Solu-Cortef hydrocortisone sodium succinate 100 mg/2mL Injection, Powder, For Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Hydrocortisone injection is used to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). It is also used to treat severe allergic reactions. Hydrocortisone injection is used in the management of multiple sclerosis (a disease in which the nerves do not function properly), lupus (a disease in which the body attacks many of its own organs), gastrointestinal disease, and certain types of arthritis. Hydrocortisone injection is also used to treat certain conditions that affect the blood, skin, eyes,...
Read the full MedlinePlus article ↗- This injection form is used when taking a pill by mouth isn't possible or practical — for example, during a medical emergency, a severe allergic reaction, or when you need a fast,...
- Why am I getting a hydrocortisone injection instead of a pill?
- Most of the time, high-dose hydrocortisone injection is used for short periods — often just 48 to 72 hours during an acute crisis. After that, your doctor may switch you to a longe...
- Some things like fluid retention, higher blood sugar, mood changes, or trouble sleeping are common and your team will be monitoring for them. The ones to flag right away are signs...
Patient education
Supplement & herbal interactions
Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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8.73 mg / 2 mL
UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
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0.8 mg / 2 mL
UNII KH7I04HPUU
A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $20.481 | $20.48 / 1 vial |
| Medicaid paysCMS SDUD · 12 mo | $36.14 | $36.14 / 1 vial |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1720 | $23.056 / J1720 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocortisone sodium succinate 100 mg/2mL 60505-6411-00 | Apotex | 1 vial | $14.908 | AP | Availability likely | save 27% |
| Hydrocortisone sodium succinate 100 mg/2mL 69097-0004-67 | Cipla | 1 vial | $14.908 | AP | Availability likely | save 27% |
| Hydrocortisone sodium succinate 100 mg/2mL 70710-1907-01 | Zydus | 1 vial | $14.908 | AP | Availability likely | save 27% |
| Solu-Cortef 100 mg/2mLthis 00009-0825-01 | Pharmacia | 1 vial | $20.481 | — | Availability likely | — |
| Solu-Cortef 100 mg/2mL 00009-0011-04 | Pharmacia | 25 vials | $24.683 | — | Availability likely | +21% |
| Solu-Cortef 100 mg/2mL 51662-1261-01 | HF | 2 ml | — | — | FDA listed | — |
| Solu-Cortef 100 mg/2mL 55154-3942-05 | Cardinal | 5 vials | — | — | FDA listed | — |
| Hydrocortisone sodium succinate 100 mg/2mL 70771-1966-01 | Zydus | 1 vial | — | AP | FDA listed | — |
| Solu-Cortef 100 mg/2mL 84549-0011-04 | ProPharma | 2 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00009-0825-01 You're viewing this | 1 VIAL in 1 CARTON (0009-0825-01) / 2 mL in 1 VIAL | 1955-04-27 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Because of possible physical incompatibilities, SOLU-CORTEF should not be diluted or mixed with other solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This 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 emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation. Therapy is initiated by administering SOLU-CORTEF Sterile Powder intravenously 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 hours to 72 hours.
When high dose hydrocortisone therapy must be continued beyond 48 –72 hours, hypernatremia may occur. Under such circumstances, it may be desirable to replace SOLU-CORTEF with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention. The initial dose of SOLU-CORTEF Sterile Powder is 100 mg to 500 mg, depending on the specific disease entity being treated.
However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. This dose may be repeated at intervals of 2, 4, or 6 hours as indicated by the patient's response and clinical condition. It Should Be Emphasized that Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient.
After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached. Situations that may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment.
In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. In pediatric patients, the initial dose of hydrocortisone may vary depending on the specific disease entity being treated.
The range of initial doses is 0.56 mg/kg/day to 8 mg/kg/day in three or four divided doses (20 mg/m 2 bsa/day to 240 mg/m 2 bsa/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone,
0.75 Prednisone, 5 Dexamethasone,
0.75Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. Preparation of Solutions: 100 mg Plain For intravenous or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride Injection to the contents of one vial.
For intravenous infusion , first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial; this solution may then be added to 100 mL to 1,000 mL of the following: 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if pat…
⛔ Contraindications ▾
CONTRAINDICATIONS SOLU-CORTEF Sterile Powder is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. SOLU-CORTEF Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
⚠️ Warnings ▾
WARNINGS Serious Neurologic Adverse Reactions with Epidural Administration: Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy.
The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General: Injection of SOLU-CORTEF may result in dermal and/or subdermal changes forming depressions in the skin at the injection site. In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections.
Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.
Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including SOLU-CORTEF, should not be used for the treatment of traumatic brain injury. Cardio-renal: Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions, Amphotericin B injection and potassium-depleting agents ).
Endocrine: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use. Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Immunosuppression and Increased Risk of Infection Corticosteroids, including SOLU-CORTEF, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens.
Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider SOLU-CORTEF withdrawal or dosage reduction as needed.…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported with SOLU-CORTEF or other corticosteroids: Allergic reactions: Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema. Blood and lymphatic system disorders: Leukocytosis. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic: Acne, allergic dermatitis, burning or tingling (especially in the perineal area, after intravenous injection), cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.
Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.
Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see WARNINGS: Neurologic ), epidural lipomatosis. Ophthalmic: Central serous chorioretinopathy, exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration (see WARNINGS ), malaise, moon face, weight gain.
🔄 Drug Interactions ▾
Drug Interactions Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions, Hepatic Enzyme Inhibitors ). Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased. Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.
Convulsions have been reported with this concurrent use. Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs that induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin): Drugs that inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids. Ketoconazole: Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests. Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines.
Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Immunosuppression and Increased Risk of Infection , Vaccination ).
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women.
Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
🧒 Pediatric Use ▾
Pediatric Use: The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age) and aggressive lymphomas and leukemias (>1 month of age). Other indications for pediatric use of corticosteroids (e.g., severe asthma and wheezing) are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.
The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity.
This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives.
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. Hypertrophic cardiomyopathy was reported after administration of hydrocortisone to prematurely born infants, therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure should be performed.
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
OVERDOSAGE Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems.
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. The 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.
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. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED SOLU-CORTEF Sterile Powder is available in the following packages: 100 mg Plain —NDC 0009-0825-01 100 mg ACT-O-VIAL (Single-Dose Vial) 250 mg ACT-O-VIAL (Single-Dose Vial) 2 mL —NDC 0009-0011-03 2 mL —NDC 0009-0013-05 25 × 2 mL —NDC 0009-0011-04 25 × 2 mL —NDC 0009-0013-06 500 mg ACT-O-VIAL (Single-Dose Vial) —NDC 0009-0016-12 1,000 mg ACT-O-VIAL (Single-Dose Vial) —NDC 0009-0005-01 STORAGE CONDITIONS Store unreconstituted product at controlled room temperature 20°C to 25°C (68°F to 77°F). Store reconstituted and/or further diluted solution at controlled room temperature 20°C to 25°C (68°F to 77°F) and protect from light.
Use the reconstituted and/or further diluted solution within 12 hours of preparation. Use reconstituted/diluted solution only if it is clear. If kept at controlled room temperature unused reconstituted and/or further diluted solution should be discarded after 12 hours post preparation.
If kept under refrigerated conditions, unused reconstituted and/or further diluted solution should be used in no more than 24 hours and any unused portion should be discarded after that time. For medical information about SOLU‑CORTEF, please visit www.pfizermedinfo.com or call 1‑800‑438‑1985. This product's label may have been updated.
For current full prescribing information please visit www.pfizer.com
📦 Storage and Handling ▾
STORAGE CONDITIONS Store unreconstituted product at controlled room temperature 20°C to 25°C (68°F to 77°F). Store reconstituted and/or further diluted solution at controlled room temperature 20°C to 25°C (68°F to 77°F) and protect from light. Use the reconstituted and/or further diluted solution within 12 hours of preparation.
Use reconstituted/diluted solution only if it is clear. If kept at controlled room temperature unused reconstituted and/or further diluted solution should be discarded after 12 hours post preparation. If kept under refrigerated conditions, unused reconstituted and/or further diluted solution should be used in no more than 24 hours and any unused portion should be discarded after that time.
For medical information about SOLU‑CORTEF, please visit www.pfizermedinfo.com or call 1‑800‑438‑1985. This product's label may have been updated. For current full prescribing information please visit www.pfizer.com
📋 Description ▾
DESCRIPTION SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration. 100 mg Plain Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried.
SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION, Preparation of Solutions ). ACT-O-VIAL ® System (Single-Dose Vial) in four strengths: 100 mg ACT-O-VIAL 250 mg ACT-O-VIAL 500 mg ACT-O-VIAL 1,000 mg ACT-O-VIAL Each 2 mL contains (when mixed): Each 2 mL contains (when mixed): Each 4 mL contains (when mixed): Each 8 mL contains (when mixed): Hydrocortisone sodium succinate equiv. to 100 mg Hydrocortisone equiv. to 250 mg Hydrocortisone equiv. to 500 mg Hydrocortisone equiv. to 1,000 mg Hydrocortisone Monobasic sodium phosphate anhydrous 0.8 mg 2 mg 4 mg 8 mg Dibasic sodium phosphate dried 8.73 mg 21.8 mg 44 mg 87.32 mg The diluent, as part of the packaging presentation for the ACT-O-VIAL ® system, is comprised of Water for Injection only, and does not contain any preservative.
When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52. The structural formula is represented below: Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid.
It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform. Chemical Structure
💬 Information for Patients ▾
Information for Patients: Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids, and to seek medical advice at once should they develop fever or other signs of infection. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.