Sufentanil Citrate (soo-FEN-ta-nil SIT-rate)

Treats severe pain. This medicine is a narcotic pain reliever.

Brand Name(s):

Dsuvia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• A nurse or other healthcare provider will give you this medicine in a medical facility. It is placed under your tongue.
• Do not chew or swallow the tablet.
• Do not eat or drink and minimize talking for 10 minutes after receiving the tablet. If you have excessive dry mouth, you may be given ice chips before receiving this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.
• Some medicines can affect how sufentanil works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, trazodone, tramadol
  • Diuretic (water pill)
  • Medicine to treat depression (including SNRIs, SSRIs, TCAs)
  • Phenothiazine medicine
  • Triptan medicine to treat migraine headache
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing or lung problems (including asthma, COPD, sleep apnea), a slow heartbeat, adrenal problems, gallbladder disease, pancreas problems, or a history of depression, mental illness, head injury, seizures, or drug or alcohol abuse.
• This medicine may cause the following problems:
  • Increased risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • Serotonin syndrome (when used with certain medicines)
  • Adrenal gland problems
  • Low blood pressure
  • Seizures
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Changes in skin color, cold feeling, weakness, tiredness, weight loss
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation, stomach pain
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088