Amboral 6 mg/ml

INDICATIONS

Ambroxol Hydrochloride is indicated in-

Productive cough
Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
Asthmatic bronchitis bronchial asthma with thick expectoration
Bronchiectasis
Chronic pneumonia etc.

PHARMACOLOGY

Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

DOSAGE & ADMINISTRATION

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.

INTERACTION

Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

SIDE EFFECTS

Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

PREGNANCY & LACTATION

Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

PRECAUTIONS & WARNINGS

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

THERAPEUTIC CLASS

Cough expectorants & mucolytics

STORAGE CONDITIONS

Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.