Depomed40 mg/ml

Methylprednisolone acetate is a long-acting, depot corticosteroid injection used, by intramuscular, intra-articular, soft tissue, or intralesional injection, as adjunctive short-term therapy for:

Rheumatic and Musculoskeletal Conditions

• Rheumatoid arthritis, osteoarthritis, acute gouty arthritis, and other synovitis conditions, via intra-articular injection into the affected joint(s)
• Bursitis, epicondylitis, tenosynovitis, and other soft tissue/peri-articular inflammatory conditions, via local injection

Systemic Inflammatory and Allergic Conditions (Intramuscular)

• Severe allergic conditions unresponsive to conventional treatment
• Certain endocrine, rheumatic, dermatologic, and gastrointestinal disorders where systemic corticosteroid therapy is indicated but a longer-acting depot effect is desired
• Certain respiratory and haematologic conditions where corticosteroid therapy is indicated

Dermatologic Conditions

• Localized inflammatory or hypertrophic skin lesions, via intralesional injection

Methylprednisolone acetate is a depot (slow-release) suspension intended for local or intramuscular injection only - it is never given intravenously, and is not interchangeable with methylprednisolone sodium succinate, which is the rapid-acting IV form used in emergencies.

Contains methylprednisolone acetate as the active ingredient, supplied as a sterile injectable suspension, commonly in strengths of 40 mg/mL and 80 mg/mL, for intramuscular, intra-articular, soft tissue, or intralesional injection.

Methylprednisolone acetate is a corticosteroid formulated as a slow-release (depot) suspension, giving it a longer duration of action than rapid-acting IV corticosteroids. It is commonly used for injection directly into an inflamed joint or soft tissue area (such as for arthritis, bursitis, or tendinitis), as well as for intramuscular injection when a sustained systemic corticosteroid effect is desired. Because it is a suspension rather than a solution, it must never be given intravenously, and requires careful injection technique to avoid complications such as skin tissue changes at the injection site.

Therapeutic Class: Depot Corticosteroid (Anti-inflammatory Glucocorticoid)

Following intra-articular injection, the onset of action occurs at around 1 week and the effect can last 1 to 5 weeks, reflecting its slow-release depot formulation. Following intramuscular injection, absorption is slower than with the water-soluble succinate salt, providing a more sustained systemic corticosteroid effect over days to weeks rather than hours. This is distinct from methylprednisolone sodium succinate, the rapid-acting, water-soluble form used for IV administration in emergencies.

• Administered only by a trained healthcare professional, using strict sterile technique to prevent infection
• Never administered intravenously - this formulation is a suspension intended only for intramuscular, intra-articular, soft tissue, or intralesional injection
• For intramuscular injection, injection into the deltoid muscle should be avoided, given a higher incidence of subcutaneous tissue atrophy at that site; the gluteal muscle is generally preferred
• Care should be taken to avoid injection or leakage into the dermis (skin layer), which can cause visible depressions or thinning of the skin at the injection site
• Local injection into a previously infected joint should be avoided, and corticosteroids should not be injected into unstable joints
• Shake the vial well before withdrawing the dose, since this is a suspension

The following should be assessed by a healthcare professional before combining with methylprednisolone acetate:

• NSAIDs and aspirin: increase the risk of gastrointestinal ulceration when combined with corticosteroids.
• Live or live-attenuated vaccines: contraindicated in patients receiving immunosuppressive doses of corticosteroids, given the risk of vaccine-related infection in an immunosuppressed patient.
• Anticoagulants such as warfarin: corticosteroids can alter anticoagulant effect, requiring closer monitoring.
• Drugs affecting liver enzymes (such as phenytoin, rifampicin, or ketoconazole): may alter methylprednisolone blood levels.
• Potassium-depleting diuretics: may increase the risk of low blood potassium when combined with corticosteroids.

Common side effects

• Injection site pain, discomfort, or temporary flare of joint pain
• Fluid retention and swelling (with systemic/intramuscular use)
• Raised blood glucose
• Insomnia, mood changes

Serious side effects (seek medical attention)

• Dermal and subdermal skin changes: visible depressions or thinning of the skin at the injection site, more likely with repeated injections exceeding recommended doses or with leakage into the dermis.
• Joint infection: increasing pain, swelling, warmth, or fever in a joint following intra-articular injection requires prompt evaluation, since corticosteroids can mask signs of infection.
• Signs of infection elsewhere, which may be masked by the corticosteroid's anti-inflammatory effect.
• Signs of a severe allergic (anaphylactoid) reaction: rash, swelling of the face or throat, difficulty breathing.
• Serious neurologic events have been reported (rarely) with inadvertent intrathecal or epidural exposure - this formulation must never be given by these routes.
• Adrenal suppression with repeated or high-dose systemic use.

Pregnancy

Corticosteroids cross the placenta; use during pregnancy should only occur if the treating physician determines the benefit outweighs the potential risk, particularly with repeated or high-dose use.

Breastfeeding

Corticosteroids are excreted in human milk; use during breastfeeding should be discussed with a healthcare professional, weighing the mother's need for treatment against potential infant exposure, particularly with repeated or high-dose use.

• Never administer intravenously or intrathecally - this is a suspension intended only for intramuscular, intra-articular, soft tissue, or intralesional injection; inadvertent intrathecal or epidural administration has been associated with severe neurologic events.
• Limit the frequency of repeat injections into the same joint - frequent intra-articular injections into the same joint can accelerate joint damage; injections into a given joint are generally limited to a few times per year.
• Avoid deltoid muscle injection for the intramuscular route, given a higher incidence of subcutaneous tissue atrophy at that site.
• Infection risk: corticosteroids may mask signs of infection and increase susceptibility to new or reactivated infection; avoid injecting into a previously infected joint.
• Use strict sterile technique for all injections to reduce infection risk.
• Monitor for adrenal suppression, blood glucose changes, and fluid retention with repeated or higher-dose systemic use.

Acute overdose from a single injection is unlikely to be immediately life-threatening in most cases, but repeated excessive dosing over time can worsen effects such as fluid retention, raised blood glucose, increased infection risk, and adrenal suppression (Cushing's syndrome with prolonged excess). If overdose is suspected, particularly with repeated high-dose use, contact a doctor; management is generally supportive.

Store at controlled room temperature, protected from light and freezing, as directed on the product label. Shake well before use, since settling of the suspension is normal on standing.

• Premature infants: Contraindicated, given the benzyl alcohol content of this formulation.
• Children: Used for specific indications under medical guidance, with growth and development monitored closely during prolonged or repeated systemic use.
• Elderly: May be more susceptible to some corticosteroid side effects, including osteoporosis, skin thinning, and glucose intolerance; use the lowest effective dose and frequency.
• Diabetes mellitus: Corticosteroids can raise blood glucose; monitor closely, particularly after intramuscular or repeated intra-articular use.

Methylprednisolone acetate is generally used as short-term, intermittent therapy - a single intra-articular or intramuscular injection to manage an acute flare or episode, repeated only as needed and limited in frequency, particularly for the same joint, given the risk of local tissue and joint damage with overly frequent repeated dosing. It is not intended for continuous, long-term systemic corticosteroid therapy, for which an oral or other formulation is generally preferred.

Drug Class: Synthetic glucocorticoid (methylprednisolone ester, depot/slow-release formulation)

Methylprednisolone acetate works by binding to glucocorticoid receptors, suppressing the local or systemic inflammatory and immune response - reducing swelling, pain, and inflammatory cell activity in the injected joint, soft tissue area, or, with intramuscular use, throughout the body. Its depot formulation releases the active drug gradually from the injection site, providing an extended duration of anti-inflammatory effect compared to rapid-acting corticosteroid preparations.

Methylprednisolone acetate is used in children for specific indications (such as certain rheumatologic or allergic conditions) under medical guidance, with dosing individualized by weight and condition. Growth and development should be monitored closely in children on prolonged or repeated systemic corticosteroid therapy. This formulation is contraindicated in premature infants, given its benzyl alcohol content.