Meeting requirements for over-the-counter (OTC) medicine laxatives containing docusate sodium and/or sennosides

This monograph only applies to medicines containing docusate sodium (CAS no. 577-11-7) and/or Sennosides USP¹ (a partially purified complex containing not less than 60% Sennosides A and B) as active ingredients and excludes preparations containing any other salts or derivatives of these substances.

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

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

Docusate sodium

Faecal softener for relief of constipation.

Sennosides A and B

Stimulant laxative for relief of constipation.

Docusate sodium and sennosides

Faecal softener and stimulant laxative for relief of constipation.

Label indications

Docusate sodium

• Stool softener or softens the stools or stool softening laxative

Sennosides A and B

• For the relief (or treatment) of constipation (required)
• Laxative or stimulant laxative (also acceptable)

Docusate sodium and sennosides

• For the relief (or treatment) of constipation (required)
• References to stool softener and  laxative or stimulant laxative as above (also acceptable)

Dosage

Dosage must be as shown in the table below.

Reference to taking the dose at bedtime is acceptable.

Advisory statements

The following statements, or words to the effect, are required:

For docusate sodium:

• Not recommended for use in children under 12 years.
• Do not take with other medicines or liquid paraffin, unless advised by a doctor.
• Drink plenty of water.
• Increase fibre in diet except in cases of medication-induced constipation (e.g. with codeine);
• If symptoms persist, seek advice from a health care practitioner.
• Prolonged use is not recommended and may lead to dependence.

For sennosides:

• Not recommended for use in children under 12 years.
• Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea.
• If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product.
• Drink plenty of water.
• Increase fibre in diet except in cases of medication-induced constipation (e.g. with codeine).
• If symptoms persist, seek advice from a health care practitioner.
• Prolonged use is not recommended and may lead to dependence or serious bowel problems.

For docusate sodium and sennosides:

Include all of the above statements for sennosides as well as the following, regarding docusate sodium:

• Do not take with other medicines or liquid paraffin, unless advised by a doctor.

Note: This monograph currently includes all required advisory statements for docusate sodium and sennosides, including those specified in the 'Australian regulatory guidelines for OTC medicines' (ARGOM) and the 'Required advisory statements for medicine labels' (RASML).

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.

Sennosides content should be expressed on labelling as 'Sennosides A and B'.

In addition to the quality requirements outlined in the document Requirements for OTC new medicine N2 applications, the specific requirements detailed below also apply.

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.

As for all N2 applications, tests for identification, assay and dissolution must use either the relevant pharmacopoeial method validated for specificity and accuracy or an alternative equivalent or superior method validated fully as described in the ICH guideline, CPMP/ICH/381/95 Note for Guidance on Validation of Analytical Procedures: Text and Methodology [PDF, 186 KB].

Docusate sodium

The tests and limits of the USP monograph Docusate Sodium Tablets or BP monograph Docusate Capsules, as relevant, with the addition of:

• tablet/capsule appearance
• uniformity of dosage units (BP)²
• microbiological quality, in compliance with TGO 77.

Sennosides

The tests and limits of the USP monograph Sennosides Tablets, with the addition of:

• tablet/capsule appearance
• microbiological quality, in compliance with TGO 77.

Docusate sodium and sennosides

The tests and limits of the USP monograph Docusate Sodium Capsules or BP monograph Docusate Capsules, as relevant, and the tests and limits of the USP monograph Sennosides Tablets, with the addition of:

• tablet/capsule appearance
• uniformity of dosage units (BP)²
• microbiological quality, in compliance with TGO 77.

1. The application form should specify both the quantity of Sennosides USP and the 'component' (or equivalent) content of Sennosides A and B.
2. Already captured in USP monographs. Included with reference to Docusate Capsules BP only.