MEDROL DOSEPAK Dosage & Rx Info | Uses, Side Effects

Medrol Dosepak Generic Name & Formulations

Legal Class

General Description

Methylprednisolone 4mg; unit-of-use 21 scored tabs.

Pharmacological Class

Glucocorticoid.

How Supplied

Tabs 2mg, 4mg—100; 8mg, 32mg—25; 16mg—50; Dosepak—21; Depo-Medrol multi-dose vial (20mg/mL)—1; (40mg/mL, 80mg/mL)—1, 25; Single-dose vial (40mg/mL, 80mg/mL)—1, 25; Solu-Medrol single-dose vial (500mg, 1g)—1; (40mg, 125mg)—25; Multi-dose vial (500mg, 1g)—1; Single-dose vial or vial with diluent (2g)—1

Manufacturer

Pfizer Inc.

Generic Availability

Tabs, dosepak (YES); Depo-medrol: 20mg/mL (NO); 40mg/mL, 80mg/mL (YES); Solu-medrol: 40mg, 125mg, 500mg, 1g (YES); 2g (NO)

Mechanism of Action

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.

Medrol Dosepak Indications

Indications

Steroid-responsive disorders.

Medrol Dosepak Dosage and Administration

Adults and Children

See full labeling. Individualize. 4–48mg daily.

Medrol Dosepak Contraindications

Contraindications

Systemic fungal infections. Live vaccines. Depo-Medrol, Solu-Medrol: also premature infants (benzyl alcohol content), intrathecal administration, idiopathic thrombocytopenic purpura (IM preparations). Allergy to cow's milk or other dairy products (Solu-Medrol 40mg).

Medrol Dosepak Boxed Warnings

Not Applicable

Medrol Dosepak Warnings/Precautions

Warnings/Precautions

Not for epidural use; serious neurologic events may occur. Cerebral malaria, optic neuritis: not recommended. Latent or active amebiasis. Strongyloides infestation. Ocular herpes simplex. Cirrhosis. Tuberculosis. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Ulcerative colitis if perforation pending. Peptic ulcer. Diverticulitis. Intestinal anastomoses. Myasthenia gravis. Systemic sclerosis. Recent MI. CHF. Hypertension. Renal insufficiency. Osteoporosis. Diabetes. Hypothyroidism. Kaposi's sarcoma. High tumor proliferative rate, high tumor burden, or sensitivity to cytotoxic agents; monitor closely. Supplement with additional steroids in physiologic stress. May increase risk and mask signs of infection. May cause electrolyte imbalances, adrenocortical insufficiency, psychotic derangements. Alternate, intermittent, or single-daily doses at 8 AM minimize adrenal suppression. Monitor weight, growth, fluid and electrolyte balance. IV: drug-induced liver injury; discontinue if toxic hepatitis occurs. Intrasynovial: avoid previously infected or unstable joints. Solu-Medrol 40mg: consider allergy to cow's milk if new or worsening allergic symptoms occur; use alternatives. Avoid abrupt cessation. Use lowest effective dose. Pregnancy. Nursing mothers: not recommended.

Medrol Dosepak Pharmacokinetics

Metabolism

Hepatic.

Elimination

Fecal, renal. Half-life: 2.3 hours.

Medrol Dosepak Interactions

Interactions

Potentiated by CYP3A4 inhibitors (eg, ketoconazole, macrolides), cyclosporine, estrogens. Antagonized by CYP3A4 inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin), cholestyramine. May potentiate cyclosporine (seizure risk). May antagonize oral anticoagulants (monitor), isoniazid. Increased risk of arrhythmias with digitalis. May need to adjust dose of antidiabetic agents. Monitor for hypokalemia with potassium-depleting drugs (eg, amphotericin B, diuretics). Concomitant neuromuscular blocking agents; increased risk of myopathy. Withdraw anticholinesterase agents at least 24hrs before initiating corticosteroid therapy. Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. Increased GI effects with aspirin, other NSAIDs. Caution with aspirin in hypoprothrombinemia. May suppress reactions to skin tests.

Medrol Dosepak Adverse Reactions

Adverse Reactions

HPA axis suppression, increased susceptibility to infection, glaucoma, cataracts, secondary infections, hypokalemia, hypocalcemia, hypernatremia, hypertension, CHF, psychic disorders, myopathy, osteoporosis, peptic ulcer, dermal atrophy, increased intracranial pressure, carbohydrate intolerance; tumor lysis syndrome. Parenteral: atrophy, flare at site; intrasynovial: septic arthritis.

Medrol Dosepak Clinical Trials

See Literature

Medrol Dosepak Note