Cortef IM/IV Injection: Each vial contains dry powder of Hydrocortisone Sodium Succinate USP equivalent to Hydrocortisone 100 mg and each ampoule contains water for injections BP 2 ml.
Hydrocortisone is a naturally occurring corticosteroid, which causes profound and varied metabolic effects. In addition, they modify body’s immune response to diverse stimuli. Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone.
Adrenocortical insufficiency, shock, hypersensitivity reactions such as angioedema, status asthmaticus, inflammatory bowel disease and rheumatic disease.
Dosage & Administration
By IM injection or slow IV injection or infusion, 100-500 mg, 3-4 times in 24 hours or as required; Child: by slow IV Injection, up to 1 year: 25 mg, 1-5 years: 50 mg, 6-12 years: 100 mg.
Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.
Warning & Precautions
Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.
Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.
Drug interaction of hydrocortisone has been reported with amphotericin B, potassium-depleting agents, macrolide antibiotics, warfarin, antidiabetics, isoniazid, digitalis glycosides, estrogens, barbiturates, phenytoin, carbamazepine, ketoconazole, aspirin etc.
Use in special groups
Use in pregnancy: Pregnancy category C drug. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in nursing mother: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to continue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Use in elderly patients: Clinical studies were not done in patients’ aged 65 and above. In general dose selection for an elderly patients should be cautious, usually starting at the low end of the dosing range.
Cortef IV/IM Injection: Each combipack contains one vial of Hydrocortisone 100 mg (as hydrocortisone sodium succinate USP) and 1 ampoule of 2 ml water for injection.