Depo-Medrol

Depo-Medrol

methylprednisolone

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Methylprednisolone acetate
Indications/Uses
IM: Primary or secondary adrenocortical insufficiency; acute adrenocortical insufficiency; congenital adrenal hyperplasia; hypercalcemia associated w/ cancer; non-suppurative thyroiditis. Adjunctive therapy for short-term administration in: Post-traumatic OA; epicondylitis; synovitis of OA; acute non-specific tenosynovitis; RA, including juvenile RA; psoriatic arthritis; acute gouty arthritis; ankylosing spondylitis; acute & subacute bursitis. During exacerbation or as maintenance therapy in selected cases of: SLE; systemic dermatomyositis (polymyositis); acute rheumatic carditis. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (SJS); severe seborrheic dermatitis; exfoliative dermatitis; mycosis fungoides; severe psoriasis. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma; drug hypersensitivity reactions; contact dermatitis; urticarial transfusion reactions; atopic dermatitis; acute non-infectious laryngeal edema; serum sickness. Severe acute & chronic allergic & inflammatory processes involving the eye eg, herpes zoster ophthalmicus; drug hypersensitivity reactions; iritis, iridocyclitis; anterior segment inflammation; chorioretinitis; allergic conjunctivitis; diffuse posterior uveitis; allergic corneal marginal ulcers; optic neuritis; keratitis. To tide the patient over a critical period of the disease in: Ulcerative colitis; regional enteritis. Fulminating or disseminated pulmonary TB when used concurrently w/ appropriate anti-tuberculous chemotherapy; symptomatic sarcoidosis; berylliosis; Loeffler's syndrome not manageable by other means; aspiration pneumonitis. Acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); secondary thrombocytopenia in adults; congenital (erythroid) hypoplastic anemia. For palliative management of: Leukemias & lymphomas; acute leukemia of childhood. To induce diuresis or remission of proteinuria in the nephrotic syndrome, w/o uremia, of the idiopathic type or that due to lupus erythematosus. Acute exacerbations of multiple sclerosis. Tuberculous meningitis w/ subarachnoid block or impending block when used concurrently w/ appropriate anti-tuberculous chemotherapy; trichinosis w/ neurologic or myocardial involvement. Intra-synovial or soft tissue administration (including peri-articular & intrabursal): Adjunctive therapy for short-term administration in: Synovitis of OA; epicondylitis; RA; acute non-specific tenosynovitis; acute & subacute bursitis; post-traumatic OA; acute gouty arthritis. Intralesional administration: Keloids, localized hypertrophic, infiltrated, inflammatory lesions of: Lichen planus, psoriatic plaques; discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; granuloma annulare; lichen simplex chronicus (neurodermatitis); alopecia areata. May also be useful in cystic tumors or an aponeurosis or tendon (ganglia). Intrarectal instillation: Ulcerative colitis.
Dosage/Direction for Use
RA & OA Large joints: 20-80 mg; medium joints: 10-40 mg; small joints: 4-10 mg. In chronic cases, may repeat inj at intervals 1 to ≥5 wk depending on degree of initial relief. Ganglion, tendinitis, epicondylitis 4-30 mg. Repeat inj in recurrent or chronic conditions if necessary. Local effect in dermatologic conditions 20-60 mg inj to the lesion. Large lesions: Distribute dose from 20-40 mg by repeated local inj. IM Adrenogenital syndrome 40 mg every 2 wk. Maintenance of RA 40-120 mg wkly. Systemic effect in dermatologic lesions 40-120 mg at wkly intervals for 1-4 wk. Acute severe dermatitis due to poison ivy 80-120 mg as a single dose. Chronic contact dermatitis Repeated inj at 5-10-day intervals may be necessary. Seborrheic dermatitis 80 mg wkly. Asthma 80-120 mg. Intrarectal Ulcerative colitis 40-120 mg as retention enemas or by continuous drip 3-7 times wkly for periods of ≥2 wk.
Contraindications
Hypersensitivity. Systemic fungal infections. Intrathecal, epidural & IV administration. Administration of live or live attenuated vaccine.
Special Precautions
Dermal &/or subdermal changes may form skin depression at the inj site. Avoid inj into the deltoid muscle due to high incidence of SC atrophy. Appropriately examine any joint fluid present to exclude septic process. Avoid local inj into previously infected joint. Not to be injected into unstable joints. May increase susceptibility to infection, may mask some signs of infection & new infections may appear during use. Do not use intra-synovially, intrabursally or intratendinous administration for local effect in presence of acute infection. 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/ 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. 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, inj site infection; leukocytosis; drug hypersensitivity, anaphylactic & anaphylactoid reaction; cushingoid, hypopituitarism, 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, 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; 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, skin hyper/hypopigmentation; muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; sterile abscess, impaired healing, peripheral edema, fatigue, malaise, inj site reaction; 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
Depo-Medrol susp for inj 40 mg/mL
Packing/Price
1's