Sufentanil Sublingual Tablets

What is this medication?

SUFENTANIL (soo FEN ta nil) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by blocking pain signals in the brain. It belongs to a group of medications called opioids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DSUVIA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Drug abuse or addiction
• Head injury
• Heart disease
• If you often drink alcohol
• Kidney disease
• Liver disease
• Lung or breathing disease, like asthma
• Seizures
• Stomach or intestine problems
• An allergic or unusual reaction to sufentanil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. This medication is given in a hospital or clinic.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply; this medication is not for regular use.

What may interact with this medication?

This medication may interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain antibiotics like clarithromycin, erythromycin, linezolid, rifampin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression, like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methylene blue
• Other narcotic medications for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take the medication for a long time.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a non-medical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

There are different types of narcotic medications (opiates). If you take more than one type at the same time or you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.