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Introduction
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of oral liquid preparations containing pholcodine 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 substances
This monograph only applies to pholcodine (CAS no. 509-67-1) as a single active ingredient and excludes preparations containing any salts and derivatives of pholcodine.
Dosage forms and strengths
Acceptable dosage forms and strengths are shown in the table below.
| Active substance | Dosage strengths | Dosage forms |
|---|---|---|
| Pholcodine | 1, 2 and 3 mg/mL | Oral liquid |
Indications
Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Required indication is "Cough suppressant for the temporary relief of non-productive, dry cough".
Label indications
Required label indication is "Temporary relief of dry cough".
Further description of the cough may be included by selecting one or more of the following:
- non-productive: stubborn
- non-productive: tickly
Directions for use
Dosages must be as shown in the following table.
| Dosage strength | Age | Single dose | Dose interval | Maximum daily dose |
|---|---|---|---|---|
| 1 mg/mL | Adults and children 12 years and over | 10-15 mL (10-15 mg) | Every 6 to 8 hours as necessary | 4 doses |
| Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner) | 5-10 mL (5-10 mg) | Every 6 to 8 hours as necessary | 4 doses | |
| Do not use in children under 6 years of age. | ||||
| 2 mg/mL | Adults and children 12 years and over | 5-7.5 mL (10-15 mg) | Every 6 to 8 hours as necessary | 4 doses |
| Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner) | 2.5-5 mL (5-10 mg) | Every 6 to 8 hours as necessary | 4 doses | |
| Do not use in children under 6 years of age. | ||||
| 3 mg/mL | Adults and children 12 years and over | 5 mL (15 mg) | Every 6 to 8 hours as necessary | 4 doses |
| Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner) | 2.5 mL (7.5 mg) | Every 6 to 8 hours as necessary | 4 doses | |
| Do not use in children under 6 years of age. | ||||
Additional instructions
The following instruction is also required:
If coughing persists, consult your doctor or pharmacist.
Labels
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 finished product specifications must comply, at a minimum, with the relevant set of requirements below:
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 all relevant BP general monograph requirements. Further reference to these is not required. Reference to the BP monograph below refer to the current monograph at the time of application.
Oral liquid
The tests and limits in the BP monograph Pholcodine Linctus with the addition of:
- oral liquid appearance;
- tests and limits for pH;
- individual unspecified impurities (NMT 1.0%); and total impurities (NMT 3.0%);
- content of any preservatives included in the formulation, and
- microbiological quality in compliance with TGO 77.
Container/measuring device
Pholcodine 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.
Copyright
© Commonwealth of Australia 2014
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | OTC Medicines Evaluation/Office of Medicines Authorisation | 10/06/2014 |
| V1.1 | Revision to additional instructions as per outcome of RASML consultation on OTC oral cough medicines | OTC Medicines Evaluation/Office of Medicines Authorisation | 09/09/2014 |
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