azithromycin, or clarithromycin. It was shown to be more effective against certain Gram-negative bacteria, particularly Legionella pneumophila. Roxithromycin exerts its antibacterial action by binding to the bacterial ribosome and interfering with bacterial protein synthesis. It is marketed in Australia as a treatment for respiratory tract, urinary and soft tissue infections.
Background
Roxithromycin is a semi-synthethic macrolide antibiotic that is structurally and pharmacologically similar to erythromycin, azithromycin, or clarithromycin. It was shown to be more effective against certain Gram-negative bacteria, particularly Legionella pneumophila. Roxithromycin exerts its antibacterial action by binding to the bacterial ribosome and interfering with bacterial protein synthesis. It is marketed in Australia as a treatment for respiratory tract, urinary and soft tissue infections.
Indication
Used to treat respiratory tract, urinary and soft tissue infections.
Associated Conditions
- Lower Respiratory Tract and Lung Infections
- Respiratory Tract Infections (RTI)
- Skin Infections
- Ear, nose, and throat infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/10 | Phase 3 | Completed | |||
2016/06/30 | Phase 4 | UNKNOWN | |||
2007/02/22 | Phase 4 | Completed | Nazilli State Hospital | ||
2005/09/20 | Not Applicable | UNKNOWN | Hamamatsu University |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|
No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
CAPSULE | 150 mg | 2000/10/20 | SIN11413P |
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20041710 | 缓释制剂 | 恒特 | 0.3g | Chemical Drug | Approved | 2020/06/30 | Domestic | ||
国药准字H20052711 | 胶囊剂(缓释) | 逻施立 | 0.15g | Chemical Drug | Approved | 2020/12/02 | Domestic | ||
国药准字H20070302 | 胶囊剂（软胶囊） | N/A | 0.15g（15万单位） | Chemical Drug | Approved | 2022/07/12 | Domestic | ||
国药准字H20030634 | 颗粒剂 | 仁苏 | 50mg | Chemical Drug | Approved | 2020/05/22 | Domestic | ||
国药准字H20074162 | 片剂 | N/A | 0.15g | Chemical Drug | Approved | 2017/09/01 | Domestic | ||
国药准字H20073146 | 片剂 | N/A | 75mg | Chemical Drug | Approved | 2020/06/15 | Domestic | ||
国药准字H20055590 | 片剂 | N/A | 150mg | Chemical Drug | Approved | 2019/12/25 | Domestic | ||
国药准字H20055591 | 片剂 | N/A | 75mg(7.5万单位) | Chemical Drug | Approved | 2019/11/22 | Domestic | ||
国药准字H20000175 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2015/10/08 | Domestic | ||
H20150027 | sanofi aventis france | 片剂 | N/A | 150mg | Approved | N/A | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-46940 | Antibiotic | POM | 2000/10/27 |
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
333546 | Active | 2020/05/04 | roxithromycin | ||
99939 | Active | 2004/03/30 | roxithromycin | ||
133747 | Active | 2008/04/10 | roxithromycin | ||
133759 | Active | 2008/04/10 | roxithromycin | ||
333543 | Active | 2020/05/04 | roxithromycin | ||
133758 | Active | 2008/04/10 | roxithromycin | ||
99937 | Active | 2004/03/30 | roxithromycin | ||
133756 | Active | 2008/04/10 | roxithromycin | ||
333545 | Active | 2020/05/04 | roxithromycin | ||
133746 | Active | 2008/04/10 | roxithromycin |