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OTC medicine monograph: Bromhexine hydrochloride

Version 1.0, September 2015

15 September 2015

Introduction

This OTC Medicine Monograph outlines the requirements for Australian market authorisation of preparations containing bromhexine hydrochloride as a single active ingredient when applied for as an OTC new medicine  N2 application. Proposed medicines must comply with all aspects of the monograph relevant to their strength and dosage form to qualify for evaluation as an N2 application.

This monograph should be read in conjunction with the document Requirements for OTC new medicine N2 applications.

Active substance

This monograph only applies to preparations that contain bromhexine hydrochloride (CAS no. 611-75-6) as the only active ingredient and excludes preparations containing any other salts and derivatives of bromhexine.

Dosage forms and strengths

Acceptable dosage forms and strengths are shown in the table below.

Active substance Dosage strengths Dosage forms
(Excludes modified release dosage forms)

Bromhexine hydrochloride

Bromhexine hydrochloride

Oral liquid

8 mg

Tablets (conventional immediate release tablets and soluble tablets only)

Indications

Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)

Mucolytic. Breaks down mucus and helps clear chest congestion.

Label indications

Required label indication is 'Helps clear chest congestion'.
Further description of the relief of chest congestion may be included by selecting one or more of the following: 

  • Thins/loosens/breaks down mucus to help clear the chest
  • Mucolytic
  • Helps clear stubborn chest congestion
  • Chesty cough

Directions for use

Directions must be as shown in the table below, as relevant.

Lozenges or pastilles
Dosage strength Age Single dose Dose interval Maximum daily dose
0.8 mg/mL oral liquid Adults and children 12 years and over

10-20 mL

(8-16 mg)

Every 8 hours as necessary 3 doses
Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner)*

10 mL

(8 mg)

Every 8 hours as necessary 3 doses
Do not use in children under 6 years of age.
1.6 mg/mL oral liquid Adults and children 12 years and over

5-10 mL

(8-16 mg)

Every 8 hours as necessary 3 doses
Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner)*

5 mL

(8  mg)
Every 8 hours as necessary 3 doses

Do not use in children under 6 years of age.

8 mg tablet Adults and children 12 years and over

1 to 2 tablets

(8-16 mg)

Every 8 hours as necessary 3 doses
Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner)*

1 tablet

(8  mg)

Every 8 hours as necessary 3 doses

Do not use in children under 6 years of age.

* If the medicine is not to be indicated for children below 'x' years of age (where 'x' is any age between 6 and 12 years of age), then the label must contain the statement "Do not give to children under 'x' years of age" as required by the Required Advisory Statements for Medicine Labels).

Advisory statements

The following advisory statement is also required:

If symptoms persist, consult your doctor or pharmacist.

Labelling

Labelling must comply with all relevant Australian requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.

Quality requirements

In addition to the quality requirements outlined in the document Requirements for OTC new medicine N2 applications, the following specific requirements apply to bromhexine hydrochloride monograph medicine.

Finished product specifications

In addition to other requirements specified in the document Requirements for OTC new medicines N2 applications, the finished product specifications must comply, at a minimum, with the relevant set of requirements below.

For tablets, the following tests and limits:

  • tablet appearance
  • identity of bromhexine hydrochloride
  • for soluble tablets only: disintegration (disintegrate within 3 minutes, using water at 15-25°C as the liquid medium)
  • uniformity of dosage units (BP)
  • dissolution (a suitable test and limit for dissolution that demonstrates the appropriate release of the active ingredient)
  • bromhexine hydrochloride content of 92.5 - 107.5%
  • individual unspecified impurity (not more than 1.0%) and total impurities (not more than 3.0%)
  • microbiological quality in compliance with Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines.

For oral liquids, the following tests and limits:

  • organoleptic properties (such as appearance, smell, taste etc)
  • pH
  • identity of bromhexine hydrochloride
  • bromhexine hydrochloride content of 90.0 - 110.0%
  • individual unspecified impurity (not more than 1.0%) and total impurities (not more than 3.0%)
  • content of any preservatives included in the formulation
  • microbiological quality in compliance with Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines.

Container/measuring device

Version History
Version Description of change Author Effective date
V1.0 Original publication OTC Medicines Evaluation/Complementary and OTC Medicines Branch 15/09/2015