AMBEET®– Ambroxol Hydrochloride BP
COMPOSITION
Syrup: Each teaspoonful (5ml) of the syrup contains Ambroxol Hydrochloride BP 15 mg.
Capsule: Each capsule contains sustained release pellets of Ambroxol hydrochloride equivalent to Ambroxol hydrochloride BP 75 mg.
PHARMACOLOGY
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolyt¬ic effect than bromhexine. It improves sputum rheology by hydration mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspenia. 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 hyperac¬tivity. Ambroxol has anti-inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachi¬donic acid metabolites. In patients with COPD it traditionally improves airway patency.
INDICATIONS
• Productive cough
• Acute and chronic inflammatory disorders of respiratory tracts associated with viscid mucus including acute and chronic bronchitis
• Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus
• Asthmatic bronchitis, Bronchial asthma with thick expectoration
• Bronchiectasis
• Chronic pneumonia
DOSAGE & ADMINISTRATION
Average daily dose (preferably after meal) Ambeet® 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.
Ambeet® Capsule: Adults and children over 12 years old: One Capsule, Once daily.
SIDE EFFECTS
Gastrointestinal side effects like epigastric pain, stomach overfills feeling may occur occasionally. Rarely allergic responses such as eruption, urticarial or angioneurotic edema have been reported.
PRECAUTIONS
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.
CONTRAINDICATIONS
There are no absolute contraindications but in patients with gastric ulceration relative caution should be observed. Contraindicated in known Gypersensitivity to Ambroxol Hydrocloride or bromhexin.
DRUG INTERACTION
Ambroxol has no interaction with cardio active glycosides, cortico¬steroids, bronchodilators, diuretics and antibiotics. But Ambroxol should not be taken simultaneously with antitussives.
USE IN PREGNANCY & LACTATION
Pregnancy: Teratogenic and fetal toxicity studies have no harmful effect of ambroxol. However, it is advisable to avoid use during the first trimester of pregnancy.
Lactation: Safety during lactation has not been established.
STORAGE
Store below 30°c in a cool & dry place. Keep out of the reach of children.
PACKAGING
Ambeet®: Syrup: Bottle containing 100 ml syrup with a measuring spoon.
Ambeet®: Capsule 75 mg: Box containing 3×10 capsules of blister pack.
