HIGHLIGHT
Mepresone 40

Mepresone 40

methylprednisolone

Manufacturer:

BioRx Pharma Labs

Distributor:

Cathay Drug
Concise Prescribing Info
Contents
Methylprednisolone Na succinate
Indications/Uses
Severe erythema multiforme (SJS); bronchial asthma, severe seasonal & perennial allergic rhinitis, angioneurotic edema, anaphylaxis; ulcerative colitis, Crohn's disease; aspiration of gastric contents, fulminating or disseminated TB (w/ appropriate anti-TB chemotherapy); cerebral oedema secondary to cerebral tumour acute exacerbations of multiple sclerosis superimposed on a relapsing-remitting background; TB meningitis (w/ appropriate anti-TB chemotherapy) transplantation.
Dosage/Direction for Use
Graft rejection reactions following transplantation Adult Suppress rejection crises Up to 1 g daily. Acute rejection 500 mg to 1 g. Limit treatment to a 48-72 hr period until the patient's conditions has stabilised. Childn 10-20 mg/kg daily for up to 3 days. Max: 1 g daily. Status asthmaticus Adult 40 mg IV, repeated as dictated by patient response. May administer by slow IV drip over a period of hr in some asthmatic patient. Childn 1-4 mg/kg daily for 1-3 days. Cerebral edema associated w/ brain tumours (primary or metastatic) Adult Schedule A: Pre-op: 20 mg IM every 3-6 hr; during surgery: 20-40 mg IV every hr; post-op: 8 mg, 12 mg, 16 mg, or 20 mg IM every 3 hr for 24 hr, or 4 mg IM every 3, 6 or 12 hr for 24 hr. Schedule B: Pre-op: 40 mg IM every 6 hr for 2-3 days; post-op: 40 mg IM every 6 hr for 3-5 days. Acute exacerbation of multiple sclerosis Adult 500 mg or 1 g daily as an IV infusion over at least 30 min for 3 days. Other indications Initially 10-500 mg depending on the treated clinical problem. Short-term management of severe, acute conditions Initially 250 mg IV over a period of at least 5 min, dose exceeding 250 mg IV should be given over a period of at least 30 min. Subsequent doses may be given IV or IM at intervals dictated by the patient's response & clinical condition.
Contraindications
Hypersensitivity. Systemic fungal infections unless specific anti-infective therapy is employed & in cerebral oedema in malaria. Intrathecal route of administration. Administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.
Special Precautions
May increase susceptibility to infection, may mask some signs of infection, & new infections may appear during use. Give passive immunization w/ varicella/zoster Ig w/in 10 days of exposure to chickenpox in non-immune patients who are receiving systemic corticosteroids or have used them w/in the previous 3 mth. Avoid exposure to measles; prophylaxis w/ normal IM Ig may be needed. Known or suspected parasitic infections eg, Strongyloides (threadworm) infestation. Live vaccines should not be given to individuals w/ impaired immune responsiveness. Restrict use in active TB (fulminating or disseminated) in which therapy is used for the management of the disease in conjunction w/ appropriate anti-TB regimen. Reactivation may occur in patients w/ latent TB or tuberculin reactivity; patients should receive chemoprophylaxis during prolonged therapy. Kaposi's sarcoma may occur during therapy & discontinuation may result in clinical remission. Should not be used in the treatment of septic syndrome or septic shock. Routine use in septic shock is not recommended. History of drug allergy. Prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). Acute adrenal insufficiency may occur w/ abrupt w/drawal. W/drawal syndrome may occur following abrupt discontinuation. Avoid in patients w/ Cushing's disease. Frequent monitoring in patients w/ hypothyroidism; DM (or a family history of DM); existing or previous history of severe affecting disorders (especially previous steroid psychosis); epilepsy; myasthenia gravis or osteoporosis (post-menopausal females); glaucoma (or a family history of glaucoma), ocular herpes simplex; CHF or recent MI; HTN. Psychological symptoms may develop especially if depressed mood or suicidal ideation is suspected. Psychiatric disturbances may occur either during or immediately after dose tapering or w/drawal. Epidural lipomatosis w/ long-term use at high doses. Posterior subcapsular cataracts & nuclear cataracts (particularly in childn), exophthalmos, or increased IOP w/ prolonged use resulting in glaucoma w/ possible damage to the optic nerves. Enhanced secondary fungal & viral infections of the eye. Central serious chorioretinopathy leading to retinal detachment. May predispose patients w/ existing CV risk factors to additional CV effects w/ high doses & prolonged courses. Patients who has or may be predisposed to thromboembolic disorders. May mask symptoms of peptic ulcer (perforation or hemorrhage may occur w/o significant pain); peritonitis or other signs or symptoms associated w/ GI disorders eg, perforation, obstruction or pancreatitis. Patients w/ ulcerative colitis, perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, peptic ulceration. Acute pancreatitis w/ high doses. Elevation of BP, salt & water retention, & increased K excretion w/ large doses. Dietary salt restriction & K supplementation may be necessary. Increased Ca excretion. Not indicated for treatment of traumatic brain injury. Should only be administered to patients w/ suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation. Patients receiving cardioactive drugs eg, digoxin. Concomitant use w/ aspirin & NSAIDs. May affect ability to drive or operate machinery. Renal insufficiency. Menstrual irregularities. Pregnancy & lactation. Growth suppression & risk from raised ICP on prolonged therapy in infants & childn. May produce pancreatitis in childn (high doses).
Adverse Reactions
Infection, opportunistic infection, recurrence of dormant TB; Kaposi's sarcoma (discontinuation may result in clinical remission); leukocytosis; drug hypersensitivity (including anaphylactic & anaphylactoid reaction); Cushingoid, hypopituitarism (including suppression of the HPA), steroid w/drawal syndrome; Na/fluid retention, impaired glucose tolerance, hypokalemic alkalosis, dyslipidemia, increased insulin requirements (for oral hypoglycemic agents in diabetics), -ve nitrogen balance, increased blood urea, increased appetite, epidural lipomatosis; affective/psychotic reactions, behavioral disturbances, irritability, anxiety, sleep disturbances, & cognitive dysfunction including confusion & amnesia; increased ICP w/ papilloedema (benign intracranial HTN), convulsion, amnesia, cognitive disorder, dizziness, headache; posterior subcapsular cataracts, exophthalmos, glaucoma, papilloedema w/ possible damage to optic nerve, corneal or scleral thinning, exacerbation of ophth viral or fungal disease, chorioretinopathy; vertigo; CHF, arrhythmia; HTN, hypotension, thrombotic events; hiccups, pulmonary embolism; peptic ulcer (w/ possible perforation or hemorrhage), gastric hemorrhage, intestinal perforation, pancreatitis, peritonitis, ulcerative esophagitis, esophagitis, esophageal candidiasis, abdominal pain/distention, diarrhea, dyspepsia, nausea, vomiting, bad taste in mouth; hepatitis, increased liver enzymes (eg, increased ALT/AST); peripheral edema, ecchymosis, skin atrophy, acne, angioedema, petechiae, skin striae, telangiectasia, skin hypo- or hyperpigmentation, hirsutism, rash, erythema, pruritus, urticaria, hyperhidrosis; growth retardation, osteoporosis, muscular weakness, osteonecrosis, pathological fracture, muscle atrophy, myopathy, neuropathic arthropathy, arthralgia, myalgia; irregular menstruation, amenorrhea; impaired wound healing, inj site reaction, fatigue, malaise, w/drawal symptoms; decreased blood K, increased blood alkaline phosphatase, increased IOP, decreased carbohydrate tolerance, increased urine Ca, suppression of reactions to skin tests; tendon rupture, spinal compression fracture.
Drug Interactions
Increased plasma conc w/ troleandomycin, INH, grapefruit juice. Increased acetylation rate & clearance of INH. Decreased plasma conc w/ rifampin, phenobarb, phenytoin. Increased or decreased plasma conc w/ aprepitant, fosaprepitant, itraconazole, ketoconazole, HIV-PIs, diltiazem, ethinylestradiol/norethindrone, clarithromycin, erythromycin; carbamazepine; cyclophosphamide, tacrolimus. May increase plasma conc w/ PIs eg, indinavir & ritonavir. May induce metabolism of HIV-PIs. Convulsions w/ ciclosporin. Enhanced/diminished effects of oral anticoagulants. Acute myopathy w/ anticholinergics eg, neuromuscular blocking drugs. Antagonism of the neuromuscular blocking effects of pancuronium & vecuronium. May reduce effects of anticholinesterase in myasthenia gravis. May increase blood glucose conc, adjust dose of antidiabetic agents. May exacerbate endocrine change w/ aminoglutethimide. Increased incidence of GI bleeding & ulceration w/ NSAIDs. May increase clearance of high-dose aspirin. Antagonized hypotensive effects of all hypertensives. Increased risk of hypokalemia w/ cardiac glycosides. Reduced effects for 3-4 days after mifepristone.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Mepresone 40 powd for inj 40 mg
Packing/Price
1's
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