SOLU-MEDROL 125 mg/2mL
methylprednisolone sodium succinate · INJECTION, POWDER, FOR SOLUTION · Medical Purchasing Solutions, LLC
Solu-Medrol is an injected corticosteroid medication used to reduce inflammation and suppress immune system activity in various conditions. It is administered as an intramuscular injection and is commonly used for allergic reactions, asthma flare-ups, rheumatoid arthritis, and other inflammatory or autoimmune disorders.
Key Facts
- Brand Name
- SOLU-MEDROL
- Generic Name
- methylprednisolone sodium succinate
- NDC Code (Product)
71872-7232- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 125 mg/2mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- NDA011856
- Marketing Start
- 04/02/1959
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 intravenous or intramuscular use of SOLU-MEDROL Sterile Powder 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 the disease in regional enteriti…
Dosage & Administration
DOSAGE AND ADMINISTRATION NOTE: Some of the SOLU-MEDROL formulations contain benzyl alcohol (see DESCRIPTION , WARNINGS and PRECAUTIONS, Pediatric Use ) Because of possible physical incompatibilities, SOLU-MEDROL should not be diluted or mixed with other solutions. Use only the accompanying diluent or Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting SOLU-MEDROL (see DESCRIPTION ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. There are reports of cardiac arrhythmias and/or cardiac arrest following the rapid administration of large intravenous doses of SOLU-MEDROL ( greater than 0.5 gram administered over a period of less than 10 minutes ). Bradycardia has been reported during or after the administration of lar…
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 Formulations with preservative (see DESCRIPTION ) contain 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 from medications is usually considered negligible compared to that received in flush so…
Contraindications
CONTRAINDICATIONS SOLU-MEDROL Sterile Powder is contraindicated: in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. The SOLU-MEDROL 40 mg presentation includes lactose monohydrate produced from cow's milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients. for intrathecal administration. Reports of severe medical events have been associated with this route of administration. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Additional contraindication for the use of SOLU-MEDROL Sterile Powder preserved with benzyl alcohol: Formulations preserved with benzyl alcohol are contraindicated for use in premature infants (see WARNINGS and PRECAUTIONS, Pediatric Use ).
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 (i.e., 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 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 monitored frequent…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported with SOLU-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, burning or tingling (especially in the perineal area after intravenous injection), 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, increa…
Frequently Asked Questions
What is SOLU-MEDROL used for?
Solu-Medrol is an injected corticosteroid medication used to reduce inflammation and suppress immune system activity in various conditions. It is administered as an intramuscular injection and is commonly used for allergic reactions, asthma flare-ups, rheumatoid arthritis, and other inflammatory or autoimmune disorders.
Is SOLU-MEDROL a controlled substance?
SOLU-MEDROL is not classified as a controlled substance by the DEA.
What is the generic name for SOLU-MEDROL?
The generic name for SOLU-MEDROL is methylprednisolone sodium succinate. There are 6 other brand versions of methylprednisolone sodium succinate.
What is the NDC code for SOLU-MEDROL 125 mg/2mL?
The NDC (National Drug Code) for SOLU-MEDROL 125 mg/2mL is 71872-7232, listed by Medical Purchasing Solutions, LLC.