Bromhexine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

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

Generic Medicine Info

Indications and Dosage

Oral
Mucolytic

Adult: For the treatment of bronchopulmonary diseases or conditions associated with excessive mucous secretion: 8 mg tid as needed, may be increased to 16 mg tid for the 1st 7 days.
Child: 2-5 years 2 mg tid or 4 mg bid (Max: 8 mg daily); 6-11 years 4-8 mg tid (Max: 24 mg daily); ≥12 years Same as adult dose. Treatment or dosage recommendations may vary among countries and individual products (refer to detailed product guideline).

Administration

May be taken with or without food.

Special Precautions

Patient with existing or history of gastric ulceration; asthma. Severe renal and hepatic impairment. Children. Pregnancy and lactation.

Adverse Reactions

Significant: Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis.
Gastrointestinal disorders: Diarrhoea, nausea, vomiting, upper abdominal pain.
Immune system disorders: Hypersensitivity reaction (including anaphylactic reaction and shock, angioedema, bronchospasm).
Investigations: Increased serum amino transaminase (transient).
Nervous system disorders: Headache, dizziness.
Skin and subcutaneous tissue disorders: Rash, sweating, urticaria, pruritus.

Drug Interactions

Enhances the penetration of antibiotic agents (e.g. amoxicillin, erythromycin, cefuroxime) into bronchial secretions.

Action

Description: Bromhexine is a mucolytic agent that acts on the mucus gland in the respiratory tract to change the structure of bronchial secretion. It enhances the transport of mucus by reducing its viscosity and increases cilia activity resulting in enhanced mucociliary clearance. This secretolytic and secretomotor effect in the bronchial tract facilitates expectoration and relieves cough.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: Approx 22.2 ± 8.5% (tab); 26.8 ± 13.1% (oral solution). Time to peak plasma concentration: Approx 1 hour.
Distribution: Crosses blood brain-barrier; placenta (small amounts). Plasma protein binding: 95% (unchanged drug).
Metabolism: Almost completely metabolised to a variety of hydroxylated metabolites, including ambroxol and dibromanthranilic acid. Undergoes extensive hepatic first-pass metabolism.
Excretion: Via urine (approx 97.4 ± 1.9%; <1% as unchanged drug). Terminal elimination half-life: 6.6-31.4 hours (single dose).

Chemical Structure

Storage

Store below 30°C. Protect from light. Storage recommendations may vary among individual products. Refer to detailed product guidelines.

MIMS Class

Cough & Cold Preparations

ATC Classification

R05CB02 - bromhexine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

References

Anon. Bromhexine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/02/2022.

Axcel Bromhexine Syrup (Kotra Pharma [M] Sdn. Bhd.). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 18/02/2022.

Buckingham R (ed). Bromhexine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/02/2022.

Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics. Bisolvon Chesty Forte Tablets and Oral Solution data sheet 20 December 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 08/02/2022.

Rexom Bromhexine Elixir (KCK Pharmaceutical Industries Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2022.

RiteMed Bromhexine Tablet (Ritemed Phils, Inc). MIMS Philippines. http://www.mims.com/philippines. Accessed 18/02/2022.

Vasican Tablets 8 mg (Actavis Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 18/02/2022.

Disclaimer: This information is independently developed by MIMS based on Bromhexine 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com