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Zelera

Zelera

hydrocortisone

Manufacturer:

Ciron

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Hydrocortisone Na succinate
Indications/Uses
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.
Dosage/Direction for Use
100-500 mg IV inj depending on the severity of the condition for over a period of 1-10 min. 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 unless specific anti-infective therapy is employed. Administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses.
Special Precautions
Do not use as treatment for traumatic brain injury or stroke; cerebral oedema associated w/ acute head injury or CVA. Hypothalamic-pituitary-adrenal suppression may occur in prolonged periods. Osteoporosis (post-menopausal females are particularly at risk), HTN or CHF, existing or previous history of severe affective disorders (especially previous steroid psychosis, including depressive or manic-depressive illness), DM (or a family history of diabetes), 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, ocular herpes simplex, corneal perforation, hypothyroidism, recent MI (myocardial rupture has been reported). Kaposi's sarcoma may occur. Pheochromocytoma. May cause elevation of BP, salt & water retention & increased K excretion; may increase Ca excretion. Psychological symptoms may develop especially if depressed mood or suicidal ideation is suspected; possible psychiatric disturbances may occur during or immediately after dose tapering or w/drawal. Avoid abrupt w/drawal. Pregnancy. May cause irreversible growth retardation in infancy, childhood & adolescence. Elderly.
Adverse Reactions
Opportunistic infection, masked infection; Kaposi's sarcoma; hypersensitivity (including anaphylaxis & anaphylactoid reactions), suppressed skin test reaction; leukocytosis; cushingoid, pituitary-adrenal axis suppression, steroid w/drawal syndrome; Na retention, water retention, alkalosis hypokalaemic, impaired glucose tolerance, increased appetite, increased wt; affective disorder, psychotic disorder, psychotic reactions including mania, delusions, hallucinations & aggravation of schizophrenia, behavioural disturbances, irritability, anxiety, sleep disturbances, cognitive dysfunction including confusion & amnesia; increased ICP, benign intracranial HTN, convulsions, epidural lipomatosis; cataract subcapsular, glaucoma, exophthalmos, increased IOP w/ possible damage to the optic nerve, corneal or scleral thinning, exacerbation of ophth viral or fungal disease, central serous chorioretinopathy; congestive cardiac failure, myocardial rupture following MI; HTN, thrombosis including thromboembolism; pulmonary embolism, hiccups; peptic ulcer (w/ possible perforation & hemorrhage), gastric hemorrhage, pancreatitis, abdominal distention, oesophageal ulceration/candidiasis, intestinal perforation, dyspepsia, nausea; petechiae, telangiectasia, ecchymosis, skin atrophy/striae/hyperpigmentation/hypopigmentation, hirsutism, acne, hyperhidrosis; myopathy, muscular weakness, osteoporosis, osteonecrosis, pathological fracture, growth retardation; irregular menstruation, amenorrhoea; impaired healing, sterile abscess, malaise; decreased carbohydrate tolerance, increased insulin requirement, decreased blood K, -ve nitrogen balance, increased urine Ca, increased ALT/AST, increased blood alkaline phosphatase; spinal compression fracture, tendon rupture.
Drug Interactions
Concurrent use w/ ciclosporin may cause convulsions. Enhanced metabolism w/ hepatic enzyme enducers eg, rifampicin, rifabutin, carbamazepine, phenobarb, phenytoin, primidone, & aminoglutethimide. Decreased metabolism w/ CYP3A4 enzyme eg, cimetidine, erythromycin, ketoconazole, itraconazole, diltiazem & mibefradil. May reduce the effects of anticholinesterases in myasthenia gravis. May antagonise the effect of hypoglycaemic agents (including insulin), anti-hypertensives & diuretics. Enhanced hypokalaemic effects of acetazolamide, loop/thiazide diuretics & carbenoxolone. Enhances anticoagulant effect of coumarin. Increased renal clearance of salicylates. Potential interaction w/ neuromuscular blocking agents eg, pancuronium.
MIMS Class
Corticosteroid Hormones
ATC Classification
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Form
Zelera powd for inj 100 mg
Packing/Price
1's
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