Introduction
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of oral medicines containing ranitidine 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 substances
This monograph only applies to medicines containing ranitidine hydrochloride (CAS no. 66357-59-3) and excludes preparations containing any other salts and derivatives of ranitidine.
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) |
|---|---|---|
| Ranitidine (as hydrochloride) | 150 mg | Coated tablet, effervescent tablet |
| 300 mg | Coated tablet, effervescent tablet | |
| 15 mg/mL | Oral liquid |
* Ranitidine content, equivalent to 167.4 mg, 334.8 mg or 16.74 mg/mL ranitidine hydrochloride, respectively.
Indications
Required therapeutic indications for inclusion in the Australian Register of Therapeutic Goods
Relief of symptoms of gastro-oesophageal reflux.
Label indications
- Symptomatic relief of heartburn
- Reference should also be made, at least once, to relief of 'symptoms of gastro-oesophageal reflux' or 'heartburn due to gastro-oesophageal reflux' or similar.
The following label indications/claims are also acceptable:
- Symptomatic relief of acid indigestion and/or dyspepsia
- 'Works by decreasing the amount of acid made by the stomach', or similar
- 'Long lasting'
- For 150 mg tablet and oral liquid: 'Up to 12 hours relief' and/or '12 hour action'
- For 300 mg tablet: A prominent statement is required on the main panel of the carton label indicating that the medicine is intended for use by patients who routinely require two 150 mg ranitidine tablets for relief of their symptoms. The statement should be presented in such a way that it clearly stands out to prospective purchasers.
Directions for use
Directions are to be as shown in the table below.
| Dosage form and strength | Directions |
|---|---|
| 150 mg tablet | Adults and children 12 years and over: Take one tablet at the first sign of symptoms. If symptoms return or persist for more than one hour, take another tablet. Do not take more than 2 tablets in 24 hours. Do not use in children under 12 years. |
| 300 mg tablet | Adults and children 12 years and over: Take one tablet at the first sign of symptoms. Do not take more than 1 tablet in 24 hours. Do not use in children under 12 years. |
| 15 mg/mL oral liquid | Adults and children 12 years and over: Take 10 mL at the first sign of symptoms. If symptoms return or persist for more than one hour, take another 10 mL. Do not take more than 2 doses (20 mL) in 24 hours. Do not use in children under 12 years. |
For effervescent tablets, refer to placing the tablet in water and waiting till dissolved.
Directions for coated tablets may refer to taking with a glass of water.
Requirements in relation to measuring devices provided with oral liquid products are included under Container/measuring device.
Labelling
- Labelling must comply with all relevant Australian regulatory requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.
- In addition to statements required by RASML, the following statement is required:
- 'If you are pregnant or intend to become pregnant, or are breastfeeding, check with your doctor or pharmacist before using this product.'#
- # This statement will be revised pending a final outcome on a RASML consultation on a pregnancy and breastfeeding warning statement for ranitidine.
- Where 150 and 300 mg strengths of the same brand name are to be marketed, there must be sufficient differentiation between the product name and labelling of the two different strengths (e.g. inclusion of 'Extra strength' in the product name of the 300 mg product and colour differentiation between labelling).
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 ranitidine 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.
The requirements below include all relevant BP general monograph/USP General Chapter requirements and TGO78 requirements. Further reference to these is not required. References to pharmacopoeial monographs below refer to the current monograph at time of application.
Coated tablets
The tests and limits in the BP monograph Ranitidine Tablets with the addition of:
- tablet appearance
- dissolution (900 mL water, paddle at 50 rpm, 80% (Q) after 45 minutes)1
- uniformity of dosage units (BP)
- microbiological quality, in compliance with TGO 77
Effervescent tablets
The tests and limits in the BP monograph Ranitidine Tablets with the addition of:
- tablet appearance
- disintegration (BP)
- uniformity of dosage units (BP)
- microbiological quality, in compliance with TGO 77
Oral liquid
The tests and limits in the BP or USP monograph Ranitidine Oral Solution with the addition of:
- solution appearance
- content of any preservatives included in the formulation
- microbiological quality, in compliance with TGO 77
Reference
- From Ranitidine Tablets USP
Container/measuring device
- If a measuring device is to be supplied with the product, 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 | 16/12/2014 |