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ARGOM Appendix 5: Guidelines on OTC applications for specific substances
Note: This guidance document contains references to warning statements that are being included in the current updating of the RASML document. Warning statements marked with an (*) which are included in the updated version of the RASML document will be removed from this guidance document once the updated RASML is implemented.
Sponsors may use indications consistent with any or all of the representative indications set out below, as appropriate to a particular product, without the need to supply supporting efficacy data:
- For the temporary relief of pain (and discomfort) and/or inflammation associated with:
- migraine headache
- tension headache
- sinus pain
- dental procedures
- muscular aches and pains
- rheumatic pain
- menstruation/period pain
- sore throat
- tennis elbow
- colds and flu
- Reduces fever and/or the discomfort associated with fever.
For paediatric formulations, relief of pain and discomfort associated with teething, earache and immunisation may be added to any of the above, as appropriate to the age group.
Sponsors may propose other indications but should contact the OTC Medicines Evaluation for advice on whether data will be required to support the safety and efficacy of the product for those indications.
Combination OTC analgesic products that contain ibuprofen and codeine may include claims of 'strong' or 'powerful' pain relief (or similar). These claims will not be accepted for products that contain ibuprofen as the only analgesic agent, or ibuprofen in combination with another analgesic agent, unless the claims are justified on the basis of clinical efficacy data.
As fever is a normal and generally beneficial response to infection, no elaboration to the words "reduces fever" will be accepted except in the context of duration of treatment, relief of discomfort associated with fever or examples of conditions where fever may occur.
Adult dosage recommendations (adults and children 12 years and over):
- 200 mg to 400 mg every four to six hours as necessary. Dosage should not exceed 1200 mg (expressed on the label as the number of units, for example tablets) in 24 hours.
Paediatric dosage recommendations (3 months to 12 years):
- The recommended paediatric dose is 5-10 mg/kg/dose. Doses should be given every 6-8 hours as necessary with no more than four doses in 24 hours.
Where dosage instructions for children under 12 months of age are included on the labelling, the dosage instructions (see Table 1) must include statements advising that the product should not be given to infants under 3 months, and that it should only be given to infants aged 3-12 months following the advice of a doctor.
Labels could include appropriate discrete doses (consistent with the table below), instead of dosage ranges. E.g. for children aged 1-3 years, the label could include a dose equivalent to 100 mg (rather than a dosage range, such as 80-120 mg).
Wider age ranges (e.g. 1-3 years) could be used on product labelling where appropriate.
|Age||Average body weight (kg)||Dose (mg)|
|3 - 6 months||6 - 8 kg||40 - 60 mg|
|6 - 12 months||8 - 10 kg||60 - 80 mg|
|1 - 2 years||10 - 12 kg||80 - 100 mg|
|2 - 3 years||12 - 14 kg||100 - 120 mg|
|3 - 4 years||14 - 16 kg||120 - 140 mg|
|4 - 5 years||16 - 18 kg||140 mg|
|5 - 6 years||18 - 20 kg||140 - 160 mg|
|6 - 7 years||20 - 22 kg||160 - 180 mg|
|7 - 8 years||22 - 25 kg||180 - 200 mg|
|8 - 9 years||25 - 28 kg||200 - 220 mg|
|9 - 10 years||28 - 32 kg||220 - 240 mg|
|10 - 11 years||32 - 36 kg||240 - 280 mg|
|11 - 12 years||36 - 41 kg||280 - 300 mg|
Paediatric dosage - Liquid dose products
Where possible, dose volumes of liquid products should be expressed in whole numbers of mL. Doses should be presented with age, weight and volumes unless otherwise justified.
Recommended doses should be able to be measured using commonly available metric measuring devices or an appropriate measuring device provided with the product. There may be instances where doses need to be slightly different from the recommended milligram doses given above, depending on the ibuprofen concentration of the product, and/or the calibrations on dosing devices.
Sponsors intending to supply measuring devices with the product should refer to ARGOM Appendix 2 - Guidelines on quality aspects of OTC application: Section 8 Finished product container. Calibrations on measuring devices should be exclusively in metric units and should allow all the doses shown on the labels to be measured accurately. A sample of the proposed measuring device, or information on the calibrations intended for the measuring device, should be provided with the submission.
Dosage instructions could include advice consistent with the following:
- If you know that your child's weight is less than the weight corresponding to their age in the table, choose the dose for their weight.
Paediatric dosage - Solid dose products
Solid dose products that are intended to be swallowed whole should not include directions for use by children aged six years and under. Recognising that dosing with solid dose products is less flexible than with liquid products, these products could include a dose of 200 mg every 6-8 hours as necessary, with no more than four doses in 24 hours, for children aged 7-12 years.
Solid dosage forms that are specially designed and suitable for administration to younger children (e.g. chewable tablets) may be indicated for use in children from two years of age.
Differentiation of strengths
Sponsors should give close consideration to the labelling and presentation of different strength liquid and solid dose ibuprofen products, with the aim of minimising the possibility that the wrong dose may accidentally administered or taken.
Products containing ibuprofen together with one or more other active ingredients which are similar to existing registered products will usually not require efficacy or safety data, provided they comply with the guideline on fixed dose combination products (see ARGOM Appendix 1 - Guidelines on efficacy and safety aspects of OTC application: Section 9 Fixed dose combination products). Where new combinations are proposed (i.e. combinations and/or strengths that are not included in the ARTG for supply in Australia), the safety and efficacy of the combination will need to be justified.
See also 'Paediatric products'
See 'Diarrhoea treatments'
This guideline applies to any OTC laxative product, including oral dose forms, enemas and suppositories.
The correct management of uncomplicated constipation consists of correct diet, adequate fluid intake and suitable exercise. In cases where occasional treatment is required, the use of bulking agents is viewed favourably.
Product labels should include the following advice:
- Drink plenty of water;
- Increase fibre in diet except in cases of medication-induced constipation (e.g. with codeine);
- Prolonged use of laxatives is undesirable and may lead to dependence (this advice does not apply to bulk forming agents); and
- If symptoms persist seek medical advice.
Weight reduction claims will not be approved for products containing laxative ingredients.
Use of the term 'gentle' will not be approved in relation to products containing a stimulant laxative (e.g. senna alkaloids, bisacodyl).
The labels of products containing senna alkaloids, aloe or cascara should include a statement such as:
- *Do not use when abdominal pain, nausea or vomiting is present. If you are pregnant or breast feeding, seek medical advice before taking this product.
Products containing purgative ingredients, such as jalap, podophyllum or wahoo, are not regarded as acceptable therapy for the treatment of simple constipation.
See 'Anaesthetics, dermal'
Questions have been raised concerning the safety of the use of lindane for the treatment of head lice, body lice, crab lice, and scabies infestations. Serious adverse reactions to products containing lindane may result from incorrect use of the products. However, evidence from the literature shows that lindane has been used safely and effectively in millions of patients.
While it is unlikely that applications will be made for the registration of new products containing lindane, it is important to maintain access to these products for use in treatment of Norwegian scabies or in case of resistance to other agents.
The labels of products containing lindane must include warning statements consistent with the following:
- *This preparation must not be used on broken skin.
- *This preparation should be used with caution on infants, small children and pregnant or lactating women. Medical advice should be sought before use.
See also 'Head lice treatments'