Consumer medicine information

Redipred Oral Liquid

Prednisolone

BRAND INFORMATION

Brand name

Redipred

Active ingredient

Prednisolone

Schedule

SUMMARY CMI

Redipred oral liquid

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 using REDIPRED?

REDIPRED contains the active ingredient prednisolone (as prednisolone sodium phosphate). REDIPRED is used to treat many different conditions that involve inflammation, as well as to prevent or reduce symptoms associated with these conditions.

For more information, see Section 1. Why am I using REDIPRED? in the full CMI.

2. What should I know before I use REDIPRED?

Do not use if you have ever had an allergic reaction to REDIPRED 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 I use REDIPRED? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with REDIPRED 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 do I use REDIPRED?

The dose of REDIPRED varies from patient to patient.
Your doctor will tell you how much to take each day, and when to take it.
REDIPRED is best taken immediately with or soon after food.

More instructions can be found in Section 4. How do I use REDIPRED? in the full CMI.

5. What should I know while using REDIPRED?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using REDIPRED. Tell your doctor if your condition worsens or returns while on REDIPRED after your dose has been reduced or stopped. If you are diabetic, tell your doctor immediately if you notice a change in results of your blood or urine sugar tests while taking REDIPRED. Tell your doctor immediately if you become pregnant while taking REDIPRED.
Things you should not do	Do not stop using this medicine suddenly unless advised by your doctor. Do not have any immunisations without your doctor's approval while being treated with REDIPRED. Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Driving or using machines	Take care of when driving, or operating machinery until you know how REDIPRED affects you.
Drinking alcohol	Check with your doctor or pharmacist before drinking alcohol while you are taking this medicine.
Looking after your medicine	Protect from light, and store in a cool, dry place under 30°C Discard 4 weeks after opening.

For more information, see Section 5. What should I know while using REDIPRED? in the full CMI.

6. Are there any side effects?

Short term use of REDIPRED is unlikely to cause any problems. But if problems do occur, they may likely involve mood changes and disturbances in your digestive system such as nausea, vomiting, anorexia, increased appetite, stomach bloating/irritation, and diarrhoea or constipation. Long term use and higher doses of REDIPRED may have a greater risk of side effects. Serious side effects include severe stomach/intestinal pain; epileptic fits; psychiatric disturbances; sudden changes in your vision; or severe dizziness, fainting, weakness, chest pain, or irregular heartbeat.

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

Redipred oral liquid

Active ingredient: prednisolone sodium phosphate

Consumer Medicine Information (CMI)

This leaflet provides important information about using REDIPRED. 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 REDIPRED.

Where to find information in this leaflet:

1. Why am I using REDIPRED?
2. What should I know before I use REDIPRED?
3. What if I am taking other medicines?
4. How do I use REDIPRED?
5. What should I know while using REDIPRED?
6. Are there any side effects?
7. Product details

1. Why am I using REDIPRED?

REDIPRED contains the active ingredient prednisolone (as prednisolone sodium phosphate). REDIPRED belongs to a group of medicines called corticosteroids. It is a synthetic version of a naturally occurring body hormone called cortisol. This hormone is made by the adrenal glands which lie just above your kidneys.

REDIPRED is used in the treatment of many different conditions. Some of these conditions include severe allergies, severe or chronic asthma, skin problems, arthritis, inflammatory diseases of the bowel, cancer and "auto-immune" diseases.

REDIPRED is also used to prevent or reduce the symptoms of inflammation (such as swelling, redness, pain, tenderness or itching) in any part of the body. These symptoms can occur in response to injury or can be caused by many different conditions.

It works by entering inflammatory cells and blocking the inflammatory reaction. REDIPRED is only able to prevent or reduce symptoms of your condition, it does not cure it.

Ask your doctor if you have any questions about why REDIPRED has been prescribed for you.

Your doctor may have prescribed it for another reason.

2. What should I know before I use REDIPRED?

Warnings

Do not use REDIPRED if:

You are allergic to prednisolone, prednisone or any of the ingredients listed at the end of this leaflet.
- Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.
- Always check the ingredients to make sure you can use this medicine.
The expiry date on the pack has passed.
The bottle shows signs of having been tampered with.
You have a current serious or uncontrolled infection, including fungal infections.

Check with your doctor if you:

Have any other medical conditions, including;
- recent surgery or serious injury
- diabetes mellitus (sugar diabetes)
- osteoporosis (softening of the bone)
- a stomach ulcer or other stomach or intestinal problems
- liver, kidney or heart disease
- tuberculosis
- epilepsy
- muscle weakness
- glaucoma (high pressure in the eye) or cataracts
- thyroid disease
- high blood pressure.
Take any medicines for any other condition.
Have had any allergy to any other medicines, or any other substances, such as 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?

Pregnancy and breastfeeding

Do not take REDIPRED if you are pregnant or plan to become pregnant.

Check with your doctor if you are breastfeeding or intend to breastfeed. It is recommended that you do not breastfeed while taking this medicine.

Use in children

REDIPRED should only be given under your doctor's supervision.
If possible, children should not be exposed to common childhood illnesses such as chickenpox or measles while they are taking this medicine. They may suffer from more serious attacks of these illnesses if such exposure occurs.
Children should not be vaccinated with “live” vaccines against common childhood illnesses while they are taking this medicine, as this may result in severe attacks of these illnesses.
Potentially serious side effects can occur in children and growing teenagers who are taking corticosteroids such as REDIPRED. Some of these include obesity, slowed growth, osteoporosis (softening of the bone) and changes to the adrenal glands.

Use in the elderly

Elderly patients may be more sensitive to the effects or side effects of this medicine.

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 REDIPRED and affect how it works. These include:

antacids (in large amounts)
medicines for diabetes
some medicines for heart disease
medicines for removal of fluid (diuretics)
some medicines for epilepsy
some types of antibiotics
potassium or salt supplements
immunisations or vaccines.

You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to avoid while taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect REDIPRED.

4. How do I use REDIPRED?

How much to take

Your doctor will tell you how much REDIPRED to take.
The dose will depend on the condition being treated and your response to the treatment. Your initial dose will be maintained or adjusted until a satisfactory response is noted.
Follow the instructions provided and use REDIPRED until your doctor tells you to stop.

When to take REDIPRED

How often REDIPRED can be taken may vary depending on what condition is being treated. It can be taken once daily, several times a day or on alternate days.

If you are taking REDIPRED:

Once a day - it is best taken at the same time each day as instructed by your doctor, preferably after breakfast.
Several times a day - it is best if you can have the doses evenly spaced throughout the day.
On alternate days - it is best to take it in the morning after breakfast. Do not miss any doses and do not stop taking the medicine even if you feel better. Missing doses may make your symptoms worse.

How to take REDIPRED

REDIPRED is best taken with or soon after food.

How long to take it for

Continue taking REDIPRED for as long as your doctor or pharmacist tells you. This will depend on your condition and on your response to treatment. Some people will need this medicine for only short periods of time whilst others may require long term therapy.

Do not miss any doses and do not stop taking the medicine even if you feel better. Missing doses may make your symptoms worse.

If you forget to take REDIPRED

If you miss a dose of this medicine the decision of whether you should take it or not will depend on how many times a day you take REDIPRED.

If you are taking REDIPRED:

Once a day -
If you miss a dose and remember in less than 12 hours, take it straight away, then continue as normal the next day. Otherwise, skip that day's dose but be sure to take the next day's dose when it is due.
Several times a day -
If you miss a dose and it is more than 2 hours before your next dose is due, take it straight away, then continue as you normally would. If it is less than 2 hours to your next dose, skip the dose you have missed but be sure to take the next dose when you are meant to.
On alternate days -
If you miss a dose and remember it the same morning, take it straight away then continue as you normally would. If you do not remember the missed dose until later, wait and take it the following morning. Then skip a day before continuing your regular dosage schedule.

Do not try to make up for missed doses by taking more than one dose at a time.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much REDIPRED

If you think that you have taken too much REDIPRED, 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 while using REDIPRED?

Things you should do

Take REDIPRED exactly as your doctor has prescribed.
If you do not follow your doctor's instructions you may not get improvement in the symptoms of your condition. Try not to miss any doses and take the medicine even if you feel well.
Tell your doctor if your condition returns or becomes worse after your dose of REDIPRED has been reduced or treatment has been stopped.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking REDIPRED especially if you are being started on any new medicines.
Tell your doctor, surgeon or dentist that you are taking REDIPRED if you are about to undergo surgery or an operation.
The trauma of the operation or surgery may mean that your dose of REDIPRED may need to be increased to cover the stressful period.
Ask your doctor when and how you should stop taking REDIPRED.
If you have been taking it for a long time your doctor may gradually reduce the amount you are taking over a period of several days, weeks or months before stopping completely. If you have been taking REDIPRED for a short period of time, this may not apply.

Call your doctor straight away if you:

Become pregnant while taking REDIPRED.
Are a diabetic, and you notice a change in the results of your blood or urine sugar tests.
This medicine may affect your blood sugar levels as it can affect the body's ability to handle glucose. For diabetics, this means that your diabetes may become more severe. For others, diabetes may develop for the first time while taking corticosteroids such as REDIPRED.

Things you should not do

Do not stop taking REDIPRED suddenly unless advised by your doctor
If you stop taking it suddenly, the symptoms of your condition may return or you may develop symptoms of cortisol deficiency such as fainting, weakness, restlessness, nausea, vomiting, headache, dizziness, muscle weakness or joint pain.
Do not take REDIPRED to treat any other complaints unless your doctor has instructed you to do so.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not have any immunisations (particularly with "live" vaccines such as measles, oral polio or yellow fever) without your doctor's approval while you are being treated with REDIPRED.

Things to be careful of

Avoid close contact with anyone who has a contagious disease such as measles or chickenpox.
Exposure to such diseases while you are taking REDIPRED, particularly if large doses are being taken, can put you at greater risk of developing these diseases if you have not had them before.
Tell your doctor straight away if you think you have been exposed to chickenpox or measles.
The signs and symptoms of infections such as fever or inflammation may be hidden by the anti-inflammatory action of REDIPRED. You should see your doctor for medical advice for any but the most minor infections.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how REDIPRED affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol while taking REDIPRED you may find that stomach problems occur.

Looking after your medicine

Keep REDIPRED in a cool dry place, protected from light, where the temperature stays below 30°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

When to discard your medicine

Discard 4 weeks after opening.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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.

Short term use of REDIPRED is unlikely to cause any problems. Use of REDIPRED long term and in high doses may result in a greater risk of side effects.

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

Less serious side effects

Less serious side effects	What to do
Short term use: mood changes nausea (feeling sick) vomiting anorexia (which may result in weight loss) increased appetite (which may result in weight gain) stomach bloating or irritation diarrhoea or constipation.	Speak to your doctor if you have any of these less serious side effects and they worry you. These side effects may occur when REDIPRED is taken for short periods of time. Most of these side effects will improve or resolve with time.
Long term use: General changes to the body: bloating and rounding of the face (moon face) headache dizziness weight gain redistribution of body fat water retention leading to swollen legs and feet, high blood pressure or an irregular heartbeat cramps or weakness in the muscles of the arms and legs slowed growth in children irregular menstrual periods. Changes to the skin: acne red or flushed face extra hair growth red or purple streaks easy bruising skin thinning increased sweating poor wound healing. Changes to the immune system: an increased seriousness or frequency of infections. Changes in behaviour: excessive mood swings (such as changes in personality) anxiety or nervousness restlessness trouble sleeping. Changes in eyes: decreased or blurred vision eyes sticking out too far cataracts	Speak to your doctor if you have any of these less serious side effects and they worry you. These side effects are associated more with long term use of REDIPRED.
Internal side effects: osteoporosis or other changes in bone which can result in an increased chance of fractures due to brittleness of softening of the bone changes in other hormone levels in your body changes in the body's ability to handle glucose (steroid diabetes) effects on the parathyroid and thyroid glands (glands which control body calcium and body metabolism) increased amounts of cholesterol in the blood changes to your white blood cells changes to your nervous system which may affect the way your nerves work changed sperm count increased blood pressure slow heart rate increased pressure in the skull.	These side effects can only be detected by your doctor. When REDIPRED is taken for long periods of time it is important to visit your doctor regularly for check-ups.

Serious side effects

Serious side effects	What to do
severe stomach or intestinal pain epileptic fits sudden changes in your vision symptoms such as severe dizziness, fainting, weakness, chest pain or irregular heart beat psychiatric disturbances.	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.

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 REDIPRED contains

Active ingredient (main ingredient)	prednisolone (as prednisolone sodium phosphate): 5 mg/1 mL
Other ingredients (inactive ingredients)	sorbitol solution (70%) non-crystallising disodium edetate dibasic sodium phosphate monobasic sodium phosphate methyl hydroxybenzoate propyl hydroxybenzoate nature identical raspberry flavour 08-3326 purified water

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

What REDIPRED looks like

REDIPRED is a raspberry flavoured, clear, colourless to slightly yellow solution. It is available in 30 mL bottles. (AUST R 62506)

Who distributes REDIPRED

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was prepared in August 2024

Published by MIMS November 2024

BRAND INFORMATION

Brand name

Redipred

Active ingredient

Prednisolone

Schedule

1 Name of Medicine

Prednisolone sodium phosphate.

2 Qualitative and Quantitative Composition

Redipred contains the active prednisolone sodium phosphate 6.72 mg/1 mL which is equivalent to prednisolone 5 mg/1 mL.
It contains excipients with known effect, sorbitol solution (70%) non-crystallising, methyl hydroxybenzoate and propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Redipred is a raspberry flavoured, clear, colourless to slightly yellow solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Wherever corticosteroid therapy is indicated.

4.2 Dose and Method of Administration

The severity, prognosis, expected duration of the disease, and the patient's reaction to medication are primary factors in determining dosage.

Adults.

The initial adult dosage may range from 20 to 40 mg daily, but can be 60 to 80 mg daily if necessary, depending on the disease being treated.

Maintenance dosage.

Usually 5 to 20 mg daily.
In long term therapy the ideal dosage should not be greater than 40 mg per day so as to minimise side-effects. It is usually administered in 2-4 divided doses or as a single daily dose after breakfast or on alternate days.

Alternate-day therapy.

Alternate-day therapy is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions. In alternate-day therapy, a single dose is administered every other morning. This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects. However, some patients may require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.

Elderly.

As for adults - though the dose should be the minimum necessary to achieve the desired therapeutic effect.

Children.

Initial dosage.

0.5 mg/kg daily in three or four divided doses after food as in adults. This dosage can be doubled or trebled if necessary.

Maintenance dosage.

0.125 to 0.25 mg/kg daily.
For infants and children, the recommended dosage should be governed by the same considerations as adults rather than by strict adherence to the ratio indicated by age or body weight.

The following therapeutic guidelines should be kept in mind for all therapy with corticosteroids.

Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days to avoid the risk of relative adrenal insufficiency (see Section 4.4 Special Warnings and Precautions for Use).
Continued supervision of the patient after cessation of corticosteroids is essential, since there may be a reappearance of severe manifestations of the disease for which the patient was treated.
In general, initial dosage should be maintained or adjusted until the anticipated response is observed. The dose should then be gradually reduced until the lowest dose which will maintain an adequate clinical response is reached.

Stress and intercurrent illness.

In patients on long term corticosteroid therapy subjected to stress from trauma or infection, steroid dosage should generally be increased to cover the stressful period. For mild infections without fever, no increase is necessary. For more serious infections, the dose of prednisone/ prednisolone should be doubled (to a maximum of 20 mg daily, if the usual dosage was below this).

Adrenocortical insufficiency.

Drug induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimised by gradual reduction of dosage (see Section 4.4 Special Warnings and Precautions for Use). 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 may need to be reinstituted. If the patient is receiving steroids already, dosage may have to be increased.

4.3 Contraindications

Uncontrolled infections; systemic fungal infections; known hypersensitivity to prednisone or prednisolone or any of the excipients in the liquid.

4.4 Special Warnings and Precautions for Use

Scleroderma renal crisis.

Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled.
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 and as to whether daily or intermittent therapy should be used.
During prolonged corticosteroid therapy, adrenal suppression and atrophy may occur and secretion of corticotrophin may be suppressed. Duration of treatment and dosage appear to be important factors in determining suppression of the pituitary adrenal axis and response to stress on cessation of steroid treatment. The patient's liability to suppression is also variable. Some patients may recover normal function rapidly. In others, the production of hydrocortisone in response to the stress of infections, surgical operations or accident may be insufficient, and death results. Therefore, withdrawal of corticosteroids should always be gradual.
Abrupt withdrawal of corticosteroid therapy may precipitate acute adrenal insufficiency (see Section 4.8 Adverse Effects (Undesirable Effects)). In some cases, withdrawal symptoms may simulate a clinical relapse of the disease for which the patient has been under treatment.
Because prednisolone manifests little sodium retaining activity, the usual early sign of hydrocortisone overdosage (i.e. increase in bodyweight due to fluid retention) is not a reliable index of prednisolone overdosage. Hence recommended dose levels should not be exceeded, and all patients receiving prednisolone should be under close medical supervision. All precautions pertinent to the use of hydrocortisone apply to Redipred.

Use with caution in the following circumstances.

Use with caution in patients with impaired hepatic function, a reduction of dosage may be necessary. In treating chronic active liver disease with the drug, major adverse reactions such as vertebral collapse, diabetes, hypertension, cataracts and Cushing's syndrome occur in about 30% of patients.
Use with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection. Caution must also be used in diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension and myasthenia gravis, when steroids are used as direct or adjunctive therapy.
Use with caution in patients with epilepsy, diabetes mellitus, uraemia and in the presence of diminished cardiac reserve or congestive heart failure (see Section 4.8 Adverse Effects (Undesirable Effects)).
The possibility of development of osteoporosis should be an important consideration in initiating and managing corticosteroid therapy, especially in post menopausal women (see Section 4.8 Adverse Effects (Undesirable Effects)).
The risk of gastrointestinal ulceration or haemorrhage is increased when alcohol is used concurrently with glucocorticoids.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect.
There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Ocular effects.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
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.

Infection.

Corticosteroids may mask some signs of infection (such as fever and inflammation), and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Susceptibility to infection is not specific for any particular bacterial or fungal pathogen.
Patients should not be vaccinated with live vaccines while on corticosteroid therapy. Other immunisation procedures should not be undertaken in patients on corticosteroid therapy, especially on high doses, because of possible hazards of neurological complications and lack of antibody response. Immunization procedures may be undertaken in patients receiving corticosteroids as replacement therapy.
Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Patients with active or doubtfully quiescent tuberculosis should not be given Redipred except as adjuncts to treatment with tuberculostatic drugs as reactivation of the disease may occur. Chemoprophylaxis is indicated during prolonged corticosteroid therapy.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Check the following before use.

During long courses of treatment, laboratory and metabolic studies should be made. Fluid retention should be watched for via a fluid balance chart and daily weighing. Sodium intake may need to be reduced to less than 1 g daily and potassium supplements may be necessary.

Use in the elderly.

Caution is recommended for elderly patients as they are more susceptible to adverse reactions.

Paediatric use.

Children on long term steroids must be carefully observed for potential serious adverse reactions such as obesity, growth retardation, osteoporosis and adrenal suppression.

Effects on laboratory tests.

Glucocorticoids may decrease I₁₃₁ uptake and protein-bound iodine concentrations, making it difficult to monitor the therapeutic response of patients receiving the drugs for thyroiditis. Glucocorticoids may produce false-negative results in the nitroblue tetrazolium test for systemic bacterial infection. Glucocorticoids may suppress reactions to skin tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following drug interactions with corticosteroids have been selected on the basis of their potential clinical significance: antacids, antidiabetic agents (oral or insulin), digitalis glycosides, diuretics, drugs which induce hepatic microsomal enzymes, such as barbiturates, phenytoin and rifampicin; potassium supplements, ritodrine, sodium-containing medications or foods, somatrem or somatropin, vaccines, live viruses or other immunisations.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse effects associated with the individual use of either drug may be more apt to occur.
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampicin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response.
Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decreased their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.
The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
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 humans. 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 new born baby after long term treatment must be considered, the needs of the mother must be carefully weighed against the risk to fetus when prescribing corticosteroids. 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. Maternal pulmonary oedema has been reported with tocolysis and fluid overload.
The drug is excreted in breast milk; therefore, administration to nursing mothers is not recommended.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

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.
Short-term administration of Redipred, even in massive dosages, is unlikely to produce harmful effects. The majority of adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses.
The side effects associated with the use of corticosteroids in the large doses necessary to produce a therapeutic response result from excessive action on electrolyte balance; excessive action on other aspects of metabolism including gluconeogenesis; the action on tissue repair and healing; and an inhibitory effect on the secretion of corticotrophin by the anterior pituitary gland. Disturbance of electrolyte and water balance is manifest in sodium retention with oedema and hypertension, and in the increased excretion of potassium with the development of hypokalaemic alkalosis. In extreme cases cardiac failure may be induced. Disturbances of electrolyte balance are common with the naturally occurring corticotrophins cortisone, deoxycortone and hydrocortisone but are less frequent with the synthetic derivatives prednisone and prednisolone. Other metabolic effects include mobilisation of calcium and phosphorus with osteoporosis and spontaneous fractures, nitrogen depletion and hyperglycaemia with accentuation or precipitation of the diabetic state. The insulin requirements of diabetic patients are increased and appetite is often increased.
The effect on tissue repair manifests as peptic ulceration with haemorrhage and perforation, delayed wound healing and increased liability to infection. Increased susceptibility to all kinds of infection, including sepsis, fungal and viral infection, has been reported.
Large doses of corticosteroids or corticotrophins may produce symptoms typical of hyperactivity of the adrenal cortex, with moonface, buffalo hump, flushing striae and acne sometimes leading to a fully developed Cushing's syndrome. If administration of the hormone is discontinued immediately on the appearance of these symptoms, they are usually reversed but such sudden cessation may be dangerous. The dose of corticosteroid required to cause a decrease or absence of corticotrophin in the blood with consequent atrophy of the adrenal cortex and the time required for its occurrence are very variable. Acute adrenal insufficiency with loss of consciousness may occur during prolonged treatment or on cessation of treatment and may be precipitated by an infection or trauma.
Growth retardation in children has been reported and in this respect cortisone is only 1/10 as potent as prednisone and prednisolone. Other toxic effects include mental and neurological disturbances, intracranial hypertension and, on sudden reduction of dosage during the treatment of rheumatoid arthritis, fatalities attributed to lesions of small arteries and arterioles similar to polyarteritis.
Infections may be masked since corticosteroids have marked anti-inflammatory and antipyretic properties and may produce a feeling of well-being. The administration of corticosteroids may also cause a reduction in the number of circulating lymphocytes. Muscular weakness is an occasional side effect of most corticosteroids, particularly when they are taken in large doses.
Toxic effects occur with all corticosteroid preparations and their incidence rises steeply if dosage increases much above 8 mg daily of prednisolone or its equivalent.

Postmarketing reaction frequencies.

(> 5%).

Gastrointestinal.

Increased appetite, indigestion.

Neurological.

Nervousness or restlessness, insomnia.
(1-5%).

Dermatological.

Local allergic reaction.

Gastrointestinal.

Pancreatitis and ulcerative oesophagitis can occur. Peptic ulceration is an occasional complication. The high incidence of haemorrhage and perforation in these ulcers and the insidious nature of their development make them severe therapeutic problems. Some investigators believe the available evidence does not support the conclusion that steroids cause ulcers. Others feel that only patients with rheumatoid arthritis have an increased incidence of ulcers. It has been proposed that the glucocorticoids alter the mucosal defence mechanism.

Ophthalmological.

Prolonged use of glucocorticoids may result in posterior subcapsular cataracts (particularly in children), exophthalmos, or increased intraocular pressure which may result in glaucoma or may occasionally damage the optic nerve and in rare cases, lead to blindness. Establishment of secondary fungal and viral infections of the eye may also be enhanced.

Biochemical.

All glucocorticoids increase gluconeogenesis. Glucose tolerance and sensitivity to insulin are decreased but provided pancreatic islet function is normal carbohydrate metabolism will not be noticeably deranged. Steroid diabetes has been reported to develop in one fifth of patients treated with high glucocorticoid dosage. High dose corticosteroid therapy may induce marked hypertriglyceridaemia with milky plasma.
(< 1%).

Dermatological.

Dermatological adverse effects of corticosteroids include impaired wound healing, facial plethora, increased sweating, easy bruising, hirsutism, an acneiform eruption on the face, chest and back, red striae on the thighs, buttocks and shoulders. Several months of high dose therapy can often result in thinning of skin. Dermatologic manifestations of hypersensitivity to the corticosteroids include hives and/or allergic dermatitis, urticaria, and angioedema.
Corticosteroid induced purpura resembles senile purpura. This purpura usually occurs on extensor surfaces, dorsum of the hand, and radial aspect of the forearm.

Neurological.

Adverse neurological effects have included headache, vertigo and increased motor activity, ischemic neuropathy, EEG abnormalities and seizures. Large doses can cause behavioural and personality changes ranging from nervousness, euphoria or mood swings to psychotic episodes which can include both manic and depressive states, paranoid states and acute toxic psychoses.
It is no longer believed that previous psychiatric problems predispose to behavioural disturbances during therapy with glucocorticoids. Conversely, the absence of a history of psychiatric illness is no guarantee against the occurrence of psychosis during hormonal therapy.

Endocrine.

The endocrine effects of the glucocorticoids involve variously the hypothalamic pituitary adrenal axis, the parathyroid and thyroid. There are also metabolic effects, primarily involving the carbohydrates. Suppression of growth may occur in children.
Cushing's syndrome may result from prolonged elevation of plasma glucocorticoid levels.
Corticosteroids have also been reported to increase or decrease motility and number of sperm in some men. Disorders of menstruation are common.
Antagonism occurs between the parathyroids and hypercorticism. Latent hypoparathyroidism may be unmasked by administration of corticosteroids. The phosphate retention occurring in renal failure caused by adrenal insufficiency may also make hypoparathyroidism manifest.

Gastrointestinal.

Adverse gastrointestinal effects of corticosteroids include nausea, vomiting, anorexia (which may result in weight loss), diarrhoea or constipation, abdominal distension and gastric irritation.

Cardiovascular.

The mineralocorticoid activity of a steroid may lead to salt and water retention which can also result in hypertension. Hypokalaemia can lead to arrhythmias and cardiac arrest.

Musculoskeletal.

Osteoporosis and vertebral compression fractures can occur in patients of all ages. Osteoporosis is an indication for withdrawal of therapy.
Myopathy, characterised by weakness of the proximal musculature of arms and legs and their associated shoulder and pelvic muscles, is occasionally reported in patients taking large doses of corticosteroids. It may occur soon after treatment is begun and be sufficiently severe to prevent ambulation. It is an indication for withdrawal of therapy.
Avascular aseptic necrosis of bone has often been described and preferentially involves the femoral and humeral head.

Withdrawal adverse effects.

Muscle weakness, hypotension, hypoglycaemia, headache, nausea, vomiting, restlessness and muscle and joint pain. Muscle weakness and stiff joints may persist for three to six months after discontinuation of treatment. Adverse reactions from corticosteroids are those resulting from withdrawal or from prolonged use of high doses.

The following adverse reactions have also been reported, however, there is no information on their incidences.

General.

Retardation of growth by long term corticosteroid treatment in children.

Haematological.

Corticosteroids will increase the total WBC count, with an increase in neutrophils and a decrease in monocytes, lymphocytes and eosinophils.

Immunological.

The frequency and severity of clinical infections increase during glucocorticoid therapy.

Serious or life threatening reactions.

Suppression of the hypothalamic pituitary adrenal axis is one of the consequences of repeated administration of glucocorticoids (see Section 4.4 Special Warnings and Precautions for Use). In some cases acute adrenal insufficiency after a period of glucocorticoid treatment has proved fatal.

Neurological.

Latent epilepsy can be rendered manifest by corticosteroid treatment. Long term treatment may result in benign intracranial hypertension.

Eye disorders.

Blurred vision.

Scleroderma renal crisis.

Frequency 'unknown'. Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).

Cardiac disorders.

Frequency 'unknown'. Bradycardia has been reported following high doses.

4.9 Overdose

Treatment is symptomatic with the dosage being reduced or the drug withdrawn.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Prednisolone is a synthetic glucocorticoid with the general properties of the corticosteroids. Prednisolone exceeds hydrocortisone in glucocorticoid and anti-inflammatory activity, being about three times more potent on a weight basis than the parent hormone, but is considerably less active than hydrocortisone in mineralocorticoid activity.
Prednisolone like hydrocortisone is a potent therapeutic agent influencing the biochemical behaviour of most tissues of the body.
The mechanism of action of corticosteroids is thought to be by control of protein synthesis. Corticosteroids react with receptor proteins in the cytoplasm of sensitive cells in many tissues to form a steroid-receptor complex.
Corticosteroids are palliative symptomatic treatment by virtue of their anti-inflammatory effects; they are never curative.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Prednisolone sodium phosphate is a pro-drug, hydrolysed in-vivo to prednisolone by alkaline phosphatase at the intestinal wall prior to absorption.
Prednisolone is rapidly and well absorbed (t_max = 1-2 hours) from the gastrointestinal tract following oral administration.

Distribution.

Prednisolone is 90-95% protein-bound, less so at higher doses. The apparent volume of distribution for unbound prednisolone is 1.5 ± 0.2 L/kg.

Metabolism.

It is metabolised mainly in the liver.

Excretion.

It is eliminated from the plasma with a half-life of 2 to 4 hours. Approximately 7-15% of an oral dose of prednisolone is excreted as unchanged prednisolone in the urine, the remainder being recovered as a variety of metabolites, including sulphate and glucuronide conjugates.

5.3 Preclinical Safety Data

Genotoxicity.

The hepatocarcinogenic response to these drugs does not appear to be related to genotoxic activity.

Carcinogenicity.

In male rats, administration of prednisolone in the drinking water at a daily dose level of 0.4 mg/kg for two years caused an increased incidence of hepatocellular tumours. Similar results were obtained with triamcinolone acetonide and budesonide, indicating a class effect of glucocorticosteroids.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sorbitol solution (70%) non-crystallising, disodium edetate, monobasic sodium phosphate, dibasic sodium phosphate, methyl hydroxybenzoate, propyl hydroxybenzoate, nature identical raspberry flavour 08-3326 and water-purified.

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.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light. Discard 4 weeks after opening.

6.5 Nature and Contents of Container

Packed in 30 mL and 100 mL* bottles.
(* Not currently marketed in Australia).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Prednisolone sodium phosphate chemical name: 11β,17,21-Trihydroxypregna-1,4-diene-3,20 dione-21-(disodium phosphate).

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