Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hydrocortisone sodium phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Hydrocortisone oral solution contains a medicine called hydrocortisone. This belongs to a group of medicines called corticosteroids, often referred to as 'steroids'. Hydrocortisone is a synthetic version of the naturally occurring hormone cortisol which is made by the adrenal glands. Hydrocortisone is used when the body is not making enough cortisol because part of the adrenal gland is not working properly (this is called adrenal insufficiency). This is often caused by an inherited condition called congenital adrenal hyperplasia.
e Hydrocortisone oral solution Do not give Hydrocortisone oral solution:
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is unwell or has an infection. The doctor may need to increase the dose of Hydrocortisone oral solution temporarily; talk to your doctor if your child is unwell. If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone. Your doctor will train you how to do this in an emergency. is due for a vaccination. Taking Hydrocortisone oral solution should not stop your child being
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vaccinated. Let your doctor know when your child is due for vaccinations. is due for an operation. Let the anaesthetist know your child is receiving Hydrocortisone oral solution before your child has their operation. has an over-active thyroid gland (hyperthyroidism). Contact your doctor promptly if your child experiences muscle weakness, muscle aches, cramps and stiffness while using hydrocortisone. These can be symptoms of a condition called Thyrotoxic Periodic Paralysis, which may occur in patients with an over-active thyroid gland (hyperthyroidism) who are treated with hydrocortisone. Your child may need additional treatment to alleviate this condition.
You should not stop giving Hydrocortisone oral solution without the advice of your doctor as this could make your child seriously unwell very quickly. As Hydrocortisone oral solution is replacing the normal hormone your child lacks, side effects are uncommon, however: –
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Too much Hydrocortisone oral solution can affect your child's growth, so your doctor will adjust the dose depending on your child's size and monitor your child's growth carefully. Let your doctor know if you are worried about your child's growth (see section 4). Too much Hydrocortisone oral solution can affect your child's bones so your doctor will adjust the dose depending on your child's size. Some adult patients taking hydrocortisone (similar to Hydrocortisone oral solution) became anxious, depressed or confused. It is not known if this would happen with children, but tell your doctor if your child develops any unusual behaviour after starting Hydrocortisone oral solution (see section 4). In some patients with allergies to other medicines, allergy to hydrocortisone has been seen. Tell your doctor straight away if your child has any reaction like swelling or shortness of breath after being given Hydrocortisone oral solution (see section 4). Contact your doctor if your child experiences blurred vision or other visual disturbances.
Other medicines and Hydrocortisone oral solution Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those which can be obtained without a prescription. Some medicines can affect the way that Hydrocortisone oral solution works, and may mean that your doctor needs to alter your child's dose of Hydrocortisone oral solution. Medicines that may mean your doctor will increase your child's dose of Hydrocortisone oral solution include:
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Grapefruit juice. Liquorice.
Pregnancy, breast-feeding and fertility Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol. There is no information on any effects of Hydrocortisone oral solution on fertility. Driving and using machines Hydrocortisone oral solution has no influence on a child's ability to perform skilled tasks (e.g. riding a bicycle) or using machines. Important – Steroid Treatment Card A steroid card would usually be given to your child by their nurse or doctor if they have adrenal insufficiency. If your child is given a steroid card, they must always carry it with them – it contains details of their steroid type and dosage, which is important information if they need medical treatment in an emergency. The doctor may also advise you that your child needs to carry this card for up to a year following completion of their steroid treatment. Hydrocortisone oral solution contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sodium and propylene glycol. This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate that may cause allergic reactions (possibly delayed). This medicine contains 1.34 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult. This medicine contains 0.80 mg propylene glycol in each ml. 3. How to give Hydrocortisone oral solution Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure. Hydrocortisone oral solution can be used in children and adolescents aged between 1 month and 18 years. It is given by mouth, usually in three doses during the day. Your doctor will decide on the right dose of Hydrocortisone oral solution based on your child's size (height and weight) and will adjust the dose according to response and as your child grows. During illness, when undergoing surgery and during times of serious stress, your doctor may recommend additional doses of Hydrocortisone oral solution or may advise that your child receives other forms of hydrocortisone as well as, or instead of, Hydrocortisone oral solution.
this medicine Hydrocortisone oral solution should be given by mouth. A 10 ml graduated oral syringe with intermediate graduations of 0.5 ml and a "Press-In" Bottle Adapter (PIBA) are provided with the product. 1. Open the bottle and at first use insert the "Press-In" Bottle Adapter (PIBA) (see pictures A-B).
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle (see pictures C-D).
3. Remove the filled syringe from the bottle in the upright position (see picture E). 4. Giving the medicine: •
Make sure that your child is sitting up or standing.
•
Put the syringe into your child's mouth, placing the barrel-opening in the area between the gums and the inside of the cheek (see picture F).
•
Push the plunger slowly, giving your child time to swallow the medicine as it squirts out. Do not push the plunger too quickly as the medicine may come out too quickly and your child may choke. Repeat steps 2 to 4 as needed to achieve the required dose.
•
Give your child some water to drink in order to ensure that all the medicine is washed down.
5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place). Alternative method of administration (with feeding tubes) If necessary, this medicine can be given down a feeding tube (called a nasogastric or gastrostomy tube). If this is the case, the following procedure should be followed and your doctor or nurse will show you how to do it: Administering this medicine via NG or PEG tubes 1. Ensure the tube is clear before administering the medicine.
2. Administer the medicine into the tube with a suitable measuring device. 3. Immediately flush the tube with 5 ml of boiled cooled water. If you give more Hydrocortisone oral solution than you should If you give your child more Hydrocortisone oral solution than you should, contact your doctor or pharmacist for further advice as soon as possible. If you forget to give Hydrocortisone oral solution If you forget to give your child a dose, give your child that dose as soon as you remember as well as their next dose at the usual time even if this means that your child receives two doses at the same time. If you stop giving Hydrocortisone oral solution Do not stop giving your child Hydrocortisone oral solution without asking your doctor first. Stopping the medicine suddenly could quickly make your child very unwell. If your child becomes unwell Tell your doctor or pharmacist if your child becomes ill, suffers severe stress, gets injured or is about to have surgery because your doctor may need to increase the dose of Hydrocortisone oral solution in these circumstances (see section 2). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. –
If your child has any reaction like swelling or shortness of breath after being given Hydrocortisone oral solution, get medical help straight away and tell your doctor as soon as possible as these can be signs of an allergic reaction (see section 2).
The following side-effects have been reported with hydrocortisone medicines used to replace cortisol:
this medicine.
Hydrocortisone oral solution Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2oC – 8oC). After first opening use within 3 months. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Hydrocortisone oral solution contains
Hydrocortisone 10mg/5ml Oral Solution comes as oral solution containing 10mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Hydrocortisone 10mg/5ml Oral Solution is hydrocortisone sodium phosphate.
This leaflet reproduces the patient information leaflet approved for Hydrocortisone 10mg/5ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Replacement therapy in adrenal insufficiency in infants, children and adolescents (from 1 month to <18 years old).
Posology
Dosage must be individualised according to the response of the individual patient. The lowest possible dosage should be used.
Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g. surgery, infection, trauma). During stress it may be necessary to increase the dosage temporarily.
Replacement therapy in primary and secondary adrenal insufficiency
Hydrocortisone is given as replacement therapy by oral administration of the solution according to clinical practice, in a dose to be titrated against individual clinical response.
Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10–15 mg/m2/day in patients with congenital adrenal hyperplasia (CAH), typically divided into 3 doses, adjusted according to response.
In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening.
Pre-operatively, during serious trauma or illness in patients with known adrenal insufficiency or doubtful adrenal reserve.
Anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.
In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency, and the normal oral daily replacement dose should be increased temporarily; the hydrocortisone total daily dose should be increased by doubling or tripling the usual dose. Once the intercurrent illness episode is over, patients can return to the normal replacement dose of hydrocortisone.
In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as serious accidents and surgery under general anaesthesia. Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of an evolving adrenal crisis.
Hepatic impairment
The elimination of hydrocortisone may be slower in connection with hepatic diseases, and dose adjustment may therefore be necessary in patients with hepatic impairment.
Method of administration
Hydrocortisone Oral Solution is for oral use.
A 10 ml graduated oral syringe with intermediate graduations of 0.5 ml and a “Press-In” Bottle Adapter (PIBA) are provided with the product.
1. Open the bottle and at first use insert the “Press-In” Bottle Adapter (PIBA).
2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle.
3. Remove the filled syringe from the bottle in the upright position.
4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose.
5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).
Note
If necessary, Hydrocortisone oral solution can be administered via intragastric feeding tubes (nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes). Tubes should be rinsed with 5 ml of water immediately after administration. For further information see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients should carry 'steroid treatment' or/and 'steroid emergency' cards, depending upon indication and exogenous steroid dose. The steroid cards give clear guidance on the precautions to be taken to minimise risk and provide details of prescriber, drug, dosage, and the duration of treatment.
Adrenal crisis
Where a child is vomiting or acutely unwell parenteral hydrocortisone should be started without delay, carers should be trained in administering this in an emergency.
Sudden discontinuation of therapy with Hydrocortisone Oral Solution risks triggering an adrenal crisis and death. Medicinal product-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
Infections and immunisation
Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
Infection should not be more likely at a replacement dose of hydrocortisone, but all infections should be treated seriously and stress dosing of steroid initiated early (see section 4.2). Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early.
Undesirable effects of corticosteroid replacement therapy
Most undesirable effects of corticosteroids are dose and duration of exposure related. Undesirable effects are therefore less likely when using corticosteroids as replacement therapy.
Corticosteroids may cause growth retardation in infancy, childhood and adolescence; this may be irreversible. Treatment should be limited to the minimum dosage required to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual. Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement. Infants require frequent assessment and should be evaluated at a minimum every 3 to 4 months to assess growth, blood pressure, and general well-being.
Bone mineral density may be impacted in children when higher doses of replacement steroids are used. The lowest appropriate dose of steroid according to the response of the individual patient should be used.
Patients/and or carers should be warned that potentially severe psychiatric adverse reactions; euphoria, mania, psychosis with hallucinations and delirium have been seen in adult patients at replacement doses of hydrocortisone (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroids, especially when a patient has a history of allergies to medicinal products.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy which have been reported after use of systemic and topical corticosteroids.
Thyrotoxic Periodic Paralysis (TPP)
Thyrotoxic Periodic Paralysis (TPP) can occur in patients with hyperthyroidism and with hydrocortisone-induced hypokalaemia. TPP must be suspected in patients treated with hydrocortisone presenting signs or symptoms of muscle weakness, especially in patients with hyperthyroidism.
If TPP is suspected, levels of blood potassium must be immediately monitored and adequately managed to ensure the restoration of normal levels of blood potassium.
Hydrocortisone 10 mg/5 ml Oral Solution contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate and propylene glycol
This medicinal product contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. May cause allergic reactions (possibly delayed).
This medicinal product contains 1.34 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicinal product contains 0.80 mg propylene glycol in each ml.
Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4). Concomitant administration of medicinal products that are inhibitors or inducers of CYP3A4 may therefore lead to unwanted alterations in serum concentrations of Hydrocortisone Oral Solution with the risk of adverse effects, particularly adrenal crisis. The need for dose adjustment when such medicinal products are used can be anticipated and patients should be closely monitored.
Medicinal products inducing CYP3A4, requiring a potential increase in Hydrocortisone Oral Solution dosing, include but are not limited to:
- Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine
- Antibiotics: rifampicin and rifabutin
- Barbiturates including phenobarbital and primidone
- Antiretroviral medicinal products: efavirenz and nevirapine
Medicinal products/substances inhibiting CYP3A4, requiring a potential decrease in Hydrocortisone Oral Solution dosing, include but are not limited to:
- Anti-fungals: itraconazole, posaconazole, voriconazole
- Antibiotics: erythromycin and clarithromycin
- Antiretroviral medicinal products: ritonavir
- Grapefruit juice
- Liquorice
Pregnancy
Hydrocortisone for replacement therapy can be used during pregnancy. The ability of corticosteroids to cross the placenta varies between the different types of corticosteroids, however, hydrocortisone readily crosses the placenta.
Studies in animals have shown reproductive toxicity of corticosteroids (see section 5.3).
Breast-feeding
Hydrocortisone for replacement therapy can be used during breast-feeding.
Fertility
There are no data available for possible effects of Hydrocortisone Oral Solution on fertility.
Hydrocortisone Oral Solution has no or negligible influence on the ability to drive and use machines.
Tabulated list of adverse reactions
The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
MedDRA system organ class
Frequency: not known
Psychiatric disorders
Psychosis with hallucinations and delirium
Mania
Euphoria
Gastrointestinal disorders
Gastritis
Nausea
Renal and urinary disorders
Hypokalaemic alkalosis
Historical cohorts of adults treated from childhood for Congenital Adrenal Hyperplasia have been found to have reduced bone mineral density and increased fracture rates and growth retardation (see section 4.4) - it is unclear if these relate to hydrocortisone therapy using current replacement regimens.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare. No antidote is available. Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone. In which case, symptomatic treatment should be instituted as necessary.
The biological half-life of hydrocortisone is about 100 minutes.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Hydrocortisone 10mg/5ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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