Overview
Dyspnea and cough are common symptoms of chronic obstructive pulmonary disease (COPD) and other respiratory conditions characterized by increased mucus production. Individuals with COPD have a greater risk of pulmonary infection due to the growth and accumulation of viruses and bacteria in thick bronchial mucus. Carbocisteine is a mucolytic drug that alleviates respiratory symptoms and infections by reducing the viscosity of mucus, allowing it to be expelled. Several licenses for this drug were withdrawn following serious and fatal paradoxical effects after carbocisteine therapy in children; respiratory dress, dyspnea, and cough aggravation were reported by physicians in France and Italy. Carbocisteine is currently not FDA or Health Canada approved, but is approved for use in Asia, Europe, and South America.
Indication
Carbocisteine is indicated over the counter and in prescription formulas to clear airway secretions in conditions associated with increased mucus.
Associated Conditions
- Cough
- Respiratory Illness
- Excess mucus or phlegm
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2013/12/19 | Not Applicable | Completed | Guangzhou Institute of Respiratory Disease | ||
2013/10/24 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| RHINATHIOL ADULTS SYRUP 5% | SIN02759P | SYRUP | 5 g/100 ml | 5/9/1989 | |
| MUCODIN TABLET 375 mg | SIN10844P | TABLET | 375 mg | 3/25/1999 | |
| SOLMUX PAEDIATRIC SUSPENSION 200 mg/5 ml | SIN12251P | SUSPENSION | 200 mg/5 ml | 4/3/2003 | |
| SCMC SYRUP 100 100 mg/5 ml | SIN02852P | SYRUP | 100 mg/5 ml | 5/22/1989 | |
| MUCODIN SYRUP 250 mg/5 ml | SIN03003P | SYRUP | 250 mg/5 ml | 5/31/1989 | |
| RHINATHIOL PROMETHAZINE SYRUP | SIN02613P | SYRUP | 2 g/100 ml | 4/21/1989 | |
| RHINATHIOL 2% CHILDREN SYRUP | SIN02771P | SYRUP | 2 g/100 ml | 5/9/1989 | |
| Mucopront Capsule | SIN13286P | CAPSULE | 375 mg | 5/29/2007 |
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 |
|---|---|---|---|---|---|
| CABOTIN TABLETS 375MG | N/A | N/A | N/A | 10/9/2024 | |
| RHINATHIOL SYRUP FOR CHILDREN 2% | N/A | N/A | N/A | 11/16/1981 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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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