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CORTEF is a brand name for Hydrocortisone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). 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 CORTEF (hydrocortisone) Page 14 of 36 Unclassified / Non classifié 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 As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, 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. 1 Pregnancy • Fertility Steroids may increase or decrease motility and number of spermatozoa in some patients.
Corticosteroids have been shown to reduce fertility when administered to rats. Sensitivity/Resistance Allergic reactions (eg, 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. This medicine contains lactose produced from cow’s milk. Caution should be exercised in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients.
1 Pregnancy 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 (see 16 NON-CLINICAL TOXICOLOGY).
There are no adequate and well-controlled studies in CORTEF (hydrocortisone) Page 15 of 36 Unclassified / Non classifié pregnant women. Since there is inadequate evidence of safety in human pregnancy, this drug should be used in pregnancy or by women of child bearing potential only if clearly needed and the potential benefit justifies the potential risk to the mother and embryo or fetus.
3 Pediatrics 04/2025 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 04/2025 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 1: Healthcare Professional Information........................................................................... 5 1 Indications ..................................................................................................................
1 Pediatrics......................................................................................................... 2 Geriatrics .........................................................................................................
6 2 Contraindications ....................................................................................................... 6 4 Dosage and Administration ........................................................................................
1 Dosing Considerations...................................................................................... 2 Recommended Dose and Dosage Adjustment ................................................... 5 Missed Dose ....................................................................................................
7 5 Overdose .................................................................................................................... 7 6 Dosage Forms, Strengths, Composition and Packaging................................................
7 7 Warnings and Precautions .......................................................................................... 8 General.......................................................................................................................
4 Drug-Drug Interactions. Viral infections Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.
How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.
If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. m. immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.
In such patients, corticosteroid induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
Corticosteroids should not be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition. The role of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and detrimental effects.
More recently, supplemental corticosteroids have been suggested to be beneficial in patients with established septic shock who exhibit adrenal insufficiency. However, their routine use in septic shock is not recommended. A systematic review of short-course, high dose corticosteroids did not support their use.
However, meta-analyses, and a review suggest that longer courses (511 days) of low dose corticosteroids might reduce mortality, especially in patients with vasopressor dependent septic shock. 4 Drug-Drug Interactions). Killed or inactivated vaccines may be administered however the response to such vaccines may be diminished.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 labour and delivery.
Some retrospective studies have found an increased incidence of low-birth weights in infants born of mothers receiving corticosteroids. In humans, 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 undergoing long-term treatment with corticosteroids during pregnancy. 2 Breastfeeding Systemically administered corticosteroids appear in human milk and could suppress 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 decision should be made whether to continue the drug, taking into account the importance of the drug to the mother. This medicinal product should be used during breast feeding only after a careful assessment of the benefit risk ratio to the mother and infant.
, 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. 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.
Growth may be suppressed in children receiving long-term, daily-divided dose glucocorticoid therapy. The use of such a regimen should be restricted to the most serious indications. 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 […]
8 Carcinogenesis and Genotoxicity ................................................................................ 8 Cardiovascular ............................................................................................................
8 Driving and Operating Machinery ............................................................................... 9 Endocrine and Metabolism ......................................................................................... 9 Gastrointestinal ........................................................................................................
10 Hematologic ............................................................................................................. 10 Hepatic/Biliary/Pancreatic........................................................................................
10 CORTEF (hydrocortisone) Page 3 of 36 Unclassified / Non classifié Immune .................................................................................................................... 10 Monitoring and Laboratory Tests ..............................................................................
12 Musculoskeletal........................................................................................................ 12 Neurologic ................................................................................................................
13 Ophthalmologic ........................................................................................................ 13 Psychiatric ................................................................................................................
13 Renal ........................................................................................................................ 14 Other ........................................................................................................................
14 Reproductive Health ................................................................................................. 14 Sensitivity/Resistance...............................................................................................
1 Special Populations ........................................................................................ 1 Pregnancy .................................................................................................. 2 Breastfeeding.............................................................................................
3 Pediatrics ................................................................................................... 4 Geriatrics ................................................................................................... 16 8 Adverse Reactions ....................................................................................................
1 Adverse Reaction Overview ............................................................................ 16 9 Drug Interactions ...................................................................................................... 2 Drug Interactions Overview ............................................................................
4 Drug-Drug Interactions................................................................................... 5 Drug-Food Interactions .................................................................................. 6 Drug-Herb Interactions...................................................................................
7 Drug-Laboratory Test Interactions .................................................................. 23 10 Clinical Pharmacology ............................................................................................... 2 […]
Indicated immunization procedures may be undertaken in patients receiving non immunosuppressive doses of corticosteroids. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.
Tuberculosis The use of hydrocortisone 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 an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Monitoring and Laboratory Tests Corticosteroids may suppress reactions to skin tests. Dosage adjustments may be required based on the following conditions: during remission or exacerbation of the disease process; the patient’s individual response to therapy; or upon exposure of the patient to emotional or physical stress such as serious infection, surgery or injury.
Monitoring for signs and symptoms of drug-induced secondary adrenocortical insufficiency may be necessary for up to one year following cessation of long-term or high-dose corticosteroid therapy. , pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis.
Elevations of creatine kinase may occur. Cases of rhabdomyolysis have been reported. Clinical improvement or recovery after stopping corticosteroids may require weeks to years. Osteoporosis is an adverse effect generally associated with long-term use and large doses of corticosteroids at any age.
, decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age.
, postmenopausal women) before initiating corticosteroid therapy. Corticosteroids should be used with caution in patients with myasthenia gravis. Neurologic Corticosteroids should be used with caution in patients with seizure disorders.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either drug may be more apt to occur.
Systemic corticosteroids, including CORTEF, are not indicated for, and therefore should not be used for the treatment of traumatic brain injury, as demonstrated by the results of a multicenter study. The study results […]