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.

NEWS HIGHLIGHTS

Published Studies Related to A-Methapred (Methylprednisolone)

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.

A review: the role of high dose methylprednisolone in spinal cord trauma in children. [2011.10.13]
BACKGROUND: The use of steroids in traumatic spinal cord injury (SCI) in children is controversial. There is a paucity of literature on its usage. To help clarify recommendations on steroid use in children, we reviewed the current literature on the administration of high dose methylprednisolone (MP) use in traumatic spinal cord injuries with an emphasis in pediatric spinal cord trauma... CONCLUSION: Data from adult studies remains controversial with insufficient data to support administration of MP for treatment of traumatic spinal cord injuries. Randomized controlled trials are needed in the pediatric population to assess the advantages of steroid use after SCI in children. On the basis of the current evidence, the use of steroids in patients is associated with increased infectious risks and no neurological improvements.

Effects of methylprednisolone infusion on markers of inflammation, coagulation, and angiogenesis in early acute respiratory distress syndrome. [2011.10.06]
OBJECTIVE:: Evaluate the effects of methylprednisolone on markers of inflammation, coagulation, and angiogenesis during early acute respiratory distress syndrome... CONCLUSIONS:: In early acute respiratory distress syndrome, administration of methylprednisolone was associated with improvement in important biomarkers of inflammation and coagulation and clinical outcomes. Biomarker changes varied with the precipitating cause of acute respiratory distress syndrome, suggesting that the underlying mechanisms and response to anti-inflammatory therapy may vary with the cause of acute respiratory distress syndrome.

Randomized controlled trial of the efficacy of isosorbide-SR addition to current treatment in medical expulsive therapy for ureteral calculi. [2011.10]
It has been suggested that nitrates are potent smooth muscle relaxants that may reduce pain and facilitate ureteral stone passage; therefore it may be an option for medical expulsive therapy in ureteral stones. In a prospective randomized controlled clinical trial, we evaluated the efficacy of medical expulsive therapy with isosorbide-SR 40 mg in patients with ureteral stones (</=10 mm)...

Neuropsychiatric manifestations in systemic lupus erythematosus: epidemiology, pathophysiology and management. [2011.09.01]
Systemic lupus erythematosus (SLE) is a relapsing-remitting autoimmune disease with CNS involvement occurring in up to 75% of patients. However, the frequency of neuropsychiatric manifestations in SLE studies varies widely, depending on the type of manifestations included and the method used for evaluation...

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.

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.

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

more trials >>