Depo-medrol

Package Leaflet: Information for the Patient

DEPO-MEDROL, 40 mg/ml, Suspension for Injection

Methylprednisolone Acetate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is DEPO-MEDROL and what is it used for
• 2. Important information before using DEPO-MEDROL
• 3. How to use DEPO-MEDROL
• 4. Possible side effects
• 5. How to store DEPO-MEDROL
• 6. Contents of the pack and other information

1. What is DEPO-MEDROL and what is it used for

The active substance of DEPO-MEDROL, methylprednisolone acetate, belongs to a group of medicines called corticosteroids. Like other corticosteroids, DEPO-MEDROL has various effects, including:

• inflammatory and immune processes
• carbohydrate, protein, and fat metabolism
• circulatory system
• cardiovascular system
• central nervous system
• skeletal muscles
• bone tissue
• connective tissue
• skin and mucous membranes
• endocrine system
• kidney function

DEPO-MEDROL should be used for symptomatic treatment, except in cases of endocrine disorders, where it is used as substitution therapy.

DEPO-MEDROL is administered intramuscularly, intra-articularly, into the joint capsule, periarticularly, into the lesion, and rectally.

A. Intramuscular Administration

Endocrine Disorders
Primary or secondary adrenocortical insufficiency
Acute adrenocortical insufficiency
Congenital adrenal hyperplasia
Hypercalcemia in malignancy
Non-suppurative thyroiditis
Rheumatic Diseases
Supportive treatment for short-term use (during episodes of exacerbation or worsening of the condition) in:

• post-traumatic osteoarthritis
• epicondylitis
• synovitis in osteoarthritis
• acute non-specific tenosynovitis
• rheumatoid arthritis, including juvenile rheumatoid arthritis (in some cases, small maintenance doses may be required)
• psoriatic arthritis
• acute gouty arthritis
• ankylosing spondylitis
• acute and subacute bursitis

B. Intra-Articular Administration

Administration into the Joint Capsule

Periarticular Administration

DEPO-MEDROL is indicated for short-term administration as supplementary therapy in:

• synovitis in osteoarthritis
• epicondylitis
• rheumatoid arthritis
• acute non-specific tenosynovitis
• acute and subacute bursitis
• post-traumatic osteoarthritis
• acute gouty arthritis

C. Administration into the Lesion

DEPO-MEDROL is indicated for injection directly into the lesion in the following conditions:

• keloids
• localized, proliferative, infiltrative, inflammatory lesions in:
• psoriasis
• lichen planus
• discoid lupus erythematosus
• localized neurodermatitis (circumscribed)
• discoid lupus erythematosus (coin-shaped)
• alopecia areata
• panniculitis

DEPO-MEDROL may also be used in the treatment of ganglions, tendinitis, or bursitis.

D. Rectal Administration

• ulcerative colitis

2. Important Information Before Using DEPO-MEDROL

When Not to Use DEPO-MEDROL

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• in patients with generalized fungal infections
• intrathecally (into the spinal canal)
• epidurally
• intravenously
• into the nose and eye, as well as other areas (scalp, oral-pharyngeal cavity, uvula)

Administration of live or live attenuated vaccines is contraindicated during treatment with DEPO-MEDROL in doses that cause immunosuppression.

Warnings and Precautions

In patients with the following conditions, treatment with DEPO-MEDROL should be of short duration and they should be under close medical supervision:

• Children: in children receiving long-term treatment with DEPO-MEDROL in daily divided doses, growth suppression may occur. The doctor should limit the use of this type of treatment to the most severe indications.
• Patients with diabetes: treatment with DEPO-MEDROL may cause the manifestation of latent diabetes or increase the need for insulin or oral antidiabetic drugs.
• Patients with hypertension: treatment with DEPO-MEDROL may cause an increase in blood pressure.
• Patients with a history of psychiatric disorders: treatment with DEPO-MEDROL may cause a worsening of existing emotional instability or psychotic tendencies.
• Patients with ocular herpes or herpes zoster with eye symptoms: treatment with DEPO-MEDROL may cause a risk of corneal perforation.

If you experience blurred vision or other visual disturbances, you should contact your doctor.

If you have hyperthyroidism before starting treatment with DEPO-MEDROL, you should discuss this with your doctor or pharmacist.

DEPO-MEDROL should not be used as a multidose vial. After administering the required dose, any remaining suspension should be discarded.

Immunosuppressive Effect / Increased Susceptibility to Infections
DEPO-MEDROL may increase the susceptibility to infections and may mask some symptoms of infection. During its use, new infections may develop. During treatment with DEPO-MEDROL, the body's immune response may be reduced, and the ability to limit local infections may be impaired; some infection symptoms may be atypical.

The use of corticosteroids in monotherapy or in combination with other immunosuppressive drugs may be associated with infections caused by pathogenic microorganisms, including viral, bacterial, fungal, protozoal, or parasitic infections, in any location of the body. Infections that occur during the use of these drugs may be mild or severe, sometimes fatal. The frequency of infectious complications increases with the increase in corticosteroid doses. Patients using immunosuppressive drugs are more susceptible to infections than healthy individuals. Chickenpox and measles may have a more severe course or even be fatal in children with impaired immunity or in adults using corticosteroids.

DEPO-MEDROL should not be administered intra-articularly, into the joint capsule, or into the tendon in the presence of acute infection for local effect.

The use of live vaccines based on attenuated viruses is contraindicated in patients receiving immunosuppressive doses of corticosteroids. In these patients, inactivated or killed vaccines may be administered, but the response to them may be limited or they may be ineffective. Patients receiving DEPO-MEDROL in doses that do not have an immunosuppressive effect may be subjected to all required vaccinations (see section: DEPO-MEDROL and other medicines).

In patients with active tuberculosis, DEPO-MEDROL should be used only in cases of fulminant or disseminated tuberculosis, in combination with other appropriate antitubercular drugs.

If it is necessary to administer DEPO-MEDROL to a patient with latent or positive tuberculin test, close monitoring of the patient is required, as reactivation of the disease may occur. In these patients, during long-term corticosteroid therapy, the doctor will decide on the use of chemoprophylaxis.

Kaposi's sarcoma has been reported in patients receiving corticosteroids. Discontinuation of these drugs may lead to clinical remission.

Effect on the Immune System
Patient's receiving DEPO-MEDROL may experience allergic reactions. DEPO-MEDROL should be used with caution, especially in patients who have had allergic reactions to corticosteroids in the past, due to the possibility of anaphylactic or anaphylactoid reactions.

Skin allergic reactions may occur during treatment, most likely due to excipients in the drug. Rarely, a reaction to methylprednisolone acetate itself has been detected in skin tests.

Endocrine Disorders
In patients exposed to severe stress, the doctor will recommend an appropriate increase in the dose of DEPO-MEDROL before, during, and after the stressful situation.

During long-term treatment with DEPO-MEDROL, adrenal insufficiency may occur, which may persist for several months after discontinuation of treatment.

The doctor may also decide to gradually reduce the dose of DEPO-MEDROL. You should inform your doctor about any stressful situations during this period. The doctor will consider initiating hormone therapy.

Sudden discontinuation of DEPO-MEDROL may cause acute adrenal insufficiency, leading to death.

After sudden discontinuation of DEPO-MEDROL, a "steroid withdrawal syndrome" may also occur. This syndrome includes symptoms such as: loss of appetite, nausea, vomiting, lethargy, headache, fever, joint pain, peeling, muscle pain, weight loss, and/or hypotension.

DEPO-MEDROL may cause or exacerbate Cushing's syndrome, so patients with Cushing's disease should not use it.

In patients with hypothyroidism, the effect of DEPO-MEDROL is enhanced.

You should immediately consult your doctor if you experience weakness or muscle pain, cramps, and stiffness during treatment with methylprednisolone. These may be symptoms of a condition called thyrotoxic periodic paralysis, which may occur in patients with hyperthyroidism treated with methylprednisolone. Additional treatment may be necessary to alleviate this condition.

Effect on Metabolism and Nutrition
Corticosteroids, including methylprednisolone, may increase blood glucose levels, exacerbate existing diabetes, and predispose patients to diabetes.

Psychiatric Disorders
During treatment with DEPO-MEDROL and after its discontinuation, psychiatric disorders may occur, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to early and severe psychotic disorders. These usually occur within a few days or weeks of starting treatment with DEPO-MEDROL. Most of them resolve after reducing the dose or discontinuing DEPO-MEDROL. Patients and their caregivers should consult a doctor if the patient develops psychiatric symptoms, especially if they suspect depressive mood or suicidal thoughts.

Effect on the Nervous System
DEPO-MEDROL should be used with caution in patients with seizure disorders.

DEPO-MEDROL should be used with caution in patients with myasthenia gravis.

In patients receiving DEPO-MEDROL, usually with long-term use of high doses, cases of suprasellar fat deposition have been reported.

Effect on the Eyes
In patients receiving long-term treatment with DEPO-MEDROL, posterior subcapsular cataracts and nuclear cataracts (especially in children) may develop, as well as exophthalmos or increased intraocular pressure, which may cause glaucoma with potential optic nerve damage. Patients receiving DEPO-MEDROL may also be more likely to develop secondary fungal or viral eye infections.

DEPO-MEDROL should be used with caution in patients with ocular herpes or herpes zoster with eye symptoms, due to the risk of corneal perforation.

Visual disturbances may occur due to systemic or local use of the drug. If they occur, the patient should contact a doctor to determine the possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy.

Central serous chorioretinopathy may lead to retinal detachment.

Effect on the Heart
In cases of high-dose and long-term treatment with DEPO-MEDROL in patients with cardiovascular risk factors, the drug should be administered with caution and additional monitoring of the cardiovascular system may be necessary if required.

In patients with congestive heart failure, DEPO-MEDROL should be administered with caution and only if absolutely necessary.

Vascular Disorders
During treatment with DEPO-MEDROL, thrombosis, including venous thromboembolism, has been reported. Therefore, caution should be exercised in patients with thromboembolic disorders or those who may be prone to them.

DEPO-MEDROL should be used with caution in patients with hypertension.

Effect on the Stomach and Intestines
After administration of high doses of DEPO-MEDROL, acute pancreatitis may occur.

During long-term therapy, the doctor will recommend regular performance of additional routine tests. In patients with a history of peptic ulcer disease or severe dyspeptic symptoms, the doctor may recommend a radiological examination of the upper gastrointestinal tract.

Treatment with DEPO-MEDROL may mask symptoms of peptic ulcers, so perforation or bleeding may occur without significant pain. Treatment with DEPO-MEDROL may mask peritonitis or other symptoms related to gastrointestinal disorders, such as perforation, obstruction, or pancreatitis. Concomitant use of DEPO-MEDROL with nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of developing peptic ulcer disease of the stomach and intestines.

In patients with non-specific ulcerative colitis, DEPO-MEDROL should be used with caution if there is a risk of perforation or abscess formation or other forms of septic infection. Caution should also be exercised in cases of diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer disease, renal insufficiency, osteoporosis, and myasthenia, when steroids are used as primary or supplementary treatment.

Effect on the Liver and Bile Ducts
Cyclic, intermittent intravenous administration of DEPO-MEDROL (usually at an initial dose of ≥ 1g per day) may cause drug-induced liver damage, including acute hepatitis or increased liver enzyme activity. Rare cases of hepatotoxicity have been reported. Symptoms may occur after several weeks or later. In most cases, adverse events resolved after discontinuation of treatment. Therefore, close monitoring is necessary.

Effect on the Musculoskeletal System
During treatment with high doses of DEPO-MEDROL, acute myopathy may occur, especially in patients with neuromuscular transmission disorders (e.g., myasthenia gravis) or patients treated with anticholinergic drugs, including neuromuscular blockers (e.g., pancuronium). Myopathy may affect the eye muscles and respiratory muscles, as well as lead to quadriparesis. Increased creatine kinase activity may occur. Improvement in clinical condition or complete recovery after discontinuation of DEPO-MEDROL may occur after several weeks or even years.

Osteoporosis may occur in patients receiving long-term treatment with high doses of DEPO-MEDROL.

Effect on the Kidneys and Urinary Tract
Caution should be exercised in patients with systemic sclerosis, as an increased frequency of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.

DEPO-MEDROL should be used with caution in patients with renal insufficiency.

Injuries, Poisoning, and Complications after Procedures
DEPO-MEDROL should not be used to treat traumatic brain injury.

Diagnostic Tests
The use of medium to high doses of DEPO-MEDROL may increase blood pressure, sodium and water retention, and potassium excretion. Therefore, it may be necessary to restrict salt intake and supplement potassium. All corticosteroids, including DEPO-MEDROL, increase calcium excretion.

Children
In children receiving long-term treatment with DEPO-MEDROL in daily divided doses, growth suppression may occur. The use of this treatment regimen should be limited to the most severe indications. Patients should remain under close medical supervision.

Infants and children receiving DEPO-MEDROL long-term are particularly at risk of increased intracranial pressure.

High doses of DEPO-MEDROL may cause pancreatitis in children.

Other Warnings
Complications of corticosteroid therapy depend on the dose and duration of treatment. The doctor will decide on the dosage and duration of treatment individually for each patient.

In case of discontinuation of long-term treatment, the doctor will recommend monitoring the patient's condition (see also section 3 Discontinuation of DEPO-MEDROL). You should inform your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.

Some medicines may enhance the effect of DEPO-MEDROL, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Patients should exercise caution when concomitantly using aspirin and nonsteroidal anti-inflammatory drugs with DEPO-MEDROL.

Due to the possibility of skin and subcutaneous tissue atrophy, the doctor will recommend appropriate dosing and injection technique to minimize the occurrence of these complications.

The use of corticosteroids may affect the results of biological tests (e.g., skin tests, thyroid hormone assays).

After administration of DEPO-MEDROL, a crisis in the course of pheochromocytoma has been reported, sometimes fatal. In patients suspected of or diagnosed with pheochromocytoma, the doctor will decide on the use of DEPO-MEDROL only after careful assessment of the benefit-risk ratio.

Tumor lysis syndrome may occur during corticosteroid therapy for cancer treatment. You should inform your doctor if you have cancer and experience symptoms of tumor lysis syndrome, such as muscle cramps, weakness, confusion, irregular heartbeat, vision loss, or shortness of breath.

INTRA-ARTICULAR ADMINISTRATION
To prevent infections, it is necessary to follow aseptic procedures.

After intra-articular administration of corticosteroids, the patient should avoid overloading the joints in which the symptoms have been relieved. Failure to do so may exacerbate joint destruction, which would outweigh the benefits of steroid administration.

Injections should not be made into unstable joints. In some cases, repeated intra-articular injections may cause joint instability. In selected cases, the doctor may decide to perform a control X-ray examination to detect possible worsening of the joint condition.

If a local anesthetic is used before administering DEPO-MEDROL, the doctor should be familiar with the contents of the package leaflet of that anesthetic and follow all recommended precautions.

IN THE EVENT OF EXTRA-ARTICULAR ADMINISTRATION OF CORTICOSTEROIDS, THE FOLLOWING ADDITIONAL PRECAUTIONS SHOULD BE TAKEN:
Intramuscular injection of a corticosteroid may cause systemic and local effects.

To rule out possible infection, it is necessary to properly examine the synovial fluid.

A significant increase in pain with accompanying local swelling, limited joint mobility, fever, and worsening of general condition are potential symptoms of acute septic arthritis. In case of occurrence of this complication and confirmation of the diagnosis of sepsis, the doctor will recommend discontinuation of local corticosteroid injections and appropriate antimicrobial treatment.

Local administration of steroids into a joint previously infected should be avoided.

Corticosteroids should not be injected into unstable joints. It is necessary to use aseptic technique to prevent infections and contamination.

DEPO-MEDROL and Other Medicines

You should inform your doctor about all medicines you are currently taking or plan to take.

DEPO-MEDROL may affect the action of other medicines, and other medicines may affect the action of DEPO-MEDROL.

It may be necessary to adjust the dose of DEPO-MEDROL when used concomitantly with the following medicines:

• antibacterial drugs: isoniazid
• antitubercular antibiotic: rifampicin
• oral anticoagulants
• antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
• anticholinergic drugs: neuromuscular blockers
• muscle relaxants, e.g., pancuronium, vecuronium
• antidiabetic drugs
• antiemetic drugs: aprepitant, fosaprepitant
• antifungal drugs: itraconazole, ketoconazole
• antiviral drugs: HIV protease inhibitors: indinavir and ritonavir
• aromatase inhibitor: aminoglutethimide
• calcium channel blocker: diltiazem
• oral contraceptives: ethinyl estradiol/norethindrone
• grapefruit juice
• immunosuppressive drugs: cyclosporine, cyclophosphamide, tacrolimus
• macrolide antibacterial drugs: clarithromycin, erythromycin, troleandomycin
• nonsteroidal anti-inflammatory drugs (NSAIDs): high doses of aspirin
• potassium-lowering drugs

Use of DEPO-MEDROL in Patients with Renal or Hepatic Impairment

DEPO-MEDROL should be used with caution in patients with renal insufficiency.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Fertility

In animal studies, DEPO-MEDROL has been shown to have a fertility-impairing effect.

Pregnancy

Some studies in animals have shown that corticosteroids given to mothers may cause fetal developmental abnormalities.

However, it does not appear that DEPO-MEDROL given to pregnant women causes congenital abnormalities in the fetus. Until appropriate studies are conducted regarding the effect of DEPO-MEDROL on human reproductive processes, this drug should not be given to pregnant women unless a thorough assessment of the benefit-risk ratio for the mother and fetus has been made.

If there is a need to discontinue chronic treatment during pregnancy, it should be done gradually. In some situations (e.g., replacement therapy for adrenocortical insufficiency), it may be necessary to continue treatment or even increase the dose.

Corticosteroids easily cross the placental barrier. In one retrospective study, an increased incidence of low birth weight in infants born to mothers receiving corticosteroids was found. In humans, the risk of low birth weight appears to be dose-dependent. This risk may be reduced by administering lower doses of corticosteroids.

Infants born to mothers who received significant doses of DEPO-MEDROL during pregnancy should be closely monitored and examined for signs of adrenal insufficiency, although adrenal insufficiency in newborns appears to be rare.

In infants born to mothers who received long-term treatment with corticosteroids during pregnancy, cataract development has been observed.

The effect of corticosteroids on the course of labor is unknown.

Breastfeeding

Corticosteroids pass into human milk.

In breastfed children, DEPO-MEDROL, which has passed into the mother's milk, may suppress growth and affect the production of endogenous corticosteroids. This drug may be used by breastfeeding women, but only after careful assessment of the benefit-risk ratio for the woman and the child.

Driving and Using Machines

The effect of DEPO-MEDROL on the ability to drive and use machines has not been studied. Patients who experience dizziness, visual disturbances, and fatigue during treatment with DEPO-MEDROL should not drive vehicles or operate machines.

DEPO-MEDROL contains sodium.
The drug contains less than 1 mmol (23 mg) of sodium per vial, i.e., the drug is considered "sodium-free".

3. How to Use DEPO-MEDROL

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Information on dosing and administration intended for healthcare professionals only is provided at the end of the package leaflet.

The doctor will decide on the appropriate dose, method, and site of administration of DEPO-MEDROL.

• A. ADMINISTRATION FOR SYSTEMIC EFFECT
  The doctor will adjust the dose of DEPO-MEDROL administered intramuscularly, depending on the severity of the disease and the patient's response to treatment. The recommended doses are usually between 40 mg and 120 mg.

The treatment period should be as short as possible. The patient should remain under medical supervision. In infants and children, the recommended doses should be reduced, but dosing should rather depend on the severity of the disease than on the exact calculation based on age or body weight.

Hormone therapy is a supplement to conventional treatment, but does not replace it.

After administration of the drug for more than a few days, the doctor will decide on gradual reduction of the dose or gradual discontinuation of the drug. If the doctor decides to discontinue long-term treatment, the patient should remain under close medical supervision. If a period of spontaneous remission begins in the case of chronic disease, the drug should be discontinued gradually, under the doctor's supervision.

During long-term treatment, the doctor will recommend regular performance of additional routine tests.

• B. LOCAL ADMINISTRATION (FOR LOCAL EFFECT)
  Treatment with DEPO-MEDROL does not eliminate the need for conventional measures. Although this treatment method leads to symptom relief, it does not ensure complete recovery, and the hormone does not affect the cause of inflammation.
• 1. Rheumatoid Arthritis and Osteoarthritis
  The dose for intra-articular administration depends on the size of the joint and the severity of the condition in the individual patient. The recommended doses are usually between 4 mg and 80 mg. In cases of chronic diseases, injections can be repeated at intervals of one to five or more weeks, depending on the degree of symptom reduction achieved after the first injection.
• 2. Bursitis
  The doctor will adjust the dose of DEPO-MEDROL administered into the joint capsule, depending on the course of the disease and the patient's response to treatment.
• 3. Other Conditions: Ganglion, Tendinitis, Epicondylitis
  The doctor will adjust the dose of DEPO-MEDROL, depending on the severity of the disease and the patient's response to treatment. The recommended doses are usually between 4 mg and 30 mg. In the treatment of recurring or chronic conditions, repeated injections may be necessary.

Each injection should be performed under aseptic conditions.

• 4. Injections for Local Effect in the Treatment of Skin Diseases
  The doctor will adjust the dose of DEPO-MEDROL, depending on the severity of the disease and the patient's response to treatment. After cleaning the skin with a suitable antiseptic preparation, such as 70% alcohol, 20 to 60 mg of methylprednisolone acetate is injected into the lesion. In the case of larger lesions, the doctor may decide to administer doses of 20 to 40 mg, divided into several consecutive local injections. One should avoid injecting amounts that may cause skin color changes, as this may lead to the formation of a small area of necrosis. The drug is usually administered in one to four injections. The duration of the intervals between injections depends on the type of lesion and the duration of improvement after the first injection.
• C. RECTAL ADMINISTRATION
  The doctor will adjust the dose of DEPO-MEDROL, depending on the severity of the disease and the patient's response to treatment. Rectal administration is used as supplementary treatment in some patients with ulcerative colitis. The usual doses are between 40 mg and 120 mg in the form of rectal suspensions (e.g., 40 mg of the drug in a volume of 30 to 300 ml of water) or continuous rectal infusion three to seven times a week for a period of two or more weeks. The doctor will also decide on the use of other recognized therapeutic measures.

Use of a Higher Than Recommended Dose of DEPO-MEDROL

There is no clinical syndrome of acute overdose of methylprednisolone acetate.

Long-term use of the drug in frequently repeated doses (once a day or several times a week) may cause Cushing's syndrome.

Missing a Dose of DEPO-MEDROL

You should not take a double dose to make up for a missed dose.

Discontinuation of DEPO-MEDROL

In case of discontinuation of long-term treatment, the doctor will recommend monitoring the patient's condition. The risk of secondary adrenal insufficiency can be minimized by gradual reduction or discontinuation of dosing. After discontinuation of long-term treatment, the doctor will assess adrenal function. The most important symptoms of insufficiency are weakness, orthostatic hypotension, and depression.

4. Possible Side Effects

Like all medicines, DEPO-MEDROL can cause side effects, although not everybody gets them.

After administration of the product by contraindicated routes of administration (intraocularly/intrathecally), the following side effects have been reported: meningitis, gastrointestinal or urinary tract disorders, headache, meningitis, transverse myelitis/paralysis, seizures, sensory disturbances.

The following side effects may occur after administration of DEPO-MEDROL:

5. How to store Depo-Medrol

The medicinal product should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicinal product after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be consulted on how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Depo-Medrol contains

• The active substance of the medicinal product is methylprednisolone acetate. 1 ml of the suspension for injection contains 40 mg of methylprednisolone.
• The other ingredients are: macrogol 3350, sodium chloride, myrystyl-gamma picoline hydrochloride, water for injections, sodium hydroxide (for pH adjustment) (see section 2 "Depo-Medrol contains sodium") and hydrochloric acid (for pH adjustment).

What Depo-Medrol looks like and contents of the pack

White suspension.
The pack contains 1 or 5 vials.

Marketing authorization holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet:

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Information intended for healthcare professionals only

Depo-Medrol should not be diluted with other solutions or mixed with other solutions.
Before administration, the vial should be inspected for the presence of solid particles and color change. To prevent iatrogenic infections, strict adherence to aseptic procedures is necessary. The medicinal product is not suitable for intravenous or intra-arterial administration. It should not be used as a multidose vial. After administration of the required dose, any remaining suspension should be discarded.
Before use, shake vigorously to obtain a uniform suspension.
ADMINISTRATION FOR SYSTEMIC EFFECT
The dose of the medicinal product administered intramuscularly depends on the severity of the disease being treated and must be individualized according to the severity of the disease and the patient's response to treatment.
When prolonged action of the medicinal product is desired, the weekly dose is calculated by multiplying the daily oral dose by 7 and administered as a single injection.
The treatment period should be as short as possible. It is necessary for the patient to remain under medical supervision. In infants and children, the recommended doses should be reduced, but dosing should rather depend on the severity of the disease than on the exact calculation of age or body weight.
Hormonal therapy is a supplement to conventional treatment, but does not replace it.
After administration of the medicinal product for more than a few days, the doctor will decide on gradual dose reduction or gradual withdrawal of the medicinal product. If the doctor decides to discontinue chronic treatment, the patient should remain under close medical supervision. If, in the case of chronic disease, a period of spontaneous remission begins, treatment should be discontinued gradually under medical supervision.
During chronic treatment, the doctor may order regular performance of additional routine tests, such as: general urine test, blood glucose measurement two hours after a meal, blood pressure measurement and body weight measurement, and chest X-ray. In patients with a history of peptic ulcer disease or with severe dyspeptic symptoms, it is desirable to perform a radiological examination of the upper gastrointestinal tract.
Example dosing:
Adrenogenital syndrome:

• single intramuscular injections of 40 mg of the medicinal product every two weeks.

Rheumatoid arthritis, maintenance treatment:

• 40 to 120 mg once a week, administered intramuscularly.

Skin changes:

• 40 to 120 mg of methylprednisolone acetate administered intramuscularly within one to four weeks.

Severe skin inflammation caused by poison ivy:

• relief of symptoms can be achieved within 8 to 12 hours after intramuscular administration of a single dose of 80 to 120 mg.

Chronic contact dermatitis:

• multiple injections may be necessary at intervals of 5 to 10 days.

Seborrheic dermatitis:

• 80 mg once a week.

Asthma:

• after intramuscular administration of 80 to 120 mg of the medicinal product, symptom reduction can be achieved within 6 to 48 hours. The effect of the medicinal product may last for several days to two weeks.

If the treated condition is associated with stress symptoms, the dose of the suspension should be increased.
If rapid achievement of maximum hormonal effect is necessary, intravenous administration of highly soluble methylprednisolone sodium succinate is indicated.
LOCAL ADMINISTRATION (FOR LOCAL EFFECT)
Treatment with Depo-Medrol does not eliminate the need for conventional measures.
Although this treatment method leads to relief of symptoms, it does not provide complete cure and the hormone does not affect the cause of inflammation.

• 1. Rheumatoid arthritis and osteoarthritis

The dose to be administered intra-articularly depends on the size of the joint and the severity of the condition being treated in the individual patient. In cases of chronic diseases, injections can be repeated at intervals of one to five or more weeks, depending on the degree of symptom reduction achieved after the first injection. The doses in the table below are given as a guide:
Joint size
Examples
Dose range
Large
Knee joints
Ankle joints
Shoulder joints
20 to 80 mg
Medium
Elbow joints
Wrist joints
10 to 40 mg
Small
Metacarpophalangeal joints
Interphalangeal joints
Metacarpophalangeal joints
Sternoclavicular joints
4 to 10 mg
It is recommended to carefully review the anatomy of the given joint before performing an intra-articular injection. To achieve optimal anti-inflammatory effect, the injection should be made into the synovial space. Using aseptic technique typical of lumbar puncture, a sterile needle of size 20 to 24 (attached to a dry syringe) should be quickly introduced into the synovial space. The use of local anesthesia with procaine may be considered. To check if the needle has been introduced into the joint space, aspiration of only a few drops of synovial fluid should be performed. Injections into each joint are performed at the site where the synovial space is most superficial and is largely free from large vessels and nerves. After introducing the needle into the injection site, the syringe to which aspiration was performed is removed and replaced with another syringe containing the desired amount of Depo-Medrol. Then, aspiration of a small amount of synovial fluid is performed to ensure that the needle is still in the synovial space.
After injection, the joint should be moved gently several times to help mix the suspension with the synovial fluid. The injection site is then covered with a small, sterile dressing.
Appropriate sites for intra-articular injections are knee joints, ankle joints, wrist joints, elbow joints, shoulder joints, finger joints, and hip joints. Introduction of the needle into the hip joint is often difficult; care should be taken not to puncture large blood vessels that pass through this area. Joints that are anatomically inaccessible, such as spinal joints and sacroiliac joints, where there is no synovial space, are not suitable for injection. Failures of treatment most often result from failure to administer the medicinal product into the joint space. Injections into surrounding tissues are ineffective or less effective.
In the event of treatment failure, when the injection was made into the joint space (which is known from aspiration of synovial fluid), subsequent administrations of the medicinal product are usually ineffective.
Local treatment does not affect the underlying disease process, and therefore, whenever possible, it should be supplemented with physical therapy and orthopedic correction.
After intra-articular administration of a corticosteroid, the joints in which symptom reduction has been achieved should not be overloaded.
Injections should not be made into unstable joints. Repeated intra-articular injections may lead to joint instability in some cases. In selected cases, radiological monitoring is recommended to detect progressive joint damage.
If a local anesthetic is to be used before administration of Depo-Medrol, the package leaflet should be consulted and the recommended precautions should be taken.

• 2. Bursitis
  The area around the injection site should be carefully cleaned and 1% procaine hydrochloride solution should be administered to the site of injection, creating a blister with the fluid. A sterile needle of size 20 to 24 attached to a dry syringe is introduced into the bursa, and the fluid is aspirated. The needle should be left in place and the syringe replaced with another one containing the dose of the medicinal product. After injection, the needle is removed and a small dressing is applied.

• 3. Other conditions: ganglion, tendinitis, epicondylitis
  In the treatment of conditions such as tendinitis or tenosynovitis, after using an appropriate antiseptic agent, care should be taken to introduce the suspension into the tendon sheath, not into the tendon tissue itself. The tendon is easier to palpate in the extended position. In the treatment of epicondylitis, the borders of the area of greatest tenderness should be carefully delineated and the suspension injected into this area. In the case of ganglions of the tendon sheaths, the suspension should be injected directly into the cyst. In many cases, a single injection of the medicinal product significantly reduces the size of the ganglion, and may even cause it to disappear. Depending on the severity of the condition being treated, the administered doses may range from 4 to 30 mg. In the treatment of recurrent or chronic conditions, repeated injections may be necessary.

Each injection should be performed under aseptic conditions (an appropriate antiseptic agent should be applied to the skin).

• 4. Injections for local effect in the treatment of skin conditions
  After thorough cleaning of the skin with a suitable antiseptic preparation, such as 70% alcohol, 20 to 60 mg of methylprednisolone acetate is injected into the lesion. In the case of larger lesions, it may be necessary to administer doses of 20 to 40 mg divided into several consecutive local injections. Injections of amounts that may cause skin discoloration should be avoided, as small areas of necrosis may occur after their administration. The medicinal product is usually administered in one to four injections. The length of the intervals between injections depends on the type of lesion and the duration of the improvement achieved after the first injection.

RECTAL ADMINISTRATION
Supplementary treatment in some patients with ulcerative colitis:
40 to 120 mg in the form of rectal enemas (e.g., 40 mg of the medicinal product in a volume of 30 to 300 ml of water) or continuous rectal enema 3 to 7 times a week for a period of 2 or more weeks. Other recognized therapeutic measures should also be used.