Erdosteine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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
<25	Contraindicated.

Hepatic Impairment

Mild to moderate: Max: 300 mg daily. Severe: Contraindicated.

Administration

cap: May be taken with or without food.

Reconstitution

Powder for oral susp: Reconstitute with the appropriate volume of water, shake well.

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

Description: 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.
Pharmacokinetics:
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: 1.46 hours (erdosteine); 1.62 hours (N-thiodiglycolyl-homocysteine).

Chemical Structure

Storage

Store below 30°C.

MIMS Class

Cough & Cold Preparations

ATC Classification

R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

References

Anon. Erdosteine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/10/2021.

Buckingham R (ed). Erdosteine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.new.medicinescomplete.com. Accessed 07/10/2021.

Ectrin (OEP Phils). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/10/2021.

Erdomed 300 mg Hard Capsules; 300 mg Dispersible Tablets (Edmond Pharma S.r.l.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/10/2021.

Erdos Capsule 300 mg (Daewoong Pharmaceutical [Thailand] Co., Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 07/10/2021.

Erdotin 300 mg Capsules (Galen Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/10/2021.

Joint Formulary Committee. Erdosteine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/10/2021.

Zertin 300 mg Capsule; 175 mg/5 mL Powder for Suspension (GlaxoSmithKline). MIMS Philippines. http://www.mims.com/philippines. Accessed 07/10/2021.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com