Patient Medication Information: uses, side effects, how to take - Sugammadex Injection (Generic Medical Partners)
What is Sugammadex Injection used for?
Sugammadex Injection is used to help speed up the recovery of your muscles after an operation in adults, adolescents and children 2 years of age or older.
How does Sugammadex Injection work?
When you have surgery you are given drugs that help your muscles relax completely. These types of drugs are known as muscle relaxants. Rocuronium and vecuronium are a type of muscle relaxant that the doctor may give to you before your surgery. When your muscles are relaxed it makes it easier for the doctor to do the surgery. At the end of your surgery, Sugammadex Injection is given to help get rid of the effects of these muscle relaxants.
What are the ingredients in Sugammadex Injection?
Medicinal ingredients: sugammadex (as sugammadex sodium).
Non-medicinal ingredients: hydrochloric acid, sodium hydroxide, water for injection
Sugammadex Injection comes in the following dosage forms:
Solution for Injection: 100 mg/mL sugammadex (as sugammadex sodium)
Do not use Sugammadex Injection if you:
- are allergic to sugammadex or to any of the other ingredients in Sugammadex Injection. Tell your doctor who will be giving you the anesthesia if you have any allergies. This includes any allergies to food or other drugs.
Serious Warnings and Precautions
- This drug should be administered only by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
- This drug may cause allergic reactions. Severe allergic or allergic-like reactions can be life threatening.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sugammadex Injection. Talk about any health conditions or problems you may have, including if you:
- have heart problems
- have liver disease or have had it in the past
- have fluid retention (edema)
- have kidney disease or have had it in the past or are on dialysis. This is important as Sugammadex Injection is removed from your body by the kidneys. Tell your doctor who will be giving you the anesthesia if this applies to you.
are pregnant or might be pregnant
- are breastfeeding
- have diseases which are known to give an increased risk of bleeding (trouble with blood clotting)
- have a history of airway or lung problems
Other warnings you should know about:
Driving and using machines: Your doctor will tell you when it is safe to drive or use machines after you have been given Sugammadex Injection. Sugammadex Injection is not expected to have an effect on alertness or concentration.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sugammadex Injection:
- toremifene (used to treat breast cancer)
- fusidic acid (used to treat infections)
It is important that you tell your doctor who will be giving you the anesthesia if you have recently taken these medicines.
Sugammadex Injection can affect hormonal contraceptives used for birth control:
Sugammadex Injection can make birth control methods less effective because it reduces how much you get of the hormone progestogen. Tell your doctor if you are currently using any of the following:
- the ‘Pill’
- vaginal ring
- implants
- hormonal Intra Uterine Device (IUD)
If you are:
- taking the “Pill” on the same day as Sugammadex Injection is given to you, follow the instructions for a missed dose in the Pill’s package insert.
- using other non-oral contraceptive methods (for example a vaginal ring, implant or IUD, you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days.
Effects on blood tests:
In general, Sugammadex Injection does not have an effect on laboratory tests. However, it may change the results of a blood test for progesterone (a hormone).
How to take Sugammadex Injection:
Sugammadex Injection will be given to you by a doctor who is trained in giving drugs used when you are having surgery. It is given through your vein as a single injection.
Usual dose:
Your doctor will determine the dose of Sugammadex Injection you need. It is based on your weight and how much the muscle relaxant drugs are still affecting you.
Usual dose: 2mg - 4 mg per kg of body weight. The doctor will determine exactly how much you will be given.
Overdose:
Your doctor will be monitoring you carefully. Sugammadex Injection is for hospital use only.
Missed Dose:
Not applicable.
What are possible side effects from using Sugammadex Injection?
These are not all the possible side effects you may feel after you have been given Sugammadex Injection. After your operation, if you experience any side effects that are not listed here or you notice any of your side effects getting worse, tell the doctor or nurse right away.
Allergic reaction such as:
- a rash or red skin
- swelling of your tongue and/ or throat
- shortness of breath
- changes in blood pressure or heart rate, sometimes resulting in a serious
If you think you, or a person you are caring for, have taken too much Sugammadex Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
- severe allergic or allergic-like reactions (anaphylaxis) that can be life threatening.
- Slow heart rate that can be life threatening.
- Complications during your procedure such as:
- airway difficulties
- changes in heart rate
- coughing or moving.
- light anesthesia that needs the attention of your doctor.
- Decreased blood pressure during the surgical procedure
- Return of muscle relaxation after the operation
- Shortness of breath due to muscle spasm of the airways (bronchospasm or laryngospasm) These are not all the possible side effects you may have when taking Sugammadex Injection. If you experience any side effects not listed here, tell your healthcare professional.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
The hospital will store Sugammadex Injection according to the correct storage conditions.
If you want more information about Sugammadex Injection:
- 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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the Generic Medical Partners website www.gmprx.com or by calling Generic Medical Partners at 416-444-4467.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
To report an adverse event related to Sugammadex Injection, please contact 416-444-4467.