X-Cold 15ml Pediatric Drops

X-Cold 15ml Pediatric Drops

DESCRIPTION

X-COLD (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. X-COLD (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.

COMPOSITION

Syrup : Each 5 ml contains Ambroxol hydrochloride BP15 mg.

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

INDICATIONS

• 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

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

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.

CONTRAINDICATIONS

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

PRECAUTIONS

X-COLD (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.

USE IN PREGNANCY AND 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.

DRUG INTERACTION

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

SUPPLY

Syrup : 100 ml syrup in amber glass bottle.

Paediatric Drops : Each bottle contains 15 ml paediatric drops and a calibrated dropper.