HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION BP 100 mg
COMPOSITION of HYDROPYX:
Each vial contains: Hydrocortisone Sodium Succinate BP
Eq. to Hydrocortisone 100 mg
THERAPEUTIC CLASS:
Corticosteroid
PHARMACOLOGICAL ACTIONS:
Hydrocortisone Sodium Succinate has the same metabolic and anti-inflammatory action as hydrocortisone. It acts by controlling the rate of protein synthesis. It forms a steroid-receptor complex with receptor proteins, moves into the nucleus where it binds the chromatin and thus directs the genetic apparatus to transcribe RNA. It also delays the mineral corticoid activity.
Pharmacokinetics: Following the intravenous injection of hydrocortisone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.
INDICATIONS of HYDROCORTISONE SODIUM SUCCINATE:
Congenital hyperplasia, bursitis, epicondylitis, ankylosing spondylitis, osteoarthritis.
Systemic lupus erythematosus, pemphigus, Stevens-Johnson syndrome, exfoliative dermatitis, severe psoriasis, mycosis, fungoides .
Bronchial asthma, dermatitis, serum sickness, hypersensitivity reactions, iritis, keratitis. Ulcerative colitis, idiopathic thrombocytopenic purpura, erythroblastopenia.
CONTRAINDICATIONS of HYDROCORTISONE SODIUM SUCCINATE:
Hypersensitivity to corticosteroids, tuberculosis, ocular herpes simplex, primary glaucoma, acute psychosis and psychoneurosis, systemic infection, peptic ulcer, and osteoporosis.
PRECAUTIONS & WARNINGS of HYDROPYX:
Hydrocortisone Sodium Succinate injection should not be administered intrathecally or subconjunctivally. Toxic effects may result from withdrawal or from continued use of large doses. Hydrocortisone Sodium Succinate should be given with extreme caution in the presence of congestive heart failure, hypertension, in patients with diabetes mellitus, chronic renal failure and uremia and in elderly patients. The use of this drug in pregnancy, nursing mothers or women of childbearing potential requires that the benefits of the drug be carefully weighed against the potential risk to the mother and embryo or foetus. Live vaccines should not be given to patients receiving high doses of Hydrocortisone Sodium Succinate. Patients receiving long courses of Hydrocortisone Sodium Succinate should be regularly checked for hypertension, glycosuria, hypokalaemia, gastric discomfort and mental changes. Sodium intake may have to be reduced and potassium supplements administered. Children are at special risk from raised intracranial pressure. Infection should be treated as an emergency. Large doses should be given by infusion to prevent cardiovascular collapse.
ADVERSE EFFECTS:
Electrolyte disturbances, characterized by hypertension, oedema due to sodium/fluid retension. hypokalemic alkalosis, increased susceptibility to infection and delayed wound healing. cardiac failure, peptic ulceration with haemorrhage and perforation, glycosuria, osteoporosis, and spontaneous fractures, increased appetite, posterior subcapsular cataract, atrophy of the adrenal cortex and acute adrenal insufficiency during prolonged treatment, inhibition or arrest of growth in children, cushing syndrome, amenorrhoea, behavioural disturbances, including mental and neurological disturbances. Intracranial hypertension, thrombo-embolic complications, lymphocytopaenia, myopathy, hyperglycaemia with accentuation or precipitations of the diabetic state, hyperhydrosis and aseptic necrosis of bone may occur.
DOSAGE AND ADMINISTRATION of HYDROCORTISONE SODIUM SUCCINATE:
The dose is 100 to 500 mg Hydrocortisone Sodium Succinate given 3 to 4 times in 24 hours, dosage depending on the severity of the condition and the response.
Children up to 1 year may be given 25 mg, 1 to 5 years 50 mg and 6 to 12 years 100 mg.
DIRECTION FOR RECONSTITUTION:
For intravenous or intramuscular injection, prepare solution by adding 2 ml of Water for Injection to the contents of vial. For intravenous infusion, first prepare solution by adding 2 ml of Water for Injection to the vial; this solution may then be added to 50/100/1000 ml of the following: 5% dextrose and Sodium Chloride 0.9%. Use immediately after reconstitution. Use solution only if it is clear. Unused solution should be discarded.
OVERDOSAGE:
There has been no experience with over dosage of Hydrocortisone Sodium Succinate for Injection. Treatment should include general supportive measures.
DRUG INTERACTIONS:
Drug may interact with Cyclosporin, Rifampicin, Rifabutin, Carbamazepine, Phenobarbitone, Phenytoin, Primidone, Aminoglutethimide, Cimetidine, Erythromycin, Ketoconazole, Itraconazole, Diltiazem, Mibefradil, Aspirin, Pancuronium, Anticoagulants, Hypoglycemic agents (including Insulin), Diuretics and Antihypertensives.
PRESENTATION:
Vial Pack.
STORAGE CONDITION:
Store below 30°C in a dry Place.
Marketed by:
PYXUS PHARMACEUTICALS PVT. LTD.
