Medicines

Fludrocortisone for hormone replacement

This leaflet is for parents and carers about how to use this medicine in children. Our information may differ from that provided by the manufacturers, because their information usually relates to adults. Read this leaflet carefully. Keep it somewhere safe so that you can read it again.

This medicine is for your child. Never give it to anyone else. It may harm them even if they have the same symptoms as your child.

Contents of this leaflet

Name of medicine

Fludrocortisone acetate

Brand names: Florinef®

This leaflet is about the use of fludrocortisone for mineralocorticoid hormone replacement.

Why is it important for my child to take fludrocortisone?

Fludrocortisone is a type of steroid medicines called a mineralocorticoid. If your child’s adrenal glands have been removed or are not working properly (this is sometimes called adrenal insufficiency), they need to take fludrocortisone to replace the hormones normally produced by the adrenal glands. They may also need to take another steroid medicine called hydrocortisone. Fludrocortisone is also used to reduce potassium in children with poor kidney function.

What is fludrocortisone available as?

Tablets: 100 micrograms fludrocortisone acetate

When should I give fludrocortisone

Fludrocortisone is usually given once each day. This is usually in the morning.

Give the medicine at about the same time each day so that this becomes part of your child’s daily routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of fludrocortisone (the dose) that is right for your child. The dose will be shown on the medicine label.

It is important that you follow your doctor’s instructions about how much to give.

How should I give fludrocortisone?

Tablets

Your doctor may prescribe a dose that means you need to cut a tablet in half. To help give a half tablet, the tablets are scored. Ideally, use a tablet splitter, which you can get from your doctor or pharmacist. If this is not available, use a sharp knife. You can store the half tablet and give it to your child for the next dose unless your doctor has told you not to.

  • You can crush the tablet and mix it with a small amount of soft food such as yogurt, jam or mashed potato. Make sure your child swallows it straight away, without chewing.
  • Tablets should be swallowed with a glass of water, squash or juice. Your child should not chew the tablet.

When should the medicine start working?

The medicine should start working straight away but you may not see much difference in your child.

What if my child is sick (vomits)?

If your child is sick less than 30 minutes after having a dose of fludrocortisone, give them the same dose again.

If your child is sick more than 30 minutes after having a dose of fludrocortisone, you do not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

Give the missed dose when you remember during the day, as long as this is at least 12 hours before the next dose of fludrocortisone is due.

Never give a double dose of fludrocortisone.

What if I give too much?

If you think you may have given your child too much fludrocortisone, contact your doctor or local NHS services (111 in England and Scotland; 111 or 0845 4647 in parts of Wales) or take your child to hospital. Take the medicine container or packet with you, even if it is empty. This will be useful to the doctor. Have the packet with you if you telephone for advice.

It may be dangerous to give too much fludrocortisone.

Are there any possible side effects?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side effects).

Side effects you must do something about

The fludrocortisone can cause ulcers in the stomach. Tell your doctor straight away if your child has severe abdomen pain.

The fludrocortisone can cause swings in mood. Tell your doctor straight away if your child:

  • Has frequent high moods
  • Feels depressed, including thinking about suicide
  • Feels anxious, has problems sleeping, seems confused, or has difficulty remembering things
  • Says they are seeing or hearing things that do not exist.

Other side-effects you need to know about

  • Your child may feel dizzy or light-headed or have headaches. If this happens often, contact your doctor to check your child’s blood pressure, as it may be too high.

  • Your child may get salt or water retention which can cause swelling in the hands and feet or puffiness of the eyes. Contact your doctor if you are worried.

  • Your child may be more hungry than usual or have indigestion, feel sick (nausea) or be sick (vomit). They may also feel tired or weak. This should get better after a week or so, but contact your doctor if you are worried.

  • The fludrocortisone can slow growth. Your doctor will check your child’s growth and development. If you have any concerns, talk to your doctor.

  • Your child may be at more risk of severe infections. They should stay away from anyone with an infection (such as chicken pox, shingles, measles) if they have not had these illnesses or have not been vaccinated. If your child is unwell and you are worried about an infection, contact your doctor straight away.

  • Your child’s skin may become thinner, and heal more slowly than usual. Acne (spots) may become worse or your child may develop mouth ulcers or thrush (candidiasis). If you are concerned, contact your doctor.

  • Your child may develop problems with their hip bones, or their bones may become weaker (osteoporosis). The muscles around the hips and shoulders may also become weaker. If your child has any difficulty walking or moving around, contact your doctor.

  • Occasionally, fludrocortisone causes diabetes. If your child seems more thirsty than normal, needs to pass urine (wee) often, or starts wetting the bed at night, contact your doctor.

There may sometimes be other side effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor. You can report any suspected side effects to a UK safety scheme at mhra.gov.uk/yellowcard

Can other medicines be given at the same time as fludrocortisone?

  • You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.

fludrocortisone should not be taken with some medicines that you get on prescription. It is important to tell your doctor and pharmacist about any other medicines your child is taking before starting fludrocortisone.

Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal and complementary medicines.

Is there anything else I need to know about this medicine?

Keep all your clinic appointments, as your doctor or nurse needs to check how your child is doing.

In a very few cases, children become very unwell when they stop or reduce the amount of any steroid medicine they are taking, including fludrocortisone (in high doses). If you are at all worried about this, contact your doctor.

The use of steroids in children receives a lot of bad press. However, use of fludrocortisone for hormone replacement provides a lot of benefit, and is unlikely to cause any long-term harm as long as you use the medicine as your doctor has told you to. If you are at all worried, talk to your doctor or pharmacist.

If your child has been taking fludrocortisone for longer than 3 weeks, they should not usually stop taking the medicine suddenly because they will get withdrawal symptoms: they will feel unwell, dizzy and thirsty and may be sick (vomit). Your doctor will give you more advice.

If your doctor wants to stop fludrocortisone, they will reduce the dose gradually before stopping it completely. Make sure you follow your doctor’s instructions.

If your child is due to have an immunisation (vaccination), tell the nurse or doctor that your child is taking fludrocortisone.

General advice about medicines

  • Try to give medicines at about the same times each day, to help you remember.
  • If you are not sure a medicine is working, contact your doctor but continue to give the medicine as usual in the meantime. Do not give extra doses, as you may do harm.
  • Only give this medicine to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.
  • Make sure that you always have enough medicine. Order a new prescription at least 2 weeks before you will run out.
  • Make sure that the medicines you have at home have not reached the ‘best before’ or ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.

If you think someone else may have taken the medicine by accident, contact your doctor straight away.

Where should I keep this medicine?

  • Keep the tablets in a fridge. Make sure the bottle is tightly closed so that moisture cannot get in.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.

Who to contact for more information?

Your doctor, pharmacist or nurse will be able to give you more information about fludrocortisone and about other medicines used to treat mineralocorticoid hormone replacement.

England: NHS 111

Tel 111

www.nhs.uk

Scotland: NHS 24

Northern Ireland: NI Direct

Wales: NHS 111 Wales

Copyright disclaimer

Version [1]. © NPPG, RCPCH and WellChild, all rights reserved. Review by March 2016.

The primary source for the information in this leaflet is the British National Formulary for Children. For details on any other sources used for this leaflet, please contact us through our website, www.medicinesforchildren.org.uk.

We take great care to make sure that the information in this leaflet is correct and up-to-date. However, medicines can be used in different ways for different patients. It is important that you ask the advice of your doctor or pharmacist if you are not sure about something. This leaflet is about the use of these medicines in the UK, and may not apply to other countries. The Royal College of Paediatrics and Child Health (RCPCH), the Neonatal and Paediatric Pharmacists Group (NPPG), WellChild and the contributors and editors cannot be held responsible for the accuracy of information, omissions of information, or any actions that may be taken as a consequence of reading this leaflet.