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Methylprednisolone (Methylprednisolone) - Indications and Dosage

 
 



INDICATIONS & USAGE

Methylprednisolone Tablets are indicated in the following conditions:
1.Endocrine Disorders
     
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 Iymphomas in adults     
Acute leukemia of childhood
10.Edematous States
     To induce 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.



DOSAGE & ADMINISTRATION

The initial dosage of Methylprednisolone Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Methylprednisolone should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.

Multiple Sclerosis
In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

ADT (Alternative Day Therapy)
Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, Corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.
A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.
The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.
During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1to 1days following a single dose) and thus are recommended for alternate day therapy.
The following should be kept in mind when considering alternate day therapy:
1)Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.
2)ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
3)In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.
     Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
4)Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (e.g., patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
5)As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (e.g., dexamethasone and betamethasone).
6)The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
7)In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
8)In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted.
9)Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.

HOW SUPPLIED

Methylprednisolone Tablets are available in the following strengths and package sizes:
4 mg (white, oval, quadrisected, imprinted TL 001)
Bottle's of 100'sNDC 51991-188-01Unit of use pack (21 tablets)NDC 51991-188-31

STORAGE AND HANDLING

Store at 20to 25C (68to 77F) [See USP Controlled Room Temperature].

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