Ambroxol


Full Generic Medicine Info
Dosage/Direction for Use

Oral
As a mucolytic
Adult: As tab: Usual dose: 30 mg bid or tid, may be increased to 60 mg bid if necessary. Max: 120 mg daily. 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. Seek medical advice if symptoms persist for more than 14 days.
Child: As 6 mg/mL drops: ≤6 months Usual dose: 3 mg bid; 7 months to <1 year Usual dose: 6 mg bid; 1-2 years Usual dose: 7.5 mg bid. As 7.5 mg/mL drops: <2 years Usual dose: 7.5 mg bid; 2-5 years Usual dose: 7.5 mg tid. As 15 mg/5 mL or 30 mg/5 mL syr: <2 years Usual dose: 7.5 mg bid; 2-5 years Usual dose: 7.5 mg tid; 6-11 years Usual dose: 15 mg bid or tid; ≥12 years Same as adult dose. As 15 mg loz: 6-12 years Dissolve 1 loz tid. As tab: 6-11 years Usual dose: 15 mg tid; ≥12 years Same as adult dose.
Renal impairment: Dose reduction may be necessary.

Oral
Sore throat
Adult: As 20 mg loz: Dissolve 1 loz slowly in the mouth as necessary. Max: 6 loz daily. Seek medical advice if symptoms persist for more than 3 days.
Child: ≥12 years Same as adult dose.
Administration
Should be taken with food.
Special Precautions
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 Interactions
May increase the concentrations of antibiotics (e.g. cefuroxime, doxycycline, erythromycin, amoxicillin) in the lung tissue.
Action
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.
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.
Storage
Oral: Store below 30°C. Protect from light and excessive heat.
ATC Classification
R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Disclaimer: This information is independently developed by CIMS based on ambroxol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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