Erdolytic® 300 mg Hard Gelatin Capsules — Erdosteine — Mucolytic / Expectorant
1- Disclaimer
This medicinal-product commentary is intended for professional educational and informational purposes only. It does not replace the current official Egyptian package leaflet, prescribing information, clinical judgment, or consultation with a qualified physician or pharmacist. Treatment decisions, dose adjustments, contraindications, and duration of therapy must be individualized according to the patient's condition and the locally approved product information.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Product formulations, excipients, pack sizes, regulatory status, and approved indications may change over time or differ between countries. The current Egyptian carton and package leaflet should therefore be checked before prescribing, dispensing, or using Erdolytic.
2- Summary
Erdolytic 300 mg Hard Gelatin Capsules contains erdosteine 300 mg, an orally administered mucolytic/expectorant. Erdosteine is a prodrug that is converted to an active metabolite containing free thiol groups. These groups reduce mucus viscosity by disrupting disulfide bonds in bronchial mucoproteins, thereby facilitating expectoration.
For the 300 mg capsule regimen described in the Egyptian product information, Erdolytic is used as an expectorant and for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. The usual adult dose is 300 mg twice daily for a maximum of 10 days.
Erdosteine also has documented antioxidant and bacterial anti-adhesive pharmacological effects, but it is not an antibiotic and not a bronchodilator.
3- Brand Name
Erdolytic®
Publicly available Al Andalous information confirms Erdolytic as an erdosteine-containing respiratory product available in 300 mg hard gelatin capsules and 175 mg/5 mL granules for oral suspension.
4- Category
- Therapeutic class: Mucolytic agent / expectorant.
- ATC code: R05CB15 — Erdosteine.
- System: Respiratory system; mucolytics.
5- Active Ingredient
Each hard gelatin capsule contains:
Erdosteine 300 mg
Erdosteine is a thiol-containing mucolytic prodrug whose pharmacological activity is largely mediated through active metabolites formed after oral administration.
6- Pharmaceutical Form & Strength
Pharmaceutical form: Hard gelatin capsule.
Strength: 300 mg erdosteine per capsule.
The Egyptian product information lists excipients including:
Microcrystalline Cellulose PH101, Povidone K30, Magnesium Stearate, Gelatin, Titanium Dioxide, Brilliant Blue, Carmoisine Red and Quinoline Yellow.
Because excipient composition may be revised, patients with known hypersensitivity to coloring agents or other excipients should verify the current package leaflet.
7- Manufacturer & Marketing Authorization Holder
Manufacturer: Al Andalous Pharmaceutical Industries, Egypt.
Manufactured for: Al Andalous Medical Company – Egypt.
Published analytical research on Egyptian marketed products also confirms Erdolytic capsules labeled to contain erdosteine 300 mg and manufactured by Al Andalous in Egypt.
Marketing Authorization Holder: The exact current legal designation should be verified from the current Egyptian registration documents, carton, or package leaflet of the marketed batch.
8- Mechanism of Action
Erdosteine is a prodrug. After oral administration it undergoes first-pass metabolism, producing active metabolites, particularly N-thiodiglycolyl-homocysteine (M1).
The active metabolite contains free sulfhydryl (thiol) groups that can break disulfide bonds within bronchial mucoproteins. This decreases mucus viscosity and facilitates clearance of mucus and purulent sputum.
Additional pharmacological actions described for erdosteine include:
- Inhibition of bacterial adhesion to respiratory epithelial cells.
- Antioxidant activity associated with the free thiol group of its active metabolite.
- Modulation of oxidative stress and other airway inflammatory processes described in experimental and clinical studies.
These additional actions should not be interpreted as a substitute for antibiotics, bronchodilators, corticosteroids, or other treatments when these are clinically indicated.
9- Spectrum of Activity
Erdosteine does not have an antimicrobial spectrum in the conventional sense because it is not an antibiotic.
Its relevant pharmacological activity is directed mainly toward:
- Reducing the viscosity and elasticity of pathological bronchial secretions.
- Facilitating expectoration and mucociliary clearance.
- Providing antioxidant activity through its active thiol-containing metabolite.
- Reducing bacterial adhesion to epithelial cells in experimental studies.
Although reduced bacterial adhesion may be therapeutically useful, Erdolytic does not eradicate bacterial infection and should not replace appropriate antimicrobial therapy when an antibiotic is clinically required.
10- Pharmacokinetics
Absorption
Erdosteine is rapidly absorbed after oral administration and undergoes rapid first-pass conversion to the biologically active metabolite M1.
After a 300 mg oral dose:
- Erdosteine Cmax: approximately 1.26 ± 0.23 µg/mL.
- Erdosteine Tmax: approximately 1.18 ± 0.26 hours.
- M1 Cmax: approximately 3.46 µg/mL.
- M1 Tmax: approximately 1.48 hours.
Erdosteine plasma concentrations increase approximately dose-dependently. M1 concentrations also increase with increasing dose, although less proportionally.
Food: Absorption is reported to be independent of food intake.
Distribution
Animal studies demonstrated distribution particularly to the kidneys, bone, spinal cord, and liver. Pharmacologically active concentrations of erdosteine and M1 have also been detected in bronchoalveolar lavage fluid.
Protein Binding
Approximately 64.5%, with a reported range of 50–86%.
Elimination
The elimination half-lives are approximately:
- Erdosteine: 1.46 ± 0.60 hours
- M1: 1.62 ± 0.59 hours
Urinary metabolites include M1 and sulfates. Fecal elimination is reported to be negligible.
No clinically relevant accumulation or change in metabolism was observed in studies administering 600–900 mg/day for eight days.
Effect of Age
Age has not been shown to produce a significant change in erdosteine pharmacokinetics.
11- Indications
For the Erdolytic 300 mg capsule regimen described in the Egyptian/UK-aligned product information:
- As an expectorant.
- For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults.
Al Andalous also presents Erdolytic within chronic bronchitis and COPD care, and longer-term clinical studies have investigated erdosteine for prevention or reduction of COPD exacerbations. Such long-term use is distinct from the maximum 10-day acute-treatment regimen described for these capsules and should only be undertaken according to the applicable local product information and the patient's clinical management plan.
12- Administration
Adults and Elderly Patients Above 18 Years
300 mg twice daily for a maximum of 10 days.
The capsule should be:
- Swallowed whole.
- Taken with a glass of water.
Persistent, worsening, recurrent, or unusually severe respiratory symptoms require medical assessment rather than repeated unsupervised courses of treatment.
13- Method of Preparation
No preparation or reconstitution is required for Erdolytic 300 mg Hard Gelatin Capsules.
The capsule is administered orally and swallowed whole with water.
Erdolytic is also available as a separate 175 mg/5 mL granules/powder for oral suspension presentation. That formulation requires preparation according to its own package leaflet and should not be prepared using instructions intended for the capsules.
14- Contraindications
Erdosteine should not be used in patients with:
- Hypersensitivity to erdosteine or any component of the product.
- Active peptic ulcer.
Use is not recommended in patients with:
- Severe renal impairment, particularly creatinine clearance <25 mL/min.
- Severe hepatic failure.
15- Warnings & Precautions
Hepatic Impairment
Patients with mild hepatic impairment should not exceed 300 mg per day. This is lower than the standard adult dose of 300 mg twice daily.
Renal Impairment
Erdosteine is not recommended when creatinine clearance is below 25 mL/min because adequate clinical data are lacking.
Peptic Ulcer
The product should not be used in patients with an active peptic ulcer.
Hypersensitivity
Treatment should be stopped and urgent medical advice sought if symptoms suggesting serious hypersensitivity occur, including facial or throat swelling, angioedema, urticaria, or breathing difficulty.
Respiratory Symptoms
Dyspnoea, hemoptysis, persistent fever, chest pain, deterioration despite treatment, or recurrent exacerbations should prompt clinical evaluation.
16- Drug Interactions
The established product information reports that no adverse drug interactions have been reported with erdosteine.
Erdosteine has been used clinically with treatments commonly prescribed for respiratory diseases, including antibiotics and bronchodilators.
However:
- The absence of reported adverse interactions does not establish that every possible combination has been formally studied.
- Patients should inform their physician or pharmacist about prescription medicines, OTC products, and supplements.
- Antibiotic therapy should be used when clinically indicated; erdosteine itself is not an antimicrobial drug.
17- Side Effects
Adverse reactions reported with erdosteine include:
Common
≥1/100 to <1/10
- Epigastric pain.
Uncommon
≥1/1,000 to <1/100
- Headache.
- Cold.
- Dyspnoea.
- Taste alterations.
- Nausea.
- Vomiting.
- Diarrhoea.
- Angioedema.
- Cutaneous hypersensitivity reactions including urticaria, erythema, oedema and eczema.
Patients should obtain urgent medical assistance for angioedema, significant breathing difficulty, or other manifestations of a severe allergic reaction.
18- Use in Special Populations
Elderly
The standard adult regimen can be used in elderly patients unless dose modification is required because of hepatic, renal, or other clinical factors.
Children and Adolescents
The cited 300 mg capsule regimen is specified for adults and elderly patients above 18 years. The adult capsule dose should not be extrapolated to children.
Other erdosteine formulations and pediatric approvals differ between countries.
Pregnancy
There is insufficient clinical experience with erdosteine during pregnancy. Use during pregnancy is therefore not recommended.
Breast-feeding
Clinical experience during breast-feeding is insufficient. Use in breast-feeding women is not recommended.
Fertility
No specific clinical fertility information is provided in the cited product information. Preclinical studies revealed no special hazard based on conventional studies of reproductive toxicity.
Renal Impairment
Use is not recommended if creatinine clearance is <25 mL/min.
Hepatic Impairment
- Mild hepatic impairment: maximum 300 mg/day.
- Severe hepatic failure: use is not recommended.
19- Storage Conditions
For the Egyptian product:
Store at a temperature not exceeding 30°C in a dry place.
Keep the medicine:
- In its original packaging.
- Protected from inappropriate heat and moisture.
- Out of the sight and reach of children.
- Away from use after the expiry date stated on the packaging.
Storage requirements of other erdosteine brands may differ and should not be substituted for the instructions on the Erdolytic package.
20- Additional Sections
Overdose
Clinical experience with acute erdosteine overdose is limited. There is no established specific antidote.
The cited erdosteine product information recommends:
- Symptomatic treatment.
- General supportive measures.
- Clinical observation.
The cited SmPC also states that gastric lavage may be beneficial, followed by observation.
However, contemporary clinical toxicology guidance does not recommend routine gastric lavage for pharmaceutical overdose, because evidence of benefit is limited and the procedure carries potential risks. If a significant overdose is suspected, management should be guided by an emergency physician, toxicology specialist, or poison-information service. Gastrointestinal decontamination should be considered only in appropriately selected cases by trained healthcare professionals.
Effects on Driving and Operating Machinery
Erdosteine has been described as having minor or negligible influence on the ability to drive or operate machinery. Patients who experience unexpected symptoms should avoid activities requiring full alertness until they know how the medicine affects them.
Egyptian Pack and Presentations
Public product information documents:
- Erdolytic 300 mg Hard Gelatin Capsules: pack of 20 capsules, generally arranged as two strips of 10 capsules.
- Erdolytic 175 mg/5 mL Granules for Oral Suspension: bottle producing 100 mL suspension after reconstitution.
The current Al Andalous catalogue continues to show both the 300 mg capsule and 175 mg/5 mL oral-suspension presentations.
Clinical Evidence in COPD
A randomized, double-blind, placebo-controlled study (RESTORE) evaluated erdosteine 300 mg twice daily for 12 months as add-on treatment in patients with moderate-to-severe COPD.
In the prespecified intention-to-treat population, erdosteine reduced the overall exacerbation rate by approximately 19.4% and reduced exacerbation duration by approximately 24.6% compared with placebo.
Importantly, the reduction in exacerbation rate was driven predominantly by a reduction in mild exacerbations. The study did not demonstrate a statistically significant reduction in the rate of moderate and severe exacerbations.
This long-term COPD study should not be confused with the maximum 10-day regimen specified for symptomatic treatment of acute exacerbations of chronic bronchitis in the capsule product information.
21- Frequently Asked Questions (FAQ)
What is Erdolytic 300 mg used for?
It is a mucolytic/expectorant used to make thick bronchial secretions easier to clear. The 300 mg capsule information includes symptomatic treatment of acute exacerbations of chronic bronchitis in adults.
Is Erdolytic an antibiotic?
No. Erdosteine is not an antibiotic. Although it may reduce bacterial adhesion to airway epithelial cells, it does not directly replace antimicrobial therapy.
What is the usual adult dose?
For the acute-treatment regimen described for the 300 mg capsules: one 300 mg capsule twice daily for a maximum of 10 days, unless the treating physician prescribes otherwise.
Does food affect Erdolytic absorption?
Available product information reports that erdosteine absorption is independent of food intake. Patients should nevertheless follow the administration instructions provided in the current product leaflet or by their healthcare professional.
Can Erdolytic be used during pregnancy or breast-feeding?
Its use is not recommended because adequate clinical experience in pregnant and breast-feeding women is lacking.
Can patients with liver disease use Erdolytic?
Patients with mild hepatic impairment should not exceed 300 mg/day. Use is not recommended in severe hepatic failure. Patients with liver disease should therefore obtain medical advice before treatment.
Can patients with kidney disease use Erdolytic?
Use is not recommended in patients with severe renal impairment, particularly when creatinine clearance is below 25 mL/min.
Can it be used in children?
The 300 mg capsule regimen described here is for adults above 18 years. Erdosteine oral-suspension formulations exist, but pediatric doses and approvals differ by product and country and must be taken from the appropriate current leaflet.
Does Erdolytic stop coughing?
Its primary therapeutic action is to reduce mucus viscosity and facilitate clearance of bronchial secretions rather than to serve as a conventional cough suppressant.
Can Erdolytic be used for long-term COPD prevention?
Erdosteine has been studied for long-term COPD exacerbation prevention, including 300 mg twice daily for 12 months in the RESTORE trial. This is a different clinical setting from the 10-day acute-treatment regimen and should only be used under appropriate medical supervision and according to locally approved indications.
22- References
- Al Andalous — Export Catalogue, Respiratory Health / Erdolytic. Current online catalogue listing Erdosteine 300 mg Hard Gelatin Capsules and Erdosteine 175 mg/5 mL Granules for Oral Suspension.
- Electronic Medicines Compendium (emc). Erdotin 300 mg Capsules — Summary of Product Characteristics. Galen Limited. Last updated 31 May 2019; text revision 23 May 2019.
- Health Products Regulatory Authority, Ireland. Erdotin 300 mg Capsules — Summary of Product Characteristics. 21 June 2019.
- Dal Negro RW, Wedzicha JA, Iversen M, et al. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. European Respiratory Journal. 2017;50(4):1700711. DOI: 10.1183/13993003.00711-2017.
- Multiple green spectroscopic methods for erdosteine determination in bulk and dosage form with extensive greenness evaluation. Scientific Reports. 2023. Includes analytical testing of marketed Egyptian Erdolytic 300 mg capsules manufactured by Al Andalous.
- American Academy of Clinical Toxicology — Position Statements and Recommendations on gastrointestinal decontamination, together with contemporary poisoning-management recommendations regarding the non-routine use of gastric lavage.