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A-Methapred (Methylprednisolone Sodium Succinate) - Summary

 
 



A-METHAPRED SUMMARY

A-METHAPRED®
Methylprednisolone
Sodium Succinate for
Injection, USP

Methylprednisolone Sodium Succinate, USP, an adrenocortical-like steroid, is the sodium succinate ester of methylprednisolone. It occurs as a white, or nearly white, odorless hygroscopic amorphous solid. Methylprednisolone sodium succinate is extremely soluble in water and is especially well suited for intravenous use in situations in which high blood levels of methylprednisolone are required rapidly.

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, A-METHAPRED (methylprednisolone sodium succinate) is indicated for intravenous or intramuscular use in the following conditions:

  1. Endocrine disorders:

    a. 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).

    b. Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).

    c. Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful.

    d. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected.

    e. Congenital adrenal hyperplasia.

    f. Hypercalcemia associated with cancer.

    g. Nonsuppurative thyroiditis.

  2. Rheumatic disorders — As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

    a. Post-traumatic osteoarthritis.

    b. Synovitis of osteoarthritis.

    c. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).

    d. Acute and subacute bursitis.

    e. Epicondylitis.

    f. Acute nonspecific tenosynovitis.

    g. Acute gouty arthritis.

    h. Psoriatic arthritis.

    i. Ankylosing spondylitis.

  3. Collagen diseases — During an exacerbation or as maintenance therapy in selected cases of:

    a. Systemic lupus erythematosus.

    b. Systemic dermatomyositis (polymyositis).

    c. Acute rheumatic carditis.

  4. Dermatologic diseases:

    a. Pemphigus.

    b. Severe erythema multiforme (Stevens-Johnson syndrome).

    c. Exfoliative dermatitis.

    d. Bullous dermatitis herpetiformis.

    e. Severe seborrheic dermatitis.

    f. Severe psoriasis.

    g. Mycosis fungoides.

  5. Allergic states — Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:

    a. Bronchial asthma.

    b. Contact dermatitis.

    c. Atopic dermatitis.

    d. Serum sickness.

    e. Seasonal or perennial allergic rhinitis.

    f. Drug hypersensitivity reactions.

    g. Urticarial transfusion reactions.

    h. Acute noninfectious laryngeal edema (epinephrine is the drug of first choice).

  6. Ophthalmic diseases — Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

    a. Herpes zoster ophthalmicus.

    b. Iritis iridocyclitis.

    c. Chorioretinitis.

    d. Diffuse posterior uveitis and choroiditis.

    e. Optic neuritis.

    f. Sympathetic ophthalmia.

    g. Anterior segment inflammation.

    h. Allergic conjunctivitis.

    i. Allergic corneal marginal ulcers.

    j. Keratitis.

  7. Gastrointestinal diseases — To tide the patient over a critical period of disease in:

    a. Ulcerative colitis — (Systemic therapy).

    b. Regional enteritis — (Systemic therapy).

  8. Respiratory diseases:

    a. Symptomatic sarcoidosis.

    b. Berylliosis.

    c. Fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy.

    d. Loeffler’s syndrome not manageable by other means.

    e. Aspiration pneumonitis.

  9. Hematologic disorders:

    a. Acquired (autoimmune) hemolytic anemia.

    b. Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated).

    c. Secondary thrombocytopenia in adults.

    d. Erythroblastopenia (RBC anemia).

    e. Congenital (erythroid) hypoplastic anemia.

  10. Neoplastic diseases — For palliative management of:

    a. Leukemias and lymphomas in adults.

    b. Acute leukemia of childhood.

  11. Edematous state — To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

  12. Nervous system:

    a. Acute exacerbations of multiple sclerosis.

  13. Miscellaneous:

    a. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

    b. Trichinosis with neurologic and myocardial involvement.


See all A-Methapred indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to A-Methapred (Methylprednisolone)

Efficacy of corticosteroids for cancer-related fatigue: A pilot randomized placebo-controlled trial of advanced cancer patients. [2014]
Objective: Cancer-related fatigue (CRF) is a common and one of the most important issues in palliative medicine, and it has been demonstrated to have a significant impact on patient quality of life (QoL)... Our results were reported as a pilot study performed to support a subsequent larger trial.

Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study). [2014]
infliximab (IFX) with MTX and intravenous corticosteroid for remission induction... CONCLUSIONS: In DMARD-naive early RA patients, initial therapy with MTX+high-dose

Efficiency of bupivacaine versus lidocaine and methylprednisolone versus placebo to reduce postoperative pain and swelling after surgical removal of mandibular third molars: a randomized, double-blinded, crossover clinical trial. [2013]
swelling after surgical removal of mandibular third molars... CONCLUSIONS: Bupivacaine combined with methylprednisolone reduced the

Methylprednisolone in neonatal cardiac surgery: reduced inflammation without improved clinical outcome. [2013]
administration varies considerably between different institutions... CONCLUSIONS: Intravenous 30 mg/kg methylprednisolone administered before

Clinical benefits of methylprednisolone in off-pump coronary artery bypass surgery. [2013]
administration... CONCLUSIONS: Preoperative steroid administration in OPCABG patients significantly

more studies >>

Clinical Trials Related to A-Methapred (Methylprednisolone)

Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone [Recruiting]

Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS) [Recruiting]
Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.

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.

High-Dose Methylprednisolone and Rituximab in High Risk B-CLL [Recruiting]
Studies have shown that both high-dose Methylprednisolone and Rituximab used as single agents are effective in relapsed and refractory B-CLL. Methylprednisolone acts independently of p53 apoptosis pathway. The combination of both drugs may improve response and outcome in previously treated high-risk B-CLL patients.

Study Objectives

Primary:

To determine the clinical benefit of high-dose Methylprednisolone and Rituximab in previously treated high-risk B-CLL patients in terms of clinical and flowcytometric response rate.

Secondary:

To determine progression free and overall survival. To characterize the safety profile of high-dose Methylprednisolone and Rituximab.

Methylprednisolone N Acetylcysteine in Hepatic Resections [Recruiting]
This is a prospective double-blind randomized phase II clinical trial, with two groups of intervention (one with administration of N-acetylcysteine and the other with administration of methylprednisolone), and one group of placebo. The purpose of this study is to investigate the role of N-acetylcysteine and Methylprednisolone in the modulation of warm ischemia of the liver during hepatic resection. In fact to avoid massive blood loss in liver surgery, continuous or intermittent vascular clamping of the hepatic hilum ('Pringle maneuver') is generally used with good results. However, as a consequence, ischemia and subsequent reperfusion result in complex metabolic, immunological, and microvascular changes, which together might contribute to hepatocellular damage and dysfunction. This phenomenon, known as ischemia-reperfusion (IR) injury of the liver, is a complex multi-path process leading to the activation of some inflammatory pathways. Any patient candidate to liver resection will be enrolled in the study based on the aforementioned criteria. The primary objective of the study is to assess the real efficacy of Methylprednisolone and N-acetylcysteine in reducing the secondary damage from ischemia reperfusion injury in liver resection and in reducing inflammatory response. Secondary objective of the study is whether the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative liver failure, improvement of postoperative liver function, and reduction of blood components transfusions. The randomization will be done the day before the operation. The drugs will be prepared in a blind fashion by the hospital pharmacy. The hospital pharmacy will provide to each patient a drip to make bolus of about an hour before the start of the liver resection and a syringe pump for an infusion of approximately 6 hours. If the patient is enrolled and randomized in the placebo arm, he/she will receive 250 ml of glucose 5% plus the infusion of 100 ml of glucose 5% If the patient is randomized in the Methylprednisolone arm, he/she will receive a dose of 500 mg in 250 ml of glucose 5% plus 100 mg of glucose 5%. If the patient is randomized in the N-acetylcysteine arm, he/she will receive a dose of 150 mg/kg in 250 ml of glucose 5% plus N-acetylcysteine 50 mg/kg in 100 ml glucose 5%. Systematic sampling of liver function tests will be done the day before the operation, at the end of the operation, as well as in postoperative day 1, 3, 5 and 7.

more trials >>


Page last updated: 2014-11-30

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