Hydrocortisone sodium succinate 100 mg/2mL
Hydrocortisone sodium succinate · INJECTION · Zydus Lifesciences Limited
Hydrocortisone sodium succinate is a injection containing hydrocortisone sodium succinate at 100 mg/2mL, taken intramuscular. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Hydrocortisone sodium succinate
- Generic Name
- Hydrocortisone sodium succinate
- NDC Code (Product)
70771-1966- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 100 mg/2mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA217191
- Marketing Start
- 05/09/2026
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 hydrocortisone sodium succinate for injection 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 reg…
Dosage & Administration
DOSAGE AND ADMINISTRATION Because of possible physical incompatibilities, hydrocortisone sodium succinate for injection 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 hydrocortisone sodium succinate for injection 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 hours to 72 hours, hypernatremia may occur. Under such circumstances, it may be desirable to replace hydrocortisone sodium su…
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 hydrocortisone sodium succinate 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 subj…
Contraindications
CONTRAINDICATIONS Hydrocortisone sodium succinate for injection 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. Hydrocortisone sodium succinate for injection is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been reported with hydrocortisone sodium succinate for injection 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…
Frequently Asked Questions
What is Hydrocortisone sodium succinate used for?
Hydrocortisone sodium succinate contains Hydrocortisone sodium succinate. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Hydrocortisone sodium succinate a controlled substance?
Hydrocortisone sodium succinate is not classified as a controlled substance by the DEA.
What is the generic name for Hydrocortisone sodium succinate?
The generic name for Hydrocortisone sodium succinate is Hydrocortisone sodium succinate. There are 7 other brand versions of Hydrocortisone sodium succinate.
What is the NDC code for Hydrocortisone sodium succinate 100 mg/2mL?
The NDC (National Drug Code) for Hydrocortisone sodium succinate 100 mg/2mL is 70771-1966, listed by Zydus Lifesciences Limited.