Kofmelt

Composition

Kofmelt syrup: Each 5 ml syrup contains Ambroxol Hydrochloride BP 15 mg.

Pharmacology

Ambroxol Hydrochloride is the active metabolite of Bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than Bromhexine. It improves sputum rheulogy by hydrating mechanism leading to liquefication 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 patient with COPD it traditionally improves airway patency.

Indication

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.

Dosage and Administration

Average daily dose (preferably after meal):

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

Side Effect

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

Contraindication

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Precaution

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.

Drug Interaction

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

Use In Pregnancy and Lactation

Teratogenic and foetal toxicity studies have shown no harmful effect of Ambroxol Hydrochloride. However it is advised not to use it in pregnancy, especially during the 1st trimester. Safety during lactation has not been established yet.

Storage

Keep out of the reach of children. Keep below 30°C, protect from light.

How supplied

Kofmelt syrup: Bottle containing 100 ml syrup with measuring cup.