Source: FDA, National Drug Code (US) Revision Year: 2019
MEDROL 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.
The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below:
Each MEDROL Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone.
Inactive ingredients:
| 2 mg | 4 mg and 8 mg |
| Calcium Stearate | Calcium Stearate |
| Corn Starch | Corn Starch |
| Erythrosine Sodium | Lactose |
| Lactose | Sucrose |
| Mineral Oil | |
| Sorbic Acid | |
| Sucrose | |
| 16 mg and 32 mg | |
| Calcium Stearate | |
| Corn Starch | |
| Lactose | |
| Mineral Oil | |
| Sucrose | |
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.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.
| How Supplied |
|---|
|
MEDROL Tablets are available in the following strengths and package sizes: 2 mg (white, elliptical, scored, imprinted MEDROL 2): Bottles of 100 NDC 0009-0020-01 4 mg (white, elliptical, scored, imprinted MEDROL 4): Bottles of 100 NDC 0009-0056-02, DOSEPAK Unit of Use (21 tablets) NDC 0009-0056-04 8 mg (white, elliptical, scored, imprinted MEDROL 8): Bottles of 25 NDC 0009-0022-01 16 mg (white, elliptical, scored, imprinted MEDROL 16): Bottles of 50 NDC 0009-0073-01 32 mg (white, elliptical, scored, imprinted MEDROL 32): Bottles of 25 NDC 0009-0176-01 |
| Drug | Countries | |
|---|---|---|
| MEDROL | Canada, Cyprus, Ecuador, Estonia, Finland, France, Croatia, Israel, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Tunisia, United States |
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