Methylprednisolone Acetate 80 mg/mL
Methylprednisolone Acetate · INJECTION, SUSPENSION · Endo USA, Inc.
Methylprednisolone Acetate is a injection, suspension containing methylprednisolone acetate at 80 mg/mL, taken intra-arterial. Manufactured by Endo USA, Inc..
Key Facts
- Brand Name
- Methylprednisolone Acetate
- Generic Name
- Methylprednisolone Acetate
- NDC Code (Product)
42023-240- Manufacturer
- Endo USA, Inc.
- Strength
- 80 mg/mL
- Dosage Form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTERIAL, INTRALESIONAL, INTRAMUSCULAR, SOFT TISSUE
- Marketing Status
- Application #
- ANDA214297
- Marketing Start
- 06/30/2022
Recall History
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
New England Compounding Center
Non-Sterility
New England Compounding Center
Non-Sterility
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Medistat RX L.L.C.
Lack of Assurance of Sterility
RXQ Compounding LLC
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
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 methylprednisolone acetate injectable 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 dermatitis, 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, nonsupportive thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period …
Dosage & Administration
DOSAGE AND ADMINISTRATION Because of possible physical incompatibilities, methylprednisolone acetate injectable suspension should not be diluted or mixed with other solutions. The initial dosage of parenterally administered methylprednisolone acetate injectable suspension will vary from 4 mg 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, and the effect of patient exp…
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 is not suitable for multi-dose use. Following administration of the desired dose, any remaining suspension should be discarded. Injection of methylprednisolone acetate 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 leak…
Contraindications
CONTRAINDICATIONS Methylprednisolone acetate injectable suspension is contraindicated in patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Methylprednisolone acetate injectable suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route. Methylprednisolone acetate injectable suspension 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: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monit…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported with methylprednisolone acetate 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 diab…
Frequently Asked Questions
What is Methylprednisolone Acetate used for?
Methylprednisolone Acetate contains Methylprednisolone Acetate. It is a injection, suspension taken intra-arterial. Consult your doctor for specific uses.
Is Methylprednisolone Acetate a controlled substance?
Methylprednisolone Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Methylprednisolone Acetate?
The generic name for Methylprednisolone Acetate is Methylprednisolone Acetate. There are 12 other brand versions of Methylprednisolone Acetate.
What is the NDC code for Methylprednisolone Acetate 80 mg/mL?
The NDC (National Drug Code) for Methylprednisolone Acetate 80 mg/mL is 42023-240, listed by Endo USA, Inc..
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
- DEPO-MEDROL40 mg/mL50090-0556
- METHYLPREDNISOLONE ACETATE80 mg/mL0781-3516
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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