Solupred 500 IM/IV

Endocrine Disorders Acute adrenocortical insufficiency Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis Rheumatic Disorders As adjunctive therapy for short-term administration in: Post-traumatic osteoarthritis Synovitis of osteoarthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Acute and subacute bursitis Epicondylitis Acute nonspecific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema (epinephrine is the drug of first choice) Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye, such as: Herpes zoster ophthalmicus Iritis, iridocyclitis Chorioretinitis Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic conjunctivitis Allergic corneal marginal ulcers Keratitis Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy) Regional enteritis (systemic therapy Respiratory Diseases Hematologic Disorders Acquired (autoimmune) hemolytic anemia Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated) Secondary thrombocytopenia in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Nervous System Acute exacerbations of multiple sclerosis

IV/IM Preparation Reconstitute for IM/IV injection with BWI containing 0.9% benzyl alcohol IV Administration Inject directly into vein or into tubing of running IV Injection: Administer over at least 1 minute Infusion: Further dilute reconstituted mixture with D5W, NS, D5/NS, or other compatible solution Push: Administer over 10-20 minutes

Intramuscular Anti-inflammatory or immunosuppressive Adult: As methyprednisolone Na succinate: 10-80 mg once daily. Anti-inflammatory or immunosuppressive Adult: As methylprednisolone Na succinate: 10-500 mg daily. Doses <250 mg are given by inj over at least 5 min while doses >250 mg are given slowly over at least 30 min. Status asthmaticus Adult: As methylprednisolone Na succinate: 40 mg, repeated according to patient's response. Acute allograft rejection in organ transplant recipients Adult: As methylprednisolone Na succinate: 0.5-1 g daily; continue until the patient has stabilised, usually not beyond 48-72 hr.

Intramuscular Anti-inflammatory or immunosuppressive Child: As methylprednisolone Na succinate: 0.5-1.7 mg/kg daily or 5-25 mg/m2 daily in divided doses 6-12 hrly. "Pulse" therapy: 15-30 mg/kg/dose over >30 min given once daily for 3 days. Intravenous Anti-inflammatory or immunosuppressive Child: As methylprednisolone Na succinate: 0.5-1.7 mg/kg daily or 5-25 mg/m2 daily in divided doses 6-12 hrly. "Pulse" therapy: 15-30 mg/kg/dose over >30 min given once daily for 3 days. Status asthmaticus Child: As methylprednisolone Na succinate: 1-4 mg/kg daily for 1-3 days. Acute allograft rejection in organ transplant recipients Child: As methylprednisolone Na succinate: 10-20 mg/kg daily for up to 3 days. Max: 1,000 mg daily.

Systemic fungal infections and known hypersensitivity to components.

Methylprednisolone is a synthetic corticosteroid with mainly glucocorticoid activity and minimal mineralocorticoid properties. It decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.

Patient w/ heart failure, HTN, DM, GI disease (e.g. diverticulitis, intestinal anastomoses, peptic ulcer, ulcerative colitis), multiple sclerosis, myasthenia gravis, acute MI, cataracts, glaucoma, osteoporosis, history of seizure disorder, thyroid disease. Avoid abrupt withdrawal. Renal and hepatic impairment (including cirrhosis). Childn. Pregnancy and lactation. Monitoring Parameters Monitor BP, blood glucose, electrolytes, growth in childn. Lactation: Drug enters milk; use with caution

Allergic Reactions Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopthy in premature infants, myocardial rupture following recent mycocardial infarction , pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increase sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, Fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible subsequent perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intra-lesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Ophthalmic Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Decreases effect of anticholinesterases in myasthenia gravis. May decrease the hypoglycaemic effects of antidiabetic agents. Decreases serum concentrations of salicylates. Increased hypokalemic effects of potassium-depleting diuretics (thiazides or furosemide), amphotericin B, bronchodilator therapy with xanthines or beta2 agonists. Increase incidence of GI bleeding and ulceration with NSAIDs. May increase the anticoagulant effects of warfarin. Decreased levels/effects with CYP3A4 inducers (aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins). Increased levels/effects with CYP3A4 inhibitors (azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, and verapamil). May decrease the effects of vaccines (dead organism) or increase the risk of vaccinal infection (live organism). Antacids and bile sequestrants may decrease the absorption of corticosteroids, separate admin by 2 hr. Increased risk of myopathy with neuromuscular-blocking agents, tendinopathies with fluoroquinolones.