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OTC medicine monograph: Mebendazole

Version 1.0, December 2014

16 December 2014

Introduction

This OTC Medicine Monograph outlines the requirements for Australian market authorisation of oral medicines containing mebendazole 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 mebendazole (CAS no. 31431-39-7) and excludes any preparations containing any other salts and derivatives of mebendazole.

Dosage forms and strengths

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

Active substance Dosage strength Dosage forms
Mebendazole 100 mg Tablet (chewable and uncoated only)
20 mg/mL Oral suspension

Indications

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

Treatment of Enterobius vermicularis (threadworm or pinworm).

For the treatment of other worms such as Ascaris lumbricoides (roundworm), Trichuris trichura (whipworm) and Ancylostoma duodenale and Necator americanus (hookworm) only under medical supervision.

Label indications

  • Treatment of threadworm.
  • Treatment of roundworm, whipworm and hookworms only on medical advice.

In addition to the above label indications, the following label claim may be included:

  • Kills worms.

Directions for use

Dosages must be as shown in the following table.

Dosage form Dosage in adults and children 2 years of age and over
Treatment of threadworm:
100 mg tablet 1 tablet to be taken as a single dose.
20 mg/mL suspension Give/take 5 mL of suspension as a single dose.
Treatment of roundworm, hookworm and whipworm:
Roundworm, hookworm and whipworm rarely occur in the general Australian population. If suspected, seek medical advice before you start treatment. If treating this condition, ask your doctor for the correct dose.
100 mg tablet The recommended dosage for this condition is 1 tablet twice a day for three days.
20 mg/mL suspension The recommended dosage for this condition is 5 mL of suspension twice a day for three days.

Additional instruction

  1. The following directions for use must be included:
    • The statements "Do not give to children under 2 years of age" and "It may be taken with or without food".
    • A statement that the tablet may be swallowed whole, chewed (if formulated as a chewable tablet) or crushed.
    • For uncoated and chewable tablets, a statement to the effect that tablets should be crushed before administering to children.
    • For oral suspensions, the direction to shake the bottle well before use.
  2. If appropriate and the formulation permits, include advice on the label that the tablets should be crushed and the contents mixed with water, jam or honey before administering to children.
  3. The following instructions (or words to the effect of) are required:
    • Threadworms or pinworms are small, very thin worms that look like white threads.
    • Before treating, signs of threadworm should be present.
    • Signs and symptoms of threadworm infestation include:
      • The presence of tiny white threads around the anal region.
      • Itching around the anus and vagina, which may result in restless sleep, grinding of teeth and irritability.
    • If a household member has threadworms, then each member should be treated at the same time even if they have no symptoms because the worms spread very easily.
    • If symptoms persist, see your doctor.
  4. To help reduce infection and prevent reinfestation, the following measures (or words to the effect of) may be included:
    • Keep fingernails short and ensure hands and nails are scrubbed clean.
    • Wash hands after using the toilet and before eating.
    • Shower rather than bathe for several days after treatment.
    • Vacuum carpet and wash floors, clothing and linen in hot water.
    • If reinfestation occurs, repeat treatment 2-4 weeks after initial dose.

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.

Advisory statement

The following statement is required:

If you are pregnant or may become pregnant, check with your doctor or pharmacist before taking this medicine.#

#This statement will be revised pending a final outcome of a RASML consultation on a pregnancy and breastfeeding warning statement for mebendazole.

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 mebendazole 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 USP General Chapter requirements and TGO 78 requirements. Further reference to these is not required. References to the pharmacopoeial monographs below refer to the current monographs at the time of application.

Mebendazole tablet

The tests and limits in the USP monograph Mebendazole Tablets with the addition of:

  • tablet appearance;
  • content of mebendazole (NLT 92.5% and NMT 107.5%)1 in compliance with TGO 78;
  • individual unspecified impurities (NMT 0.5%); and total impurities (NMT 1.0%), and
  • microbiological quality in compliance with TGO 77.

Mebendazole oral suspension

The tests and limits in the USP monograph Mebendazole Oral Suspension with the addition of:

  • solution appearance;
  • individual unspecified impurities (NMT 0.5%); and total impurities (NMT 1.0%);
  • content of any preservatives included in the formulation, and
  • microbiological quality in compliance with TGO 77.

Reference

  1. in place of the Mebendazole Tablets USP requirement of NLT 90.0% and NMT 110.0%

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