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Basic Drug Info
Drug Name:MethylPREDNISolone
Manufacturer:Qualitest Pharmaceuticals
Other Info:Manufactured for:QUALITEST PHARMACEUTICALSHuntsville, AL 358118181310P/8181310RR11/07-R3



Clinical Trials:


Indications and Usage
MethylPREDNISolone Tablets are indicated in the following conditions:Endocrine DisordersPrimary 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 hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditisRheumatic DisordersAs 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 spondylitisAcute and subacute bursitisSynovitis of osteoarthritis Acute nonspecific tenosynovitisPsoriatic arthritisEpicondylitisAcute gouty arthritisPost-traumatic osteoarthritisCollagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)Dermatologic DiseasesBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasisAllergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisSerum sicknessContact dermatitisDrug hypersensitivity reactionsBronchial asthmaAtopic dermatitisOphthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersAnterior segment inflammationSympathetic ophthalmiaKeratitisOptic neuritisIritis and iridocyclitisHerpes zoster ophthalmicusDiffuse posterior uveitis and choroiditisAllergic conjunctivitisChorioretinitisRespiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other means Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitisBerylliosisHematologic DisordersIdiopathic thrombocytopenia purpura in adultsAcquired (autoimmune) hemolytic anemiaCongenital (erythroid) hypoplastic anemiaSecondary thrombocytopenia in adultsErythroblastopenia (RBC anemia)Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhoodEdematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritisNervous SystemAcute exacerbations of multiple sclerosisMiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.
Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Chronic Childhood Arthritis -- Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

Posterior Uveitis -- Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Unspecified pulmonary tuberculosis, unspecified examination -- MYCOBACTERIUM infections of the lung.

TUBERCULOSIS DISSEMINATED --

Thrombocytopenic purpura -- Any form of purpura in which the PLATELET COUNT is decreased. Many forms are thought to be caused by immunological mechanisms.

leukemia -- A progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemias were originally termed acute or chronic based on life expectancy but now are classified according to cellular maturity. Acute leukemias consist of predominately immature cells; chronic leukemias are composed of more mature cells. (From The Merck Manual, 2006)

Lymphoma -- A general term for various neoplastic diseases of the lymphoid tissue.

Proteinuria -- The presence of proteins in the urine, an indicator of KIDNEY DISEASES.

Nephrotic Syndrome -- A condition characterized by severe PROTEINURIA, greater than 3.5 g/day in an average adult. The substantial loss of protein in the urine results in complications such as HYPOPROTEINEMIA; generalized EDEMA; HYPERTENSION; and HYPERLIPIDEMIAS. Diseases associated with nephrotic syndrome generally cause chronic kidney dysfunction.

Uremia -- A clinical syndrome associated with the retention of renal waste products or uremic toxins in the blood. It is usually the result of RENAL INSUFFICIENCY. Most uremic toxins are end products of protein or nitrogen CATABOLISM, such as UREA or CREATININE. Severe uremia can lead to multiple organ dysfunctions with a constellation of symptoms.

SPONDYLOMETAEPIPHYSEAL DYSPLASIA, SHORT LIMB-HAND TYPE --

Lupus Erythematosus -- A chronic inflammatory connective tissue disease marked by skin rashes, joint pain and swelling, inflammation of the kidneys, inflammation of the fibrous tissue surrounding the heart (i.e., the pericardium), as well as other problems. Not all affected individuals display all of these problems. Also called systemic lupus erythematosus.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Trichinosis -- A disease due to infection with TRICHINELLA SPIRALIS. It is caused by eating undercooked meat, usually pork.

Contraindications
Systemic fungal infections and known hypersensitivity to components.
Systemic mycosis --

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.Corticosteroids may mask some signs of infection, and new infections may appear during their use.

There may be decreased resistance and inability to localize infection when corticosteroids are used.Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Branded Drugs
The following US Branded drugs contain MethylPREDNISolone


MEDROL -- PHARMACIA AND UPJOHN CO

NEO-MEDROL -- PHARMACIA AND UPJOHN CO


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