Details for: SUFENTANIL CITRATE INJECTION USP
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02244147 | SUFENTANIL CITRATE INJECTION USP | SUFENTANIL (SUFENTANIL CITRATE) | 50 MCG / ML | SOLUTION | EPIDURAL |
| 02244147 | SUFENTANIL CITRATE INJECTION USP | SUFENTANIL (SUFENTANIL CITRATE) | 50 MCG / ML | 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
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
Do not use Sufentanil Citrate Injection USP if:
- you are 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 a 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, sodium hydroxide, 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 single use vials, 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 a 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
- 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 and 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.
Seek immediate medical help for your baby.
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
Interactions with this medication
Proper use of this medication
Usual Dose
Overdose
Missed Dose
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 |
|---|---|---|---|
| Frequent | |||
| Example: 1 | ✔ | ||
| ✔ | |||
| ✔ | |||
| ✔ | |||
| Less Frequent | |||
| Rare | |||
| Very rare | |||
How to store
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:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
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.