Solu-Medrol

Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, shock secondary to adrenocortical insufficiency, or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present, pre-op or in the event of serious trauma or illness in patients w/ known adrenal insufficiency or when adrenocortical reserve is doubtful, congenital adrenal hyperplasia, non-suppurative thyroiditis, & hypercalcemia associated w/ cancer. Adjunctive therapy for short-term administration in the management of an acute episode or exacerbation: Post-traumatic OA, synovitis of OA, RA including juvenile RA, acute & subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis. During an exacerbation or as maintenance therapy in selected cases of SLE (& lupus nephritis), acute rheumatic carditis, systemic dermatomyositis (polymyositis), polyarteritis nodosa, Goodpasture syndrome. Pemphigus, severe erythema multiforme (SJS), exfoliative dermatitis, severe psoriasis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, mycosis fungoides. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Bronchial asthma, contact/atopic dermatitis, serum sickness, drug hypersensitivity reactions, urticarial transfusion reactions, acute non-infectious laryngeal edema. Severe acute & chronic allergic & inflammatory processes involving the eye: Herpes zoster ophthalmicus, iritis, iridocyclitis, chorioretinitis, diffuse posterior uveitis & choroiditis, optic neuritis, sympathetic ophthalmia, anterior segment inflammation, allergic conjunctivitis, allergic corneal marginal ulcers, keratitis. Management of critical periods of ulcerative colitis & regional enteritis. Symptomatic sarcoidosis, berylliosis, fulminating or disseminated TB when used concurrently w/ appropriate anti-TB chemotherapy, Loeffler's syndrome not manageable by other means, aspiration pneumonitis, moderate to severe Pneumocystis jiroveci pneumonia in AIDS patients, exacerbations of COPD. Acquired (autoimmune) hemolytic anemia, ITP/secondary thrombocytopenia in adults, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Palliative management of leukemia & lymphomas in adults, acute leukemia of childhood, improve quality of life in patients w/ terminal cancer. Induce diuresis or remission of proteinuria in the nephrotic syndrome w/o uremia. Cerebral edema from primary or metastatic tumors or surgical or RT, acute exacerbation of multiple sclerosis, acute spinal cord injury. Tuberculous meningitis w/ subarachnoid block or impending block (when used concurrently w/ appropriate anti-TB chemotherapy), trichinosis w/ neurologic or myocardial involvement, organ transplantation, prevention of nausea & vomiting associated w/ cancer chemotherapy.

Adjunctive therapy in life-threatening conditions 30 mg/kg IV over a period of at least 30 min, may be repeated every 4-6 hr for up to 48 hr. Exacerbation episodes or conditions unresponsive to standard therapy eg, rheumatic disorders, SLE, edematous states eg, glomerulonephritis or lupus nephritis IV pulses consisting of ≥250 mg/day for a few days (usually ≤5 days). Multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes) Administer pulses of 500 or 1,000 mg/day for 3 or 5 days over 30 min. Adjunctive therapy in other conditions Initial dose: 10-500 mg IV depending on clinical condition. Larger doses may be required for short-term management of severe, acute conditions. Initial doses up to 250 mg should be administered IV over a period of at least 5 min, while larger doses should be administered over at least 30 min. Subsequent doses may be administered IV or IM at intervals dictated by the patient's response & clinical condition. Ped patient Dose should not be <0.5 mg/kg every 24 hr.

Hypersensitivity. Systemic fungal infections. Intrathecal & epidural route of administration. Live or live attenuated vaccines.

May increase susceptibility to infection, may mask some signs of infection & new infections may appear during use. Use in active TB should be restricted to those cases of fulminating or disseminated TB in which corticosteroid is used for the management of the disease in conjunction w/ appropriate anti-TB regimen. Reactivation of TB may occur in patients w/ latent TB or tuberculin reactivity. Reports of Kaposi's sarcoma. Routine use in septic shock is not recommended. Allergic reactions may occur. Pharmacologic doses administered for prolonged periods may result in hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency). Avoid abrupt w/drawal. Avoid use in patients w/ Cushing's disease. Enhanced effect of corticosteroids in patients w/ hypothyroidism. May increase blood glucose, worsen pre-existing diabetes & predispose those on long-term therapy to DM. Psychic derangements may appear & existing emotional instability or psychotic tendencies may be aggravated. Reports of epidural lipomatosis, typically w/ long-term use at high doses. Posterior subcapsular & nuclear cataracts (particularly in childn), exophthalmos or increased IOP w/ prolonged use. Associated w/ central serous chorioretinopathy which may lead to retinal detachment. Risk of acute pancreatitis w/ high doses. May mask symptoms of peptic ulcer; peritonitis or other signs or symptoms associated w/ GI disorders eg, perforation, obstruction or pancreatitis. Reports of cardiac arrhythmias, circulatory collapse &/or cardiac arrest following rapid administration of large IV doses; bradycardia during or after administration of large doses; acute myopathy; osteoporosis. Drug induced liver injury eg, acute hepatitis can result from cyclical pulsed IV methylprednisolone. Can cause elevation of BP, salt & water retention, & increased excretion of K. Not to be used to treat traumatic brain injury. Patients subjected to unusual stress; patients w/ seizure disorders; myasthenia gravis; ocular herpes simplex; existing CV risk factors, CHF; predisposition to thromboembolic disorders, HTN; non-specific ulcerative colitis; diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer; systemic sclerosis; renal insufficiency; suspected or identified pheochromocytoma; patients at high risk of tumor lysis syndrome. Concomitant use w/ aspirin & NSAIDs. May affect ability to drive or use machinery. Pregnancy & lactation. Growth suppression & risk of raised ICP on prolonged therapy in infants & childn. May produce pancreatitis in childn (high doses). Hypertrophic cardiomyopathy may develop after administration to prematurely born infants. 500-mg & 1-g powd for inj: Benzyl alcohol is included in the diluent; associated w/ serious adverse events, including "gasping syndrome", & death in ped patients. Benzyl alcohol can cross the placenta.

Opportunistic infection, infections, peritonitis; leukocytosis; drug hypersensitivity, anaphylactic/anaphylactoid reaction; cushingoid, hypothalamic pituitary adrenal axis suppression, steroid w/drawal symptoms; metabolic acidosis, Na retention, fluid retention, alkalosis hypokalemic, dyslipidemia, impaired glucose tolerance, increased insulin requirement or oral hypoglycemic agents in diabetics, lipomatosis, increased appetite; affective disorder, psychotic disorder, mental disorder, personality change, confusional state, anxiety, mood swings, abnormal behavior, insomnia, irritability; epidural lipomatosis, increased ICP w/ papilledema (benign intracranial HTN), seizure, amnesia, cognitive disorder, dizziness, headache; chorioretinopathy, cataract, glaucoma, exophthalmos; vertigo; congestive cardiac failure, arrhythmia; thrombosis, HTN, hypotension, flushing; pulmonary embolism, hiccups; peptic ulcer w/ possible perforation & hemorrhage, intestinal perforation, gastric hemorrhage, pancreatitis, ulcerative esophagitis, esophagitis, abdominal distention/pain, diarrhea, dyspepsia, nausea; hepatitis; angioedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae, rash, pruritus, urticaria, acne, skin hypopigmentation; muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; impaired healing, peripheral edema, fatigue, malaise, inj site reaction; increased IOP, decreased carbohydrate tolerance & blood K, increased urine Ca, ALT, AST, blood alkaline phosphatase & blood urea, suppression of reactions to skin tests; spinal compression fracture, tendon rupture.

Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors (eg, INH, aprepitant, fosaprepitant, itraconazole, ketoconazole, HIV PIs, diltiazem, ethinyl estradiol/norethindrone, grapefruit juice, cyclosporine, clarithromycin, erythromycin, troleandomycin). Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenobarb, phenytoin). Hepatic clearance may be affected by another CYP3A4 substrate (eg, cyclophosphamide, tacrolimus); adverse events associated w/ the use of either drug alone may be more likely to occur w/ co-administration. Reports of enhanced or diminished effects of oral anticoagulants. Reports of acute myopathy w/ anticholinergics eg, neuromuscular blocking drugs. Antagonism of neuromuscular blocking effects of pancuronium & vecuronium. May reduce anticholinesterases effects in myasthenia gravis. Dose adjustments of antidiabetics may be required due to increased blood glucose conc w/ corticosteroids. Aminoglutethimide-induced adrenal suppression may exacerbate endocrine changes caused by prolonged glucocorticoid treatment. Increased incidence of GI bleeding & ulceration w/ NSAIDs. May increase clearance of high-dose aspirin leading to decreased salicylate serum levels. Increased risk of hypokalemia w/ K-depleting agents (eg, diuretics); amphotericin B, xanthines or β₂-agonists. Physically incompatible in soln w/ allopurinol Na, doxapram HCl, tigecycline, diltiazem HCl, Ca gluconate, vecuronium Br, rocuronium Br, cisatracurium besylate, glycopyrrolate, propofol.

Corticosteroid Hormones

H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

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