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HYDROCORTISONE SODIUM SUCCINATE FOR is a brand name for Hydrocortisone, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hydrocortisone sodium succinate for injection USP is indicated for: 1. Endocrine Disorders • In primary, secondary and acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy,…
Verbatim from this product's HC label. Tap a section to expand.
). 4 Geriatrics, 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS Hydrocortisone sodium succinate for injection USP (hydrocortisone sodium succinate) is contraindicated: • in patients with known hypersensitivity to any components of the product (see
). Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown.
Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.
Renal Corticosteroids should be used with caution in patients with renal insufficiency. Other In post marketing experience tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents.
Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.
Reproductive Health:
Female and Male Potential Hydrocortisone sodium succinate for injection USP Page 17 of 41 Fertility Steroids may increase or decrease motility and number of spermatozoa in some patients (see 16 NON- CLINICAL TOXICOLOGY). , angioedema) may occur.
Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug (see 8 ADVERSE REACTIONS).
1 PREGNANT WOMEN 08/2025 7 WARNINGS AND PRECAUTIONS, MUSCULOSKELETAL 08/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................................ 2 TABLE OF CONTENTS ..........................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................... 4 1 INDICATIONS..........................................................................................................................
1 Pediatrics ............................................................................................................................... 2 Geriatrics ...............................................................................................................................
6 2 CONTRAINDICATIONS ............................................................................................................. 6 4 DOSAGE AND ADMINISTRATION .............................................................................................
1 Dosing Considerations ........................................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................................
3 Reconstitution ....................................................................................................................... 4 Administration .......................................................................................................................
Hydrocortisone sodium succinate for injection USP (hydrocortisone sodium succinate) is contraindicated: • in patients with known hypersensitivity to any components of the product (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING); Hydrocortisone sodium succinate for injection USP Page 7 of 41 • in patients with systemic fungal infections; • in idiopathic thrombocytopenic purpura when administered intramuscularly; • in patients administered with live or live, attenuated vaccines while receiving immunosuppressive doses of corticosteroids; • in herpes simplex of the eye, except when used for short-term or emergency therapy as in acute sensitivity reactions; • in patients with vaccinia and varicella, except when used for short-term or emergency therapy as in acute sensitivity reactions.
Hydrocortisone sodium succinate for injection USP is not indicated for epidural route of administration. Hydrocortisone sodium succinate for injection USP is not indicated for intrathecal route of administration, except as part of certain chemotherapeutic regimens (diluents containing benzyl alcohol must not be used).
Reports of serious medical events, including death, have been associated with epidural and intrathecal routes of corticosteroid administration.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Skin Injection of Hydrocortisone sodium succinate for injection USP 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. 1 Pregnant Women Corticosteroids readily cross the placenta. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to human dose.
Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits, have yielded an increase incidence of cleft palate in the off-spring. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.
There are no adequate and well-controlled studies in pregnant women. Some retrospective studies have found an increased incidence of low birth weights in infants born of mothers receiving corticosteroids. The risk of low birth weight appears to be dose related and may be minimized by administering lower corticosteroid doses.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy. Since there is inadequate evidence of safety in human pregnancy, Hydrocortisone sodium succinate for injection USP should be used during pregnancy at the lowest possible dose, only if clearly needed and the potential benefit justifies the potential risk to the embryo or fetus.
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.
Cataracts have been observed in infants born to mothers undergoing long-term treatment with corticosteroids during pregnancy. 2 Breast-feeding Hydrocortisone sodium succinate for injection USP Page 18 of 41 Systemically administered corticosteroids are excreted in breast milk and may suppress infant growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a careful benefit-risk assessment should be conducted and a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
3 Pediatrics Pediatrics (<18 years of age) Pediatric patients may experience a decrease in their growth velocity at low systemic doses and in the absence of laboratory evidence of HPA axis suppression. 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.
In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose over the shortest period of time. The growth and development of pediatric patients on prolonged corticosteroid therapy 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.
Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure. High doses of corticosteroids may produce pancreatitis in children. Hypertrophic cardiomyopathy was reported as one of the adverse effects of prophylactic or therapeutic administration of hydrocortisone to prematurely born infants and few months old babies (< 12 months), therefore appropriate diagnostic evaluation and monitoring of cardiac function and structure must be performed (preferably two-dimensional echocardiography).
4 Geriatrics 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 […]
9 5 OVERDOSAGE ...................................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................
10 7 WARNINGS AND PRECAUTIONS ............................................................................................ 1 Special Populations..............................................................................................................
1 Pregnant Women .......................................................................................................... 2 Breast-feeding...............................................................................................................
3 Pediatrics....................................................................................................................... 4 Geriatrics .......................................................................................................................
19 8 ADVERSE REACTIONS............................................................................................................ 1 Adverse Reaction Overview ................................................................................................
19 9 DRUG INTERACTIONS ........................................................................................................... 2 Drug Interactions Overview.................................................................................................
4 Drug-Drug Interactions ........................................................................................................ 5 Drug-Food Interactions........................................................................................................
6 Drug-Herb Interactions ........................................................................................................ 7 Drug-Laboratory Test Interactions ......................................................................................
27 10 CLINICAL PHARMACOLOGY ................................................................................................... 1 Mechanism of Action ....................................................................................................
2 Pharmacodynamics ....................................................................................................... 3 Pharmacokinetics ..........................................................................................................
27 11 STORAGE, STABILITY AND DISPOSAL ..................................................................................... 28 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................................
29 PART II: SCIENTIFIC INFORMATION.................................................................................................... 30 13 PHARMACEUTICAL INFORMATION ........................................................................................
30 14 CLINICAL TRIALS ................................................................................................................... 30 15 MICROBIOLOGY ...................................................................................................................
30 16 NON-CLINICAL TOXICOLOGY ................................................................................................. 30 PATIENT MEDICATION INFORMATION...............................................................................................
32 Hydrocortisone sodium succinate for injection USP Page 4 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Hydrocortisone sodium succinate for injection USP is indicated for: 1. Endocrine Disorders • In primary, secondary and acute […]