HYDROVEX Hydrocortisone Sodium Succinate 250mg Powder for IM/IV Injection 1's
RXDRUG-DRP-2464-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Status asthmaticus and acute allergic reaction, in anaphylactic reaction to drugs, severe shock (surgical, accidental trauma or overwhelming infection). Addison's disease, Simmond's disease, tuberculous meningitis and other meningitis.
Dosage/Direction for Use
The preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection. The preferred method for initial emergency use being intravenous injection. Following the initial period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. In treating severe shock, there is a tendency in current medical practice to use massive (pharmacologic) doses of corticosteroids. Therapy is initiated by administering HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION intravenously over a period of one to several minutes.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized-usually not beyond 48 to 72 hours. Although adverse effects are associated with high dose, short-term corticoid therapy is uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. When massive hydrocortisone therapy must be continued beyond 48-72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace HYDROCORTISONE SODIUM SUCCINATE for injection with corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.
Hydrocortisone may be given intravenously, by slow injection or infusion, in the form of water-soluble derivative such as hydrocortisone sodium succinate or hydrocortisone sodium phosphate when a rapid effect is required in emergencies: such conditions are acute adrenocortical insufficiency caused by Addisonian or post-adrenalectomy crises, by the abrupt accidental withdrawal of therapy in corticosteroid-treated patients, or by the inability of the adrenal glands to cope with increased stress in such patients; certain allergic emergencies such as anaphylaxis; acute severe asthma and shock. The usual dose is the equivalent of 100 to 500 mg of hydrocortisone, repeated 3 or 4 times in 24 hours, according to the severity of the condition and the patient's response.
Fluids and electrolytes should be given as necessary to correct any associated metabolic disorder. Similar doses to those specified previously may also be given intramuscularly but the response is likely to be less rapid than that observed following intravenous administration. Corticosteroids are considered to be of secondary value in anaphylactic shock because of their relatively slow onset of action, but intravenous hydrocortisone may be a useful adjunct to adrenaline to prevent further deterioration in severely affected patients.
In patients with adrenal deficiency states supplementary corticosteroid therapy may be necessary during some surgical operations and hydrocortisone sodium succinate or sodium phosphate may be given intramuscularly or intravenously before surgery. Various regimens have been proposed. In patients taking more than 10 mg of prednisolone or its equivalent by mouth daily, the British National Formulary recommends the following regimen: minor surgery under general anaesthesia, either the usual oral corticosteroid dose on the morning of surgery of hydrocortisone 25 to 50 mg (usually as the sodium succinate) intravenously at induction; the usual oral corticosteroid dose is recommenced after surgery; moderate of major surgery, the usual oral corticosteroid dose on the morning of surgery, plus hydrocortisone 25 to 50 mg intravenously at induction, and followed by similar doses of hydrocortisone 3 times daily, for 24 hours after moderate surgery and 48 to 72 hours after major surgery; the usual corticosteroid dose is resumed once hydrocortisone injections are stopped.
Preparation of solution for injection for I.V./I.M. administration: See table.
In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized-usually not beyond 48 to 72 hours. Although adverse effects are associated with high dose, short-term corticoid therapy is uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. When massive hydrocortisone therapy must be continued beyond 48-72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace HYDROCORTISONE SODIUM SUCCINATE for injection with corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.
Hydrocortisone may be given intravenously, by slow injection or infusion, in the form of water-soluble derivative such as hydrocortisone sodium succinate or hydrocortisone sodium phosphate when a rapid effect is required in emergencies: such conditions are acute adrenocortical insufficiency caused by Addisonian or post-adrenalectomy crises, by the abrupt accidental withdrawal of therapy in corticosteroid-treated patients, or by the inability of the adrenal glands to cope with increased stress in such patients; certain allergic emergencies such as anaphylaxis; acute severe asthma and shock. The usual dose is the equivalent of 100 to 500 mg of hydrocortisone, repeated 3 or 4 times in 24 hours, according to the severity of the condition and the patient's response.
Fluids and electrolytes should be given as necessary to correct any associated metabolic disorder. Similar doses to those specified previously may also be given intramuscularly but the response is likely to be less rapid than that observed following intravenous administration. Corticosteroids are considered to be of secondary value in anaphylactic shock because of their relatively slow onset of action, but intravenous hydrocortisone may be a useful adjunct to adrenaline to prevent further deterioration in severely affected patients.
In patients with adrenal deficiency states supplementary corticosteroid therapy may be necessary during some surgical operations and hydrocortisone sodium succinate or sodium phosphate may be given intramuscularly or intravenously before surgery. Various regimens have been proposed. In patients taking more than 10 mg of prednisolone or its equivalent by mouth daily, the British National Formulary recommends the following regimen: minor surgery under general anaesthesia, either the usual oral corticosteroid dose on the morning of surgery of hydrocortisone 25 to 50 mg (usually as the sodium succinate) intravenously at induction; the usual oral corticosteroid dose is recommenced after surgery; moderate of major surgery, the usual oral corticosteroid dose on the morning of surgery, plus hydrocortisone 25 to 50 mg intravenously at induction, and followed by similar doses of hydrocortisone 3 times daily, for 24 hours after moderate surgery and 48 to 72 hours after major surgery; the usual corticosteroid dose is resumed once hydrocortisone injections are stopped.
Preparation of solution for injection for I.V./I.M. administration: See table.
Note: Discard any remaining portion after use.
Contraindications
Systemic infections, unless specific anti-infective therapy is employed. Live virus immunization.
Hypersensitivity should not be injected directly to tendons.
Hypersensitivity should not be injected directly to tendons.
Special Precautions
Hydrocortisone Sodium succinate should only be given only with full knowledge of the characteristic activity of, and the varied responses to, adrenocortical hormones.
Because of its inhibitory effect on fibroplasias, hydrocortisone may mask the signs of infection and enhance dissemination of the infecting organism.
If possible, abrupt cessation of corticosteroid therapy should be avoided because of the danger of superimposed adrenocorticoid insufficiency on the infectious process.
Prolonged hormone therapy usually causes a reduction in the activity and size of the adrenal cortex. Relative adrenocortical insufficiency upon discontinuation of therapy may be avoided by gradual reduction of dosage.
However, a potentially critical degree of insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after treatment has been terminated, hormone therapy should be augmented or reinstituted and continued for the duration of stress and immediately following it.
Use in pregnancy & lactation: During pregnancy the clinical benefit and possible risk of corticosteroid treatment should be considered.
Adverse effect is proven in animal experiments. Sufficient data is not available for a safe application in human pregnancy (possibility of cleft-palate formation and fetus growth retardation are low). Signs of hypo-adrenalism should be monitored in case of newborn whose mother has received corticosteroid treatment during pregnancy. In such case signs are observed, the appropriate treatment should be applied.
Corticosteroids delay growth during infancy, childhood and adolescence. Treatment should be applied for the shortest possible time and for the most severe indications only.
Because of its inhibitory effect on fibroplasias, hydrocortisone may mask the signs of infection and enhance dissemination of the infecting organism.
If possible, abrupt cessation of corticosteroid therapy should be avoided because of the danger of superimposed adrenocorticoid insufficiency on the infectious process.
Prolonged hormone therapy usually causes a reduction in the activity and size of the adrenal cortex. Relative adrenocortical insufficiency upon discontinuation of therapy may be avoided by gradual reduction of dosage.
However, a potentially critical degree of insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after treatment has been terminated, hormone therapy should be augmented or reinstituted and continued for the duration of stress and immediately following it.
Use in pregnancy & lactation: During pregnancy the clinical benefit and possible risk of corticosteroid treatment should be considered.
Adverse effect is proven in animal experiments. Sufficient data is not available for a safe application in human pregnancy (possibility of cleft-palate formation and fetus growth retardation are low). Signs of hypo-adrenalism should be monitored in case of newborn whose mother has received corticosteroid treatment during pregnancy. In such case signs are observed, the appropriate treatment should be applied.
Corticosteroids delay growth during infancy, childhood and adolescence. Treatment should be applied for the shortest possible time and for the most severe indications only.
Adverse Reactions
Cushing's syndrome, moon faces, supraclavicular fat pads, hirsutism, striae & acne, relative adrenocortical insufficiency particularly in time of stress due to trauma, surgery or severe illness; protein catabolism w/ -ve nitrogen balance, electrolyte imbalance, alteration of glucose metabolism w/ aggravation of DM including hyperglycemia & glycosuria; osteoporosis; spontaneous fractures; activation & complication of peptic ulcer including perforation & hemorrhage; aggravation or masking of infection; increased BP.
Drug Interactions
Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone and barbiturates. Rifampicin reduces corticosteroid activity. Peptic ulcer with concurrent NSAIDs administration. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum concentration of salicylates and antimuscarinic agents.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. 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 4-6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.
MedsGo Class
Corticosteroid Hormones
Features
Brand
Hydrovex
Full Details
Dosage Strength
250 mg
Drug Ingredients
- Hydrocortisone
Drug Packaging
Powder for Injection (I.M./I.V.) 1's
Generic Name
Hydrocortisone Sodium Succinate
Dosage Form
Powder For Injection (I.M./I.V.)
Registration Number
DRP-2464
Drug Classification
Prescription Drug (RX)
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