Consumer medicine information

Redipred

Prednisolone

BRAND INFORMATION

Brand name

Redipred

Active ingredient

Prednisolone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Redipred.

What is in this leaflet

This leaflet answers some common questions about REDIPRED. It does not contain all the information that is known about this medicine. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking REDIPRED against the benefits they expect it will have for you.

If you have any concerns about taking this medicine ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What REDIPRED is used for

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.

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.

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.

REDIPRED is only available with a doctor's prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take REDIPRED if you have ever had an allergic reaction to:

  • prednisolone or prednisone
  • any of the ingredients listed at the end of this leaflet.

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.

Do not take REDIPRED after the expiry date printed on the label. It may have no effect at all or an entirely unexpected effect if you take it after the expiry date.

Do not take REDIPRED if the bottle shows signs of having been tampered with.

Do not take REDIPRED if you have a current serious or uncontrolled infection, including fungal infections.

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.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you have or have had any of the following medical conditions:

  • a current serious or uncontrolled infection, including fungal infections
  • 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.

It may not be safe for you to take REDIPRED if you have any of these medical conditions.

Do not take REDIPRED if you are pregnant or plan to become pregnant. It is recommended that you do not breastfeed while taking this medicine as it is found in breast milk.

If you have not told your doctor about any of these things, tell them before you take REDIPRED.

Taking other medicines

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

Some of the medicines in common use that may interfere with REDIPRED 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.

These medicines may be affected by REDIPRED or may affect how well it works. 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.

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 it, 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. Some of these include obesity, slowed growth, osteoporosis (softening of the bone) and changes to the adrenal glands.

Use in elderly

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

How to take it

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.

How to take it

REDIPRED is best taken with or immediately after food.

When to take it

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.
  • 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 long to take it

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.

What to expect

Individuals will vary greatly in their response to REDIPRED. Your doctor will check your progress at regular intervals.

If you forget to take it

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 (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital if you think that you or anyone else may have taken too much REDIPRED. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking it

Things you must 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 your doctor immediately if you become pregnant while taking REDIPRED.

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.

Tell your doctor straight away if you 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.

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.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

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 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.

Things to be aware of

As with any new medicine, you should take care when driving, operating machinery or drinking alcohol until you know how REDIPRED affects you.

Check with your doctor or pharmacist before drinking alcohol while you are taking this medicine. If you drink alcohol while taking it you may find that stomach problems occur.

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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking REDIPRED.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Short term use

When REDIPRED is taken for short periods of time it is unlikely to cause any problems.

Tell your doctor if you notice any of the following side effects and they worry you:

  • 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.

These common 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

When REDIPRED is taken for long periods of time and in high doses the risk of side effects is greater.

Tell your doctor if you notice any of the following and they worry you:

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.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following symptoms:

  • 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.

These are all serious side effects of REDIPRED which may occur with high doses and long term use. You may need urgent medical attention or hospitalisation.

Some side effects can only be detected by your doctor. So, when REDIPRED is taken for long periods of time it is important to visit your doctor regularly for check-ups. Such side effects can include:

  • osteoporosis or other changes in bone which can result in an increased chance of fractures due to brittleness or 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.

Tell your doctor if you notice anything else that is making you feel unwell. Some people may get other side effects while using REDIPRED.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

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

Discard 4 weeks after opening.

Do not store it or any other medicine in the bathroom or near a sink or stove. Do not leave it on a window sill or in the car on hot days. Heat and dampness can destroy some medicines.

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.

Disposal

Dispose of the medicine where children cannot reach it.

If your doctor tells you to stop taking REDIPRED, or you find that the expiry date has passed, ask your pharmacist what to do with any liquid you have left over.

Product description

What it looks like

REDIPRED is a raspberry flavoured, clear, colourless to slightly yellow solution. It is available in 30 mL bottles.

Ingredients

REDIPRED contains 6.72 mg/mL prednisolone sodium phosphate (equivalent to 5 mg prednisolone) as the active ingredient.

It also contains the following 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.

Sponsor

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

Australian Registration Number:
AUST R 62506

This leaflet was revised in April 2021.

Published by MIMS June 2021

BRAND INFORMATION

Brand name

Redipred

Active ingredient

Prednisolone

Schedule

S4

 

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 (tmax = 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).

Chemical structure.


CAS number.

125-02-0.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes