Solu-Cortef

Solu-Cortef

hydrocortisone

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Hydrocortisone Na succinate
Indications/Uses
Primary or secondary adrenocortical insufficiency; acute adrenocortical insufficiency; pre-op, & in the event of serious trauma or illness in patients w/ known adrenal insufficiency or when adrenocortical reserve is doubtful; shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected; congenital adrenal hyperplasia; non-suppurative thyroiditis; hypercalcemia associated w/ cancer. Adjunctive therapy for short-term administration in acute & subacute bursitis; acute gouty arthritis; acute non-specific tenosynovitis; ankylosing spondylitis; epicondylitis; post-traumatic OA; psoriatic arthritis; RA, including juvenile RA; synovitis of OA. During an exacerbation or as maintenance therapy in acute rheumatic carditis; systemic dermatomyositis (polymyositis); SLE. Bullous dermatitis herpetiformis; exfoliative dermatitis; mycosis fungoides; pemphigus; severe erythema multiforme (SJS); severe psoriasis; severe seborrheic dermatitis. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in acute non-infectious laryngeal edema; atopic dermatitis; bronchial asthma; contact dermatitis; drug hypersensitivity reactions; serum sickness; urticarial transfusion reactions. Severe acute & chronic allergic & inflammatory processes involving the eye eg, allergic conjunctivitis; allergic corneal marginal ulcers; anterior segment inflammation; chorioretinitis; diffuse posterior uveitis & choroiditis; herpes zoster ophthalmicus; iritis & iridocyclitis; keratitis, optic neuritis; sympathetic ophthalmia. To tide the patient over a critical period of the disease in ulcerative colitis & regional enteritis (systemic therapy). Aspiration pneumonitis; berylliosis; fulminating or disseminated pulmonary TB when concurrently used w/ appropriate anti-TB chemotherapy; Loeffler's syndrome not manageable by other means; symptomatic sarcoidosis. Acquired (autoimmune) hemolytic anemia; congenital (erythroid) hypoplastic anemia; erythroblastopenia (RBC anemia); ITP in adults (IV only); secondary thrombocytopenia in adults. Palliative management of acute leukemia of childhood & leukemias & lymphomas in adults. To induce diuresis or remission of proteinuria in the nephrotic syndrome, w/o uremia, of the idiopathic type or that due to lupus erythematosus. Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present. Acute allergic disorders (status asthmaticus, anaphylactic reactions, insect stings) following epinephrine. Trichinosis w/ neurologic or myocardial involvement. Tuberculous meningitis w/ subarachnoid block or impending block when used concurrently w/ appropriate anti-TB chemotherapy.
Dosage/Direction for Use
Initially 100 mg to ≥500 mg (hydrocortisone equiv of hydrocortisone Na succinate) IV over a period of 30 sec (hydrocortisone 100 mg) to 10 min (≥500 mg). Dose may be repeated at intervals of 2, 4, or 6 hr as indicated by the patient's responses & clinical condition. High-dose therapy should be continued only until condition has stabilized, usually not beyond 48-72 hr. Childn & infant Not <25 mg daily.
Contraindications
Hypersensitivity. Systemic fungal infection. Intrathecal (except as part of certain chemotherapeutic regimens) or epidural route of administration. Live or live-attenuated vaccines.
Special Precautions
May increase susceptibility to infection, may mask some signs of infection & new infections may appear during use. Use in active TB should be restricted to those cases of fulminating or disseminated TB in which corticosteroid is used for the management of the disease in conjunction w/ appropriate anti-TB regimen. Reactivation of TB may occur in patients w/ latent TB or tuberculin reactivity. Reports of Kaposi's sarcoma. Routine use in septic shock is not recommended. Allergic reactions may occur. Pharmacologic doses administered for prolonged periods may result in hypothalamic-pituitary-adrenal suppression (secondary adrenocortical insufficiency). Avoid abrupt w/drawal. Avoid use in patients w/ Cushing's disease. Enhanced effect of corticosteroids in patients w/ hypothyroidism. May increase blood glucose, worsen pre-existing diabetes & predispose those on long-term therapy to DM. Psychic derangements may appear & existing emotional instability or psychotic tendencies may be aggravated. Reports of epidural lipomatosis, typically w/ long-term use at high doses. Posterior subcapsular & nuclear cataracts (particularly in childn), exophthalmos or increased IOP w/ prolonged use. Associated w/ central serous chorioretinopathy which may lead to retinal detachment. Risk of acute pancreatitis w/ high doses. May mask symptoms of peptic ulcer; peritonitis or other signs or symptoms associated w/ GI disorders eg, perforation, obstruction or pancreatitis. Reports of hepatobiliary disorders; acute myopathy; osteoporosis. Can cause elevation of BP, salt & water retention, & increased excretion of K. Not to be used to treat traumatic brain injury. Patients subjected to unusual stress; patients w/ seizure disorders; myasthenia gravis; ocular herpes simplex; existing CV risk factors, CHF; predisposition to thromboembolic disorders, HTN; non-specific ulcerative colitis; diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer; liver disease; renal insufficiency; suspected or identified pheochromocytoma; patients at high risk of tumor lysis syndrome. Concomitant use w/ aspirin & NSAIDs. May affect ability to drive or use machinery. Pregnancy & lactation. Growth suppression & risk of raised ICP on prolonged therapy in infants & childn. May produce pancreatitis in childn (high doses). Hypertrophic cardiomyopathy may develop after administration to prematurely born infants.
Adverse Reactions
Opportunistic infection, infection; Kaposi's sarcoma; leukocytosis; drug hypersensitivity, anaphylactic/anaphylactoid reaction; cushingoid, hypothalamic pituitary adrenal axis suppression, steroid w/drawal syndrome; metabolic acidosis, Na retention, fluid retention, hypokalemic alkalosis, dyslipidemia, impaired glucose intolerance, increased insulin requirement (or oral hypoglycemic agents in diabetics), lipomatosis, increased appetite; affective disorder, psychotic disorder, mental disorder, personality change, confusional state, anxiety, mood swings, abnormal behavior, insomnia, irritability; epidural lipomatosis, increased ICP, benign intracranial HTN, seizure, amnesia, cognitive disorder, dizziness, headache; central serous chorioretinopathy, cataract, glaucoma, exophthalmos; vertigo; congestive cardiac failure, hypertrophic cardiomyopathy (in prematurely born infants); thrombosis, HTN, hypotension; pulmonary embolism, gasping syndrome, hiccups; peptic ulcer (w/ possible perforation & hemorrhage), intestinal perforation, gastric hemorrhage, pancreatitis, esophagitis, abdominal distension/pain, diarrhea, dyspepsia, nausea; angioedema, hirsutism, petechiae, ecchymosis, skin atrophy, erythema, hyperhidrosis, skin striae/hypopigmentation, rash, pruritus, urticaria, acne; muscular weakness, myalgia, myopathy, muscle atrophy, osteoporosis, osteonecrosis, pathological fracture, neuropathic arthropathy, arthralgia, growth retardation; irregular menstruation; impaired healing, peripheral edema, fatigue, malaise, inj site reaction; increased IOP, decreased carbohydrate tolerance & blood K, increased urine Ca, ALT, AST, blood alkaline phosphatase & blood urea, suppression of reactions to skin tests; spinal compression fracture, tendon rupture.
Drug Interactions
Decreased hepatic clearance & increased plasma conc w/ CYP3A4 inhibitors (eg, INH, aprepitant, fosaprepitant, itraconazole, ketoconazole, HIV PIs, diltiazem, estrogens, grapefruit juice, cyclosporine, clarithromycin, erythromycin, troleandomycin). Increased hepatic clearance & decreased plasma conc w/ CYP3A4 inducers (eg, rifampin, carbamazepine, phenobarb, phenytoin). Hepatic clearance may be affected by another CYP3A4 substrate (eg, cyclophosphamide, tacrolimus); 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 arrhythmias 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. Reports of cardiac enlargement & CHF w/ amphotericin B.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Solu-Cortef powd for inj 100 mg
Packing/Price
1's
Form
Solu-Cortef powd for inj 100 mg/2 mL
Packing/Price
(Act-O-Vial) 1's
Form
Solu-Cortef powd for inj 250 mg/2 mL
Packing/Price
(Act-O-Vial) 1's
Form
Solu-Cortef powd for inj 500 mg/4 mL
Packing/Price
(Act-O-Vial) 1's