Medrol

Medrol

methylprednisolone

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Methylprednisolone
Indications/Uses
Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, non-suppurative thyroiditis, & hypercalcemia associated w/ cancer. Adjunctive therapy for short-term administration in psoriatic arthritis, RA including juvenile RA, ankylosing spondylitis, acute & subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic OA, synovitis of OA, & epicondylitis. During an exacerbation or as maintenance therapy in selected cases of SLE, systemic dermatomyositis (polymyositis), acute rheumatic carditis, polymyalgia rheumatica, & giant cell arteritis. Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (SJS), exfoliative dermatitis, mycosis fungoides, severe psoriasis, & severe seborrheic dermatitis. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, drug hypersensitivity reactions, & contact/atopic dermatitis. Severe acute & chronic allergic & inflammatory conditions involving the eye & its adnexa eg, allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis & choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis & iridocyclitis. Symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary TB when used concurrently w/ appropriate anti-TB chemotherapy, & aspiration pneumonitis. ITP & secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), & congenital (erythroid) hypoplastic anemia. Palliative management of leukemias & lymphomas in adults, & acute leukemia of childhood. Induce diuresis or remission of proteinuria in the nephrotic syndrome, w/o uremia, or the idiopathic type or that due to lupus erythematosus. Tide the patient over a critical period of the disease in ulcerative colitis & regional enteritis. Acute exacerbations of multiple sclerosis & management of edema associated w/ brain tumor. Organ transplantation. TB meningitis w/ subarachnoid block or impending block when used concurrently w/ appropriate anti-TB chemotherapy. Trichinosis w/ neurologic or myocardial involvement.
Dosage/Direction for Use
Cerebral edema 200-1,000 mg/day. Organ transplantation Up to 7 mg/kg/day. Acute exacerbations of multiple sclerosis 500 mg/day for 5 days or 1,000 mg/day for 3 days.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Systemic fungal infections. Live or live attenuated vaccines.
Special Precautions
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 hepatobiliary disorders; acute myopathy; osteoporosis. 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/ known or suspected hypersensitivity to cow's milk or other dairy products; 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).
Adverse Reactions
Opportunistic infection, infection, peritonitis; leukocytosis; drug hypersensitivity, anaphylactic & anaphylactoid reaction; cushingoid, hypothalamic pituitary adrenal axis suppression, steroid w/drawal syndrome; metabolic acidosis, Na & fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose tolerance, increased insulin requirement (or oral hypoglycemic agents in diabetics), lipomatosis, increased appetite (which may result in wt increased); affective, psychotic & mental disorders, psychotic behavior, personality change, confusional state, anxiety, mood swings, abnormal behavior, insomnia, irritability; epidural lipomatosis, increased ICP, seizure, amnesia, cognitive disorder, dizziness, headache; chorioretinopathy, blindness, cataract, glaucoma, exophthalmos; vertigo; congestive cardiac failure; thrombosis, HTN, hypotension, flushing; pulmonary embolism, hiccups; peptic ulcer, intestinal perforation, gastric hemorrhage, pancreatitis, ulcerative esophagitis, esophagitis, abdominal distention & pain, diarrhea, dyspepsia, nausea; angioedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae, rash, pruritus, urticaria, acne; muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; impaired healing, peripheral edema, fatigue, malaise; increased IOP, urine Ca, ALT, AST, blood alkaline phosphatase & blood urea, decreased carbohydrate tolerance & blood K, suppression of reactions to skin tests; spinal compression fracture, tendon rupture.
Drug Interactions
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.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Medrol tab 16 mg
Packing/Price
30's
Form
Medrol tab 4 mg
Packing/Price
100's