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Details for: SUFENTANIL CITRATE INJECTION, USP

Company: STERIMAX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02442213SUFENTANIL CITRATE INJECTION USPSUFENTANIL (SUFENTANIL CITRATE)50 MCG / MLSOLUTIONEPIDURAL
02442213SUFENTANIL CITRATE INJECTION USPSUFENTANIL (SUFENTANIL CITRATE)50 MCG / MLSOLUTIONINTRAVENOUS
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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

Sufentanil Citrate Injection USP is indicated for the following uses:

  • When injected in a vein, to induce and maintain unconsciousness during a major surgery;
  • When injected in the spine, to relieve pain after surgery, and during labour and vaginal delivery.
What it does

Sufentanil Citrate Injection USP is a fast acting pain relief medication and belongs to a class of medicines known as opioids. It provides pain relief for a short period of time. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

When it should not be used

  • you allergic to sufentanil or any of the other ingredients in Sufentanil Citrate Injection USP
  • you can control your pain by the occasional use of other pain medications. This includes those available without prescription
  • you have severe asthma, trouble breathing, or other breathing problems
  • you have any heart problems
  • you have bowel blockage or narrowing of the stomach or intestines
  • you have severe pain in your abdomen
  • you have a head injury
  • you are at risk for seizures
  • you suffer from alcoholism
  • you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
  • you are going to have, or recently had, a planned surgery
What the medicinal ingredient is

Sufentanil citrate.

What the non-medicinal ingredients are

Citric acid, sodium chloride, water for injection

What dosage form it comes in

Sufentanil Citrate Injection USP is available in 1 mL ampoules, boxes of 10, and in 5 mL ampoules, boxes of 10. For single use.

Warnings and precautions

Serious Warnings and Precautions

  • Even if you take Sufentanil Citrate Injection USP as prescribed you are at risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
  • You may get life-threatening breathing problems while taking Sufentanil Citrate Injection USP. This is less likely to happen if you take it as prescribed by your doctor.
  • You should never give anyone your Sufentanil Citrate Injection USP. They could die from taking it. If a person has not been prescribed Sufentanil Citrate Injection USP, taking even one dose can cause a fatal overdose. This is especially true for children.
  • If you took Sufentanil Citrate Injection USP while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
    • has changes in their breathing (such as weak, difficult or fast breathing)
    • is unusually difficult to comfort
    • has tremors (shakiness)
    • has increased stools, sneezing, yawning, vomiting, or fever
    Seek immediate medical help for your baby.
  • Taking Sufentanil Citrate Injection USP with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Sufentanil Citrate Injection USP should only be administered by persons with the appropriate training an experience with this kind of drug.
  • Complete resuscitation (life-saving) equipment and an antidote to rapidly counteract the effects of the drug should always be available.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sufentanil Citrate Injection USP. Talk about any health conditions or problems you may have, including if you:

  • have a history of illicit or prescription drug or alcohol abuse
  • have severe kidney, liver or lung disease
  • have low blood pressure
  • have past or current depression
  • suffer from chronic or severe constipation
  • have problems with your thyroid, adrenal or prostate gland
  • have, or had in the past hallucinations or other severe mental problems
  • suffer from migraines
  • are planning to become pregnant
  • plan on operating a car or heavy machinery after receiving the drug
  • are an elderly
  • are taking any medication, such as blood thinners, pain killers
  • have heavy alcohol use
  • use any drugs not given you by a doctor
  • are pregnant or breast feeding
  • have a known allergic reaction to this drug or any other pain medications or any other general anesthetics
  • have had a head injury, or if you experience difficulties breathing

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction, It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Sufentanil Citrate Injection USP can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Sufentanil Citrate Injection USP outweigh the risks to your unborn baby or nursing infant.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Sufentanil Citrate Injection USP. Sufentanil Citrate Injection USP can cause:

  • drowsiness
  • dizziness or
  • lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

  • nausea, vomiting
  • feeling tired, weak or dizzy
  • decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Sufentanil Citrate Injection USP

Serotonin Syndrome: Sufentanil Citrate Injection USP can cause Serotonin Syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take Sufentanil Citrate Injection USP with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

  • fever, sweating, shivering, diarrhea, nausea, vomiting;
  • muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
  • fast heartbeat, changes in blood pressure;
  • confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Sufentanil Citrate Injection USP. It can lead to:
    • drowsiness
    • unusually slow or weak breathing
    • serious side effects or
    • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by Sufentanil Citrate Injection USP
  • other opioid analgesics (drugs used to treat pain)
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety
    • )
  • antidepressants (for depression and mood disorders). Do not take Sufentanil Citrate Injection, USP with MAO inhibitors (MAOi) or if you have taken MAO is in the last 14 days.
  • drugs used to treat serious mental or emotional disorders (such as schizophrenia)
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (drugs used for the prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots)
  • anti-retroviral drugs (used to treat viral infections)
  • anti-fungal drugs (used to treat fungal infections)
  • antibiotic drugs (used to treat bacterial infections)
  • some heart medication (such as beta blockers)
  • grapefruit juice
  • drugs used to treat migraines (e.g. triptans)
  • St. John’s Wort

Proper use of this medication

Sufentanil Citrate Injection USP can only be used by a doctor in a facility with life-saving equipment.

Sufentanil Citrate Injection USP is given via an injection.

You should be given it:

  • only in a hospital or a clinic that has the proper monitoring and support equipment in place.
  • by a healthcare professional that has been specifically trained in the use of intravenous anesthetics.

Usual Dose

Your doctor will decide the best dose for you. It will depend on your age, weight, your health, medications you are currently taking and the type of surgery you are having.

Overdose

If you think you have taken too much Sufentanil Citrate Injection USP, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

  • unusually slow or weak breathing
  • dizziness
  • confusion
  • extreme drowsiness
Side effects and what to do about them

These are not all the possible side effects you may feel when taking Sufentanil Citrate Injection USP. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Drowsiness
  • Insomnia
  • Dizziness
  • Fainting
  • Nausea, vomiting, or a poor appetite
  • Dry mouth
  • Headache
  • Problems with vision
  • Weakness, uncoordinated muscle movement
  • Itching
  • Light Headedness
  • Sweating
  • Constipation
  • High or low blood pressure
  • Excessive sweating
  • Feeling of intense happiness or excitement (euphoria)
  • Feeling agitated
  • Crying
  • Headache
  • Trouble with your vision
  • Sleep apnea (a sleep disorder where your breathing is interrupted during sleep)
  • Pain at injection site
  • Feeling tired
  • Chills
  • Low sex drive, impotence (erectile dysfunction), infertility
Serious side effects and what to do about them
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
COMMON
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing   ✔  
Drowsiness, dizziness   ✔  
Fast, slow, or uneven heartbeat   ✔  
Severe nausea or vomiting ✔    
Stiffness in the muscles of your neck, chest, hands, or legs      
Trouble breathing, or chest tightness      
UNCOMMON
Mild skin rash or itching ✔    
Twitching or muscle movements you cannot control ✔    
Pain, itching, burning, swelling, or lump under your skin where the needle is placed ✔    
RARE
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone cold and clammy skin     ✔
Respiratory Depression: slow, shallow or weak breathing     ✔
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea     ✔
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating   ✔  
Fast, Slow or Irregular Heartbeat: heart palpitations   ✔  
Low Blood Pressure: dizziness, fainting, lightheadedness ✔    
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor, diarrhea     ✔

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
  • Sufentanil Citrate Injection USP should be stored between 15 and 30°C and protected from light.

Disposal:

Sufentanil Citrate Injection USP should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Medeffect Canada Web site https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This leaflet was prepared by SteriMax Inc.

Last revised: May 22, 2019.

Date modified: