Hanall Biopharma


Concise Prescribing Info
Hydrocortisone Na succinate
Endocrine disorders: Primary & secondary adrenocortical insufficiency, acute adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated w/ cancer, pre-op & in the event of serious trauma or illness, patients w/ known adrenal insufficiency or when adrenocortical reserve is doubtful, nonsuppurative thyroiditis. Rheumatic disorders: Adjunctive therapy for short-term administration in post-traumatic OA, RA including juvenile RA, ankylosing spondylitis, acute nonspecific tenosynovitis, psoriatic arthritis, temporal arthritis, synovitis or OA, acute & subacute bursitis, acute gouty arthritis, epicondylitis. Collagen disorders: During exacerbation or maintenance therapy in cases of SLE, systemic dermatomyositis, acute rheumatic carditis. Dermatologic disorders: Pemphigus, Stevens-Johnson syndrome, bullous dermatitis herpetiformis, mycosis fungoides, severe psoriais, exfoliative dermatitis, severe seborrheic dermatitis. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults & childn w/ bronchial asthma, contact dermatitis, serum sickness, urticarial transfusion reactions, acute noninfectious laryngeal edema, seasonal or perennial allergic rhinitis, atopic dermatitis, drug hypersensitivity reactions. Ophth diseases: Severe acute & chronic allergic & anti-inflammatory processes involving the eye & its adnexa eg, herpes zoster ophthalmicus, chorioretinitis, optic neuritis, anterior segment inflammation, keratitis, ritis, iridocyclitis, diffuse posterior uveitis & choroiditis, sympathetic ophthalmis, allergic conjunctivitis, allergic corneal marginal ulcers. GI diseases: Ulcerative colitis (systemic therapy), Crohn's disease, regional enteritis (systemic therapy). Resp diseases: Symptomatic sarcoidosis, fulminating or disseminated pulmonary TB when used concurrently w/ appropriate anti-TB chemotherapy, Loeffler's syndrome not manageable by other means, aspiration pneumonitis, idiopathic eosinophilic pneumonias, berylliosis, aspirations of gastric contents. Hematologic disorders: Idiopathic thrombocytopenic purpura in adults (IV only, IM administration is CI), erythroblastopenia (RBC anemia, pure red cell aplasia), selected cases of secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia, aspirations of gastric contents, idiopathic eosinophilic pneumonias. Neoplastic disease: Palliative management of acute leukemia in childn, leukemias & lymphomas in adults. Edematous states/renal diseases: Induce diuresis or remission or proteinuria in nephrotic syndrome, w/o uremia, idiopathic type or due to lupus erythematosus. Nervous system disorders: Acute exacerbations of multiple sclerosis. Medical emergencies: Shock secondary adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenocortical insufficiency may be present, acute allergic disorders following epinephrine. TB meningitis w/ subarachnoid block or impending block when used concurrently w/ appropriate anti-TB chemotherapy, trichinosis w/ neurologic or myocardial involvement.
Dosage/Direction for Use
Individualized dosage. Initial dose range: 100-500 mg. Administer IV over a period of 30 sec to 1-10 min. Dose may be repeated at intervals of 2, 4 or 6 hr. Acute exacerbations of multiple sclerosis 800 mg/day for 1 wk, followed by 320 mg every other day for 1 mth. Childn Usual dosage range: 0.56-8 mg/kg daily in 3 or 4 divided doses.
Hypersensitivity. Bacterial, systemic fungal & viral infections. Patients w/ herpes simplex, herpes zoster & chicken pox. Patients w/ articular artery infection or peritenonitis/tenosynovitis. Patients w/ articular cavity instability. Administration of live or live attenuated vaccines. IM administration of corticosteroid for idiopathic thrombocytopenic purpura. Intrathecal administration.
Special Precautions
Anaphylactoid reactions may occur & gradual dose reduction is recommended. Avoid abrupt w/drawal after prolonged therapy. Incidence of dermal & subdermal atrophy. Dietary salt restriction & K supplementation may be advised. Patients w/ HTN, CHF or renal insufficiency, DM, osteoporosis (especially in postmenopausal women & geriatric or debilitated patients). Increased risk of perforation in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses & nonspecific ulcerative colitis. Do not administer live or live attenuated vaccines. May suppress the immune system & increase susceptibility or mask symptoms of infection. Concomitant use w/ amphotericin B. May activate latent amoebiasis. Patients w/ known or suspected strongyloides infestations. Do not use in cerebral malaria. Closely observe patients w/ latent TB or tuberculin activity & administer chemoprophylaxis during prolonged therapy. Prolonged use may cause posterior subcapsular & nuclear cataracts (particularly in childn), exophthalmus or increased IOP. Monitor IOP if therapy is continued for >6 wk. Do not use in active ocular herpes simplex. Acute myopathy may occur in patients w/ myasthenia gravis or those receiving therapy w/ neuromuscular blocking agents eg, pancuronium. May aggravate emotional instability or psychotic tendencies. Pregnancy & lactation. Childn (inhibition of bone growth). Elderly (≥60 yr).
Adverse Reactions
GI, musculoskeletal, dermatological, endocrine-metabolic, neuro-psychiatric, ophth, CV & immune system effects; fluid electrolyte disturbances. Abnormal fat deposits, decreased resistance to infection, hiccups, increased motility & number of spermatozoa, inj site infections following non-sterile administration, malaise, moon face, wt gain.
Drug Interactions
May enhance metabolism, shorten plasma t½ & decreased effect w/ barbiturates, phenytoin, carbamazepine, rifampicin & other drugs that stimulate hepatic metabolism. Increased plasma conc w/ CYP3A4 inhibitors (eg, troleandomycin, ketoconazole & macrolide antibiotics. May alter plasma protein binding & metabolism w/ OCs & estrogen. Increased risk of GI adverse effects w/ aspirin or other NSAIDs. Decreased response w/ warfarin. Hypokalemia may occur w/ K-depleting agents eg, diuretics. Cardiac enlargement & CHF may occur w/ amphotericin B. May produce severe weakness in patients w/ myesthenia gravis in concomitant w/ anticholinesterase agents. May increase blood glucose conc of insulin or oral antidiabetics. May diminish adrenal suppression w/ aminoglutethimide. Decreased serum conc w/ INH. May increase clearance w/ cholestyramine. Convulsion may occur w/ ciclosporin. Increased risk of arrhythmia due to hypokalemia w/ digitalis glycosides. Diminished response to toxoids & live or live attenuated vaccines. May suppress reactions to skin tests.
ATC Classification
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Pharmacort inj 100 mg
10 × 1's (P275/box)
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