Erdosteine


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Acute exacerbations of chronic bronchitis, Acute respiratory disorders associated with excessive mucus production, Chronic respiratory disorders associated with excessive mucus production
Adult: As cap or dispersible tab: 300 mg bid or tid. Treatment duration for acute exacerbations of chronic bronchitis not to exceed 10 days. As susp: 350 mg bid. Dosing recommendations may vary among individual products or preparations and between countries (refer to specific product guidelines).
Child: As susp: 15-<20 kg: 175 mg bid; 20-30 kg: 175 mg tid; >30 kg: Same as adult dose. Dosing recommendations may vary among individual products or preparations and between countries (refer to specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<25Contraindicated.
Hepatic impairment: Mild to moderate: Max: 300 mg daily. Severe: Contraindicated.
Contraindications
Active peptic ulcer. Severe renal (CrCl <25 mL/min) and hepatic impairment (including hepatic cirrhosis and cystathionine-synthase deficiency). Children (<2 years).
Special Precautions
Mild to moderate hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Epigastric pain, taste alteration. Gastrointestinal disorders: Diarrhoea, nausea, vomiting. Immune system disorders: Angioedema, cutaneous hypersensitivity reactions (e.g. urticaria, oedema, erythema, eczema). Nervous system disorders: Headache. Respiratory, thoracic and mediastinal disorders: Cold, dyspnoea.
Overdosage
Symptoms: Dizziness, sweating, flushing. Management: Symptomatic and supportive treatment. May perform gastric lavage if necessary.
Action
Erdosteine is a prodrug which becomes active after metabolism whereby free thiol groups are formed. This results in the opening of disulfide bonds in bronchial mucoproteins thus reducing mucous viscosity. Additionally, it inhibits bacterial adhesion to epithelial cells.
Absorption: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 1 hour.
Distribution: Plasma protein binding: 50-86%.
Metabolism: Undergoes rapid first-pass metabolism to N-thiodiglycolyl-homocysteine (active metabolite).
Excretion: Via urine (as active metabolite and sulfates). Elimination half-life: 11.46 hours (erdosteine); 1.62 hours (N-thiodiglycolyl-homocysteine).
Storage
Oral: Store below 30°C.
CIMS Class
Cough & Cold Preparations
ATC Classification
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Disclaimer: This information is independently developed by CIMS based on erdosteine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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