Methylprednisolone (Methylprednisolone) - Summary

SUMMARY

METHYLPREDNISOLONE TABLETS, USP 4 MG

Methylprednisolone Tablets USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water.

Methylprednisolone Tablets are indicated in the following conditions:

1. Endocrine Disorders

   Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).

   Congenital adrenal hyperplasia

   Nonsuppurative thyroiditis

   Hypercalcemia associated with cancer

2. Rheumatic Disorders

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

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

   Ankylosing spondylitis

   Acute and subacute bursitis

   Synovitis of osteoarthritis

   Acute nonspecific tenosynovitis

   Post-traumatic osteoarthritis

   Psoriatic arthritis

   Epicondylitis

   Acute gouty arthritis

3. Collagen Diseases

   During an exacerbation or as maintenance therapy in selected cases of:

   Systemic lupus erythematosus

   Systemic dermatomyositis (polymyositis)

   Acute rheumatic carditis

4. Dermatologic Diseases

   Bullous dermatitis herpetiformis

   Severe erythema multiforme (Stevens-Johnson syndrome)

   Severe seborrheic dermatitis

   Exfoliative dermatitis

   Mycosis fungoides

   Pemphigus

   Severe psoriasis

5. Allergic States

   Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

   Seasonal or perennial allergic rhinitis

   Drug hypersensitivity reactions

   Serum sickness

   Contact dermatitis

   Bronchial asthma

   Atopic dermatitis

6. Ophthalmic Diseases

   Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

   Allergic corneal marginal ulcers

   Herpes zoster ophthalmicus

   Anterior segment inflammation

   Diffuse posterior uveitis and choroiditis

   Sympathetic ophthalmia

   Keratitis

   Optic neuritis

   Allergic conjunctivitis

   Chorioretinitis

   Iritis and iridocyclitis

7. Respiratory Diseases

   Symptomatic sarcoidosis

   Berylliosis

   Loeffler’s syndrome not manageable by other means

   Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

   Aspiration pneumonitis

8. Hematologic Disorders

   Idiopathic thrombocytopenic purpura in adults

   Secondary thrombocytopenia in adults

   Acquired (autoimmune) hemolytic anemia

   Erythroblastopenia (RBC anemia)

   Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases

   For palliative management of:

   Leukemias and lymphomas in adults

   Acute leukemia of childhood

10. Edematous States

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

11. Gastrointestinal Diseases

    To tide the patient over a critical period of the disease in:

    Ulcerative colitis

    Regional enteritis

12. Nervous System

    Acute exacerbations of multiple sclerosis

13. Miscellaneous

    Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

NEWS HIGHLIGHTS

Published Studies Related to 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.

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.

Methylprednisolone versus triamcinolone in painful shoulder using ultrasound-guided injection. [2009]
There is little evidence about the comparative efficacy of corticosteroids in the treatment of painful shoulder. The main aim was to compare the efficacy of methylprednisolone (MTP) versus triamcinolone (TMC) in the treatment of painful shoulder using an ultrasound-guided injection... Relief of pain tends to be more rapid with MTP than TMC.

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Clinical Trials Related to Methylprednisolone

Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis [Completed]
Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

Combination Treatment of Relapsing-Remitting Multiple Sclerosis With Methylprednisolone and Interferon-Beta-1a [Recruiting]
This study is to find out if methylprednisolone in combination with Interferon-beta-1a improves the overall course and shortens relapses of Multiple Sclerosis.

Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans [Completed]
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans

The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS [Terminated]
To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model [Active, not recruiting]
The purpose of the study is to determine whether prednisolone acetate 1% ophthalmic suspension is effective in preventing signs and symptoms of allergic conjunctivitis in comparison with prednisolone acetate 0. 12% ophthalmic suspension, loteprednol etabonate 0. 2% ophthalmic suspension and placebo in a modified conjunctival allergen challenge (CAC) model.

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