Prednivex 4/Prednivex 16

Prednivex 4/Prednivex 16



Vexxa Lifesciences


VE Pharma
Concise Prescribing Info
Allergic states; dermatologic, GI, neoplastic, ophth, renal & resp diseases; endocrine, hematologic, nervous system, rheumatic disorders & disorders including trichinosis w/ neurologic or myocardial involvement, TB meningitis w/ subarachnoid & impending block. Palliative management of leukemias & lymphomas.
Dosage/Direction for Use
Severe RA Initially 12-16 mg daily, moderately severe 8-12 mg daily, moderate 4-8 mg daily. Childn 4-8 mg daily. Systemic dermatomyositis 48 mg daily. SLE 20-100 mg daily. Acute rheumatic fever 48 mg for 1 wk until normal ESR. Allergic diseases 12-40 mg. Bronchial asthma Up to 64 mg single dose/alternate day up to 100 mg max. Ophth diseases 12-40 mg daily. Hematological disorders & leukaemias 16-100 mg daily. Malignant lymphoma 16-100 mg daily. Ulcerative colitis 16-60 mg daily. Crohn's disease Up to 48 mg/day in acute episodes. Organ transplantation Up to 3.6 mg/kg/day. Pulmonary sarcoid 32-48 mg on alternate days. Giant cell arteritis/polymyalgia rheumatica 64 mg daily. Pemphigus vulgaris 80-360 mg daily.
Should be taken with food.
Hypersensitivity. Systemic fungal infections; systemic infections unless specific anti-infective therapy is employed.
Special Precautions
May increase susceptibility to infection. Not be used in patients w/ impaired immune responsiveness & treatment for traumatic brain injury. Avoid exposure to measles. Known or suspected parasitic infections; active TB, Kaposi's sarcoma; acute adrenal insufficiency; Cushing's disease; psychiatric disturbances; CHF; acute myopathy. Patients w/ hypothyroidism; DM; existing or previous history of severe affective disorders; seizure disorders & myasthenia gravis, glaucoma (or history) & ocular herpes simplex; secondary fungal & viral infections of the eye; recent MI; HTN, predisposition to thrombophlebitis; peptic ulceration; fresh intestinal anastomoses, abscess or other pyogenic infections, ulcerative colitis, diverticulitis, liver failure or cirrhosis; osteoporosis; renal insufficiency. In conjunction w/ aspirin & NSAIDs. Concomitant use w/ methylprednisolone; cardioactive drugs eg, digoxin. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; fructose intolerance or sucrase-isomaltase insufficiency. Growth retardation in infant, childn & adolescent. Elderly.
Adverse Reactions
Allergic/hypersensitivity or 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, dry scaly skin, ecchymoses & petechiae, edema, erythema, 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 insulin or oral hypoglycemics (diabetes), manifestation of latent DM, menstrual irregularities, secondary adrenocortical & pituitary unresponsiveness, growth suppression in ped; CHF, fluid retention, hypokalemic alkalosis, K loss, Na retention; abdominal distention, bowel/bladder dysfunction (intrathecal), elevated serum liver enzyme levels, hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer w/ possible perforation & hemorrhage, perforation of small & large intestine, ulcerative esophagitis; -ve nitrogen balance; aseptic necrosis of femoral & humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures; convulsions, depressions, emotional instability, euphoria, headache, increased intracranial pressure w/ papilledema (pseudotumor cerebi), insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo; exophthalmos, glaucoma, increased IOP, posterior subcapsular cataracts; abnormal fat deposits, decreased resistance to infection, hiccups, increased/decreased motility & number of spermatozoa, malaise, moon face, wt gain.
Drug Interactions
Decreased plasma conc w/ rifampin, rifabutin, phenobarb, phenytoin, primidone, aminoglutethimide. Inhibited or induced hepatic clearance w/ carbamazepine; aprepitant, fosaprepitant; itraconazole, ketoconazole; diltiazem; ethinylestradiol/norethindrone; ciclosporin; clarithromycin, erythromycin; HIV-PIs; cyclosphosphamide, tacrolimus. Decreased hepatic clearance & increased plasma conc w/ troleandomycin, grapefruit juice, mibefradil, cimetidine. May increase incidence of GI bleeding & ulceration w/ NSAIDs. Increased risk of salicylate toxicity w/ aspirin. Acute myopathy w/ anticholinergics eg, neuromuscular-blocking drugs (at high-dose corticosteroids). May enhance coumarin anticoagulant effects.
ATC Classification
H02AB04 - methylprednisolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Prednivex 4 tab 4 mg
Prednivex 16 tab 16 mg
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