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Purpose
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of oral preparations containing dextromethorphan hydrobromide 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.
Legislation
Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (29/10/2008)
Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines (22/09/2008)
Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)
Active substance
This monograph only applies to medicines containing dextromethorphan hydrobromide (CAS no. 6700-34-1) and excludes preparations containing any other salts and derivatives of dextromethorphan.
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) |
|---|---|---|
| Dextromethorphan hydrobromide | 5 and 10 mg | Lozenge Pastille |
| 2 mg/mL and 3mg/mL | Oral liquid |
Indications
Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Cough suppressant for the temporary relief of non-productive cough.
For lozenges, 'helps soothe sore throats' may be included.
Label indications
Temporary relief of dry cough.
The following may also be included:
- Qualification with 'due to common colds'.
- Further description of the cough with one or more of the following terms: non-productive/irritating/stubborn/tickly.
- Relieves dry coughs by suppressing the urge to cough
The following label claims are also acceptable:
- For lozenges:
- Helps soothe sore throats
- Fast/rapid relief from dry cough
- For oral liquid:
- Long lasting relief for up to 8 hours (for those with 30 mg single dose every 6-8 hours frequency)
- Fast/rapid relief from dry cough
Directions for use
Dosages must be as shown in the following table.
| Dosage strength | Age | Dosage |
|---|---|---|
| 5 mg | Adults and children 12 years and over | Slowly suck 2 lozenges/pastilles, one after the other, every 2 - 3 hours if necessary. Maximum 24 lozenges/pastilles in 24 hours. |
| Children 6 -11 years* | Slowly suck 1 lozenge/pastille every 2 - 3 hours if necessary. Maximum 12 lozenges/pastilles in 24 hours. | |
| 10 mg | Adults and children 12 years and over | Slowly suck 1 - 2 lozenges/pastilles, one after the other, every 4 hours if necessary. Maximum 12 lozenges/pastilles in 24 hours. |
OR Slowly suck 1 - 3 lozenges/pastilles, one after the other, every 4 - 6 hours if necessary. Maximum 12 lozenges/pastilles in 24 hours. | ||
| Children 6 - 11 years* | Slowly suck 1 lozenge/pastille every 4 - 6 hours if necessary. Maximum 6 lozenges/pastilles in 24 hours. |
*only on the advice of a doctor, pharmacist or nurse practitioner.
| Dosage strength | Age | Dosage |
|---|---|---|
| 2 mg/mL | Adults and children 12 years and over | 5 - 10 mL (10 - 20 mg) every 4 hours if necessary, maximum 6 doses (120 mg) per day. |
OR 15 mL (30 mg) every 6 - 8 hours if necessary, maximum 4 doses (120 mg) per day. | ||
| Children 6 - 11 years* | 2.5 - 5 mL (5 - 10 mg) every 4 hours if necessary, maximum 6 doses (60 mg) per day. | |
OR 7.5 mL (15 mg) every 6 - 8 hours if necessary, maximum 4 doses (60 mg) per day. | ||
| 3 mg/mL | Adults and children 12 years and over | 10 mL (30 mg) every 6- 8 hours if necessary, maximum 4 doses (120 mg) per day. |
| Children 6 - 11 years* | 5 mL (15 mg) every 6 - 8 hours if necessary, maximum 4 doses (60 mg) per day. |
*only on the advice of a doctor, pharmacist or nurse practitioner.
Include the following for all dosage forms:
- Do not give to 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 11 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 (RASML).
Advisory statements
The following advisory statements are required:
- If coughing persists, consult your doctor or pharmacist.
- Do not take this medicine if you are taking a monoamine oxidase inhibitor (MAOI) or an antidepressant or have taken the MAOI or antidepressant medicine within the past two weeks.
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 dextromethorphan hydrobromide monograph medicines:
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.
The requirements below include relevant BP general monograph/USP General Chapter requirements and TGO78 requirements. References to pharmacopoeial monographs below refer to the current monograph at time of application.
For lozenges, the following tests and limits:
- organoleptic properties such as lozenge appearance, odour, taste, etc
- identification of dextromethorphan hydrobromide
- dextromethorphan hydrobromide content of 92.5 - 107.5%
- uniformity of dosage units (BP)
- microbiological quality in compliance with TGO 77.
For oral solutions, the tests and limits in the USP monograph Dextromethorphan Hydrobromide Oral Solution with the addition of:
- organoleptic properties such as solution appearance, odour, taste, etc
- content of any preservatives included in the formulation
- pH
- microbiological quality in compliance with TGO 77.
Container/measuring device
- Dextromethorphan medicines must be sold in containers that comply with Therapeutic Goods Order No 80, Child Resistant Packaging Requirements for Medicines.
- If a measuring device is to be supplied with the medicine, calibrations must be exclusively in metric units and must allow all the doses shown on the labels to be measured accurately. Details of the calibrations on the measuring device must be provided with the submission (a sample may also be requested). Further considerations and requirements regarding measuring devices are detailed in ARGOM Appendix 2: Guidelines on quality aspects of OTC applications, 8. Finished product container.
Page history
Original publication.
Original publication.