Patient Medication Information: uses, side effects, how to take - Acetylcysteine Injection (Auro Pharma)
What is Acetylcysteine Injection used for?
Acetylcysteine Injection is used to:
- Treat or prevent damage to your liver which may occur after you have taken too much acetaminophen (overdose).
How does Acetylcysteine Injection work?
Acetylcysteine Injection works:
By protecting your liver after you have taken too much acetaminophen. It may do this by:
- restoring and keeping the right levels of a naturally occurring substance in your liver or
- lowering the amount of harmful substances in your liver
What are the ingredients in Acetylcysteine Injection?
Medicinal ingredient: Acetylcysteine
Non-medicinal ingredients: Edetate Disodium, Sodium Hydroxide and water for Injection.
Acetylcysteine Injection comes in the following dosage forms:
Sterile solution for injection: 200 mg / mL.
Do not use Acetylcysteine Injection if:
- You are allergic to acetylcysteine or to any of the other ingredients in Acetylcysteine Injection.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Acetylcysteine Injection. Talk about any health conditions or problems you may have, including if you:
- have had a serious allergic reaction in the past such as a rash, low blood pressure, wheezing and/ or shortness of breath.
are pregnant or planning on becoming pregnant
- breastfeeding or planning on breastfeeding
- have brain damage caused by liver failure and are taking this drug as intravenously (I.V).
Other warnings you should know about:
To treat acetaminophen poisoning:
General:
- Acetylcysteine Injection is not compatible with rubber and metals, particularly iron, copper and nickel.
If the vial is left punctured/open, the solution may change to a light purple colour. This
- colour change does not significantly impair the safety of the acetylcysteine solution.
- Your doctor will take samples of your blood after an overdose. This is to monitor the levels of acetaminophen in your body. Your doctor will also monitor your liver and kidney function, the levels of electrolytes and fluid in your body.
When taken as an Intravenous Injection:
- The contents of the vial are to be used only once. Throw away the rest. Do not use the contents in a vial if it has been previously opened.
- Taking Acetylcysteine Injection as an injection can cause your body to hold on to excess fluid. This may cause hyponatremia. This is a condition that occurs when the level of sodium in your blood becomes too low. It may also cause seizures and can lead to death. You should be careful if you are taking this drug and you weigh less than 40 kilograms or you are giving this drug as an injection to a child.
- You may notice that your face or skin becomes hot and red (flush). This usually happens 30 to 60 minutes after you start taking the drug. It usually goes away on its own. If it gets worse or does not go away, tell your doctor.
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 Acetylcysteine Injection:
Acetylcysteine Injection is not compatible with rubber and metals, particularly iron, copper and nickel.
How to take Acetylcysteine Injection:
Acetylcysteine Injection can be taken intravenously (IV). Your doctor will determine the amount of Acetylcysteine Injection you will receive based on your condition and your weight.
Overdose:
| If you think you, or a person you are caring for, have taken too much Acetylcysteine Injection, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Signs of an overdose include those that are similar to an allergic reaction but may be more severe such as:
- rash
- difficulty breathing
- shortness of breath
- swelling of the face, eyes, lips, tongue or throat
What are possible side effects from using Acetylcysteine Injection?
These are not all the possible side effects you may feel when taking Acetylcysteine Injection. If you experience any side effects not listed here, contact your healthcare professional.
Side effects include:
- swelling in the mouth or a sore mouth
- nausea
- vomiting
- runny nose
- cough
- a feeling of tightness in the chest or chest pain
- puffy eyes and/or blurred vision
- sweating
- generally feeling unwell
- fever
- a slow heart rate
- pain in your eyes or your face
- a condition called acidosis which may cause weariness, vomiting, thirst or feeling restless
- feeling anxious
- pain, stiffness, swelling and redness in your joints.
- bluish skin
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||||
| Only if severe | In all cases | ||||||
UNKNOWN Allergic reaction: sudden wheeziness, chest pain or tightness, swelling of face, eyelids, tongue, lips or throat and a skin rash anywhere on the body (hives) | √ | ||||||
| Bronchospasm: sudden worsening of shortness of breath, trouble breathing and wheezing after inhalation. | √ | ||||||
| High blood pressure: rapid heart rate | √ | ||||||
| Low blood pressure: dizziness | √ | ||||||
Injection site reaction: irritation at the site of injection | √ | ||||||
Thrombocytopenia: increased risk of bleeding or bruising after injury | √ | ||||||
| Respiratory arrest (stop breathing) | √ | ||||||
| Cardiac arrest (heart stops beating) | √ | ||||||
Decreased liver function: yellowing of the skin, feeling tired, nausea, vomiting | √ | ||||||
| Seizures | √ | ||||||
| Low blood potassium: Muscle weakness and spasms | √ | ||||||
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.
Reporting Side Effects
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. |
Storage:
Store at room temperature (15-30˚C). Protect the vials from light.
For intravenous (IV) use:
Use the contents of the vial only once (single use). Throw away the rest. Do not use the contents of the vial if it has been previously opened.
For Solutions that have been diluted for intravenous (IV) use:
Solutions should be prepared as needed and used over specific times.
Keep out of reach and sight of children.
If you want more information about Acetylcysteine 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 manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8, Canada.
Last Prepared: June 20, 2022