Medrol

MEDROL Tablets are indicated in the following conditions:

The initial dosage of MEDROL 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, MEDROL should be discontinued and the patient transferred to other appropriate therapy.

• •Sodium retention
• •Congestive heart failure in susceptible patients
• •Hypertension
• •Fluid retention
• •Potassium loss
• •Hypokalemic alkalosis

• •Muscle weakness
• •Loss of muscle mass
• •Steroid myopathy
• •Osteoporosis
• •Tendon rupture, particularly of the Achilles tendon
• •Vertebral compression fractures
• •Aseptic necrosis of femoral and humeral heads
• •Pathologic fracture of long bones

• •Peptic ulcer with possible perforation and hemorrhage
• •Pancreatitis
• •Abdominal distention
• •Ulcerative esophagitis

Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

• •Impaired wound healing
• •Petechiae and ecchymoses
• •May suppress reactions to skin tests
• •Thin fragile skin
• •Facial erythema
• •Increased sweating

• •Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
• •Convulsions
• •Vertigo
• •Headache

• •Development of Cushingoid state
• •Suppression of growth in children
• •Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
• •Menstrual irregularities
• •Decreased carbohydrate tolerance
• •Manifestations of latent diabetes mellitus
• •Increased requirements of insulin or oral hypoglycemic agents in diabetics

• •Posterior subcapsular cataracts
• •Increased intraocular pressure
• •Glaucoma
• •Exophthalmos

• •Negative nitrogen balance due to protein catabolism

• •Flushing

The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

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: