Hydropac

Hydropac

hydrocortisone

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Hydrocortisone sodium succinate.
Description
Each vial contains: Hydrocortisone Sodium Succinate Equivalents Hydrocortisone 100 mg.
Excipients/Inactive Ingredients: Sodium phosphate A Sodium Acid phosphate added as buffering agent.
Action
Pharmacology: Hydrocortisone sodium succinate 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 Mineralocorticoid activity.
Indications/Uses
As substitution therapy in the treatment of adrenal insufficiency states, where high levels of hydrocortisone are required rapidly.
In patients with known or suspected adrenal insufficiency prior to surgery, or if shock, severe trauma or other stress conditions occur.
Hydrocortisone sodium succinate is also used for the symptomatic relief of inflammatory conditions and as an immunosuppressant.
Dosage/Direction for Use
Hydrocortisone sodium succinate is administered intravenously, intramuscularly or by intravenous infusion. The dose is 100 to 500 mg Hydrocortisone 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.
If reconstituted with the diluent provided, the solution is stable for 3 days.
The addition of Hydrocortisone sodium succinate to the solution tor intravenous use should be made at the time of administration.
DIRECTION FOR USE: 100mg Plain - For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Sterile Water for injection or Sterile Sodium Chloride injection to the contents of one vial.
Contraindications
Hypersensitivity to corticosteroids. Tuberculosis. Ocular herpes simplex. Primary glaucoma. Acute psychosis and psychoneurosis. Systemic infection. Peptic ulcer. Osteoporosis.
Side Effects
Hydrocortisone sodium succinate may cause electrolyte disturbances, characterized by hypertension and oedema due to the retention of sodium and water and the increase in potassium excretion. Increased potassium excretion may cause hypokalaemic alkalosis. Increased susceptibility to infection (e,g. sepsis fungal and viral) and delayed wound healing. Cardiac failure. Peptic ulcerations 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. lntracranial hypertension. Thrombo-embolic complications. Lymphocytopaenia. Myopathy. Hyperglycaemia with accentuation or precipitation of the diabetic state. Insulin requirements of diabetic patients are increased. Infections may be masked by anti-inflammatory properties of Hydrocortisone sodium succinate. Hyperhidrosis and aseptic necrosis of bone may occur. 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. Daily mass records may indicate fluid retention and back pain may signify osteoporosis. Children are at special risk from raised intracranial pressure. Infections should be treated as an emergency. Large doses should be given by infusion to prevent cardiovascular collapse. Concurrent administration of barbiturates, phenytoin or rifampicin may enhance the metabolism and reduce the effects of Hydrocortisone sodium succinate. Response to anti-coagulants may be reduced or enhanced. Concurrent administration of Hydrocortisone sodium succinate with potassium depleting diuretics may cause excessive potassium loss.
Drug Interactions
Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin.
This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.
Storage
Store below 30°C in a dry place. Protect from light.
ATC Classification
H02AB09 - hydrocortisone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Soln for inj (vial) 100 mg x 10's.
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