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CORTROSYN INJ is a brand name for Cosyntropin (also known as Tetracosactide), supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. WARNINGS AND PRECAUTIONS General It is not advisable to add a synthetic polypeptide such as tetracosactide to blood and plasma transfusions because prolonged interaction with enzymes, present in these fluids, can cause breakdown of the polypeptide.
Sensitivity/Resistance Allergic reactions may occur in response to CORTROSYN®. Reactions of this type include: marked redness and pain at the injection site, urticaria, pruritis, severe malaise or dyspnea. Should prodromal signs occur, further use of CORTROSYN® should be stopped.
Severe anaphylactic reactions usually can be avoided by discontinuing the use of the drug at the earliest sign of local or systemic hypersensitivity. V. aqueous epinephrine, as well as a large I. V. g. hydrocortisone or methylprednisolone.
Repeat administration of CORTROSYN® may increase the risk of hypersensitivity. Patients should be instructed to inform subsequent physicians of previous use of corticotropic hormones. Hematologic ACTH induces the release of glucocorticoid such as cortisol which tends to increase the hemoglobin and red-cell content of the blood, as evidence by the occurrence of polycythemia in Cushing’s syndrome and a mild normochromic, normocytic anemia in Addison’s disease.
ACTH also induces the release of glucocorticoid such as cortisol which tends to affect circulating white cells. Administration of corticosteroid including ACTH may lead to an increase in the number of polymorphonuclear leukocytes in the blood, while the number of lymphocytes, eosinophils, monocytes, and basophils decrease.
(4) Adverse reactions related to glucocorticoid effects are unlikely to be observed with short-term use of cosyntropin when used as a diagnostic tool.
Special Populations Pregnant Women:
When pregnancy is present or suspected the benefits of the use of CORTROSYN® should be weighed against the possible hazards to the fetus. 25 mg ) Page 5 of 16 Nursing Women: It is unknown if the drug is excreted in human milk. Because many drugs are excreted in human milk precaution should be exercised.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cosyntropin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Geriatrics (> 65 years of age):
No data is available.
Pediatrics (< 16 years of age):
No data is available.
Monitoring and Laboratory Tests:
As ACTH has the ability to stimulate the adrenal glands to release corticosteroids such as cortisol which has pharmacological effects on systemic electrolyte such as sodium, potassium, calcium, blood urea nitrogen, creatinine, glucose, hemoglobin, hematocrit and white blood cells, standard laboratory monitoring such as a metabolic panel and complete blood count are recommended.
25 mg) is intended for short-term use only. Hypersensitivity is thus anticipated, but rarely observed. To date, only nine such reactions have been reported in the literature and in each instance, the patient had a pre-existing allergic disease and/or a previous reaction to natural ACTH.
Post-Market Adverse Drug Reactions General disorders and administration site conditions: Lack of efficacy, chest pain, injection site atrophy.
Gastrointestinal disorders:
Abdominal pain and tremor, churning of stomach, nausea.
Nervous system disorders:
Fainting, paralysis, headache, numbness of upper extremity, slurred speech. Hypotension, feeling flushed.
Skin and subcutaneous tissue disorders:
Skin reported to be “sloughing off” and turned red. DRUG INTERACTIONS Drug-Drug Interactions Patients taking inadvertent doses of hydrocortisone on the test day may exhibit abnormally high basal plasma cortisol levels. A paradoxical response may be noted, as seen in a decrease in plasma cortisol values following a stimulating dose of CORTROSYN®.
Women taking estrogen containing drugs may exhibit abnormally high basal plasma cortisol levels. Only a normal incremental response is to be expected. Please refer to Dosing Consideration section for more details on how to interpret test results in these patients.
25 mg ) Page 6 of 16 Drug-Food Interactions Interactions with food have not been established. Drug-Herb Interactions Interactions with herbal products have not been established. Drug-Laboratory Interactions Changes to systemic electrolytes and hematologic lab values might occur.
Please refer to the Monitoring and Laboratory Tests section and Hematologic warnings and precautions for more details. DOSAGE AND ADMINISTRATION Dosing Considerations It is not advisable to add a synthetic polypeptide such as tetracosactide to blood and plasma transfusions because prolonged interaction with enzymes, present in these fluids, can cause breakdown of the polypeptide.
Patients taking inadvertent doses of hydrocortisone on the test day and women taking estrogen containing drugs may exhibit abnormally high basal plasma cortisol levels. A paradoxical response may be noted in the former group as seen in a decrease in plasma cortisol values following a stimulating dose of CORTROSYN®.
In the latter group, only a normal incremental response is to be expected. Patients receiving hydrocortisone should omit their pre-test doses on the day selected for testing. The test may be performed at any time during the day but because of the physiological diurnal variation of […]