Details for: CORTROSYN INJ 0.25MG
Company: AMPHASTAR PHARMACEUTICALS, INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00022381 | CORTROSYN INJ 0.25MG | TETRACOSACTIDE | 0.25 MG / VIAL | POWDER FOR SOLUTION | INTRAMUSCULAR |
| 00022381 | CORTROSYN INJ 0.25MG | TETRACOSACTIDE | 0.25 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your healthcare professional is using this medicine as part of a diagnostic medical test of the adrenal glands.
Because of the possibility of an allergic reaction CORTROSYN® should only be given under medical supervision.
What it does
CORTROSYN® is a synthetic version of a hormone produced by the pituitary gland that stimulates the adrenal glands to release a hormone called cortisol. CORTROSYN® is used to see how well the adrenal glands are working.
When it should not be used
- allergic to corticotrophins
- hypersensitive to this drug or to any ingredient in the formulation
What the medicinal ingredient is
Cosyntropin
What the non-medicinal ingredients are
mannitol and water for injection. May contain glacial acetic acid and sodium hydroxide for pH adjustment.
What dosage form it comes in
Lyophilized powder for injection: 0.25 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CORTROSYN®. Talk about any health conditions or problems you may have, including if you: are pregnant or breastfeeding.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Hydrocortisone
- Estrogen containing products
Proper use of this medication
A nurse or other healthcare professional will give you this medicine.
An intra-venous (IV) injection is given through an IV line that is put in one of your veins, usually in your arm, wrist, or hand.
An intra-muscular (IM) injection is a shot given in the muscle of your upper arm, thigh, or buttocks.
A blood sample will be taken before the dose of CORTROSYN® is given. Another blood sample will be taken 30 minutes after the dose of CORTROSYN®.
Usual Dose
Adults
0.25 mg to 0.75 mg given by IV or IM injection.
Children ≤ 2 years of age: A dose of up to 0.125 mg, given by IM injection.
Overdose
Missed Dose
If you miss your scheduled administration of the drug, contact your healthcare professional as soon as possible to reschedule your appointment.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking CORTROSYN®. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Allergic reaction with symptoms such as redness and pain at the injection site, hives, itchiness, general lack of wellbeing, difficulty breathing | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store at 15-30° C.
Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect MedEffect (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (www.hc-sc.gc.ca); the manufacturer’s website http://www.amphastar.com/, or by calling 1-800-423-4136.
This leaflet was prepared by Amphastar Pharmaceuticals, Inc.
Last Revised: December 1, 2015