Solu-cortef
Solu-cortef Medication Information:
Solu-cortef medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.
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Solu-cortef 100 mg
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Solu-cortef 250 mg
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Pharmacology
Sterile Solu-Cortef, the highly water-soluble sodium succinate ester of hydrocortisone, permits the immediate i.v. administration of high doses of hydrocortisone in a small volume of diluent and is, therefore, particularly useful in situations where high blood levels of hydrocortisone are required rapidly.
Solu-Cortef has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the 2 compounds are equivalent in biologic activity. Following the i.v. injection of hydrocortisone sodium succinate, experimental evidence of its effects has been noted within a few minutes and persists for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, hydrocortisone sodium succinate should be injected every 4 to 6 hours. Hydrocortisone sodium succinate may also be administered by i.v. infusion, or by i.m. injection. The preferred method for initial emergency use is i.v. injection.
Indications
Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used).
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.
Congenital adrenal hyperplasia.
Nonsuppurative thyroiditis.
Hypercalcemia associated with cancer.
Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis, synovitis or osteoarthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis, (selected cases may require low dose maintenance therapy), acute and subacute bursitis, epicondylitis, acute nonspecific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis.
Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis, systemic dermatomyositis (polymyositis).
Dermatologic Diseases: pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, mycosis fungoides.
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, seasonal or perennial allergic rhinitis, drug hypersensitivity reactions, urticarial transfusion reactions, acute noninfectious laryngeal edema (epinephrine is the drug of first choice).
Ophthalmic 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.
Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy), regional enteritis (systemic therapy).
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.
Hematologic Disorders: acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenia purpura in adults (i.v. only; i.m. administration is contraindicated), erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia, secondary thrombocytopenia in adults.
Neoplastic Diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
Edematous States: To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, or the idiopathic type or that due to lupus erythematosus.
Medical Emergencies: Hydrocortisone sodium succinate is indicated in the treatment of 1) shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present; and 2) acute allergic disorders (status asthmaticus, anaphylactic reactions, insect stings, etc.) following epinephrine.
Although there are no well-controlled (double-blind, placebo) clinical trials, data from experimental animal models indicate that corticosteroids may be useful in hemorrhagic, traumatic and surgical shock in which standard therapy (e.g., fluid replacement, etc.) has not been effective (see Warnings).
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.
Precautions
Drug Interactions
The pharmacokinetic interactions listed below are potentially clinically important.
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 ASA. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. ASA 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 anticoagulant when given concurrently with corticosteroids. Therefore coagulation indices should be monitored to maintain the desired anticoagulant effect.
Lactation
Because prednisone is excreted in breast milk, it is reasonable to assume that all corticoids are. No data is known for hydrocortisone sodium succinate.
Children
Growth may be supressed in children receiving long-term, daily-divided dose glucocorticoid therapy. The use of such a regimen should be restricted to the most serious indications.
Supplied
1 g
Each 8 mL (when mixed) contains: hydrocortisone (as hydrocortisone sodium succinate) 1 g, monobasic sodium phosphate anhydrous 8 mg, dibasic sodium phosphate dried 87.32 mg, benzyl alcohol 66.9 mg and sterile water for injection q.s. Sodium: <0.4978 mmol/mL. Vial packs of 5.
100 mg
Each 2 mL (when mixed) contains: hydrocortisone (as hydrocortisone sodium succinate) 100 mg, monobasic sodium phosphate anhydrous 0.8 mg, dibasic sodium phosphate dried 8.76 mg, benzyl alcohol 18.1 mg and sterile water for injection q.s. Sodium: <0.5 mmol/mL. Vial packs of 10.
500 mg
Each 4 mL (when mixed) contains: hydrocortisone (as hydrocortisone sodium succinate) 500 mg, monobasic sodium phosphate anhydrous 4 mg, dibasic sodium phosphate dried 44 mg, benzyl alcohol 33.4 mg and sterile water for injection q.s. Sodium: <0.5002 mmol/mL. Vial packs of 5.
Act-O-Vials
250 mg
Each 2 mL (when mixed) contains: hydrocortisone (as hydrocortisone sodium succinate) 250 mg, monobasic sodium phosphate anhydrous 2 mg, dibasic sodium phosphate dried 21.8 mg, benzyl alcohol 16.4 mg and sterile water for injection q.s. Sodium: <1 mmol/mL. Vial packs of 10.
Contraindications
In patients with known hypersensitivity to any components of the product and in patients with systemic fungal infections.
Warnings
Lactation
See Pregnancy.
Pregnancy
Some animal studies have shown that corticosteroids, when administered to the mother at high doses, may cause fetal malformations. Adequate human reproductive studies have not been done with corticosteroids. Therefore 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 fetus. Since there is inadequate evidence of safety in human pregnancy, this drug should be used in pregnancy only if clearly needed.
Corticosteroids readily cross the placenta. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. There are no known effects of corticosteroids on labor and delivery. Corticosteroids are excreted in breast milk.
Adverse Effects
Gastrointestinal
peptic ulceration with possible perforation and hemorrhage, gastric hemorrhage, pancreatitis, esophagitis, ulcerative esophagitis, perforation of the bowel, abdominal distention.
Increases in ALT, AST and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.
Fluid and Electrolyte Disturbances
congestive heart failure in susceptible patients, hypertension, hypokalemic alkalosis. Sodium retention, fluid retention and potassium loss which are correctable and largely preventable by restricting sodium intake to 500 mg/day and supplementing potassium intake, and increased calcium excretion.
Musculoskeletal
steroid myopathy, muscle weakness, osteoporosis, pathologic fractures, vertebral compression fractures, aseptic necrosis, loss of muscle mass, tendon rupture (particularly of the Achilles tendon).
Immune System
masking of infections, latent infections becoming active, opportunistic infections, hypersensitivity reactions including anaphylaxis, may suppress reactions to skin tests.
The following additional reactions are related to parenteral corticosteroid therapy: hyperpigmentation or hypopigmentation, s.c. and cutaneous atrophy, sterile abscess, anaphylactoid reaction (e.g., bronchospasm, laryngeal edema, urticaria).
Endocrine
menstrual irregularities, development of Cushingoid state, suppression of pituitary-adrenal axis leading to secondary adrenocortical and pituitary unresponsiveness, decreased carbohydrate tolerance, manifestation of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics, suppression of growth in children.
Miscellaneous
This product contains benzyl alcohol that has been associated with fatal “Gasping Syndrome” in premature infants.
Dermatologic
impaired wound healing (usually at high doses), petechiae and ecchymoses, thin fragile skin, facial erythema, increased sweating.
Metabolic
negative nitrogen balance due to protein catabolism.
Neurological
increased intracranial pressure, pseudotumor cerebri, psychic derangements/psychotic, manifestations including euphoria, insomnia, mood swings, personality changes, depression; exacerbation of pre-existing emotional instability or psychotic tendencies, seizures, headache, vertigo.
Ophthalmic
posterior subcapsular cataracts (associated with prolonged, high dose systemic therapy), glaucoma, increased intraocular pressure, exophthalmos.
Overdose
Symptoms
There is no clinical syndrome of acute overdosage with hydrocortisone. Hydrocortisone is dialyzable.
Treatment
See Symptoms.
Dosage
This preparation may be administered by i.v. injection, by i.v. infusion, or by i.m. injection; the preferred method for initial emergency use being i.v. injection. Following the initial emergency period, consideration should be given to employing a longer-acting injectable preparation or an oral preparation.
Therapy is initiated by administering hydrocortisone sodium succinate i.v. over a period of 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more). 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 associated with high dose, short-term corticoid therapy are uncommon, peptic ulceration may occur. Prophylactic antacid therapy may be indicated. When high-dose hydrocortisone therapy must be continued beyond 48 to 72 hours, hypernatremia may occur. Under such circumstances it may be desirable to replace hydrocortisone sodium succinate with a corticosteroid product such as methylprednisolone sodium succinate which causes little or no sodium retention.
The initial dose of hydrocortisone sodium succinate is 100 to 500 mg or more depending on the severity of the condition. This dose may be repeated at intervals of 2, 4, or 6 hours as indicated by the patient's response and clinical condition. While the dose may be reduced for infants and children, it is governed more by the severity of the condition and response of the patient than by age or body weight but should not be less than 25 mg daily.
Patients subjected to severe stress following corticosteroid therapy should be observed closely for signs and symptoms of adrenocortical insufficiency.
Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy.
Preparation of Solutions: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
I.V./I.M. Injection: To use Solu-Cortef Act-O-Vial reconstitute Act-O-Vial according to Directions For Using The Act-O-Vial System. Further dilution is not necessary for i.v. or i.m. injection.
I.V. Infusion: For i.v. infusion, first reconstitute Act-O-Vials according to instructions. The 100 mg solution may then be added to 100 to 1 000 mL of 5% Dextrose in Water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). The 250 mg solution may be added to 250 to 1 000 mL, the 500 mg solution may be added to 500 to 1 000 mL and the 1 000 mg solution to 1 000 mL of the same diluents. In cases, where administration of a small volume of fluid is desirable, 100 mg to 3 000 mg of Solu-Cortef may be added to 50 mL of the above diluents. The resulting solutions are stable for at least 4 hours and may be administered either directly or by i.v. piggy back.
Table 1 provides the stability data of hydrocortisone in 5% Dextrose in Water, USP (D5W) or 0.9% Sodium Chloride Injection, UPS (NS), at room temperature.
Table 1: Solu-Cortef
Solu-Cortef Stability
| Concentration | Stability (time) |
|---|---|
| ≤1 mg/mL | 24 hours |
| 1 mg/mL < x <25 mg/mLa | unpredictable, 4 to 6 hours |
| ≥25 mg/mL | 3 days |
Freezing: In-house studies have shown reconstituted hydrocortisone sodium succinate 50 mg/mL and 125 mg/mL to be physically and chemically stable after 1 month of freezing. Once thawed, the above guidelines should be followed for hydrocortisone sodium succinate.
Directions for Using the Act-O-Vial System: Press down on plastic activator to force diluent into the lower compartment. Gently agitate to effect solution. Remove plastic tab covering center of stopper. Sterilize top of stopper with a suitable germicide. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.
Storage: Store unreconstituted product at controlled room temperature 15 to 30°C. Store solution at controlled room temperature 15 to 30°C and protect from light. Use solution only if it is clear. Discard unused solutions after 3 days. The Act-O-Vial is a single dose vial and once reconstituted solution is used, any remaining portion should be discarded.
