Medrone

Medrone

methylprednisolone

Manufacturer:

Hanlim Pharma

Distributor:

One Pharma
Concise Prescribing Info
Contents
Methylprednisolone Na succinate
Indications/Uses
Primary or secondary adrenocortical insufficiency, acute adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated w/ cancer, nonsuppurative thyroiditis. As adjunctive therapy for short-term administration in RA including juvenile RA, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, acute & subacute bursitis. Dermatomyositis, temporal arteritis, polymyositis & SLE. During exacerbation or as maintenance therapy in selected cases of SLE, systemic dermatomyositis, acute rheumatic carditis. Pemphigus, severe erythema multiforme, exfoliative erythroderma, bullous dermatitis herpetiformis, mycosis fungoides. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, contact dermatitis, atopic dermatitis, serum sickness, seasonal or perennial allergic rhinitis, drug hypersensitivity reactions, transfusion reactions. Ulcerative colitis & regional enteritis (systemic therapy). Symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary TB when used concurrently w/ appropriate anti-TB chemotherapy, Loeffler's syndrome not manageable by other means. Acquired hemolytic anemia, selective cases of secondary thrombocytopenia in adults, erythroblastopenia, congenital hypoplastic anemia, ITP in adults (IV only). Palliative management of leukemias & lymphomas. To induce or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Acute exacerbations of multiple sclerosis; cerebral edema associated w/ primary or metastatic brain tumor, or craniotomy.
Dosage/Direction for Use
High dose therapy 30 mg/kg IV over at least 30 min. May be repeated every 4-6 hr for 48 hr. Other indications Initially 10-40 mg depending on specific disease entity being treated. Infant & childn Dosage may be reduced (not <0.5 mg/kg every 24 hr) but should be governed more by severity of condition & response of patients than by age or size. Childn 1-30 mg/kg daily by IV/IM. Max daily dose: 1 g.
Contraindications
Hypersensitivity. Systemic fungal infections. Premature infants due to benzyl alcohol content that has been associated w/ fatal gasping syndrome.
Special Precautions
History of allergy. Induce increased dosage of rapidly acting corticosteroids before, during, & after stressful situation in patients on corticosteroid therapy subjected to any unusual stress. May mask some signs of infection & new infections may appear during use. Inability to localize infection. Prolonged use may produce posterior subcapsular cataracts, glaucoma w/ possible damage to optic nerves, & may enhance establishment of secondary ocular infections due to fungi or viruses. Elevation of BP, salt & water retention, & increased excretion of K in ave & large doses. Increased Ca excretion. Do not vaccinate patients against small pox & undertake other immunization procedures in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications & lack of Ab response. Restrict use in active TB to those cases of fulminating or disseminated TB in which corticosteroid is used for management of disease in conjunction w/ appropriate antiTB regimen. Cardiac arrhythmias &/or circulatory collapse &/or cardiac arrest following rapid administration of large IV doses (>500 mg administered over a period of <10 min). Bradycardia during or after administration of large doses. Minimize drug-induced secondary adrenocortical insufficiency by gradual reduction of dosage. Administer salt &/or mineralocorticoid concurrently since mineralocorticoid secretion may be impaired. Enhanced effect on patients w/ hypothyroidism & cirrhosis. Ocular herpes simplex. Psychic derangements ranging from euphoria, insomnia, mood swings, personality changes, & severe depression, to frank psychotic manifestations may appear. Existing emotional instability or psychotic tendencies may be aggravated. Nonspecific ulcerative colitis, if there is probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; HTN; osteoporosis; & myasthenia gravis. Convulsions w/ concurrent use w/ cyclosporine. Concomitant use w/ aspirin in patients suffering from hypoprothrombinemia. Pregnancy & lactation. Growth & development of infant & childn on prolonged corticosteroid therapy. Observe signs of hypoadrenalism carefully in infants born of mothers who received substantial doses during pregnancy.
Adverse Reactions
Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema; bradycardia, cardiac arrest, arrhythmias & enlargement, circulatory collapse, CHF, fat embolism, HTN, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent MI, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis; acne, allergic dermatitis, burning or tingling (especially in perineal area after IV inj), cutaneous & SC atrophy, dry scaly skin, ecchymoses & petechiae, edema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria; decreased carbohydrate & glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent DM, menstrual irregularities, secondary adrenocortical & pituitary unresponsiveness, suppression of growth in ped patients; CHF in susceptible patients, fluid retention, hypokalemic alkalosis, K loss, Na retention; abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels, hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer w/ possible perforation & hemorrhage, perforation of small & large intestine (particularly in patients w/ inflammatory bowel disease), ulcerative esophagitis; -ve nitrogen balance due to protein catabolism; aseptic necrosis of femoral & humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post inj flare (following IA use), steroid myopathy, tendon rupture, vertebral compression fractures; convulsions, depression, emotional instability, euphoria, headache, increased ICP w/ papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo; arachnoiditis, meningitis, paraparesis/paraplegia & sensory disturbances after intrathecal administration; exophthalmos, glaucoma, increased IOP, posterior subcapsular cataracts & rare instances of blindness associated w/ periocular inj.
Drug Interactions
Mutual inhibition of metabolism w/ ciclosporin. Clearance may be increased w/ drugs that induce hepatic enzymes eg, phenobarb, phenytoin & rifampicin. Metabolism may be inhibited & thus clearance is being decreased w/ troleandomycin & ketoconazole. May increase clearance of chronic high dose aspirin that could lead to decreased salicylate serum levels or increase risk of salicylate toxicity when methylprednisolone is w/drawn. Enhanced/diminished effects of anticoagulant.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Medrone lyo powd for inj 500 mg
Packing/Price
(vial + 8 mL amp diluent) 1's
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