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

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

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

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.

Efficacy and tolerability of systemic methylprednisolone in children and adolescents with chronic rhinosinusitis: a double-blind, placebo-controlled randomized trial. [2011.08]
BACKGROUND: The place of systemic corticosteroids in the treatment of children with chronic rhinosinusitis (CRS) remains unclear. OBJECTIVE: We sought to assess the effectiveness and tolerability of oral methylprednisolone as an anti-inflammatory adjunct in the treatment of CRS in children... CONCLUSION: Oral methylprednisolone is well tolerated and provides added benefit to treatment with antibiotics for children with CRS. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

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Clinical Trials Related to 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.

The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy [Recruiting]
The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy. Sodium Chloride is the placebo. The following parameters are registered:

1. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.

2. The postoperative use of additional analgesics.

3. Inflammatory parameters before and after surgery.

4. Time until mobilization.

5. Time until discharge.

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.

Preoperative Methylprednisolone in Endovascular Aortic Repair [Recruiting]

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Reports of Suspected Methylprednisolone Side Effects

Pyrexia (47),  Drug Ineffective (42),  Cytomegalovirus Infection (40),  Pneumonia (33),  Aspergillosis (33),  Anaemia (29),  Respiratory Failure (27),  Sepsis (27),  Multi-Organ Failure (26),  Tendon Rupture (25), more >>