Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before being treated with DEPO-MEDROL suspension for injection. This leaflet answers some common questions about DEPO-MEDROL. It does not contain all the available information. 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 being treated with DEPO-MEDROL against the benefits this medicine is expected to have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Consider keeping this leaflet even after treatment with DEPO-MEDROL is finished. You may need to read it again.

What DEPO-MEDROL is used for

DEPO-MEDROL is used to treat disorders of many organ systems such as skin, lung, eye, gastrointestinal tract, nervous system, joints and blood. DEPO-MEDROL 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-MEDROL for another reason.
Ask your doctor if you have any questions about why DEPO-MEDROL has been prescribed for you.
This medicine is available only with a doctor's prescription.

Before treatment with DEPO-MEDROL

Some information is provided below. However, always talk to your doctor if you have concerns or questions about your treatment.

When DEPO-MEDROL must not be used

• methylprednisolone acetate

• any of the other ingredients listed under Product Description at the end of this leaflet.

Before treatment with DEPO-MEDROL

• 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)

• 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.

Children

Elderly

Taking other medicines

• 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 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 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.

Treatment with DEPO-MEDROL

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-MEDROL 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)

While you are being treated with it

Things you must do

• before having any skin tests

• before having any kind of surgery

• if you get a serious injury or infection.

• fever

• tiredness

• sore or swollen 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.

Side effects

Check with your doctor as soon as possible if you have any concerns while being treated with DEPO-MEDROL, even if you do not think the concerns are connected with the medicine or are not listed in this leaflet.
Like other medicines, DEPO-MEDROL can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and it worries you:

• nausea

• vomiting

• headache or dizziness

• lightheadedness

• forgetfulness

• sleeplessness

• mood changes e.g. over-excitement, depression, suicidal thoughts, hallucinations, anxiety

• changes to menstrual periods

• fluid retention

• muscle weakness, pain or loss of muscle mass

• problems with your joints, including pain

• problems with your growth

• thin fragile skin or bruising

• itchy or peeling skin

• increased sweating

• facial flushing/redness, heat

• changes to skin at the injection site

• injection site pain

• rashes, acne, hives

• diarrhoea or constipation

• heartburn

• increased appetite

• loss of appetite or weight loss

• persistent hiccups

• tiredness.

• 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.

• 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, increased thirst and appetite

• pain and tenderness in the leg, pain on extending the foot, swelling of the lower leg, ankle and foot

• chest pain and breathlessness.

After treatment with DEPO-MEDROL

Storage

Product Description

What it looks like

Ingredients

Identification

Supplier

1 Name of Medicine

Methylprednisolone acetate.

2 Qualitative and Quantitative Composition

Each mL of Depo-Medrol 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

4.9 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-Medrol (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-Medrol 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

5.3 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 that are 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

6.7 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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETACT.gif Chemical name: 11β, 17α, 21-trihydroxy-6α-methylpregna-1,4-diene-3,20-dione acetate.
Molecular formula: C₂₄H₃₂O₆.
Molecular weight: 416.51.
CAS number. 53-36-1.

7 Medicine Schedule (Poisons Standard)

S4, Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DEPMEDST.gif