Ambroxol: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
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.

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.

Renal Impairment

Mucolytic:
Dose reduction may be necessary.

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

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.

Chemical Structure

Storage

Store below 30°C. Protect from light and excessive heat.

MIMS Class

Cough & Cold Preparations

ATC Classification

R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

References

Amxol Tablets/Syrup (Medispec Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 06/05/2020.

Anon. Ambroxol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/05/2020.

Buckingham R (ed). Ambroxol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/05/2020.

Expel 6 mg/mL Oral Drops and 15 mg/5 mL Syrup (UNILAB, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/05/2020.

Expel OD Sustained-Release Capsule (UNILAB, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/05/2020.

Mucoangin Lozenge (Sanofi-Aventis). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/05/2020.

Mucosolvan 24 Hours (Boehringer Ingelheim Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/05/2020.

Mucosolvan 30 mg Tablets (Sanofi-Aventis Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/05/2020.

Mucosolvan 30 mg/5 mL Liquid (Sanofi-Aventis Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/05/2020.

Sinecough Expel Tablet; Oral Drops; Syrup (SmithKline Beecham). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/05/2020.

Strepsils Chesty Cough (Reckitt Benckiser Healthcare Manufacturing Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/05/2020.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com