Usage
- Erdosteine is prescribed for the symptomatic treatment of acute exacerbations of chronic bronchitis and other respiratory disorders associated with excessive mucus production. It is also used as an expectorant to help clear mucus from the airways.
- Pharmacological classification: Mucolytic.
- Mechanism of Action: Erdosteine is a prodrug metabolized to its active form, N-thiodiglycolyl-homocysteine. This active metabolite breaks disulfide bonds in mucus glycoproteins, reducing sputum viscosity. Additionally, it inhibits bacterial adhesion to epithelial cells, potentially contributing to its efficacy in treating acute exacerbations of chronic bronchitis.
Alternate Names
Erdosteine is the generic name. Some brand names include Erdomed, Erdotin, Zertin, and Ectrin. Brand names can vary by country.
How It Works
- Pharmacodynamics: Erdosteine’s primary effect is to reduce the viscosity of mucus in the airways, making it easier to expectorate. Its active metabolite also exhibits antioxidant and anti-inflammatory properties by scavenging free radicals.
- Pharmacokinetics:
- Absorption: Erdosteine is rapidly absorbed after oral administration.
- Metabolism: It undergoes rapid first-pass metabolism in the liver to its active metabolite, N-thiodiglycolyl-homocysteine.
- Elimination: Primarily eliminated renally (via the urine) as the active metabolite and sulfates. The elimination half-life is approximately 1.5-1.7 hours.
- Mode of Action: The active metabolite of erdosteine cleaves disulfide bonds in mucus glycoproteins, reducing cross-linking and decreasing mucus viscosity. This action promotes easier clearance of airway secretions. It also inhibits bacterial adhesion to the respiratory epithelium.
Dosage
Standard Dosage
Adults:
- 300 mg twice daily (bid), orally, for up to 10 days for acute exacerbations of chronic bronchitis. Some studies suggest longer durations for chronic conditions, under physician guidance. Capsules should be swallowed whole with water. Dispersible tablets can be dissolved in water.
Children:
- Dosage is weight-based for children over 2 years of age:
- 15-20 kg: 175 mg bid (oral suspension)
- 20-30 kg: 175 mg three times daily (tid) (oral suspension)
-
30 kg: Same as adult dose (oral suspension or capsules/tablets if appropriate)
- Erdosteine is contraindicated in children under 2 years old. Mucolytics can induce bronchospasm in this age group due to limited mucus clearance capacity.
Special Cases:
- Elderly Patients: Standard adult dose can be used, but close monitoring is recommended.
- Patients with Renal Impairment: Contraindicated in patients with severe renal impairment (creatinine clearance <25 mL/min). No dosage adjustments are provided for mild to moderate impairment.
- Patients with Hepatic Dysfunction: Contraindicated in patients with severe hepatic impairment (including cirrhosis). Maximum dose of 300 mg daily for mild to moderate hepatic impairment.
- Patients with Comorbid Conditions: Use with caution in patients with active peptic ulcer. Adjustments might be necessary based on specific comorbid conditions. Consult product guidelines or specialist advice.
Clinical Use Cases
Dosages in specific clinical settings such as intubation, surgical procedures, mechanical ventilation, and ICU use are not explicitly defined in the provided sources. Dosage should be determined on a case-by-case basis by the physician considering the patient’s specific condition and needs. Standard dosage guidelines apply for acute exacerbations of chronic bronchitis.
Dosage Adjustments
Dose adjustments are based on renal and hepatic function, as outlined above. No specific dosage adjustments are described for metabolic disorders or genetic polymorphisms.
Side Effects
Common Side Effects
Epigastric pain, nausea, vomiting, diarrhea, taste alterations, headache, cold symptoms, and dyspnea.
Rare but Serious Side Effects
Angioedema, cutaneous hypersensitivity reactions (urticaria, edema, erythema, eczema).
Long-Term Effects
No long-term effects from usual usage are specifically reported in the sources.
Adverse Drug Reactions (ADR)
Significant ADRs include the rare but serious side effects listed above, requiring immediate attention if they occur.
Contraindications
Hypersensitivity to erdosteine, active peptic ulcer, severe renal impairment (CrCl <25 mL/min), severe hepatic impairment (including cirrhosis), children under 2 years old.
Drug Interactions
No specific drug interactions are explicitly stated in the provided information. However, always consult resources for potential interactions with specific medications the patient is taking.
Pregnancy and Breastfeeding
Use of erdosteine during pregnancy and breastfeeding is not recommended due to lack of sufficient safety data.
Drug Profile Summary
- Mechanism of Action: Reduces mucus viscosity by breaking disulfide bonds, promotes mucociliary clearance.
- Side Effects: Epigastric pain, nausea, vomiting, diarrhea, taste alterations, headache, cold symptoms, dyspnea. Rare: angioedema, hypersensitivity.
- Contraindications: Hypersensitivity, peptic ulcer, severe renal/hepatic impairment, age <2 years.
- Drug Interactions: No specific interactions listed in available information.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: 300 mg bid, up to 10 days; Pediatric dosing is weight-based (see above).
- Monitoring Parameters: Respiratory symptoms (cough, sputum production, dyspnea), liver and kidney function tests in specific cases.
Popular Combinations
Erdosteine is sometimes used in combination with antibiotics like amoxicillin for acute infective exacerbations of chronic bronchitis. This combination may improve antibiotic penetration into the sputum.
Precautions
- Screen patients for allergies, renal/hepatic dysfunction, peptic ulcers before initiating therapy.
- Pregnant Women: Use not recommended.
- Breastfeeding Mothers: Use not recommended.
- Children & Elderly: See dosage section for age-specific recommendations and precautions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Erdosteine?
A: Adults: 300 mg twice daily for up to 10 days. Pediatric dosing is weight-based (see dosage section).
Q2: How does Erdosteine work?
A: It reduces mucus viscosity by breaking disulfide bonds in mucus glycoproteins, facilitating expectoration.
Q3: What are the common side effects of Erdosteine?
A: Epigastric pain, nausea, vomiting, diarrhea, taste alterations, headache.
Q4: Is Erdosteine safe for pregnant or breastfeeding women?
A: No, it’s generally not recommended due to limited safety data.
Q5: Can Erdosteine be used in children?
A: Yes, but only in children over 2 years of age, with weight-based dosing.
Q6: What are the contraindications for using Erdosteine?
A: Hypersensitivity, active peptic ulcer, severe renal or hepatic impairment.
Q7: How long can Erdosteine be used for?
A: Typically up to 10 days for acute exacerbations. Longer use in chronic conditions may be considered under physician guidance.
Q8: Can Erdosteine be combined with other medications?
A: It’s sometimes used with antibiotics, but always check for potential interactions.
Q9: Does Erdosteine interact with food?
A: No significant food interactions are known. Can be taken with or without food.
Q10: How should Erdosteine be stored?
A: Store below 30°C.
