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Methylprednisolone Tablets

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Indication: 1. Rheumatic disease 
As adjunctive therapy for short-term administration ......
Usage volume: Oral dose. The initial dosage of Methylprednisolone may vary from 4mg to 48 mg......
Product specifications:

Product introduction

[Brand Name]
Methylprednisolone Tablets
[Generic Name]
Methylprednisolone Tablets
[Active Ingredient]
Methylprednisolone
[Chemical name]
11β, 17, 21-trihydroxy-6α-methylpregna-1,4-diene-3,20-dione
[Chemical structure]

Formula:                   C22H30O5         Molecular weight:    374.48
[Character]
White, elliptical tablets, press “MP” on the surface and “+” on the reverse

[Pharmacokinetics]
In the small intestine dose test for human body, it shows that steroid is mainly absorbed by the proximal end of small intestine. For distal of the small intestine, its absorbance is only 50 percent of proximal end.
In human body, Methylprednisolone, albumin and transcortin can form weak, dissociatable conjugation. The conjugated Methylprednisolone is around 40%-90%. Methylprednisolone and cortisone are metabolized in the liver to inactive metabolites, the major ones being 20β-hydroxymethyl-prednisolone and 20β-hydroxy-6a-methylprednisone. They excrete as glucuronate, sulphate and non-conjugated compound with urine. They mainly occur in liver, partly in kidney. 
 

[Indications, Dosage]

 

1. Rheumatic disease
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Post-traumatic osteoarthritis
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
Ankylosing spondylitis.
Synovitis of osteoarthritis.
Acute and subacute bursitis.
Acute nonspecific tenosynovitis.
Acute gouty arthritis.
Epicondylitis.

2. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus.
Systemic dermatomyositis (polymyositis).
Acute rheumatic carditis.

3. Dermatologic Diseases:
Bullous dermatitis herpetiformis.
Severe erythema multiforme (Stevens-Johnson syndrome).
Severe seborrheic dermatitis.
Exfoliative dermatitis.
Mycosis fungoides.
Pemphigus.
Severe psoriasis.

4. Allergic States:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis.
Serum sickness.
Bronchial asthma.
Drug hypersensitivity reactions.
Contact dermatitis.
Atopic dermatitis. 
 
5. 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.

6. Respiratory Diseases:
Symptomatic sarcoidosis.
Loeffler's syndrome not manageable by other means.
Berylliosis.
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.
Aspiration pneumonitis.

7. 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.

8. Gastrointestinal Diseases:
To tide the patient over a critical period of the disease in:
Ulcerative colitis.
Regional enteritis.

9. Nervous System:
Management of oedema associated with brain tumour.
Acute exacerbations of multiple sclerosis
10. Miscellaneous:
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.

11. Organ Transplantations

 [Dosage & Administration]
Oral dose. The initial dosage of Methylprednisolone may vary from 4mg to 48 mg (1~12 tablets) 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. In the clinical practice, the higher dose is select to treat multiple sclerosis (200mg/day), brain oedema (200-100mg/ day) and organ transplantations (7mg/kg/day). 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.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Methylprednisolone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

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.

ADT (Alternate 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.

[Side-effects]
1. Fluid and Electrolyte Disturbances:
sodium retention
fluid retention
congestive heart failure in susceptible patients
potassium loss
hypokalemic alkalosis
hypertension