Averroes Pharma
Concise Prescribing Info
Methylprednisolone Na succinate
Severe hypersensitivity & dermatological reaction; severe acute & chronic inflammatory & allergic eye processes; status asthmaticus; suppression of graft rejection reactions; cerebral oedema; GI diseases; fulminating SLE; shock unresponsive to conventional therapy; rheumatic disorders. Short-term adjuvant treatment in acute phase or exacerbation of post-traumatic & synovitis OA. Acute & subacute bursitis, epicondylitis, acute non-specific tenosynovitis & gouty arthritis, spondylitis ankylopoetica. TB meningitis.
Dosage/Direction for Use
Adult Graft rejection reactions 1 g daily. Acute rejection 500 mg-1 g. Status asthmaticus 40 mg IV. Pre-op oedema due to brain tumour 20 mg IM 3-6 hrly or 40 mg IM 6 hrly for 2-3 days. During surgery of oedema due to brain tumour 20-40 mg IV hrly. Post-op oedema due to brain tumour 8, 12, 16 or 20 mg IM 3 hrly for 24 hr. Acute exacerbations of multiple sclerosis 1,000 mg daily for 3 days. Other indications Initially 10-500 mg. Childn Haematological, rheumatic, renal & dermatological conditions 30 mg/kg daily to max: 1 g daily. Graft rejection reactions 10-20 mg/kg daily for 3 days to max: 1 g daily. Status asthmaticus 1-4 mg/kg daily for 1-3 days.
Hypersensitivity. Systemic fungal infections, cerebral oedema in malaria. Concomitant use w/ live or live, attenuated vaccines. Intrathecal use.
Special Precautions
Not to be used for septic syndrome or septic shock. Not be used for management of head injury or stroke. Immunosuppressant effects/increased susceptibility to infections, parasitic infections, impaired immune responsiveness, latent TB or tuberculin reactivity, allergic reactions, hypothalamic-pituitary adrenal (HPA) suppression, unusual stress, Cushing's disease, hypothyroidism, DM, existing or previous history of severe affective disorders, seizure disorders, epilepsy, myasthenia gravis, osteoporosis, glaucoma, ocular herpes simplex, prolonged use, existing CV risk factors, CHF, recent MI, HTN, ulcerative colitis, perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, peptic ulceration, acute pancreatitis. Avoid abrupt w/drawal. Concomitant use w/ aspirin, NSAIDs, cardioactive drugs. Renal insufficiency. Pregnancy & lactation. Growth retardation in childn. Childn <2 yr. Infant, not to be used in neonate. Elderly.
Adverse Reactions
Infection; Cushingoid; Na & fluid retention; psychiatric reactions ie, affective disorders, psychotic reactions, behavioural disturbances, irritability, anxiety, sleep disturbances, cognitive dysfunction ie, confusion & amnesia; posterior subcapsular cataracts; HTN; peptic ulcer; peripheral oedema, ecchymosis, skin atrophy, acne; growth retardation in childn, osteoporosis, muscular weakness; impaired wound healing; decreased blood K.
Drug Interactions
Increased plasma conc by troleandomycin, INH, grapefruit juice. Decreased plasma conc by rifampicin, phenobarb, phenytoin. Inhibited/induced hepatic clearance w/ aprepitant, fosaprepitant, itraconazole, ketoconazole, HIV-PIs, diltiazem, OCs, carbamazepine, cyclophosphamide, tacrolimus. Mutual inhibition of metabolism w/ ciclosporin. Antagonized pancuronium & vecuronium neuromuscular blocking effects. Increased blood glucose conc. Aminoglutethimide-induced adrenal suppression may impede endocrine changes. Increased incidence of GI bleeding & ulceration w/ NSAIDs. Increased high-dose aspirin clearance. Development of hypokalemia w/ K-depleting agents. Antagonized diuretic & hypotensive effects. Increased risk of hypokalaemia w/ cardiac glycosides. Reduced effect by mifepristone.
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Medixon powd for inj 500 mg
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