Philcort-16

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 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 in 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, 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. 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 uraemia, 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. TB meningitis w/ subarachnoid block or impending block when used concurrently w/ appropriate anti-TB chemotherapy, trichinosis w/ neurologic or myocardial involvement. Organ transplantation.

Initially 4-48 mg daily depending on the disease states. Cerebral edema 200-1,000 mg daily. Organ transplantation Up to 7 mg/kg daily. Acute exacerbations of multiple sclerosis 500 mg daily for 5 days or 1,000 mg daily for 3 days.

Should be taken with food: Do not break/crush.

Hypersensitivity. Patients w/ systemic infections unless specific anti-infective therapy is given. Administration of live attenuated vaccines in patients w/ immunosuppressive doses of corticosteroids.

Allergic reactions (eg, angioedema) may occur. Known or suspected hypersensitivity to cow's milk or its components or other dairy products. Activation of latent infection or exacerbation of existing parasitic infections eg, Strongyloides infestation. May increase susceptibility to infection, & may mask some signs of infection. Not recommended for use in patients w/ septic shock or sepsis syndrome. Diminished response w/ killed or inactivated vaccines. Restrict use in active TB (fulminating or disseminated) in which therapy is used for the management of the disease in conjunction w/ an appropriate anti-TB regimen. Reactivation of disease may occur in patients w/ latent TB or tuberculin reactivity. Kaposi's sarcoma. Pharmacologic doses administered for prolonged periods may result in hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency). W/drawal of corticosteroid should always be gradual. Avoid in patients w/ Cushing's disease. Enhanced effect on patients w/ hypothyroidism. Corticosteroids increases blood glucose, worsens preexisting diabetes, & predispose to DM in those on long-term therapy. Existing emotional instability or psychotic tendencies may be aggravated. Patients w/ existing or previous history of severe affective disorders. 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 serous chorioretinopathy leading to retinal detachment. May predispose patients w/ existing CV risk factors to additional CV effects w/ high doses & prolonged courses. Acute pancreatitis w/ high doses. May mask the 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. Hepatobiliary disorders. Creatine kinase elevations may occur. Acute myopathy (w/ high doses) in patients w/ neuromuscular transmission disorders (eg, myasthenia gravis) or those receiving concomitant therapy w/ anticholinergics eg, neuromuscular blocking drugs (eg, pancuronium). 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. Seizure disorders; myasthenia gravis; corneal perforation in patients w/ ocular herpes simplex; CHF; thrombosis including VTE, HTN; non-specific ulcerative colitis; systemic sclerosis; suspected or identified pheochromocytoma. Combination w/ aspirin & NSAIDs. Renal insufficiency. Pregnancy & lactation. Growth suppression & risk from raised ICP on prolonged therapy in infants & childn. May produce pancreatitis in childn (high doses).

Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole; aprepitant, fosaprepitant; indinavir, ritonavir; diltiazem; ethinylestradiol & norethindrone; grapefruit juice; ciclosporin; clarithromycin, erythromycin, troleandomycin). Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers (eg, phenobarb, phenytoin, carbamazepine, primidone; rifampicin, rifabutin). May affect hepatic clearance w/ another CYP3A4 substrates (eg, cyclophosphamide, tacrolimus). Increased acetylation rate & clearance of INH. Decreased absorption w/ antacids. 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 the effects of anticholinesterases in myasthenia gravis. May increase blood glucose conc, adjust dose of antidiabetic agents. May induce metabolism of HIV-PIs. May exacerbate endocrine changes w/ aminoglutethimide-induced adrenal suppression. Convulsions w/ ciclosporin. Risk of toxicity if hypokalemia occurs w/ cardiac glycosides. Reduced effect for 3-4 days after taking mifepristone. Increased incidence of GI bleeding & ulceration w/ NSAIDs. May increase renal clearance of high-dose aspirin. May inhibit growth promoting effect of somatropin. Increased risk of hypokalemia w/ K-depleting agents (eg, diuretics) or carbonic anhydrase inhibitors (eg, acetazolamide); amphotericin B, xanthines, or B₂ agonists; sympathomimetics (eg, salbutamol, terbutaline, formoterol).

Corticosteroid Hormones

H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

Rx