DEPO-MEDROL 80 mg/mL
methylprednisolone acetate · INJECTION, SUSPENSION · A-S Medication Solutions
DEPO-MEDROL is a injection, suspension containing methylprednisolone acetate at 80 mg/mL, taken intra-articular. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- DEPO-MEDROL
- Generic Name
- methylprednisolone acetate
- NDC Code (Product)
50090-0436- Manufacturer
- A-S Medication Solutions
- Strength
- 80 mg/mL
- Dosage Form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, SOFT TISSUE
- Marketing Status
- Application #
- NDA011757
- Marketing Start
- 05/28/1959
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Pfizer Inc.
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of …
Dosage & Administration
DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL ( see WARNINGS and PRECAUTIONS: Pediatric Use ). Because of possible physical incompatibilities, DEPO-MEDROL Sterile Aqueous Suspension should not be diluted or mixed with other solutions. The initial dosage of parenterally administered DEPO-MEDROL will vary from 4 to 120 mg, depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. It Should Be Emphasized that Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, …
Warnings
WARNINGS 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. Adm…
Contraindications
CONTRAINDICATIONS 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: Immunosuppression and Increased Risk of Infection , Fungal Infections ).
Drug Interactions
Drug Interactions Aminoglutethimide : Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents : When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics : Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions, Hepatic Enzyme Inhibitors ). Anticholinesterases : Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulants, oral : Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be moni…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported with DEPO-MEDROL or other corticosteroids: Allergic reactions : Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema. Blood and lymphatic system disorders : Leukocytosis. Cardiovascular : Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic : Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine : Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifest…
Frequently Asked Questions
What is DEPO-MEDROL used for?
DEPO-MEDROL contains methylprednisolone acetate. It is a injection, suspension taken intra-articular. Consult your doctor for specific uses.
Is DEPO-MEDROL a controlled substance?
DEPO-MEDROL is not classified as a controlled substance by the DEA.
What is the generic name for DEPO-MEDROL?
The generic name for DEPO-MEDROL is methylprednisolone acetate. There are 11 other brand versions of methylprednisolone acetate.
What is the NDC code for DEPO-MEDROL 80 mg/mL?
The NDC (National Drug Code) for DEPO-MEDROL 80 mg/mL is 50090-0436, listed by A-S Medication Solutions.
Other DEPO-MEDROL Dosages
Other Methylprednisolone Brands
See all →- Physicians EZ Use M-pred76420-520
- METHYLPREDNISOLONE ACETATE40 mg/mL42023-239
- Medroloan II SUIK40 mg/mL76420-262
- Dyural 80 Kit76420-755
- Depo-Medrol80 mg/mL0009-0306
- Methylprednisolone acetate40 mg/mL70121-1609
- Depo-Medrol80 mg/mL76420-081
- Depo-Medrol20 mg/mL0009-0274
- METHYLPREDNISOLONE ACETATE80 mg/mL0781-3516
- methylprednisolone acetate80 mg/mL25021-821
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)