COMPOSITION
Solupred 2 Tablet: Each flim coated tablet contains Methylprednisolone USP 2 mg.
Solupred 4 Tablet: Each flim coated tablet contains Methylprednisolone USP 4 mg.
Solupred 8 Tablet: Each flim coated tablet contains Methylprednisolone USP 8 mg.
Solupred 16 Tablet: Each flim coated tablet contains Methylprednisolone USP 16 mg.
DESCRIPTION
Solupred Tablets 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.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties,
are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used
for their potent anti-inflammatory effects in disorders of many organ systems.
DOSAGE AND ADMINISTRATION
The initial dosage of Solupred Tablets may vary from 4 mg to 48 mg of Solupred 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, Solupred 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 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. Multiple Sclerosis: In 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).
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