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The information provided in this report is intended for educational and professional reference purposes only and does not replace professional medical advice, diagnosis, or treatment. Healthcare professionals should consult the current Summary of Product Characteristics (SmPC), local regulatory approvals, and manufacturer-issued prescribing information.
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2. Summary
MUCOSIN® is a branded range of mucolytic and expectorant medicinal products manufactured by RAMEDA (Egypt). The formulations primarily contain Ambroxol Hydrochloride, either alone or in combination with Guaifenesin (MUCOSIN PLUS). The product line is indicated for the symptomatic management of acute and chronic respiratory tract conditions associated with excessive, thick, or difficult-to-expectorate mucus. By reducing mucus viscosity and enhancing mucociliary clearance, MUCOSIN® improves sputum expectoration and relieves productive cough.
3. Brand Name
MUCOSIN®
(MUCOSIN PLUS® for combination formulations)
4. Category
- Pharmacological Class: Mucolytic agent
- Therapeutic Class: Expectorant / Respiratory tract secretion modifier
5. Active Ingredient
- Ambroxol Hydrochloride
- Ambroxol Hydrochloride + Guaifenesin (MUCOSIN PLUS)
6. Pharmaceutical Form & Strength
Available formulations include:
- Lozenges: Ambroxol 15 mg
- Oral Drops: Ambroxol 7.5 mg/mL (15 mL bottle)
- Syrup:
- Ambroxol 15 mg/5 mL
- Ambroxol 15 mg + Guaifenesin 100 mg/5 mL (MUCOSIN PLUS)
- Sustained-Release Capsules: Ambroxol 75 mg
Exact pack sizes and availability may vary and should be verified locally.
7. Manufacturer & Marketing Authorization Holder
RAMEDA (The Tenth of Ramadan Company)
For Pharmaceutical Industries & Diagnostic Reagents
6th of October City, Arab Republic of Egypt
8. Mechanism of Action
Ambroxol Hydrochloride:
- Stimulates pulmonary surfactant production by type II pneumocytes
- Reduces mucus viscosity by altering mucopolysaccharide structure
- Enhances ciliary beat frequency, improving mucociliary clearance
- Exhibits mild local anesthetic and antioxidant properties
Guaifenesin (when present):
- Increases hydration and volume of respiratory secretions
- Reduces sputum tenacity
- Facilitates productive cough and expectoration
The combined effect leads to more efficient clearance of bronchial secretions.
9. Spectrum of Activity
Not applicable.
MUCOSIN® has no antibacterial, antiviral, or antifungal activity and is used solely for symptomatic relief.
10. Pharmacokinetics
Ambroxol Hydrochloride:
- Absorption: Rapid and nearly complete after oral administration
- Distribution: Extensive tissue distribution with high lung affinity
- Metabolism: Hepatic, primarily via CYP3A4
- Elimination: Mainly renal as metabolites
- Elimination half-life: Approximately 7–12 hours (longer with SR formulation)
Guaifenesin:
- Rapid gastrointestinal absorption
- Short plasma half-life (1–3 hours)
- Hepatic metabolism
- Renal excretion primarily as metabolites
11. Indications
Indicated as adjunctive therapy in respiratory conditions associated with abnormal mucus production or impaired mucus clearance, including:
- Acute and chronic bronchitis
- Asthmatic bronchitis
- Bronchiectasis
- Chronic obstructive pulmonary disease (COPD) with mucus hypersecretion
- Inflammatory conditions of the nasopharyngeal cavity
- Supportive treatment in respiratory infections with productive cough
12. Administration
- Route: Oral
- Dosage depends on age, formulation, and clinical condition
- Sustained-release capsules are generally administered once daily
- Adequate fluid intake is recommended to enhance therapeutic effect
13. Method of Preparation
Not applicable.
All formulations are ready-to-use and require no reconstitution.
14. Contraindications
- Known hypersensitivity to Ambroxol, Guaifenesin, or any excipients
- First trimester of pregnancy (precautionary)
- Severe hepatic or renal impairment without medical supervision
- Rare hereditary fructose intolerance (for syrup formulations containing sorbitol)
15. Warnings & Precautions
- Use with caution in patients with peptic ulcer disease
- Dose adjustment may be required in severe renal or hepatic impairment
- Discontinue immediately if severe cutaneous reactions (e.g., Stevens–Johnson syndrome or toxic epidermal necrolysis) are suspected
- Avoid use when cough reflex is significantly impaired due to risk of mucus retention
- Not intended for dry, non-productive cough
16. Drug Interactions
- Antitussives (e.g., codeine): May impair mucus clearance; concomitant use is generally discouraged
- Antibiotics: Ambroxol may increase bronchopulmonary concentrations of certain antibiotics (e.g., amoxicillin, cefuroxime, erythromycin)
- No clinically significant CYP-mediated interactions have been conclusively established
17. Side Effects
Generally well tolerated. Reported adverse effects include:
Common:
- Nausea, dyspepsia, diarrhea, abdominal pain, taste disturbance
Uncommon:
- Headache, dizziness, vomiting, skin rash, urticaria
Rare:
- Hypersensitivity reactions, angioedema
Very rare:
- Severe cutaneous adverse reactions (SJS/TEN)
18. Use in Special Populations
- Pregnancy: Avoid during the first trimester; use in later trimesters only if benefit outweighs risk
- Lactation: Ambroxol is excreted in breast milk in small amounts; caution advised
- Pediatrics: Approved in age-appropriate formulations and doses under medical guidance
- Elderly: No routine dose adjustment required unless renal or hepatic impairment is present
19. Storage Conditions
- Store at temperatures not exceeding 25°C
- Protect from light and moisture
- Keep out of reach of children
- Do not freeze liquid formulations
20. Additional Sections
Overdosage:
No specific antidote. Symptoms may include gastrointestinal upset or dizziness. Management is supportive.
Clinical Effectiveness Note:
Evidence supports modest benefit in chronic bronchitis and COPD for selected patients. Benefit in acute cough is symptomatic rather than curative.
21. Frequently Asked Questions (FAQ)
Q: Is MUCOSIN® an antibiotic?
A: No. It has no antimicrobial activity.
Q: Can it be used with antibiotics?
A: Yes, as adjunct therapy.
Q: Is it suitable for dry cough?
A: No. It is intended for productive cough.
Q: How long should treatment last?
A: Typically 5–10 days for acute conditions unless otherwise directed by a physician.
22. References
- RAMEDA Pharmaceuticals – Product Literature and Technical Data
- European Medicines Agency (EMA). Ambroxol/Bromhexine Assessment Reports
- World Health Organization (WHO) Drug Information Monographs
- Gillissen A, Nowak D. Respiratory Medicine, 1998
- Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2024 Report
- LactMed Database, U.S. National Library of Medicine
