Ambroxol: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

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

Generic Medicine Info

Indications and Dosage

Oral
Mucolytic

Adult: For the treatment of bronchopulmonary diseases associated with abnormal mucus secretion and clearance: As immediate-release preparation: 60-120 mg daily in 2-3 divided doses. As slow-release (retard) cap: 75 mg once daily. As 15 mg loz: Suck up to 6 loz daily (Max: 2 loz per dose). Seek medical advice if symptoms persist for more than 14 days.
Child: As immediate-release preparation: 2-5 years 7.5-15 mg tid; 6-12 years 15-30 mg bid or tid; ≥12 years Same as adult dose. As 15 mg loz: 6-12 years Suck 1 loz tid.

Administration

Should be taken with food.

Special Precautions

Patient with history of peptic ulceration. Renal and hepatic impairment. Treatment with a cough medicine in children should be considered carefully due to potential risks and limited evidence on efficacy. Pregnancy and lactation.

Adverse Reactions

Significant: Hypersensitivity reactions (e.g. rash, pruritus, urticaria, anaphylactic shock, angioedema).
Gastrointestinal disorders: Diarrhoea, dyspepsia, nausea, vomiting, abdominal pain, heartburn, bloated feeling, dry mouth or throat, dysgeusia, oral and pharyngeal hypoaesthesia.
Potentially Fatal: Rarely, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug Interactions

May increase the concentrations of antibiotics (e.g. amoxicillin, cefuroxime, erythromycin).

Lab Interference

May give false-positive results for lysergic acid diethylamide (LSD) using cloned enzyme donor immunoassay technology for drugs of abuse in urine (CEDIA DAU).

Action

Description:
Mechanism of Action: Ambroxol is a mucolytic agent that increases respiratory tract secretion by enhancing the production of pulmonary surfactants and stimulating ciliary activity. This results in the improvement of mucociliary clearance and enhancement of fluid secretion which facilitates expectoration and eases cough.
Onset: Rapid (loz); within 2 hours (oral solution and syr).
Duration: ≥3 hours (loz).
Pharmacokinetics:
Absorption: Rapidly and completely absorbed (immediate-release). Bioavailability: 79% (immediate-release); 95% (slow-release). Time to peak plasma concentration: 1-2.5 hours (immediate-release); 6.5 hours (slow-release).
Distribution: Rapid and pronounced distribution into body tissues with the highest concentration in the 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 and minor metabolites; undergoes first-pass metabolism.
Excretion: Mainly via urine (approx 83%). Elimination half-life: Approx 10 hours.

Chemical Structure

Storage

Store below 30°C. Protect from light.

MIMS Class

Cough & Cold Preparations

ATC Classification

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

References

Ambrodil 75 mg Sustained Release Capsule (Lloyd Laboratories, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/02/2023.

Ambroxyl 15 mg/5 mL Syrup (Lloyd Laboratories Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/02/2023.

Ambroxyl 30 mg Tablet (Lloyd Laboratories Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/02/2023.

Amxol Tablets/Syrup (Medispec [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/02/2023.

Anon. Ambroxol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/02/2023.

Buckingham R (ed). Ambroxol Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/02/2023.

Mucosolvan (Delpharm Reims). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/02/2023.

Mucosolvan 24 Hours (Boehringer Ingelheim [M] Sdn.Bhd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/02/2023.

Mucosolvan 24 Hours (Sanofi-Aventis Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/02/2023.

Mucosolvan 30 mg Tablets (Sanofi-Aventis Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/02/2023.

Mucosolvan 30 mg/5 mL Liquid (Sanofi-Aventis Singapore Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/02/2023.

Strepsils Chesty Cough (Reckitt Benckiser Healthcare Manufacturing Thailand Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 06/02/2023.

Strepsils Chesty Cough Lozenges (Reckitt Benckiser Healthcare Manufacturing Thailand Ltd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/02/2023.

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