MedPath

Erdosteine

Generic Name
Erdosteine
Drug Type
Small Molecule
Chemical Formula
C8H11NO4S2
CAS Number
84611-23-4
Unique Ingredient Identifier
76J0853EKA

Overview

Erdosteine is a drug that causes a breakdown of mucus, also known as a mucolytic agent. It is a thiol derivative produced for the clinical management of chronic obstructive bronchitis, in addition to infective exacerbations of chronic bronchitis. This drug contains sulfhydryl groups which are released after erdosteine undergoes hepatic first pass metabolism. Three active metabolites result and possess mucolytic activity in addition to free radical scavenging activity. Erdosteine acts to control mucus production and control its viscosity while increasing mucociliary transport. It also combats the effects of free radicals resulting from cigarette smoke. Erdosteine has been shown to be safe and well tolerated in clinical trials. Erdosteine 300mg twice daily reduced cough (both frequency and severity) and sputum viscosity more quickly and more effectively than placebo and reduced the adhesivity of sputum more effectively than ambroxol 30mg twice daily. Co-administration of erdosteine and amoxicillin in patients with acute infective exacerbation of chronic bronchitis resulted in higher concentrations of the antibiotic in the sputum, leading to earlier and more pronounced amelioration of clinical symptoms compared with placebo. Erdosteine is associated with a low incidence of adverse events, most of which are gastrointestinal and generally mild.

Indication

Fro the treatment of chronic bronchitis in adults.

Associated Conditions

  • Excess mucus or phlegm

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
ERDOMED HARD CAPSULES 300MG
SIN15825P
CAPSULE
300mg
10/2/2019
ERDOMED DISPERSIBLE TABLETS 300MG
SIN15826P
TABLET, FOR SOLUTION
300mg
10/2/2019

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Erdosteine Capsules
H20150462
化学药品
胶囊剂
3/20/2020
Erdosteine Capsules
edmond pharma s.r.l
国药准字HJ20150462
化学药品
胶囊剂
3/19/2025
Erdosteine Capsules
H20160221
化学药品
胶囊剂
3/20/2020
Erdosteine Capsules
国药准字H20213487
化学药品
胶囊剂
6/16/2021
Erdosteine Capsules
国药准字H20030907
化学药品
胶囊剂
6/19/2020
Erdosteine Capsules
国药准字H20020410
化学药品
胶囊剂
6/19/2020
Erdosteine Capsules
国药准字H20010797
化学药品
胶囊剂
4/7/2020
Erdosteine Capsules
国药准字H20030653
化学药品
胶囊剂
3/31/2020
Erdosteine Dispersible Tablets
国药准字H20080771
化学药品
片剂
6/26/2023
Erdosteine Tablets
国药准字H20030840
化学药品
片剂
4/27/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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