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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

Media Articles Related to A-Methapred (Methylprednisolone)

ACC: Steroids Hike MIs After Heart Surgery
Source: MedPage Today Surgery [2014.04.01]
WASHINGTON (MedPage Today) -- Giving methylprednisolone to patients undergoing cardiac surgery with cardiopulmonary bypass heightened the risk of myocardial infarction, a large randomized trial showed.

more news >>

Published Studies Related to A-Methapred (Methylprednisolone)

Intravenous immunoglobulin versus intravenous methylprednisolone for chronic inflammatory demyelinating polyradiculoneuropathy: a randomised controlled trial. [2012]
intravenous methylprednisolone... INTERPRETATION: Treatment of CIDP with IVIg for 6 months was less frequently

Effect of MRI on treatment results or decision making in patients with lumbosacral radiculopathy referred for epidural steroid injections: a multicenter, randomized controlled trial. [2012]
patients with lumbosacral radiculopathy referred for ESI... CONCLUSION: Magnetic resonance imaging does not improve outcomes in patients who

Evaluation of epidural analgesic paste components in lumbar decompressive surgery: a randomized double-blind controlled trial. [2012]
facilitating early discharge from hospital after lumbar decompressive surgery... CONCLUSION: An analgesic paste containing methylprednisolone acetate is effective

Efficacy of methylprednisolone in preventing lung injury following pulmonary thromboendarterectomy. [2012]
pulmonary thromboendarterectomy... CONCLUSIONS: Perioperative methylprednisolone does not reduce the incidence of

Efficacy of corticosteroid therapy in patients with an acute exacerbation of chronic obstructive pulmonary disease receiving ventilatory support. [2011.11.28]
BACKGROUND: Randomized trials assessing the effect of systemic corticosteroids on chronic obstructive pulmonary disease (COPD) exacerbations excluded patients who were mechanically ventilated or admitted to the intensive care unit (ICU). Critically ill patients constitute a population of persons who are prone to develop complications that are potentially associated with the use of corticosteroids (eg, infections, hyperglycemia, ICU-acquired paresis) that could prolong the duration of mechanical ventilation and even increase mortality... CONCLUSION: Systemic corticosteroid therapy in patients with COPD exacerbations requiring mechanical ventilation is associated with a significant increase in the success of noninvasive mechanical ventilation and a reduction in the duration of mechanical ventilation Trial Registration clinicaltrials.gov Identifier: NCT01281748.

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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.

Prednisolone and Acupuncture in Bell's Palsy: a Randomised, Placebo-controlled, Multicentre Trial in China [Recruiting]
The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify that whether in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients.

more trials >>


Page last updated: 2014-04-01

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