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for Injection (IM/IV) Description Hydrocortisone sodium succinate or pregn-4-ene-3, 20-dione, 21-(3-carboxy-1-oxopropoxy)-11, 17-dihydroxy;monosodium salt, (11B) is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of hydrocortisone permits the immediate intravenous administration of high doses of hydrocortisone in a small volume of diluent and is particularly useful where high blood levels of hydrocortisone are required rapidly. When necessary, the pH of Hydrocortisone sodium succinate was adjusted with Sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. Actions Hydrocortisone sodium succinate 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 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 When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition. Hydrocortisone sodium succinate Sterile Powder is indicated for intravenous or intramuscular use in the following conditions: 1.Endocrine Disorders Primary or Secondary adrenocortical insufficiency. Acute adrenoortical insufficiency. Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Nonsuppurative thyroiditis Congenital adrenal hyperplasia Hypercalcemia associated with cancer
2.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Post-traumatic osteoarthritis Synoviits of osteoarthritis Rheumatoid arthritis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Urticarial transfusion reactions .Dermatologic Disease Pemphigus Severe erythema multiforme (Stevens-Johnsons syndrome) Exfoliative dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides 5.Collagen Diseases During an exacerbation or as maintenance therapy in selected case of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. including juvenile rheumatoid arthritis (selected cases may require lowdose maintenance therapy) Acute and subacute bursitis Epicondylitis Acute nonspecific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis 3.
Hematologic Disorders Acquired (autoimmune) hemolytic anemia Idiopathic thrombocytopenia purpura in adults (IV only.Acute noninfectious laryngeal edema Seasonal or perennial allergic rhinitis 6.Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis (systemic therapy) Regional enteritis (systemic therapy) 8. IM administration is contraindicated) Secondary thrombocytopenia in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 10.Neoplastic Diseases .Ophthlmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye. such as: Herpes zoster ophthalmicus Iritis iridocyclitis Chorioretinitis Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic conjunctivitis Allergic corneal marginal ulcers Keratitis 7. Respiratory Diseases Symptomatic sarcoidosis Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Loeffler¶s syndrome not manageable by other means Aspiration pneumonitis 9.
attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity. and new infections may appear during their use. etc. insect stings. Infections with any pathogen including viral.g. anaphylactic reactions.For palliative management of: Leukeias and lymphomas in adults Adult leukemia of childhood 11. humoral immunity or neutrophil function. without uremia. Although there are no well controlled (double-blind. and may enhance the establishment of secondary ocular . bacterial. In any location of the body.) following epinephrine.Edematous States To induce diuresis or remission of proteinuria in the nephritic syndrome. Acute allergic disorders (status asthmaticus. but can be severe. glaucoma with possible damage to the optic nerves. the rate of occurrence of infectious complications increases. Prolonged use of corticosteroids may produce posterior subcapsular cataracts. Corticosteroids may mask some signs of infection. and at times fatal. drug. There may be decreased resistance and inability to localize infection when corticosteroids are used. data from experimental animal models indicate that corticosteroids may be useful in hemorrhagic. increased dosage of rapidly acting corticosteroids before. fluid replacement) has not been effective (see Warningis and Precautions) Contraindications Systemic fungal infections and known hypersensitivity to the drug or any component of formulation. These infections may be mild. Trichinosis with neurologic or myocardial involvement.Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. fungal. and after the stressful situation is indicated. of the idiopathic type or that due to lupus erythamatosus 12. Medical Emergencies: Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present. traumatic and surgical shock in which standard therapy (e. placebo) clinical trials. Administration of live or live. protozoan or helminthic infections. With increasing doses of corticosteroids. Warnings In patients on corticosteroid therapy subjected to unusual stress.
Because rare instances of anaphylactoid reactions (eg. Psychic derangements may appear when corticosteroids are used. studies of meethylprednisolone sodium succinate in septic shock suggest that increased mortality may occur in some subgroups of patients at higher risk (i. Hydrocortisone can cause elevation of blood pressure. Benzyl alcohol has been reported to be associated with a fatal ³Gasping syndrome´ in premature infants. ranging from euphoria.infections due to fungi or viruses. Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids. nursing mothers. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity. Dietary salt restriction and potassium supplementation may be necessary.e. There are no known effects of corticosteroids on labor and delivery. the use of these drugs in pregnancy. salt and water retention. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of adrenal insufficiency. attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. During prolonged corticosteroid therapy. personality changes. and severe depression to frank psychotic . close observation is necessary as reactivation of the disease may occur. or women of childbearing potential requires that the possible benefit of the drug be carefully weighed against the potential risks to the mother and embryo or fetus. the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving non-immunosuppressive doses of corticosteroids. mood swings. appropriate precautionary measures should be taken prior to administration. This product contains benzyl alcohol. especially when the patient has a history of allergy to any drug. Precautions General precautions Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation. Although recent studies have not been conducted with hydrocortisone or other corticosteroids. All corticosteroids increase calcium excretion. elevated creatinine greater than 2. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids. Administration of live or live. however. The use of Hydrocortisone sodium succinate Sterile Powder in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with appropriate antitubercular regimen. and increased excretion of potassium.0mg% or with secondary infections). Bronchospasm) have occurred in patients receiving parenteral corticosteroid therapy. these patients should receive chemoprophylaxis.
most often occuring in patients with disorders of neuromusuclar transmission (e. Therefore. Discontinuation of corticosteroids may result in clinical remission. abscess. elevations of creatine kinase may occur. fresh intestinal anatomoses. the dose of corticosteroid should be titrated to avoid steroid toxicity. Also.manifestations. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Corticosteroids may incrase the clearance of chronic high dose aspirin. active or latent peptic ulcer.g. This could lead to decreased salicylate serum level or increase the risk of salicylate toxicity when corticosteroid is withdrawn. If there is a probability of impending perforation. Growth may be suppressed in children receiving long term. This acute myopathy is generalized. The effect of corticosteroids on oral anticoagulants is variable.g. or other pyogenic infection. myasthenia gravis). or in patients receiving concomitant therapy with neuromuscular blocking drugs (e. may involve ocular and respiratory muscles. Therefore. Steroids should be used with caution in nonspecific ulcerative colitis. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. also in diverticulitis. hypertension. renal insufficiency. daily divided dose glucocorticoid therapy. phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. osteoporosis and myasthenia gravis. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. and may result in quadriparesis. Drug Interactions The pharmacokinetic interactions listed below are potentially clinically important. the use of such regimen should be restricted to the most serious indications. coagulation indices should be monitored to maintain the desired anticoagulant effect. Kaposi¶s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Drugs that induce hepatic enzymes such as phenobarbital. Aspirin should be use cautiously in conjunction with corticosteroids in patients suffering from hypoprothorombinemia. An acute myopathy has been observed with the use of high doses of corticosteroids. Adverse Reactions Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis . existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. pancuronium).
Hypertensio Increase calcium excretion Muscuskeletal Muscle weakness Steroid myopathy Osteoporosis Tendon rupture. personality changes depression: exacerbation of pre-existing emotional instability or psychotic tendencies.SGPT). Neurological Increase intracranial pressure Seizures Pseudotumor cerebri Psychi derangements/psychotic manifestations including euphoria. These changes are usually small. Endocrine Menstrual irregularities Development of Cushingoid state Suppression of growth in children . mood swings. insomnia. not associated with any clinical syndrome and are reversible upon discontinuation. aspartate transaminase (AST. particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis Pathologic fractures Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Ulcerative esophagitis Gastric hemorrhage Esophagitis Perforation of the bowel Increases in alanine transaminase (ALT. SGOT). Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Kaposi¶s sarcoma has been reported in patients receiving corticosteroid therapy. and alkaline phosphatase have been observed following corticosteroid treatment.
Dosage and Administration This preparation may be administered by intravenous injection. from mild to fatal Hypersensitivity reactions including anaphylaxis and anaphylatoid reaction (e. peptic ulceration may occur.usually not beyond 48 to 72 hours. short-term corticosteroid thearpy are uncommon. Therapy is initiated by administering Hydrocortisone sodium succinate Sterile Powder intravenously over a period of 30 seconds (e. bronchospasm. the preferred method for initial emergency use being intraveous injection. Following the initial emergency period.g. high dose corticosteroid thearpy should be continued only until the patient¶s condition has stabilied . urticaria) May suppress reactions to skin tests Miscellaneous This prouct contains benzyl alcohol which has been associated with a fatal ³Gasping Syndrome´ in premature infants.g. . including reactivation of tuberculosis Opportunistic infections with any pathogen. in any location in the body.Suppression of pituitary-adrenal axis Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements of insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism Immune system Masking of infections Latent infections becoming active. or by intramuscular injection. consideration should be given to employing a longer acting injectable preparation or an oral preparation. 500 mg or more). 100 mg) to 10 minutes (e. In general. laryngeal edema.g. by intravenous infusion. Prophylactic antacid thearpyp may be indicated. Although adverse effects associated with high dose.
Directions for Using the Act-O-vial System 1.28 osmolar). Insert vial and withdrawn dose. first prepare solution as just describe. 0. Preparation of Solution 100 mg Plain . The 100 mg solution may then be added to 100 to 1000 mL of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). Sterilize top of stopper with a suitable germicide.36 osmolar.When high dose hydrocortisone therapy must be continued beyond 48-72 hours. Press down on plastic activator to force diluent into the lower compartment. 100 mg to 3000 mg of Hydrocortisone sodium sucinate may be added to 50 mL of the above diluents. the 500 mg solution may be adde to 500 to 1000 mL and the 1000 mg solution to 1000 mL of the same diluents. Gently agitate to effect solution. 500 mg ACT-O-VIAL. first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial.4 or 6 hours as indicated by the patient¶s response and clinical response of the patient than by age or body weight but should not be less than 25 mg daily. 4. Insert needle squarely through center of stopper until tip is just visible. 0. When reconstituted as directed.57 osmolar. . and ot a replacement for. For intravenous infusion. (Isotonic saline = 0. This dose may be repeated at intervals of 2. The initial dose of Hydrocortisone sodium succiate Sterile Powder is 100 mg to 500 mg. In cases where administration of a small volume of fluid is desirable. 250 mg ACT-O-VIAL. Remove plastic tab covering center of stopper. For intravenous infusion. Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency. Under such circumstances it may be desirable to replace Hydrocortisone sodium succinate with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention. hypernatremia may occur. The 250 mg solution may be added to 250 to 1000 mL. this solution may then be added to 100 to 1000 mL of the following: 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). 3. prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride to the conetnts of one vial. conventional therapy. The resulting solutions are stable for at least 4 hours and may be administered either directly or by IV piggyback. and the 1000 mg ACT-O-VIAL. 2. Further dilution is not necessary for intravenous or intramuscular injection. pH¶s of the solutions range from 7 to 8 and the tonicities are: 100 mg ACT-O-VIAL.For intravenous or intramuscular injection. depending on the severity of the condition. 5. Corticosteroid therapy is an adjunt to.
Availability 100 mg vial x 1¶s 100 mg ACT-O-VIAL x 1¶s 250 mg ACT-O-VIAL x 1¶s 500 mg ACT-O-VIAL x 1¶s Storage conditions Store unreconstituted product at controlled temperature 15 degrees to 30 degrees. . and Cosmetics Act prohibits dispensing without prescription. Cautions Foods. Devices. Use solution only if it is clear. Store solution at controlled temperature 15 degrees to 30 degrees and protect from light. Drugs. Unused solution should be discarded after 3 days.
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