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INCEPTA PHARMACEUTICALS LTD.


Ambolyt

Indications.


Dosage


Side Effects



Ambolyt
Ambroxol hydrochloride

Presentation
Ambolyt Syrup: Each 5 ml of syrup contains Ambroxol hydrochloride BP 15 mg.

Ambolyt Paediatric Drops: Each 1 ml of drop contains Ambroxol hydrochloride BP 6 mg.

Description
Ambroxol is a metabolite of Bromhexine. It possesses mucokinetic (improvement in mucus transport) and secretolytic (liquefies secretions) properties. Ambroxol stimulates the serous cells of the glands of the mucous membrane of bronchi, increasing the content of mucus secretion. The mucolytic effect is associated with depolymerization and splitting of mucoproteins and mucopolysaccharide fibres, which leads to reduction in the viscosity of mucus. Expectoration of mucus is facilitated and breathing is eased considerably. Ambroxol stimulates production of phospholipids of surfactant by alveolar cells. Ambroxol has anti-inflammatory properties. In patients with COPD, it improves airway patency. Beside these, Ambroxol also exhibits anti-oxidant activity. Long-term use is possible because of the good tolerability of the preparation.

Indications and Uses
Acute and chronic diseases of respiratory tracts associated with viscid mucus including acute and chronic bronchitis Productive cough Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus Bronchiectasis Chronic pneumonia

Contraindications
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Dosage And Administration
Average daily dose (preferably after meal):
Ambolyt Paediatric 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
Ambolyt 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

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.

Side Effects
Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

Use in pregnancy & lactation
Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established.

Commercial Pack
Ambolyt Syrup: Amber color bottle containing 100 ml syrup and a measuring cup.
Ambolyt Paediatric Drops: Amber color bottle containing 15 ml paediatric drops and a calibrated dropper.;



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