Levecortix-100/Levecortix-250

Levecortix-100 Adrenocortical insufficiency, shock, hypersensitivity reactions like anaphylactic shock & angioedema, inflammatory bowel disease, hemorrhoids, rheumatic disease, ophth & other conditions requiring immediate metabolic & anti-inflammatory actions. Levecortix-250 Anti-inflammatory agent for any condition in which rapid & intense corticosteroid effect is required eg, primary or secondary adrenocortical insufficiency; SLE; severe erythema multiforme (SJS); bronchial asthma, anaphylactic reactions; ulcerative colitis, Crohn's disease; aspiration of gastric contents. Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present.

Levecortix-100 slow IV inj or infusion 100-500 mg, repeated tid or qid in 24 hr, according to severity of the condition & patient's response. Childn 6-12 yr 100 mg, 1-5 yr 50 mg, up to 1 yr 25 mg. Local administration by inj into soft tissues 100-200 mg. IA inj 5-50 mg depending upon the size of joint. Levecortix-250 IV/IM 100-500 mg depending on the severity of the condition, administered by IV inj over a period of 1-10 min. May be repeated at intervals of 2, 4 or 6 hr as indicated by patient's response & clinical condition. Continue high-dose therapy only until the patient's condition has stabilised usually not beyond 48-72 hr.

Hypersensitivity. Patients w/ systemic fungal infection unless specific anti-infective therapy is employed. Administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

Adrenal cortical atrophy w/ prolonged therapy; may persist for mth after stopping treatment. Do not abruptly w/draw treatment in patients who have received more than physiological doses of systemic corticosteroids (approx hydrocortisone 30 mg) for >3 wk. Consider gradual w/drawal in the following patient groups even after courses lasting ≤3 wk: Patients who have had repeated courses of systemic corticosteroids, particularly if taken for >3 wk; when a short course has been prescribed w/in 1 yr of cessation of long-term therapy (mth or yr); patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy; patients receiving doses of systemic corticosteroid hydrocortisone >160 mg; patients repeatedly taking doses in the evening. May increase susceptibility to infection, may mask some signs of infection, & new infections may appear during treatment. Response to killed or inactivated vaccines may be diminished. Chickenpox & measles can have more serious or even fatal course in non-immune childn or adults on corticosteroids. Use in active TB should be restricted to those cases of fulminating or disseminated TB in which the corticosteroid is used for the management of the disease in conjunction w/ appropriate anti-TB regimen. Allergic reactions may occur. Establishment of secondary fungal & viral infections of eye may be enhanced in patients receiving glucocorticoids. Reports of visual disturbance; thrombosis including VTE; Kaposi's sarcoma; pheochromocytoma crisis. Risk of hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency) w/ pharmacologic doses of corticosteroids administered for prolonged periods. Can produce or aggravate Cushing's syndrome; avoid in patients w/ Cushing's disease. Enhanced effect of corticosteroids on patients w/ hypothyroidism. Can increase blood glucose, worsen pre-existing diabetes, & predispose those on long-term corticosteroid therapy to DM (or a family history of diabetes). Caution in patients w/ ocular herpes simplex; patients who have or may be predisposed to thromboembolic disorders; patients w/ pre-existing CV risk factors or CHF; osteoporosis; HTN; existing or previous history of severe affective disorders (especially previous steroid psychosis); history of TB; glaucoma (or a family history of glaucoma); previous corticosteroid-induced myopathy; liver failure or cirrhosis; renal insufficiency; epilepsy; peptic ulceration; fresh intestinal anastomoses; predisposition to thrombophlebitis; abscess or other pyogenic infections; ulcerative colitis; diverticulitis; myasthenia gravis; recent MI. Risk of BP elevation, salt & water retention, increased excretion of K & Ca; potentially severe psychiatric adverse reactions; acute pancreatitis. Be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering or w/drawal. May mask symptoms of peptic ulcer; peritonitis or other signs or symptoms associated w/ GI disorders eg, perforation, obstruction or pancreatitis. Concomitant use w/ cardioactive drugs eg, digoxin; CYP3A inhibitors, including cobicistat-containing products; aspirin & nonsteroidal anti-inflammatory agents. Should only be prescribed during pregnancy & lactation when benefits to the mother & child outweigh the risks. Can cause growth retardation in infancy, childhood & adolescence, which may be irreversible. Carefully observe growth & development of infants & childn on prolonged corticosteroid therapy. Infants & childn on prolonged therapy are at special risk from raised ICP. Reports of hypertrophic cardiomyopathy in prematurely born infants. Close clinical supervision is required in elderly. Should not be used to treat traumatic brain injury or stroke. Levecortix-250 Reports of hepatobiliary disorders. Increased effect in patients w/ liver diseases. Routine use in septic shock is not recommended. Contains 10.1 mg of Na.

Levecortix-100 Anaphylactoid reactions; dyspepsia, peptic ulcer w/ perforation & haemorrhage, abdominal distension, oesophageal ulceration, oesophageal candidiasis, acute pancreatitis, bowel perforation; increase in ALT, AST, & alkaline phosphatase; increased susceptibility & severity of infections w/ suppression of clinical symptoms & sign, opportunistic infections, may suppress reactions to skin tests, recurrence of dormant TB; proximal myopathy, osteoporosis, vertebral & long bone fractures, avascular osteonecrosis, tendon rupture, aseptic necrosis, muscle weakness. Levecortix-250 Opportunistic infection; Kaposi's sarcoma; leucocytosis; drug hypersensitivity; anaphylactic/anaphylactoid reaction; cushingoid, hypopituitarism, steroid w/drawal syndrome; metabolic acidosis, Na retention, water retention, alkalosis hypokalaemic, dyslipidaemia, impaired glucose tolerance, increased insulin requirement (or oral hypoglycemic agents in diabetics), lipomatosis, increased appetite; increased wt; affective disorders (including depression, euphoric mood, affect lability, drug dependence, suicidal ideation), psychotic disorder (including mania, delusion, hallucination, & aggravation of schizophrenia), mental disorder, personality change, confusional state, anxiety, mood swings, abnormal behaviour, insomnia, irritability; epidural lipomatosis; increased ICP w/ papilloedema in childn (pseudotumour cerebri), benign intracranial HTN, seizure, amnesia, cognitive disorders, dizziness, headache; central serous chorioretinopathy, cataract, glaucoma, exophthalmos, blurred vision, increased IOP w/ possible damage to optic nerve, corneal or scleral thinning, exacerbation of ophth viral or fungal disease; vertigo; cardiac failure congestive (in susceptible patients), myocardial rupture following MI, hypertrophic cardiomyopathy in prematurely born infants; thrombosis including thromboembolism, HTN, hypotension; pulmonary embolism, hiccups; peptic ulcer (w/ possible peptic ulcer perforation & haemorrhage), intestinal perforation, gastric haemorrhage, pancreatitis, oesophageal ulceration, oesophageal candidiasis, abdominal distension, abdominal pain, diarrhoea, dyspepsia, nausea; angioedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae, rash, pruritus, urticaria, acne, skin hypopigmentation, telangiectasia, skin hyperpigmentation; muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation, amenorrhoea; impaired healing, peripheral oedema, fatigue abscess sterile; malaise; inj site reaction; decreased carbohydrate tolerance, decreased blood K, increased urine Ca, increased ALT/AST, increased blood alkaline phosphatase, increased blood urea, suppression of reactions to skin tests; spinal compression fracture; tendon rupture (particularly of the Achilles tendon).

Levecortix-100 Reports of convulsions w/ ciclosporin. Enhanced metabolism & reduced therapeutic effects w/ drugs that induce hepatic enzymes eg, rifampicin, rifabutin, carbamazepine, phenobarb, phenytoin, primidone, & aminoglutethimide. Decreased rate of metabolism & increased serum conc w/ CYP3A4 inhibitors eg, cimetidine, erythromycin, ketoconazole, itraconazole, diltiazem & mibefradil. May reduce effects of anticholinesterases in myasthenia gravis. Antagonised desired effects of hypoglycaemic agents (including insulin), antihypertensives & diuretics. Enhanced hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics & carbenoxolone. Efficacy of coumarin anticoagulants may be enhanced. Increased renal clearance of salicylates. Use cautiously in conjunction w/ salicylates & NSAIDs in hypothrombinaemia. Reports of interaction w/ neuromuscular blocking agents eg, pancuronium w/ partial reversal of neuromuscular block. Levecortix-250 Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, & grapefruit juice). Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenobarb, phenytoin). Hepatic clearance may be affected in the presence of another CYP3A4 substrate; adverse events associated w/ the use of either drug alone may be more likely to occur w/ co-administration. Reports of enhanced or diminished effects of oral anticoagulants. Reports of acute myopathy w/ anticholinergics eg, neuromuscular blocking drugs. Antagonism of neuromuscular blocking effects of pancuronium & vecuronium. May reduce anticholinesterases effects in myasthenia gravis. Dose adjustments of antidiabetics may be required due to increased blood glucose conc w/ corticosteroids. Aminoglutethimide-induced adrenal suppression may exacerbate endocrine changes caused by prolonged glucocorticoid treatment. Concurrent use w/ cardiac glycosides may enhance possibility of arrhythmia or digitalis toxicity associated w/ hypokalemia. Increased incidence of GI bleeding & ulceration w/ NSAIDs. May increase clearance of high-dose aspirin leading to decreased salicylate serum levels. Increased risk of hypokalemia w/ K-depleting agents (eg, diuretics); amphotericin B, xanthines or β₂-agonists.

Corticosteroid Hormones

H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

Rx