Depo-Medrol

Methylprednisolone is a steroid that prevents the release of substances in the body that cause inflammation.

Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

Methylprednisolone may also be used for purposes not listed in this medication guide.

You should not use methylprednisolone if you have a fungal infection anywhere in your body. Methylprednisolone injection should not be given to a premature baby.

You should not use methylprednisolone if you are allergic to it, or if you have a fungal infection anywhere in your body. Methylprednisolone injection should not be given to a premature baby.

Methylprednisolone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

To make sure methylprednisolone is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;
• kidney disease;
• cirrhosis or other liver disease;
• past or present tuberculosis;
• glaucoma or cataracts;
• herpes infection of the eyes;
• seizures, epilepsy or recent head injury;
• stomach ulcers, ulcerative colitis, diverticulitis, or recent intestinal surgery;
• a parasite infection that causes diarrhea (pinworms, or threadworms);
• a thyroid disorder;
• osteoporosis or low bone mineral density (steroid medication can increase your risk of bone loss);
• depression or mental illness;
• a muscle disorder such as myasthenia gravis;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• high levels of calcium in the blood related to cancer (also called hypercalcemia of malignancy);
• if you use insulin or oral diabetes medication; or
• if you take aspirin on a daily basis or at high doses.

It is not known whether methylprednisolone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether methylprednisolone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child (especially a baby) without medical advice.

Methylprednisolone is a prescription medication used to treat:

• low corticosteroid levels. Corticosteroids are steroids naturally produced by the body that are required for normal body function.
• arthritis
• allergic reactions
• asthma
• multiple sclerosis. Multiple sclerosis is a disease in which nerves do not function properly due to inflammation.
• lupus. Lupus is a disease in which the body’s immune system attacks itself.
• severe psoriasis. Psoriasis is a disease in which the skin becomes red, irritated, and flaky.
• certain conditions affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines. Methylprednisolone frequently treats diseases of these organs by reducing inflammation.
• some types of cancer such as leukemia (cancer in bone marrow) and lymphoma (cancer of white blood cells)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

 

Take methylprednisolone exactly as prescribed.

Methylprednisolone comes as a tablet or liquid to be given directly by a healthcare professional.

Methylprednisolone tablet can be taken with or without food. It is recommended to take with food to prevent stomach irritation.

To avoid steroid withdrawal side effects, do not stop taking methylprednisolone suddenly. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of methylprednisolone at the same time.

Take methylprednisolone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will determine the appropriate dosage and schedule of prednisone depending the disease being treated and your response to the medication. The starting dosage of methylprednisolone may vary from 4 mg to 48 mg a day depending on reason for use.

• Store methylprednisolone at room temperature.
• Keep this and all medicines out of the reach of children.

Depo-Medrol is contraindicated in patients with known hypersensitivity to the product and its constituents.

Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Depo-Medrol Sterile Aqueous Suspension is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.

Depo-Medrol is contraindicated for use in premature infants because the formulation contains benzyl alcohol. (See WARNINGS and PRECAUTIONS: Pediatric Use.)

Depo-Medrol is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections).

Serious Neurologic Adverse Reactions with Epidural Administration

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

General

This product contains benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol in medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: Pediatric Use).

Multidose use of Depo-Medrol Sterile Aqueous Suspension from a single vial requires special care to avoid contamination. Although initially sterile, any multidose use of vials may lead to contamination unless strict aseptic technique is observed. Particular care, such as use of disposable sterile syringes and needles, is necessary.

Injection of Depo-Medrol may result in dermal and/or subdermal changes, forming depressions in the skin at the injection site.

In order to minimize 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.

It is critical that, during administration of Depo-Medrol, appropriate technique be used and care taken to ensure proper placement of drug.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.

Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, or after the stressful situation (see ADVERSE REACTIONS).

Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Depo-Medrol, should not be used for the treatment of traumatic brain injury.

Cardio-renal

Average and large doses of corticosteroids 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.

Literature reports suggest an apparent association between the use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine

Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia: Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized 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.

Infections

Persons who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents.

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. Corticosteroids may mask some signs of current infection. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of acute local infection.

Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions, Amphotericin B injection and potassium-depleting agents).

Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids should not be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition.

The use of corticosteroids 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 an appropriate antituberculous 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.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy (e.g., for Addison's disease).

Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents should be considered.

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of systemic corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.

NDC 0009-0274-01

5 mL
Multidose Vial

Depo-Medrol®
(methylprednisolone
acetate injectable
suspension, USP)

20 mg/mL

For intramuscular,
intrasynovial and
soft tissue injection only

NOT for IV use

Contains Benzyl Alcohol
as a Preservative

Rx only

Pfizer Injectables

255 mL Multidose Vials

NDC 0009-0280-51
Contains 25 of NDC 0009-0280-02

Depo-Medrol®
(methylprednisolone acetate injectable suspension, USP)

40 mg/mL

For intramuscular, intrasynovial and soft tissue injection only
NOT for IV use
Contains Benzyl Alcohol as a Preservative

Pfizer Injectables

Rx only

NDC 0009-0306-02

5 mL
Multidose Vial

Depo-Medrol®
(methylprednisolone
acetate injectable
suspension, USP)

80 mg/mL

For intramuscular,
intrasynovial and
soft tissue injection only

NOT for IV use

Contains Benzyl Alcohol
as a Preservative

Rx only

Pfizer Injectables