Ambroxol Hydrochloride is indicated for:

• Productive cough
• Acute and chronic inflammatory conditions of the upper and lower respiratory tract associated with thick (viscid) mucus, including acute and chronic bronchitis
• Inflammatory disorders of the rhinopharyngeal tract such as laryngitis, pharyngitis, sinusitis, and rhinitis with thick mucus
• Asthmatic bronchitis and bronchial asthma with difficult expectoration
• Bronchiectasis
• Chronic pneumonia and related conditions

Ambroxol is the active metabolite of bromhexine and exhibits a stronger bronchosecretolytic effect. It improves the properties of sputum by increasing hydration, leading to thinning of mucus within the respiratory tract and facilitating its removal, thereby reducing breathing difficulty. It stimulates surfactant production by alveolar cells, which lowers surface tension in the alveoli and supports better lung function. Ambroxol also reduces bronchial hyperreactivity and possesses anti-inflammatory properties by inhibiting the release of inflammatory mediators such as cytokines and arachidonic acid derivatives. In patients with chronic obstructive pulmonary disease (COPD), it helps improve airway patency.

Average daily dose (preferably after meal):

Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.

Ambroxol should not be used together with antitussive agents (e.g., codeine), as suppression of cough may prevent the clearance of loosened mucus.

Contraindicated in patients with known hypersensitivity to Ambroxol or Bromhexine.

Occasionally, gastrointestinal disturbances such as epigastric discomfort and a sensation of fullness in the stomach may occur. Rarely, allergic reactions including skin rash, urticaria, or angioedema have been reported.

Animal studies have not demonstrated teratogenic or fetal toxicity. However, its use is not recommended during pregnancy, particularly in the first trimester. Safety during breastfeeding has not been fully established.

Ambroxol should be used with caution in patients with gastric or duodenal ulcers and in those with seizure disorders. Patients with impaired liver or kidney function should also use it carefully.

Expectorants and mucolytic agents.

Store in a dry place below 30°C, protected from direct light. Keep out of reach of children.