https://www.gosh.nhs.uk/conditions-and-treatments/medicines-information/dihydrotestosterone-adractim-25-gel-topical-application/

Dihydrotestosterone (Andractim®) 2.5% gel for topical application

Dihydrotestosterone is a synthetic version of a hormone called testosterone. It is used for children with hormone deficiencies. This information sheet from Great Ormond Street Hospital (GOSH) explains what andractim 2.5% gel is, how it is used and some of the possible side effects.

It is available as a 2.5% gel under the brand name Andractim®, which is imported from abroad. It works by correcting the hormone deficiency, either in a particular part of the body or affecting the body as a whole.

How is it used?

Dihydrotestosterone 2.5% gel is for external use only. It should be applied over the required area of skin after washing. The gel should be left to dry for five minutes or so before putting on clothes.

  1. Put on a pair of gloves
  2. Gently squeeze the gel onto the mark on the ruler illustrated on the laminated information sheet – as instructed on the dispensing label.
  3. Spread over the required area evenly
  4. Leave for five minutes
  5. Wipe the laminated information sheet with a damp piece of kitchen paper ready for the next dose. Remove the gloves and wash them in warm soapy water ready for the next dose. 

Note: Dihydrotestosterone 2.5% gel should not be applied to any broken areas of skin.

Who should not use Dihydrotestosterone 2.5% gel?

People who are hypersensitive to Dihydrotestosterone or its excipients (Carbomer 934, triethanolamine, Alcohol 95%) should discuss using this medicine with their doctor.

What are the side effects?

The following side effects are rare and are usually due to the dose being too high, so will disappear when the dosage is reduced.

  • Mood swings and irritability
  • Excessive energy or signs of being hyperactive
  • Weight gain
  • Extra hair growth
  • Hoarseness
  • Oily skin
  • Acne

Dihydrotestosterone 2.5% gel and other medicines

Dihydrotestosterone is applied externally so it should not react with any other medicines.

Important information

  • As this is a specialist treatment, GOSH or your local hospital will supply your child’s medicine.
  • Keep medicines in a safe place where children cannot reach them.
  • Keep the gel at room temperature, away from bright light or direct sunlight and away from heat. Do not store in the fridge.
  • If the doctor decides that your child should stop using dihydrotestosterone, return any remaining gel to your pharmacist. Do not throw away.
Compiled by:
The Pharmacy department in collaboration with the Child and Family Information Group
Last review date:
July 2017
Ref:
2017F0390

Disclaimer

Please read this information sheet from GOSH alongside the patient information leaflet (PIL) provided by the manufacturer. If you do not have a copy of the manufacturer’s patient information leaflet please talk to your pharmacist. A few products do not have a marketing authorisation (licence) as a medicine and therefore there is no PIL.

For children in particular, there may be conflicts of information between the manufacturer’s patient information leaflet (PIL) and guidance provided by GOSH and other healthcare providers. For example, some manufacturers may recommend, in the patient information leaflet, that a medicine is not given to children aged under 12 years. In most cases, this is because the manufacturer will recruit adults to clinical trials in the first instance and therefore the initial marketing authorisation (licence) only covers adults and older children.  

For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.