Depomed 40 mg/ml is indicated in the treatment of asthma, atopic dermatitis, contact dermatitis, bullous dermatitis herpetiformis, mycosis fungoides, pemphigus, severe erythema multiforme, primary or secondary adrenocortical insufficiency, hypercalcemia associated with cancer, nonsuppurative thyroiditis, ulcerative colitis, hematologic disorders, palliative management of leukemias and lymphomas, sympathetic ophthalmia, keratitis, allergic conjunctivitis, juvenile rheumatoid arthritis, ankylosing spondylitis, symptomatic sarcoidosis, and aspiration pneumonitis.

Methylprednisolone Acetate binds to and activates intracellular glucocorticoid receptors. Activated receptors bind to DNA promoter regions, regulating gene transcription by either activating or suppressing it. Unbound glucocorticoids cross cell membranes and bind with high affinity to cytoplasmic receptors, modifying transcription and protein synthesis. Through this mechanism, glucocorticoids inhibit leukocyte infiltration at inflammation sites, interfere with inflammatory mediators, and suppress humoral immune responses. Anti-inflammatory effects are also mediated via phospholipase A2 inhibitory proteins (lipocortins), which regulate the synthesis of prostaglandins and leukotrienes.

Methylprednisolone Acetate

1. Administration For Local Effect:Rheumatoid and Osteoarthritis: The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. The doses in the following table are given as a general guide:

• Large Size of joint (Knees, Ankles, Shoulders): 20 to 80 mg
• Medium Size of joint (Elbows, Wrists): 10 to 40 mg
• Small Size of joint (Metacarpophalangeal, Interphalangeal, Sternoclavicular, Acromioclavicular): 4 to 10 mg.

Miscellaneous (Ganglion, Tendinitis, Epicondylitis): The dose in the treatment of the various conditions of the tendinous or bursal structures varies with the condition being treated and ranges from 4 to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.

Dermatological Conditions: 20 to 60 mg of the suspension is injected into the lesion. It may be necessary to distribute doses ranging from 20 to 40 mg by repeated local injections in the case of large lesions. One to four injections are usually employed, the intervals between injections varying with the type of lesion being treated and the duration of improvement produced by the initial injection.

2. Administration For Systemic Effect: In patients with the adrenogenital syndrome, a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with rheumatoid arthritis, the weekly intramuscular dose will vary from 40 to 120 mg. The usual dosage for patients with dermatologic lesions benefited by systemic corticoid therapy is 40 to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single dose of 80 to 120 mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition. Following intramuscular administration of 80 to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 to 120 mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.

3. Multiple Sclerosis: In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone). Or, as directed by the registered physician.

Methylprednisolone Acetate sterile aqueous suspension is contraindicated for intrathecal administration. It is also contraindicated in systemic fungal infections and in patients with known hypersensitivity to the product or its constituents.

Congestive heart failure in susceptible patients, hypertension, sodium retention, muscle weakness, osteoporosis, peptic ulcer with possible hemorrhage, abdominal distention, increased sweating, convulsions, vertigo, headache, menstrual irregularities, secondary adrenocortical and pituitary suppression, increased intraocular pressure, glaucoma, allergic or hypersensitivity reactions, urticaria, hyperpigmentation or hypopigmentation.

Pregnancy Category C. Adequate human reproduction studies have not been done with corticosteroids. Use during pregnancy, nursing mothers, or women of childbearing potential requires weighing the possible benefits against potential risks to the mother and fetus.

Methylprednisolone Acetate should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.

Glucocorticoids

Store between 20–25°C.