Consumer medicine information

Hydrocortisone-AFT

Hydrocortisone

BRAND INFORMATION

Brand name

Hydrocortisone-AFT

Active ingredient

Hydrocortisone

Schedule

SUMMARY CMI

Hydrocortisone-AFT

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being treated with Hydrocortisone-AFT?

Hydrocortisone-AFT contains the active ingredient hydrocortisone. It belongs to a group of medicines called corticosteroids. Hydrocortisone-AFT is used to reduce inflammation (pain, swelling, redness and heat) in certain glandular disorders, rheumatic disorders, skin diseases, allergic conditions, inflammation of the eyes, stomach or gut disorders, respiratory diseases and blood disorders.

For more information, see Section 1. Why am I being treated with Hydrocortisone-AFT? in the full CMI.

2. What should I know before treatment with Hydrocortisone-AFT?

Do not use if you have ever had an allergic reaction to hydrocortisone or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before treatment with Hydrocortisone-AFT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Hydrocortisone-AFT and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Hydrocortisone-AFT given?

Hydrocortisone-AFT is given as an injection into a muscle, or slowly into a vein by a doctor or nurse.
Your doctor will decide the dose and frequency of Hydrocortisone-AFT depending on your condition.

More instructions can be found in Section 4. How is Hydrocortisone-AFT given? in the full CMI.

5. What should I know during treatment with Hydrocortisone-AFT?

Things you should do	If you get an infection or suspect an infection during a course of treatment, tell your doctor as soon as possible. Tell your doctor if you plan to have surgery; you are about to be given a vaccine or start on any new medicine; you become pregnant during treatment, you are diabetic; or you have liver disease.
Driving or using machines	Be careful before you drive or use any machines or tools until you know how Hydrocortisone-AFT affects you. Hydrocortisone-AFT may cause dizziness, lightheadedness, visual disturbances, and fatigue in some people.
Drinking grapefruit juice	Avoid drinking grapefruit juice while you are being treated with Hydrocortisone-AFT. Grapefruit may interact with Hydrocortisone-AFT and affect the way your body uses the medicine.
Looking after your medicine	The hospital staff will store Hydrocortisone-AFT in a safe place at a temperature below 30°C.

For more information, see Section 5. What should I know during treatment with Hydrocortisone-AFT? in the full CMI.

6. Are there any side effects?

Side effects include nausea and vomiting, changes in appetite, weight gain caused by fluid retention, muscle weakness or tenderness, increased sweating, excessive thirst, changes in mood, changes in skin, excessive hairiness, tiredness or drowsiness. Serious side effects are rare and may include sudden signs of allergy, severe stomach pain, vomiting blood, or blood in the stools, convulsions or fits, changes in vision, eye infections, pain and tenderness of the lower leg, ankle and foot, chest pain and breathlessness. Long term treatment with corticosteroids can affect growth and development in children.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Hydrocortisone-AFT

Active ingredient(s): hydrocortisone sodium succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Hydrocortisone-AFT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Hydrocortisone-AFT.

Where to find information in this leaflet:

1. Why am I being treated with Hydrocortisone-AFT?
2. What should I know before treatment with Hydrocortisone-AFT?
3. What if I am taking other medicines?
4. How is Hydrocortisone-AFT given?
5. What should I know during treatment with Hydrocortisone-AFT?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Hydrocortisone-AFT?

Hydrocortisone-AFT contains the active ingredient hydrocortisone sodium succinate. It belongs to a group of medicines called corticosteroids. Hydrocortisone-AFT acts by reducing inflammation (pain, swelling, redness and heat).

Hydrocortisone-AFT is an injection. It is used when oral treatment is not possible. Your doctor has prescribed Hydrocortisone-AFT for the treatment of one or more of the following:

certain glandular disorders
rheumatic disorders
skin diseases
allergic conditions
inflammation of the eyes
stomach or gut disorders
respiratory diseases
blood disorders

2. What should I know before treatment with Hydrocortisone-AFT?

Warnings

Do not use Hydrocortisone-AFT if you:

are allergic to hydrocortisone sodium succinate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
Have severe fungal infections

Check with your doctor if you:

have or have had any of the following medical conditions:
- stomach or gut disorders e.g., stomach ulcers
- disease of the heart e.g., high blood pressure
- a problem with blood clots forming in your blood vessels such as painful inflammation of the veins (thrombophlebitis) or blockage of blood vessels in the legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism)
- tuberculosis
- herpes simplex of the eye
- chicken pox or measles
- mental or mood disorders
- thin or weak bones that tend to break easily (osteoporosis)
- myasthenia gravis (ongoing chronic fatigue and muscle weakness)
- underactive thyroid gland
- condition or tumour of the adrenal and/or pituitary glands
- kidney or liver disease
- recent head injury
- fits or convulsions
- ulcerative colitis (disease of the bowel)
- diabetes or increased blood sugar in the blood
take any medicines for any other condition.
have allergies to any other medicines, foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Before you are treated with Hydrocortisone-AFT:

Tell your doctor if you plan to have surgery.

The use of Hydrocortisone-AFT may disguise the signs of infections due to a decrease in the body's response to the infection. Talk to your doctor if you have any concerns.

Children

Long term treatment with corticosteroids can affect growth and development in children. Other side effects may occur when Hydrocortisone-AFT is given to children.

Talk to your doctor if you have any concerns about Hydrocortisone-AFT being given to your child.

Growth in children may be affected by treatment with Hydrocortisone-AFT, so your doctor may also monitor your child's height.

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Hydrocortisone-AFT and affect how it works. These include:

non-steroidal anti-inflammatory medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis e.g. aspirin or salicylates
some antibiotics e.g. erythromycin, clarithromycin, rifampicin
medicines used to treat tuberculosis e.g. isoniazid
antifungal agents e.g. ketoconazole, itraconazole
medicines used to treat HIV e.g. indinavir, ritonavir
some medicines used to treat blood pressure and stroke e.g., digoxin and diltiazem
some diuretics (a medicine to help kidneys get rid of salt and water by increasing the amount of urine produced) medicines for nausea e.g., aprepitant, fosaprepitant
oral contraceptives
medicines used for myasthenia gravis, glaucoma
medicines for psychiatric disorders
bronchodilators (a type of medicine that opens up the airways in the lungs) used to treat asthma, bronchitis, emphysema and other lung diseases e.g. salbutamol
anticonvulsants e.g. carbamazepine, phenytoin, phenobarbitone
oral medicines to reduce blood clotting e.g. warfarin
antidiabetic medicines e.g. insulin, glibenclamide and metformin
immunosuppressants e.g. methotrexate or ciclosporin (a medicine used in kidney transplant patients)
some immunisation, inoculation or vaccinations
medicine used to relieve stomach cramps or spasms, to prevent travel sickness and to treat Parkinson's disease (anticholinergics)
medicines used to treat breast cancer or hormone disorder

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Hydrocortisone-AFT. You may need different amounts of your medicine, or you may need to take different medicines.

4. How is Hydrocortisone-AFT given?

How much will be given

Your doctor will decide the dose and frequency of Hydrocortisone-AFT depending on your medical condition.
Your doctor may change the dose and how many times a day you are given Hydrocortisone-AFT as your condition changes.
You may be given a single dose, or several doses 2 to 6 hours apart.

How long is Hydrocortisone-AFT given

Your doctor will continue giving you Hydrocortisone-AFT for as long as your condition requires or before changing to another similar medicine that can be given less frequently or taken orally.

After long-term treatment with Hydrocortisone-AFT, your doctor will determine how to slowly withdraw the medicine.

Hydrocortisone-AFT is not addictive.

How is Hydrocortisone-AFT given

You will not usually be handling this product directly. It will be given to you as an injection by an experienced health care professional.
Hydrocortisone-AFT is given as an injection into a muscle, or as a slow injection into a vein over a period of 30 seconds to 10 minutes depending on the dose required.
Hydrocortisone-AFT must not be injected into the spinal cord (intrathecal or epidural) or by any other unapproved route of administration.

If a dose of Hydrocortisone-AFT is missed

As Hydrocortisone-AFT is given to you under medical supervision, it is very unlikely that a dose will be missed. However, if you feel that a dose has been missed, talk to your doctor or nurse.

If you use too much Hydrocortisone-AFT

As Hydrocortisone-AFT is given to you under medical supervision, it is very unlikely that you will receive too much. Symptoms of an overdose may include the side effects listed under Section 6. Are there any side effects? If you think that you have been given too much Hydrocortisone-AFT, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know during treatment with Hydrocortisone-AFT?

Things you should do

Tell any doctor or nurse giving you this medicine:

if you are about to be given a vaccine or start on any new medicine
if you become pregnant during treatment with Hydrocortisone-AFT
if you get an infection or suspect an infection during a course of treatment. Tell your doctor as soon as possible as Hydrocortisone-AFT may hide some signs of infection
if you are diabetic. Your need for insulin or glucose lowering medicines may increase while being treated with Hydrocortisone-AFT
if you have liver disease. Your doctor may need to monitor your response and/or adjust your dose.

Remind any doctor, dentist or pharmacist you visit that you are being treated with Hydrocortisone-AFT.

Things you should not do

Avoid drinking grapefruit juice while you are being treated with Hydrocortisone-AFT. Grapefruit may interact with Hydrocortisone-AFT and affect the way your body uses the medicine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Hydrocortisone-AFT affects you.

Hydrocortisone-AFT may cause dizziness, lightheadedness, visual disturbances, and fatigue in some people.

Looking after your medicine

The hospital staff will store Hydrocortisone-AFT in a safe place at a temperature below 30°C. They will also check that the expiry date has not passed.

Getting rid of any unwanted medicine

The hospital staff will dispose of any unused Hydrocortisone-AFT.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Side effects

What to do

weight gain as a result of fluid retention or increased appetite
muscle weakness or loss of muscle mass
increased sweating
headache, dizziness or light headedness
effects on your menstrual periods
mood changes and other mental disorders e.g. over-excitement, depression, suicidal thoughts, hallucinations, anxiety, irritability, feeling of confusion, memory loss, reduced perception and problem solving abilities, abnormal behaviour, addiction to drugs or medicines
itchy skin
acne
thin fragile skin, bruising or change in skin colour, redness of the skin, stretch marks, pale areas of the skin
excessive hairiness, particularly in women
excessive thirst, the passing of an increased amount of urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed, irritable, and generally unwell
loss of appetite, weight loss, nausea, vomiting, feeling of tiredness, drowsiness or lack of energy, headache, fever, joint pain, peeling skin, aching muscle, muscle tenderness or weakness not caused by exercise
small lumps under the skin as a result of fat deposits in the tissues
inflammation of the food pipe. You may experience difficulty or pain when swallowing, or heartburn problems with your growth
hiccups
pain, redness at the injection site

Speak to your doctor if you have any of these less serious side effects and they worry you.
Do not be alarmed by this list of side effects. You may not experience any of them.

Serious side effects

Serious side effects	What to do
bone fractures or muscle pain wounds that will not heal red, purple or brown patches on your skin problems with your back, including pain or weakness loss of sensation of problems with your reflexes (slow or too fast) bouts of anxiety and headaches, sweating, palpitations, dizziness, a feeling of weakness, nausea, vomiting, diarrhoea, dilated pupils and blurred vision, stomach pains, and raised blood pressure. These could be symptoms of the adrenal gland, which sits near the kidney.	Tell your doctor immediately if you experience any of these side effects.
allergic reactions e.g., skin rash, itching, difficulty breathing, wheezing or coughing swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing swelling of hands, ankles or feet severe stomach pain, nausea and vomiting vomiting blood or material that looks like coffee bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhea convulsions or fits blurred or distorted vision or loss of vision, eye infections pain and tenderness in the leg, pain on extending the foot swelling of the lower leg, ankle and foot chest pain and breathlessness	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. These may be serious effects. You may need urgent medical attention. Serious side effects are rare.

Hydrocortisone-AFT may also cause chemical imbalances in the blood and urine, swelling of the pancreas (pancreatitis), bleeding in the stomach, masking of infections, increased risk of infection, hormone changes, metabolic changes, changes in liver enzymes, increased blood pressure, or increased number of white blood cells (leucocytosis).

Some of these side effects can only be found when your doctor does tests to check on your progress.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Hydrocortisone-AFT contains

Active ingredient (main ingredient)	Hydrocortisone sodium succinate
Other ingredients (inactive ingredients)	sodium dihydrogen phosphate dihydrate and/or disodium hydrogen phosphate dodecahydrate
Potential allergens	Nil

Do not take this medicine if you are allergic to any of these ingredients.

What Hydrocortisone-AFT looks like

Hydrocortisone-AFT is a sterile white or almost white powder packed in clear glass vial (AUST R 384230). The hospital staff makes it into a solution ready for injection.

Who distributes Hydrocortisone-AFT

AFT Pharmaceuticals Pty Ltd.
North Ryde, NSW 2113, Australia
[email protected]

This leaflet was prepared in July 2023.

Published by MIMS July 2025

BRAND INFORMATION

Brand name

Hydrocortisone-AFT

Active ingredient

Hydrocortisone

Schedule

1 Name of Medicine

Hydrocortisone (as sodium succinate).

2 Qualitative and Quantitative Composition

Each Hydrocortisone-AFT powder for injection vial contains 133.7 mg hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone.

3 Pharmaceutical Form

White to or almost white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

When oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, Hydrocortisone-AFT powder for injection is indicated for intravenous or intramuscular use in the following conditions:

1. Endocrine disorders.

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used).
Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.
Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.
Congenital adrenal hyperplasia.
Nonsuppurative thyroiditis.
Hypercalcaemia associated with cancer.

2. Rheumatic disorders.

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); acute and subacute bursitis; epicondylitis; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spondylitis.

3. Collagen diseases.

During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus; systemic dermatomyositis (polymyositis); acute rheumatic carditis.

4. Dermatological diseases.

Pemphigus; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; bullous dermatitis herpetiformis; severe seborrhoeic dermatitis; severe psoriasis; mycosis fungoides.

5. Allergic states.

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma; drug hypersensitivity reactions; contact dermatitis; urticarial transfusion reactions; atopic dermatitis; serum sickness; acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).

6. Ophthalmic diseases.

Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus; iritis, iridocyclitis; chorioretinitis; diffuse posterior uveitis and choroiditis; optic neuritis; sympathetic ophthalmia; anterior segment inflammation; allergic conjunctivitis; allergic corneal marginal ulcers; keratitis.

7. Gastrointestinal diseases.

To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy); regional enteritis (systemic therapy).

8. Respiratory diseases.

Symptomatic sarcoidosis; Loeffler's syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.

9. Haematological disorders.

Acquired (autoimmune) haemolytic anaemia; erythroblastopenia (RBC anaemia); idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated); secondary thrombocytopenia in adults; congenital (erythroid) hypoplastic anaemia.

10. Neoplastic diseases.

For palliative management of: leukaemias and lymphomas in adults; acute leukaemia in childhood.

11. Oedematous states.

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.

12. Miscellaneous.

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurological or myocardial involvement.

4.2 Dose and Method of Administration

Infants.

Formulations containing benzyl alcohol are contraindicated for use in premature infants (see Section 4.3 Contraindications). Hydrocortisone-AFT does not contain benzyl alcohol.

Adults.

This preparation may be administered by intravenous injection or infusion, or by intramuscular injection, the preferred method for initial emergency use is intravenous injection. Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation.
Therapy is initiated by administering Hydrocortisone-AFT powder for injection intravenously over a period of 30 seconds (e.g. 100 mg) to 10 minutes (e.g. 500 mg or more).
Dosage requirements are variable and must be individualised on the basis of the disease under treatment, its severity and the response of the patient over the entire duration of treatment. A risk/benefit decision must be made in each individual case on an ongoing basis.
The lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period. The proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage, which will maintain an adequate clinical response, is reached.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilised - usually not beyond 48 to 72 hours. Although adverse effects associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated.
When high dose hydrocortisone therapy must be continued beyond 48 to 72 hours, hypernatraemia may occur. Under such circumstances it may be desirable to replace Hydrocortisone-AFT with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.
If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly (see Section 4.4 Special Warnings and Precautions for Use).
The initial dose of Hydrocortisone-AFT powder for injection is 100 mg to 500 mg or more, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily.
Patients subjected to severe stress following corticosteroid therapy should be closely observed for signs and symptoms of adrenocortical insufficiency.
Corticoid therapy is an adjunct to, and not a replacement for, conventional therapy.

Dosage adjustment in hepatic impairment.

In patients with liver disease, there may be an increased effect of hydrocortisone resulting from decreased metabolism and elimination of the drug, and reduced dosing may be considered. Monitoring the clinical response to hydrocortisone in these patients should be considered (see Section 4.4 Special Warnings and Precautions for Use).

Preparation of solutions.

For intravenous or intramuscular injection.

Prepare solution by aseptically adding not more than 2 mL of bacteriostatic water for injections or bacteriostatic sodium chloride injection to the contents of one vial.

For intravenous infusion.

First prepare solution by adding not more than 2 mL of bacteriostatic water for injections to the vial; this solution may then be added to 100 to 1000 mL of the following: 5% glucose in water (or isotonic saline solution or 5% glucose in isotonic saline solution if patient is not on sodium restriction).
Use in one patient on one occasion only. The vial does not contain an antimicrobial agent. Use solution immediately and discard any residue.
Use diluted/reconstituted solution as soon as possible and only if it is clear.

4.3 Contraindications

Hydrocortisone-AFT is contraindicated:
in patients who have systemic fungal infections;
in patients with known hypersensitivity to the drug or any component of the formulation;
for use by the intrathecal route of administration;
for use by the epidural route of administration.
Some water for injection may contain benzyl alcohol as a bacteriostatic agent. Benzyl alcohol has been reported to be associated with a fatal Gasping syndrome in premature infants. Hydrocortisone-AFT does not contain benzyl alcohol.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids (also see Section 4.4 Special Warnings and Precautions for Use).
Hydrocortisone-AFT is not indicated for intrathecal, epidural or local injection, or any other unspecified route of administration.

4.4 Special Warnings and Precautions for Use

Immunosuppressant effects/increased susceptibility to infections.

Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunisation procedures may be undertaken in patients receiving non-immunosuppressive doses of corticosteroids.
The use of Hydrocortisone-AFT in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antituberculosis regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Controlled clinical trials have failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of sepsis syndrome and septic shock. Two studies suggest that treatment of these conditions with methylprednisolone sodium succinate may increase the risk of mortality in certain patients (i.e. patients with elevated serum creatinine levels or patients who develop secondary infections after receiving methylprednisolone sodium succinate). Although this trial used methylprednisolone sodium succinate only, AFT recommends that Hydrocortisone-AFT not be used for septic shock or sepsis syndrome either.

Immune system effects.

Allergic reactions may occur. Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions (e.g. bronchospasm) have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Endocrine effects.

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of corticosteroid therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur if corticosteroids are withdrawn abruptly.
Drug-induced secondary adrenocortical insufficiency may therefore 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, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
A steroid "withdrawal syndrome", seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
High doses of corticosteroids can produce or aggravate Cushing's syndrome. Careful consideration and/or consultation with an endocrinologist are recommended when administering hydrocortisone to patients with Cushing's disease.
There is an enhanced effect of corticosteroids in patients with hypothyroidism.

Metabolism and nutrition.

Corticosteroids, including hydrocortisone, can increase blood glucose, worsen pre-existing diabetes, and predispose those on long-term corticosteroid therapy to diabetes mellitus.

Psychiatric effects.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Potentially severe psychiatric adverse reactions may occur with systemic steroids. Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown. Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.

Nervous system effects.

Corticosteroids should be used with caution in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (also see myopathy statement in Musculoskeletal effects).
Severe medical events have been reported in association with the intrathecal/epidural routes of administration.
There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.

Ocular effects.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible risk of corneal perforation.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos, or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves. Establishment of secondary fungal and viral infections of the eye may also be enhanced in patients receiving corticosteroids.
Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment.
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.

Cardiac effects.

Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidaemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Accordingly, corticosteroids should be employed judiciously in such patients and attention should be paid to risk modification and additional cardiac monitoring if needed. Low dose therapy may reduce the incidence of complications in corticosteroid therapy.
Systemic corticosteroids should be used with caution, and only if strictly necessary, in patients with congestive heart failure.
Hypertrophic cardiomyopathy has been reported after administration of hydrocortisone to prematurely born infants, therefore appropriate investigation should be undertaken in order to monitor cardiac function and structure in this patient population.

Vascular effects.

Thrombosis including venous thromboembolism has been reported to occur with corticosteroids. As a result, corticosteroids should be used with caution in patients who have or may be predisposed to thromboembolic disorders.
Steroids should be used with caution in patients with hypertension.

Gastrointestinal effects.

High doses of corticosteroids may produce acute pancreatitis.
There is no universal agreement on whether corticosteroids per se are responsible for peptic ulcers encountered during therapy; however, corticosteroid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain. Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with nonsteroidal anti-inflammatory drugs (NSAIDs), the risk of developing gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, or active or latent peptic ulcer.

Musculoskeletal effects.

An acute myopathy has been described with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g. myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (e.g. pancuronium). This acute myopathy is generalised, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Corticosteroids should be used with caution in patients with osteoporosis.

Investigations.

Hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Injury, poisoning and procedural complications.

Systemic corticosteroids are not indicated for, and should therefore not be used to treat traumatic brain injury. A large multicentre randomised study in patients administered corticosteroid therapy after significant head injury revealed an increased risk of mortality in the corticosteroid group compared to the placebo group.

Other.

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment as to whether daily or intermittent therapy should be used.
The lowest possible dose of corticosteroids should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual.
Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with malignancies, including haematological malignancies and solid tumours, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumours that have a high proliferative rate, high tumour burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.

Use in hepatic impairment.

Hepatobiliary disorders have been reported which may be reversible after discontinuation of therapy. Therefore, appropriate monitoring is required.
There is an enhanced effect of corticosteroids in patients with cirrhosis.
Hydrocortisone may have an increased effect in patients with liver disease since the metabolism and elimination of hydrocortisone is significantly decreased in these patients.

Use in renal impairment.

Corticosteroids should be used with caution in patients with renal insufficiency.

Use in the elderly.

No data available.

Paediatric use.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Growth may be suppressed in children receiving long-term, daily-divided dose of glucocorticoid therapy and use of such a regimen should be restricted to the most serious indications. Alternate-day glucocorticoid therapy usually avoids or minimises this side effect.
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Hydrocortisone is metabolised by 11β-hydroxysteroid dehydrogenase type 2 (11β-HSD2) and the cytochrome P450 (CYP) 3A4 enzyme. The CYP3A4 enzyme catalyses 6β-hydroxylation of steroids, the essential Phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which have been shown to alter glucocorticoid metabolism by induction (upregulation) or inhibition of the CYP3A4 enzyme.

CYP3A4 inhibitors.

May decrease hepatic clearance and increase the plasma concentrations of hydrocortisone. In the presence of a CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, clarithromycin, and grapefruit juice), the dose of hydrocortisone may need to be decreased to avoid steroid toxicity.

CYP3A4 inducers.

May increase hepatic clearance and decrease the plasma concentrations of hydrocortisone. In the presence of a CYP3A4 inducer (e.g. rifampin, carbamazepine, phenobarbital, and phenytoin), the dose of hydrocortisone may need to be increased to achieve the desired response.

CYP3A4 substrates.

In the presence of another CYP3A4 substrate, the hepatic clearance of hydrocortisone may be affected, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with co-administration.

Non-CYP3A4-mediated effects.

Other interactions and effects that occur with hydrocortisone are described in Table 1.
Table 1 provides a list and descriptions of the most common and/or clinically important drug interactions or effects with hydrocortisone.

The pharmacokinetic interactions listed below are potentially clinically important.
1. Oral contraceptives retard the metabolism of hydrocortisone due to its increased binding to globulin (transcortin). This increases the plasma levels of hydrocortisone thus potentiating its biological effect. Dosage adjustments of hydrocortisone may be required if estrogens are added to or withdrawn from a stable dosage regimen.
2. Drugs that induce hepatic enzymes such as phenobarbitone, phenytoin and rifampicin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response.
3. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No specific animal or clinical studies on the effects of hydrocortisone on fertility have been performed. Corticosteroids have been shown to impair fertility and reduce embryonic viability in studies in mice and rats.
(Category C)
Since adequate human reproductive studies have not been done with hydrocortisone sodium succinate, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.
In animal experiments, corticosteroids have been found to cause malformations of various kinds (cleft palate, skeletal malformations) and abortion. These findings do not seem to be relevant to human beings. Some corticosteroids readily cross the placenta. Reduced placental and birth weight have been recorded in animals and humans after long-term treatment. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing corticosteroids. Some retrospective studies have found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. In humans, the risk of low birth weight appears to be dose-related and may be minimised by administering lower corticosteroid doses. The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant.
Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency.
Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.
Prednisolone is excreted in breast milk; therefore, it is reasonable to assume that all corticosteroids are. No specific data are known for hydrocortisone sodium succinate. Therefore, it is recommended that breastfeeding should cease in women who will be or are receiving corticosteroids.

4.7 Effects on Ability to Drive and Use Machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as syncope, vertigo and convulsions are possible after treatment with corticosteroids (see Section 4.8 Adverse Effects (Undesirable Effects)). If affected, patients should not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Infections and infestations.

Infection masked opportunistic infections (with any pathogen, in any location in the body, from mild to fatal; infections (becoming active, including reactivation of tuberculosis).

Neoplasms benign, malignant and unspecified (including cysts and polyps).

Kaposi's sarcoma (has been reported to occur in patients receiving corticosteroid therapy).

Blood and lymphatic system disorders.

Leucocytosis.

Immune system disorders.

Drug hypersensitivity; anaphylactic reaction; anaphylactoid reaction.

Endocrine disorders.

Cushingoid; hypothalamic-pituitary-adrenal axis suppression; steroid withdrawal syndrome; manifestations of latent diabetes mellitus.

Metabolism and nutrition disorders.

Metabolic acidosis; sodium retention; fluid retention; alkalosis hypokalaemic; dyslipidaemia; glucose tolerance impaired; increased insulin requirement (or oral hypoglycaemic agents in diabetics); lipomatosis; increased appetite (which may result in weight increased).

Psychiatric disorders.

Affective disorder (including depression, euphoric mood, affect lability, drug dependence, suicidal ideation); psychotic disorder (including mania, delusion, hallucination and schizophrenia); mental disorder; personality change; confusional state; anxiety; mood swings; abnormal behaviour; insomnia; irritability.

Nervous system disorders.

Epidural lipomatosis; intracranial pressure increased; benign intracranial hypertension; seizure; amnesia; cognitive disorder; dizziness; headache.

Eye disorders.

Central serous chorioretinopathy; cataract; glaucoma; exophthalmos; vision blurred.

Ear and labyrinth disorders.

Vertigo.

Cardiac disorders.

Congestive heart failure (in susceptible patients); hypertrophic cardiomyopathy in prematurely born infants.

Vascular disorders.

Thrombosis; hypertension; hypotension.

Respiratory, thoracic and mediastinal disorders.

Pulmonary embolism; gasping syndrome; hiccups.

Gastrointestinal disorders.

Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage); intestinal perforation; gastric haemorrhage; pancreatitis; oesophagitis; abdominal distension; abdominal pain; diarrhoea; dyspepsia; nausea.

Skin and subcutaneous tissue disorders.

Angioedema; hirsutism; petechiae; ecchymosis; skin atrophy; erythema; hyperhidrosis; skin striae; rash; pruritus; urticaria; acne; skin hypopigmentation.

Musculoskeletal and connective tissue disorders.

Muscle weakness; myalgia; myopathy; muscle atrophy; osteoporosis; osteonecrosis; pathological fracture; neuropathic arthropathy; arthralgia; growth retardation.

Reproductive system and breast disorders.

Menstruation irregular.

General disorders and administration site conditions.

Impaired healing; oedema peripheral; fatigue; malaise; injection site reaction.

Investigations.

Intraocular pressure increased; carbohydrate tolerance decreased; blood potassium decreased; urine calcium increased; alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Blood urea increased; suppression of reactions to skin tests.

Injury, poisoning and procedural complications.

Spinal compression fracture; tendon rupture.

Additional reactions related to parenteral corticosteroid therapy.

Hyperpigmentation or hypopigmentation; subcutaneous and cutaneous atrophy; sterile abscess.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms and signs.

Reports of acute toxicity and metabolic disturbances with glucocorticoids are rare but do occur. There is no clinical syndrome of acute overdosage with hydrocortisone sodium succinate. Acute overdose may possibly aggravate pre-existing disease states such as ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes and oedema.
Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid state. The possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time.

Treatment.

In the event of acute overdose, treatment is symptomatic and supportive, including respiratory and cardiovascular function. In chronic toxicity, fluids and electrolytes should be monitored closely. Serum levels are not clinically useful.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Hydrocortisone sodium succinate is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of hydrocortisone permits the immediate intravenous administration of high doses of hydrocortisone in a small volume of diluent and is particularly useful where high blood levels of hydrocortisone are required rapidly.
Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biological activity.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following the intravenous injection of hydrocortisone sodium succinate, demonstrable effects are evident within 1 hour and persist for a variable period. This preparation is also rapidly absorbed when administered intramuscularly. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours.

Metabolism.

Excretion.

Excretion of the intravenously administered dose is nearly complete within 12 hours. Intramuscular injections are excreted in a pattern similar to that observed after intravenous injections.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Dibasic sodium phosphate, monobasic sodium phosphate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).
The expiry date can be found on the packaging.
After reconstitution, solution may be stored at 2°-8°C for not more than 24 hours provided aseptic procedures are followed. Any solution not used within 24 hours should be discarded.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.
See Section 6.3 for solution stability after reconstitution.

6.5 Nature and Contents of Container

Hydrocortisone-AFT is supplied in glass vials closed with a rubber stopper. One vial is packed in a carton (1's pack) or 10 vials are packed in a carton (10's pack).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Hydrocortisone sodium succinate is a white or nearly white, odourless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone and insoluble in chloroform.

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