Europe — EMA
Mucosolvan Pro Dospělé (Ambroxol Hydrochloride)
GNH USA supplies Mucosolvan Pro Dospělé (Ambroxol Hydrochloride), a mucolytic for acute or chronic bronchitis with productive cough.
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What is Ambroxol Hydrochloride?
Ambroxol Hydrochloride, the active ingredient in Mucosolvan Pro Dospělé, is a mucolytic presented as an oral tablet for oral use. Available in the European Union market, it facilitates clearance of bronchial secretions and helps relieve productive cough in adults suffering from acute or chronic bronchitis and other bronchopulmonary conditions characterized by thick mucus.
GNH USA supplies Mucosolvan Pro Dospělé as a licensed, GDP‑compliant international pharmaceutical supplier, providing reliable supply chains to hospitals, pharmacies and clinics worldwide.
What is Ambroxol Hydrochloride used for?
Ambroxol Hydrochloride is used as an expectorant in respiratory conditions where thick mucus impairs clearance. - Acute bronchitis with productive cough: reduces mucus viscosity and promotes expectoration. - Chronic bronchitis: aids in clearing persistent sputum and improves breathing comfort. - Chronic obstructive pulmonary disease (COPD): facilitates mucus clearance to lessen cough frequency.
What are the side effects of Ambroxol Hydrochloride?
Ambroxol Hydrochloride may cause a range of adverse reactions, most of which are mild and transient.
Common Side Effects: - Taste disturbance: a temporary bitter or metallic taste in the mouth. - Nausea: mild stomach upset after oral administration. - Abdominal discomfort: mild cramps or discomfort in the abdomen. - Diarrhoea: loose stools occurring shortly after dosing. - Headache: mild to moderate headache. - Skin rash: mild erythema or itching.
Serious or Rare Side Effects: - Allergic reactions: urticaria, swelling, or anaphylaxis. - Angioedema: rapid swelling of face, lips, or tongue. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Eosinophilia: elevated eosinophil count in blood. - Hepatic enzyme elevation: increased ALT/AST levels. - Neutropenia: reduced neutrophil count leading to infection risk.
What precautions apply to Ambroxol Hydrochloride?
When prescribing Ambroxol Hydrochloride, several safety considerations should be observed. - Assess renal function: adjust use in patients with severe renal impairment. - Monitor for allergic reactions: discontinue if rash, urticaria, or anaphylaxis occurs. - Caution in asthma: ensure cough is productive before use to avoid airway obstruction. - Avoid concomitant antitussives: do not combine with cough suppressants that may retain mucus. - Pregnancy and lactation: use only if benefit outweighs potential risk, as safety data are limited. - Store at ambient temperature below 25 °C: keep in the original packaging, protect from moisture and direct sunlight.
What does Ambroxol Hydrochloride interact with?
Ambroxol Hydrochloride can interact with other medicines, affecting efficacy or safety.
Major Interactions (Avoid): - Antitussive agents (e.g., codeine, dextromethorphan): may suppress cough and hinder mucus clearance. - Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase ambroxol plasma levels, raising risk of side effects.
Moderate Interactions (Monitor Closely): - Bronchodilators (e.g., salbutamol): may have additive respiratory effects; monitor response. - Antibiotics metabolised by the liver (e.g., erythromycin): ambroxol may alter their pharmacokinetics. - Anticoagulants (e.g., warfarin): occasional reports of altered INR; check coagulation parameters.



