Depo-Medrol (Methylprednisolone Acetate) - Summary

DEPO-MEDROL SUMMARY

DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection.

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, seasonal or perennial allergic rhinitis, 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 enteritis (systemic therapy), ulcerative colitis

Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.

Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Neoplastic Diseases: For palliative management of leukemias and lymphomas.

Nervous System: Acute exacerbations of multiple sclerosis. Cerebral edema associated with primary or metastatic brain tumor or craniotomy.

Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.

Respiratory Diseases: Berylliosis, symptomatic sarcoidosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

B. FOR INTRA-ARTICULAR OR SOFT TISSUE ADMINISTRATION

(See WARNINGS)

DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis

C. FOR INTRALESIONAL ADMINISTRATION

DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus, keloids, localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques, necrobiosis lipoidica diabeticorum.
DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).

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NEWS HIGHLIGHTS

Published Studies Related to Depo-Medrol (Methylprednisolone)

Steroids for early acute respiratory distress syndrome: Critical appraisal of Meduri GU, Golden E, Freire AX, et al: Methylprednisolone infusion in early severe ARDS: Results of a randomized controlled trial. Chest 2007; 131:954-963. [2009.10.13]
OBJECTIVES:: To review the findings and discuss the implications of studies evaluating the use of corticosteroids in early acute respiratory distress syndrome... CONCLUSIONS:: The protocol suggested by Meduri and colleagues presents an attractive therapeutic adjunct, but steroids in early acute respiratory distress syndrome cannot be recommended as standard therapy at this time.

Influence of methylprednisolone on levels of neuron-specific enolase in cardiac surgery: a corticosteroid derivative to decrease possible neuronal damage. [2009.07]
BACKGROUND: Cerebral injury is a well-known complication after cardiac surgery with cardiopulmonary bypass (CPB), especially in adult patients. Specific biochemical markers like neuron-specific enolase (NSE) and S-100beta protein were developed previously for early detecting neuronal damage after CPB. Corticosteroids are shown to reduce multisystemic deleterious effects of cardiopulmonary bypass due to their anti-inflammatory characteristics. The aim of this study is to demonstrate the decrease of serum neuron-specific enolase levels in patients who received corticosteroids before CPB... CONCLUSION: The lower levels of NSE in patients who received methylprednisolone may suggest that corticosteroids might be useful in decreasing possible neuronal damage during heart surgery. However, we were not able to demonstrate an adverse neurological outcome.

Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage. [2009.06.12]
Object The object of this study was to determine the efficacy of methylprednisolone in reducing symptomatic vasospasm and poor outcomes after subarachnoid hemorrhage (SAH). Methods Ninety-five patients with proven SAH were recruited into a double-blind, placebo-controlled, randomized trial... Conclusions A safe and simple treatment with methylprednisolone did not reduce the incidence of symptomatic vasospasm but improved ability and functional outcome at 1 year after SAH.

Local application of low-dose Depo-Medrol is effective in reducing immediate postoperative back pain. [2009.06]
This prospective, randomised case-control study was made to determine effectiveness of low-dose Depo-Medrol applied to the affected nerve root after discectomy. Fifty seven patients with L4-5 or L5-S1 single level disc herniation with unilateral leg pain were selected for the study and were divided in two groups...

NORdic trial of oral Methylprednisolone as add-on therapy to Interferon beta-1a for treatment of relapsing-remitting Multiple Sclerosis (NORMIMS study): a randomised, placebo-controlled trial. [2009.06]
BACKGROUND: Treatment of relapsing-remitting multiple sclerosis with interferon beta is only partly effective, and new more effective and safe strategies are needed. Our aim was to assess the efficacy of oral methylprednisolone as an add-on therapy to subcutaneous interferon beta-1a to reduce the yearly relapse rate in patients with relapsing-remitting multiple sclerosis... INTERPRETATION: Oral methylprednisolone given in pulses every 4 weeks as an add-on therapy to subcutaneous interferon beta-1a in patients with relapsing-remitting multiple sclerosis leads to a significant reduction in relapse rate. However, because of the small number of patients and the high dropout rate, these findings need to be corroborated in larger cohorts.

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Clinical Trials Related to Depo-Medrol (Methylprednisolone)

Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE) [Recruiting]
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on immune homeostasis of the background medications that must be continued, in most study designs, in these flare-prone patients.

Purpose of Study: This study will purposefully study a population equivalent to the placebo group of typical trials in SLE. Patients will enter the trial in mild-moderate flare, be treated with depomedrol, and background treatments will be withdrawn. Biomarkers at entry on various medications will be compared to biomarkers after steroid efficacy with background medications withdrawn. Depomedrol usually slowly wears off over one to three months. Patients will be closely observed, with serial biomarkers drawn at monthly intervals or, immediately at the time of a new flare. Those patients who do develop new flares during the course of the next year (maximal participation time) will donate blood samples for biomarkers (flaring on tapering or absent depomedrol effect) and will then be immediately treated as deemed appropriate, exiting the study. The study will end when 50 patients have met this endpoint. A control population of matched, healthy individuals will donate blood once for the same biomarker studies.

A Comparison of Three Different Formulations of Prednisolone Acetate 1% [Recruiting]

The Efficacy of Three Months-Prednisolone Therapy for Chronic Eosinophilic Pneumonia [Recruiting]
A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.

Prednisolone Pharmacokinetics in Severe Asthma [Recruiting]
The purpose of the study is to evaluate whether severe asthmatic subjects have abnormal prednisolone absorption, and how this might affect the anti-inflammatory effects of prednisolone.

The aims of the study are

1. to compare the effect of high dose prednisolone on clinical and physiological responses

2. to determine the effect of long-term oral prednisolone therapy on corticosteroid responsiveness and prednisolone pharmacokinetics

3. to measure the effect of high dose prednisolone for 14 days on p38 MAPK activity, GR translocation and activation of NF-kB

4. to validate an easier method of measuring corticosteroid insensitivity using whole blood, and a spot prednisolone serum level as a measure of adherence to prednisolone therapy

Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.

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