Rindovect

Rindovect

erdosteine

Manufacturer:

Yarindo Farmatama

Marketer:

Yarindo Farmatama
Full Prescribing Info
Contents
Erdosteine.
Description
Each capsule contains Erdosteine 300 mg.
Each 5 mL dry syrup contains Erdosteine 175 mg.
Action
Pharmacology: Erdosteine is classified as a mucolytic drug that pharmacologically works as a mucus diluent drug in the bronchus.
Pharmacodynamics: Erdosteine tends to dilute the secretions or mucus in the respiratory tract (bronchus) to facilitate expectoration. Erdosteine turns into an active metabolite that contains -SH chemical group. This metabolite breaks the -SH group and reduce the elasticity and viscosity of the mucus to help the expectoration.
Pharmacokinetics: Erdosteine is metabolized rapidly into active metabolites that contains the cluster of free thiol, such as N-thiodiglycolylhomocysteine (metabolite I), N-acetylhomocysteine (metabolite II), and homocysteine (metabolite III). The average elimination half-life of erdosteine is 1.4 hours, metabolite I was 1.2 hours and metabolite II was 2.7 hours.
Erdosteine can be absorbed rapidly after oral administration, after a single oral dose, Tmax: 1.2 hours.
Erdosteine pharmacokinetics does not change with repeated administration.
Age does not change the pharmacokinetics of Erdosteine and its metabolites.
In elderly patients with renal failure with creatinine clearance between 25 and 40 ml/min, the pharmacokinetic characteristics of Erdosteine and its metabolites did not show significant differences with healthy elderly subjects.
Indications/Uses
As a mucilage diluent in acute and chronic respiratory diseases (mucolytic).
Dosage/Direction for Use
Capsule: Adults: 1 capsule, 2-3 times daily.
Dry syrup: Children 15-19 kg: 1 tsp (5 mL), twice daily; Children 20-30 kg: 1 tsp (5 mL), 3 times daily; Children >30 kg & adult: 2 tsp (10 mL), twice daily.
Reconstitution: Add 46 mL water to the bottle. The suspension may be used for 7 days.
Contraindications
Hypersensitivity to any component of this medication; Patients with hepatic cirrhosis and enzyme cyctathionine-synthetase deficiency; Phenylketonuria (caused by aspartame), only for granules in the suspension preparation; Patients with severe renal failure (creatinine clearance <25 mL/min).
Special Precautions
It is not advisable to use erdosteine during pregnancy and lactation.
Effects on the ability to drive a vehicle and use the machine: No effects are reported.
Use In Pregnancy & Lactation
It is not advisable to use erdosteine during pregnancy and lactation.
Adverse Reactions
No gastrointestinal or systemic side effects were observed. If an adverse effect occurs, it should be informed to the doctor.
Drug Interactions
There is no harmful interaction with other drugs ever observed and Erdosteine may be given together with antibiotics, bronchodilators (theophylline, β2-mimetic, sedative cough agent, etc.).
Storage
Store below 30°C. Protected from light exposure.
ATC Classification
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Cap 300 mg x 3 x 10's. Dry syr (bottle) 175 mg/5 mL x 60 mL x 1's.
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