Contents

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Indication

Listed in Dosage.

Dosage / Direction For Use

Adult : PO Mucolytic As tab: Usual dose: 30 mg bid or tid, may be increased to 60 mg bid if necessary. Max: 120 mg/day. As 30 mg/5 mL syr: Usual dose: 30 mg bid or tid, or 60 mg bid. As 15 mg/5 mL syr: Usual dose: 30 mg bid or tid. As 15 mg loz: Dissolve 2 loz slowly in the mouth tid. As sustained-release or retard cap: 75 mg once daily. Sore throat As 20 mg loz: Dissolve 1 loz slowly in the mouth as necessary. Max: 6 loz/day.

Overdosage

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Administration

Should be taken with food.

Contraindication

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Special Precaution

Patient with stomach or duodenal ulcers, ciliary dyskinesia, and bronchial conditions. Renal and hepatic impairment. Children. Pregnancy and lactation.

Adverse Reactions

Significant: Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), erythema multiforme.Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, dry mouth or throat, abdominal pain, heartburn, oral or pharyngeal hypoaesthesia, dysgeusia.Potentially Fatal: Rarely, anaphylactic reactions (e.g. anaphylactic shock, angioedema, rash, urticaria, pruritus).

Drug Interaction

May increase the concentrations of antibiotics (e.g. cefuroxime, doxycycline, erythromycin, amoxicillin) in the lung tissue.

Storage

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Description

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Action

Description: Ambroxol is a mucolytic agent that increases respiratory tract secretion by enhancing the production of pulmonary surfactants and stimulating the ciliary activity. This activity results in the improvement of mucociliary clearance and enhancement of fluid secretion which facilitates expectoration and eases cough.Pharmacokinetics:Absorption: Rapidly and completely absorbed from the gastrointestinal tract (immediate-release). Bioavailability: 79% (immediate-release); 95% (slow-release). Time to peak plasma concentration: 1-2.5 hours (immediate-release); 6.5 (slow-release).Distribution: Rapid and pronounced distribution into blood, tissues and lungs. Crosses the placenta and enters breast milk. Volume of distribution: Approx 552 L. Plasma protein binding: Approx 90%.Metabolism: Mainly metabolised in the liver via glucuronidation by CYP3A4 and some cleavage into dibromanthranilic acid (approx 10%) and minor metabolites. Undergoes first-pass metabolism (approx 30%).Excretion: Via urine. Terminal elimination half-life: Approx 10 hours.