Consumer medicine information

Depo-Nisolone

Methylprednisolone acetate

BRAND INFORMATION

Brand name

Depo-Nisolone

Active ingredient

Methylprednisolone acetate

Schedule

SUMMARY CMI

DEPO-NISOLONE^®

Consumer Medicine Information (CMI) summary

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

1. Why am I being given DEPO-NISOLONE?

DEPO-NISOLONE contains the active ingredient Methylprednisolone. DEPO-NISOLONE is used to treat disorders of many organ systems such as skin, lung, eye, gastrointestinal tract, nervous system, joints and blood.

For more information, see Section 1. Why am I being given DEPO-NISOLONE? in the full CMI.

2. What should I know before receiving DEPO-NISOLONE?

Do not receive DEPO-NISOLONE if you have ever had an allergic reaction to DEPO-NISOLONE or any of the ingredients listed at the end of the CMI, or if you have a severe fungal infection or if you have been given a live vaccine.

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 receiving DEPO-NISOLONE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DEPO-NISOLONE and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy with or without a prescription from your pharmacy, supermarket or health food shop.

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

4. How is DEPO-NISOLONE given?

This medicine will be administered under medical supervision. It may be given into a muscle, or into a joint, or into a lesion. Due to the risk of serious side effects, it must not be injected into the spinal cord or into a vein.

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

5. What should I know while receiving DEPO-NISOLONE?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are receiving DEPO-NISOLONE. Tell your doctor that you are being treated with DEPO-NISOLONE: - before having any skin tests - before having any kind of surgery - if you get a serious injury or infection.
Driving or using machines	DEPO-NISOLONE may cause tiredness, dizziness or slow reflexes in some people. Do not drive, operate machinery or do anything else that could be dangerous if you feel tired, or if you feel that DEPO-NISOLONE has affected your co-ordination in any way.
Looking after your medicine	DEPO-NISOLONE will normally be stored in a hospital or doctor's surgery. It should be stored in its original packaging in a cool, dry place where the temperature stays below 30°C. It must not be frozen.

For more information, see Section 5. What should I know while receiving DEPO-NISOLONE? in the full CMI.

6. Are there any side effects?

Side effects include: nausea, vomiting, diarrhoea, headache, dizziness, mood changes, muscle weakness, pain, rash, injection site pain, fragile skin, acne, slow growth, sleeplessness, weight gain, increased sweating, bone weakness or pain, wounds that will not heal, loss in control in your diabetes, changes in menstruation, red, purple or brown patches on your skin, dilated pupils and blurred vision, fever, sore throat, mouth ulcers, itching, wheezing, drowsiness, double vision, anxiety, chest pain, severe chills, severe stomach pain, convulsions, breathlessness, increased thirst. 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

DEPO-NISOLONE^®

Active ingredient(s): methylprednisolone acetate

Consumer Medicine Information (CMI)

This leaflet provides important information about DEPO-NISOLONE.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about DEPO-NISOLONE.

Where to find information in this leaflet:

1. Why am I being given DEPO-NISOLONE?
2. What should I know before receiving DEPO-NISOLONE?
3. What if I am taking other medicines?
4. How is DEPO-NISOLONE given?
5. What should I know while receiving DEPO-NISOLONE?
6. Are there any side effects?
7. Product details

1. Why am I being given DEPO-NISOLONE?

DEPO-NISOLONE contains the active ingredient methylprednisolone.

DEPO-NISOLONE is used to treat disorders of many organ systems such as skin, lung, eye, gastrointestinal tract, nervous system, joints and blood. DEPO-NISOLONE works by reducing inflammation and changing the body's natural ability to respond when the immune response is not working properly. It is also used in certain conditions where the adrenal gland doesn't function correctly.

Your doctor may have prescribed DEPO-NISOLONE for another reason.

Ask your doctor if you have any questions about why DEPO-NISOLONE has been prescribed for you.

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

2. What should I know before receiving DEPO-NISOLONE?

Warnings

DEPO-NISOLONE must not be used:

If you are allergic to methylprednisolone acetate or any of the ingredients listed at the end of this leaflet
If you have a severe fungal infection
It must not be injected into the spinal cord (intrathecal or epidural) or into a vein (intravenous)
It must not be given by any other unapproved route of administration
If you have been given a live vaccine

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you have or have had any other medical conditions, especially the following:

tuberculosis
underactive thyroid gland
kidney or liver disease
herpes in the eye
hypoprothrombinaemia (a blood clotting disorder)
disease of the bowel, e.g., ulcerative colitis or diverticulitis
stomach ulcers
diabetes
emotional problems or mental disorder
any pus-producing infection
problems with your heart, including high blood pressure or congestive heart failure
Cushing's disease (a hormone disorder)
seizure disorders e.g. epilepsy
myasthenia gravis (ongoing muscle weakness and chronic fatigue)
muscle pain, tenderness or weakness from other medicines, especially those used to treat high cholesterol or triglycerides
thin or weak bones, or bones that tend to break easily (osteoporosis)
recent head injuries
blood clots
systemic sclerosis
a solid cancer or cancer of the blood because you may be at risk of a very rare, potentially life-threatening condition resulting from a sudden breakdown of tumour cells.

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

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

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

Children

Long term treatment with corticosteroids can affect growth and development in children. It can also increase the risk of high pressure in the brain. Your doctor will monitor your child closely if your child needs long term treatment with DEPO-NISOLONE.

Elderly

If you are over 65 years old, you may have an increased chance of side effects such as bone weakness possibly leading to fractures. You may also experience fluid retention which may lead to increased blood pressure.

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 or food and DEPO-NISOLONE may interfere with each other. Some of these medicines and food include:

cyclosporin, cyclophosphamide, tacrolimus (medicines used to suppress the immune system e.g. after a transplant)
isoniazid (a medicine to treat tuberculosis)
non-steroidal anti-inflammatory drugs [NSAID] such as salicylates or aspirin (medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis)
some antifungals e.g. ketoconazole, itraconazole
some antibiotics e.g. rifampicin, erythromycin, clarithromycin
phenobarbitone, phenytoin, carbamazepine (medicines used to treat epilepsy, convulsions)
anticoagulants (medicines used to prevent blood clots) e.g. warfarin, heparin
some immunisations, inoculations or vaccinations
some diuretics e.g. frusemide, a medicine to help kidneys get rid of salt and water by increasing the amount of urine (wee) produced
neuromuscular blocking drugs (medicines that block nerve and muscle action) e.g. pancuronium
medicines used to treat myasthenia gravis (ongoing muscle weakness and chronic fatigue), glaucoma, Alzheimer's disease
medicines used to treat psychiatric disorders
medicines used to treat anxiety
bronchodilators (a type of medicine that opens up the airways in the lungs) used to treat asthma, bronchitis, emphysema, and other lung diseases, e.g., salbutamol
medicines used to treat diabetes e.g. insulin, glibenclamide and metformin
anti-nausea medicines e.g. aprepitant, fosaprepitant
medicines to treat HIV e.g. indinavir, ritonavir
some medicines to treat blood pressure, heart conditions and stroke, e.g., digoxin and diltiazem
oral contraceptives e.g. ethinylestradiol, norethisterone
grapefruit juice
medicines used to treat breast cancer and hormone disorders.

These medicines and food may be affected by DEPO-NISOLONE or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have a more complete list of medicines to be careful with or avoid while being treated with DEPO-NISOLONE.

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

4. How is DEPO-NISOLONE given?

How much to use

This medicine will be administered under medical supervision.

It may be given into a muscle (intramuscularly) or into a joint (intra-articularly) or into a lesion (intralesional). Due to the risk of serious side effects, it must not be injected into the spinal cord (intrathecally or epidural) or into a vein (intravenously).

How and where DEPO-NISOLONE is injected and the dose given will depend on the nature and the severity of your condition. You will be given a different dosage depending on your condition and how you react to the medicine.

If you are given too much (overdose)

Overdose is unlikely with DEPO-NISOLONE. However, repeated frequent doses over a long period of time may cause an increase in side effects.

If you think that you or anyone else may have been given too much DEPO-NISOLONE, 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.

5. What should I know while receiving DEPO-NISOLONE?

Things you must do

If you become pregnant while you are being treated with DEPO-NISOLONE, tell your doctor.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are being treated with DEPO-NISOLONE.

Tell all doctors, dentists and pharmacists who are treating you that you are being treated with DEPO-NISOLONE.

Tell your doctor that you are being treated with DEPO-NISOLONE:

before having any skin tests
before having any kind of surgery
if you get a serious injury or infection.

Medicines such as DEPO-NISOLONE can increase the risk of infection and mask symptoms of infection.

Tell your doctor if you notice any of the following:

fever
tiredness
sore or swollen joints.

Your doctor may request you follow a low-salt diet and/or take potassium supplements.

If you are a diabetic, your need for insulin or glucose lowering medicines may increase while being treated with DEPO-NISOLONE.

For patients having this medicine injected into their joints:

be careful not to put too much stress onto that joint for a while
ask your doctor how much you can move this joint while it is healing.

Your doctor may reduce the dose of DEPO-NISOLONE gradually if you have been on long-term treatment.

Driving or using machines

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

DEPO-NISOLONE may cause tiredness, dizziness or slow reflexes in some people.

Do not drive, operate machinery or do anything else that could be dangerous if you feel tired, or if you feel that DEPO-NISOLONE has affected your co-ordination in any way.

Drinking alcohol

No information available.

Tell your doctor if you drink alcohol.

Looking after your medicine

DEPO-NISOLONE will normally be stored in a hospital or doctor's surgery. It should be stored in its original packaging in a cool, dry place where the temperature stays below 30°C. It must not be frozen.

Disposal

Your doctor, nurse or pharmacist will dispose of any left-over medicine.

6. Are there any side effects?

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

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

Side effects

	What to do
Gastrointestinal (stomach-related) nausea (feeling sick) vomiting diarrhoea or constipation heartburn increased appetite loss of appetite or weight loss persistent hiccups Head and mind related tiredness headache or dizziness lightheadedness forgetfulness sleeplessness mood changes e.g. over-excitement, depression, suicidal thoughts, hallucinations, anxiety changes to menstrual periods Body (skin, bone and muscle) related fluid retention muscle weakness, pain or loss of muscle mass problems with your joints, including pain problems with your growth increased sweating thin fragile skin or bruising itchy or peeling skin facial flushing/redness, heat rashes, acne, hives Injection site related changes to skin at the injection site injection site pain	Speak to your doctor if you have any of these side effects and they worry you.
bone weakness (can lead to fractures) wounds that will not heal loss in the control of your diabetes red, purple or brown patches on your skin problems with your back, including pain or weakness loss of sensation or problems with your reflexes (slow or too fast) bouts of anxiety and headaches, sweating, palpitations, dizziness, a feeling of weakness, nausea, vomiting, diarrhoea, dilated pupils and blurring vision, stomach pains, and raised blood pressure. These could be symptoms of a rare tumour of the adrenal gland, which sits near the kidney.	Call your doctor straight away
signs of increased pressure in the skull, including drowsiness, vomiting, headache, weakness, numbness and /or eye problems such as double vision allergic type reactions e.g. skin rash, itching and difficulty breathing, wheezing or coughing, chest pain (anaphylactic reaction) signs of infection such as fever, severe chills, sore throat or mouth ulcers severe stomach pains blurred or distorted vision or loss of vision, eye infections breathlessness, fatigue and swelling (heart failure) convulsions or fits passing large amounts of urine (wee), increased thirst and appetite severe muscle pain or weakness often with passing of dark red or brown urine (wee), or only passing small amounts of wee pain and tenderness in the leg, pain on extending the foot, swelling of the lower leg, ankle and foot	Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of these symptoms

DEPO-NISOLONE can also cause chemical imbalances in the blood, swelling of the pancreas (pancreatitis), masking of infections, increased risk of infection, hormone changes, metabolic changes and changes in liver enzymes, increased blood pressure, increased number of white blood cells (leucocytosis), or cataracts. Some of these side effects can only be found when your doctor does tests to check on your progress.

This is not a complete list of all possible side effects. Some people may get other side effects while being treated with DEPO-NISOLONE.

It is very important to tell your doctor if you notice any side effects while being treated with DEPO-NISOLONE.

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

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/safety/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

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

What DEPO-NISOLONE contains

Active ingredient (main ingredient)	methylprednisolone acetate
Other ingredients (inactive ingredients)	Macrogol 3350 Sodium chloride Miripirium chloride

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

What DEPO-NISOLONE looks like

DEPO-NISOLONE (AUST R 59388) is a suspension for injection packaged in a glass vial. It is supplied in cartons of 5 x 1 mL or 1 x 1 mL vials.

Who distributes DEPO-NISOLONE

DEPO-NISOLONE is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll free number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in March 2025

Published by MIMS May 2025

BRAND INFORMATION

Brand name

Depo-Nisolone

Active ingredient

Methylprednisolone acetate

Schedule

1 Name of Medicine

Methylprednisolone acetate.

2 Qualitative and Quantitative Composition

Each mL of Depo-Nisolone contains 40 mg of methylprednisolone acetate as the active substance.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for Injection.
White to off white suspension when mixed.

4 Clinical Particulars

4.1 Therapeutic Indications

A. For intramuscular administration.

When oral therapy is not feasible and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of Depo-Nisolone is indicated as follows.

1. Endocrine disorders.

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

2. Rheumatic disorders.

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

3. Collagen diseases.

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

4. Dermatological diseases.

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

5. Allergic states.

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

6. Ophthalmic diseases.

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

7. Gastrointestinal diseases.

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

8. Respiratory diseases.

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

9. Haematological disorders.

Acquired (autoimmune) haemolytic anaemia, erythroblastopenia (RBC anaemia), secondary thrombocytopenia in adults, congenital (erythroid) hypoplastic anaemia.

10. Neoplastic diseases.

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

11. Oedematous states.

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

12. Miscellaneous.

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

B. For intra-articular or soft tissue administration.

Depo-Nisolone is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in synovitis of osteoarthritis, epicondylitis, rheumatoid arthritis, acute nonspecific tenosynovitis, acute and subacute bursitis, post-traumatic osteoarthritis, acute gouty arthritis.

C. For intralesional administration.

Depo-Nisolone is indicated for intralesional use in the following conditions: keloids, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, alopecia areata, localised hypertrophic, infiltrated inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis).
Depo-Nisolone may also be useful in cystic tumours of an aponeurosis or tendon (ganglia).

4.2 Dose and Method of Administration

Dosage.

Because of possible physical incompatibilities, Depo-Nisolone should not be diluted or mixed with other solutions.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Each vial of Depo-Nisolone is for single use in a single patient only. Discard any unused product.
It is critical that, during administration of Depo-Nisolone, appropriate technique be used and care taken to assure proper placement of drug.

A. Administration for local effect.

Therapy with Depo-Nisolone does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure, and the hormone has no effect on the cause of the inflammation.
1. Rheumatoid and osteoarthritis. The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks depending upon the degree of relief obtained from the initial injection. The doses in Table 1 are given as a general guide.

Procedure.

It is recommended that the anatomy of the joint involved be reviewed before attempting intra-articular injection. In order to obtain the full anti-inflammatory effect it is important that the injection be made into the synovial space. Employing the same sterile technique as for a lumbar puncture, a sterile 20 to 24 gauge needle (on a dry syringe) is quickly inserted into the synovial cavity. Procaine infiltration is elective. The aspiration of only a few drops of joint fluid proves the needle has entered the joint space. The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves. With the needle in place, the aspirating syringe is removed and replaced by a second syringe containing the desired amount of Depo-Nisolone. The plunger is then pulled outward slightly to aspirate synovial fluid and to make sure the needle is still in the synovial space. After injection, the joint is moved gently a few times to aid mixing of the synovial fluid and the suspension. The site is covered with a small sterile dressing. Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal and hip joints. Since difficulty is not infrequently encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area. Joints not suitable for injection are those that are anatomically inaccessible such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile. Local therapy does not alter the underlying disease process and, whenever possible, comprehensive therapy including physiotherapy and orthopaedic correction should be employed.
Following intra-articular steroid therapy, care should be taken to avoid overuse in joints in which symptomatic benefit has been obtained. Negligence in this matter may permit an increase in joint deterioration that will more than offset the beneficial effects of the steroid. Unstable joints should not be injected. Repeated intra-articular injection may in some cases result in instability of the joint. X-ray follow-up is suggested in selected cases to detect deterioration.
If a local anaesthetic is used prior to injection of Depo-Nisolone, the anaesthetic package insert should be read carefully and all the precautions observed.
2. Bursitis. The area around the injection site is prepared in a sterile way, and a weal at the site made with 1% procaine hydrochloride solution. A 20 to 24 gauge needle attached to a dry syringe is inserted into the bursa and the fluid aspirated. The needle is left in place, and the aspirating syringe changed for a small syringe containing the desired dose. After injection, the needle is withdrawn and a small dressing applied.
3. Miscellaneous: ganglion, tendinitis, epicondylitis. In the treatment of conditions such as tendinitis or tenosynovitis, care should be taken, following application of a suitable antiseptic to the overlying skin, to inject the suspension into the tendon sheath rather than into the substance of the tendon. The tendon may be readily palpated when placed on a stretch. When treating conditions such as epicondylitis, the area of greatest tenderness should be outlined carefully and the suspension infiltrated into the area.
For ganglia of the tendon sheaths, the suspension is injected directly into the cyst. In many cases, a single injection causes a marked decrease in the size of the cystic tumour and may affect disappearance.

Note.

Due to the absence of a true tendon sheath, the Achilles tendon should not be injected with Depo-Nisolone.
The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 mg to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.
The usual sterile precautions should be observed with each injection.
4. Injections for local effect in dermatological conditions. Following cleansing with an appropriate antiseptic such as 70% alcohol, 20 mg to 60 mg is injected into the lesion. It may be necessary to distribute doses ranging from 20 mg to 40 mg by repeated local injections in the case of large lesions. Care should be taken to avoid injection of sufficient material to cause blanching, since this may be followed by a small slough. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.

B. Administration for systemic effect.

The intramuscular dosage will vary with the condition being treated. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection.
Dosage must be individualised according to the severity of the disease and response of the patient. For infants and children, the recommended dosage will have to be reduced, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or bodyweight.
Hormone therapy is an adjunct to, and not a replacement for, conventional therapy. Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis and expected duration of the disease and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two hour postprandial blood sugar, determination of blood pressure and bodyweight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper gastrointestinal X-rays are desirable in patients with an ulcer history or significant dyspepsia.
In patients with adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks may be adequate.
For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 mg to 120 mg.
The usual dosage for patients with skin lesions benefited by systemic corticoid therapy is 40 mg to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In chronic contact dermatitis repeated injections at 5 to 10 day intervals may be necessary. In seborrhoeic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.
Following intramuscular administration of 80 mg to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks.
If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intravenous administration of highly soluble methylprednisolone sodium succinate (Solu-Medrol) is indicated.

4.3 Contraindications

Systemic fungal infections.
Known hypersensitivity to methylprednisolone or any component of the formulation.
Intravenous, intrathecal, extradural, epidural or any unspecified route of administration.
Administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids (see Section 4.4 Special Warnings and Precautions for Use, Immunosuppressant effects/ increased susceptibility to infections).

4.4 Special Warnings and Precautions for Use

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual. 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.

Administration precautions.

This product is not suitable for multidose use. Following administration of the desired dose, any remaining suspension should be discarded.
While crystals of adrenal steroids in the dermis suppress inflammatory reactions, their presence may cause disintegration of the cellular elements and physiochemical changes in the ground substance of the connective tissue. The resultant infrequently occurring dermal and/or subdermal changes may form depressions in the skin at the injection site. The degree to which this reaction occurs will vary with the amount of adrenal steroid injected. Regeneration is usually complete within a few months or after all crystals of the adrenal steroid have been absorbed.
In order to minimise the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular and intramuscular injection should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.
Methylprednisolone acetate should not be administered by any route other than those listed under Section 4.1 Therapeutic Indications. It is critical that, during administration of methylprednisolone acetate, appropriate technique be used and care taken to assure proper placement of drug.
Severe medical events have been reported in association with the contraindicated intrathecal/ epidural routes of administration (see Section 4.8 Adverse Effects (Undesirable Effects)). Appropriate measures must be taken to avoid intravascular injection.

Immunosuppressant effects/ increased susceptibility to infections.

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

Immune system effects.

Allergic reactions may occur. Because rare instances of skin reactions and anaphylactic/ anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Allergic skin reactions have been reported, apparently related to the excipients in the formulation. Rarely has skin testing demonstrated a reaction to methylprednisolone acetate per se.

Cardiac effects.

Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidaemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects if high doses and/or prolonged courses are used. When using corticosteroids in these patients, attention should be paid to risk modification and additional cardiac monitoring should be considered.
Use of systemic corticosteroid is not recommended in patients with congestive heart failure.

Vascular effects.

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

Endocrine effects.

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.
Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic pituitary adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. This effect may be minimised by use of alternate day therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly.
Drug induced secondary adrenocortical insufficiency may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
A steroid 'withdrawal syndrome', seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Because glucocorticoids can produce or aggravate Cushing syndrome, glucocorticoids should be avoided in patients with Cushing disease.
There is an enhanced effect of corticosteroids in patients with hypothyroidism.
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/ benefit evaluation.

Hepatobiliary effects.

Hepatobiliary disorders have been reported which may be reversible after discontinuation of therapy. Therefore, appropriate monitoring is required.
There is an enhanced effect of corticosteroids in patients with cirrhosis.

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 and nuclear cataracts (particularly in children), exophthalmos or increased intraocular pressure which may result in 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.

Psychiatric effects.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Potentially severe psychiatric adverse reactions may occur with systemic steroids (see Section 4.8 Adverse Effects (Undesirable Effects)). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown. Patients/ caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/ caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/ withdrawal of systemic steroids.

Gastrointestinal effects.

High doses of corticosteroids may produce acute pancreatitis.
Corticosteroid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain. Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, or active or latent peptic ulcer.

Nervous system effects.

Use of corticosteroids is not recommended in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis (see Section 4.4 Special Warnings and Precautions for Use, Musculoskeletal effects).
There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.

Musculoskeletal effects.

An acute myopathy has been described with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g. myasthenia gravis), or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (e.g. pancuronium). This acute myopathy is generalised, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Cases of rhabdomyolysis have been reported. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Corticosteroids should be used with caution in osteoporosis. Osteoporosis is a common but infrequently recognised adverse effect associated with a long-term use of large doses of glucocorticoid.

Metabolism and nutrition.

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

Investigations.

Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Injury, poisoning and procedural complications.

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

Other.

Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, CYP3A4 substrates, NSAIDs).
In post-marketing experience, tumour lysis syndrome (TLS) has been reported in patients with malignancies, including haematological malignancies and solid tumours, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumours that have a high proliferative rate, high tumour burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.

Additional precautions specific for parenteral corticosteroids.

Intra-articular injection of a corticosteroid may produce systemic as well as local effects.
Appropriate examination of any joint fluid present is necessary to exclude a septic process.
A marked increase in pain accompanied by local swelling, further restriction of joint motions, fever and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected joint is to be avoided.
Corticosteroids should not be injected into unstable joints.
Sterile technique is necessary to prevent infections or contamination.
The slower rate of absorption by intramuscular administration should be recognised.

Use in renal impairment.

Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone. Corticosteroids should be used with caution in patients with renal insufficiency.

Use in the elderly.

Caution is recommended with prolonged corticosteroid treatment in the elderly due to a potential increased risk for osteoporosis, as well as increased risk for fluid retention with possible resultant hypertension.

Paediatric use.

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

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Methylprednisolone has a wide spectrum of clinical use and is therefore used with numerous concurrent drugs. The interactions summarised in Tables 2 and 3 are of known or likely clinical significance. The need for dosage adjustment of either medication will depend on the clinical situation, the dose regimen prescribed and the observed clinical response. The interactions listed have either pharmacokinetic or pharmacodynamic basis.
Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolised by the CYP3A4 enzyme. CYP3A4 catalyses 6β-hydroxylation of steroids, the essential phase I metabolic step for both endogenous and synthetic corticosteroids. Many other compounds are also substrates of CYP3A4, some of which (as well as other drugs) have been shown to alter glucocorticoid metabolism by induction (up-regulation) or inhibition of the CYP3A4 enzyme.

CYP3A4 inhibitors.

Drugs that inhibit CYP3A4 activity generally decrease hepatic clearance, resulting in increased plasma concentrations of corticosteroids. Coadministration of these substances may require titration of corticosteroid dosage to reduce the risk of adverse effects and avoid steroid toxicity.

CYP3A4 inducers.

Drugs that induce CYP3A4 activity generally increase hepatic clearance, resulting in decreased plasma concentrations of corticosteroids. Coadministration of these substances may require an increase in corticosteroid dosage to achieve the desired result.

CYP3A4 substrates.

In the presence of another CYP3A4 substrate, the hepatic clearance of methylprednisolone may be affected, with corresponding dosage adjustments required. It is possible that adverse events associated with the use of either drug alone may be more likely to occur with coadministration.
The most common and/or clinically important drug interactions or effects resulting from coadministration of Depo-Nisolone and examples of CYP3A4 inhibitors, inducers and substrates are provided in Tables 2 and 3. Tables 2 and 3 should be used in conjunction with the detailed information provided above.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Animal studies on the effects of methylprednisolone did not show an adverse impact on fertility in male and female rats treated with methylprednisolone aceponate at subcutaneous doses up to 0.1 mg/kg/day, although there was an increase in the number of nonviable fetuses. Other corticosteroids have been shown to impair fertility and reduce embryonic viability in studies in mice and rats.
(Category C)
Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. In animal experiments, corticosteroids (such as methylprednisolone) have been shown to increase the incidence of fetal malformations of various kinds (cleft palate, ventricular septal defect, skeletal malformations), embryofetal lethality (e.g. increase in resorptions), intrauterine growth retardation and abortions. There is limited data on the use of methylprednisolone acetate in human pregnancies, and animal reproduction studies have not been done. Methylprednisolone acetate should be used in pregnancy only after a careful assessment of the benefit/ risk ratio to the mother and fetus.
Corticosteroids readily cross the placenta. Increased incidence of reduced placental and birthweight has been recorded in infants born of mothers receiving corticosteroids.
Infants exposed in utero to substantial doses of corticosteroids must be carefully observed and evaluated for signs of adrenal insufficiency. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing corticosteroids.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.
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. No effect is known relating to use in labour and delivery.
Corticosteroids are excreted in breast milk.
Corticosteroids distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. This medicinal product should be used during breastfeeding only after a careful assessment of the benefit/ risk ratio to the mother and infant.

4.7 Effects on Ability to Drive and Use Machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances, and fatigue are possible after treatment with corticosteroids. If affected, patients should not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Serious undesirable adverse events are also mentioned (see Section 4.4 Special Warnings and Precautions for Use).
Administration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/ paraplegia, sensory disturbances, headache, functional gastrointestinal disorder/ bladder dysfunction, seizures, visual impairment including blindness, ocular and periocular inflammation, and residue or slough at injection site.
The adverse effects are listed in Table 4 by system organ class.

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/safety/reporting-problems.

4.9 Overdose

Reports of acute toxicity and metabolic disturbances with glucocorticoids are rare but do occur. There is no clinical syndrome of acute overdosage with Depo-Nisolone (methylprednisolone acetate). Acute overdose may possibly aggravate pre-existing disease states such as ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes and oedema. Repeated high doses of methylprednisolone have caused hepatic necrosis and an increase in amylase. Bradyarrhythmias, ventricular arrhythmias and cardiac arrest have been observed in cases of intravenous administration of high doses of methylprednisolone.
Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid state. The possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time.
In the event of an overdose, treatment is symptomatic and supportive, including respiratory and cardiovascular function. In chronic toxicity, fluids and electrolytes should be monitored closely. Serum levels are not clinically useful.
Depo-Nisolone contains macrogol (polyethylene glycol) as an excipient. Hypokalaemia has been reported following an unintentional large intravenous administration of macrogol. In case of overdose, monitor acid balance; renal, cardiac and pulmonary function in symptomatic patients and treat accordingly. Onset of acute lung injury may be delayed.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Naturally occurring glucocorticoids (hydrocortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogues are used primarily for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Methylprednisolone acetate has not been formally evaluated for genotoxicity. However, methylprednisolone sulfonate, which is structurally similar to methylprednisolone, was not mutagenic in bacteria (Ames test) or in a mammalian cell gene mutation assay using Chinese hamster ovary cells. Methylprednisolone suleptanate did not induce unscheduled DNA synthesis in primary rat hepatocytes. Prednisolone farnesylate, which is also structurally similar to methylprednisolone, was not mutagenic in bacteria, but displayed weak clastogenic activity in vitro in Chinese hamster lung fibroblasts in the presence of metabolic activation.

Carcinogenicity.

Methylprednisolone has not been formally evaluated in rodent carcinogenicity studies.
Negative results for carcinogenicity have been obtained with various other glucocorticoids including budesonide, prednisolone and triamcinolone acetonide, in mice. However, all three of these compounds were shown to increase the incidence of hepatocellular adenomas and carcinomas after oral administration in a 2-year study in male rats. These tumorigenic effects occurred at doses which were less than the typical clinical doses on a mg/m² basis. Hepatocarcinogenicity is likely to involve an interaction with the glucocorticoid receptor.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each mL contains: macrogol 3350 29 mg, sodium chloride 8.7 mg, miripirium chloride (added as preservative) 0.195 mg, water for injections QS.
When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range, i.e. 3.0 to 7.0.

6.2 Incompatibilities

Because of possible physical incompatibilities, Depo-Nisolone should not be diluted or mixed with other solutions.

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

Depo-Nisolone is for single use in a single patient only. Discard any unused product.
Store below 30°C. Protect from freezing.

6.5 Nature and Contents of Container

Depo-Nisolone Suspension for Injection is available in single dose glass vials and supplied in pack sizes of 5 x 1 mL and 1 x 1 mL vials.
Not all presentations are marketed.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Methylprednisolone acetate is a 6-methyl derivative of prednisolone.
Methylprednisolone acetate is a white or practically white, odourless, crystalline powder which melts at about 215°C with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, in alcohol, in chloroform, and in methanol, and slightly soluble in ether. It is practically insoluble in water.

Chemical structure.

Chemical name: 11β, 17α, 21-trihydroxy -6α-methylpregna -1,4-diene-3,20-dione acetate.
Molecular formula: C₂₄H₃₂O₆.
Molecular weight: 416.51.

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