Description
Sufentanil sublingual tablet is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. This medicine should only be used for up to 72 hours. Sufentanil belongs to the group of medicines called narcotic analgesics (pain medicines) that act on the central nervous system (CNS) to relieve pain.
When sufentanil is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. Since sufentanil is only used for short-term (72 hours or less) relief of pain, physical dependence will probably not occur.
This medicine is available only under a restricted distribution program called the Dsuvia™ REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sufentanil sublingual tablet in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sufentanil sublingual tablet in the elderly. However, elderly patients are more likely to have confusion and severe drowsiness and age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving sufentanil sublingual tablet.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Naltrexone
- Safinamide
- Samidorphan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal gland problem) or
- Alcohol abuse or
- Brain tumor, history of or
- Breathing or lung problems (eg, apnea, COPD, low oxygen levels, sleep apnea) or
- Cor pulmonale (serious heart condition) or
- Depression, history of or
- Drug dependence, especially with narcotics, or history of or
- Electrolyte imbalance or
- Gallbladder disease or
- Head injury, history of or
- Heart rhythm problems (eg, slow heartbeat) or
- Mental health problems, history of or
- Stomach or bowel problems or
- Weakened immune system—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problems (eg, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is placed under your tongue.
It is very important that you understand the rules of the Dsuvia™ REMS program to prevent addiction, abuse, and misuse of sufentanil. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your doctor or pharmacist for the medication guide if you do not have one.
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.
Precautions
It is very important that your doctor check your progress closely while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may be habit-forming. If you feel that the medicine is not working as well, check with your doctor.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if think you are pregnant or if you plan to become pregnant while using this medicine.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual tiredness or weakness
Rare
- Bloody urine
- blue lips, fingernails, or skin
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- decreased frequency or amount of urine
- decreased urine output
- difficult or trouble breathing
- difficulty in passing urine (dribbling)
- extremely shallow or slow breathing
- fainting
- fast heartbeat
- increased blood pressure
- increased thirst
- indigestion
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness or fainting
- loss of appetite
- lower back or side pain
- nausea
- painful urination
- seeing, hearing, or feeling things that are not there
- severe constipation
- severe vomiting
- slow or irregular heartbeat
- stomach pain or upset
- swelling of the face, fingers, or lower legs
- tenderness in the stomach area
- unusual drowsiness, dullness, or feeling of sluggishness
- vomiting
- weakness
- weight gain
Incidence not known
- Agitation
- chest tightness
- cough
- darkening of the skin
- diarrhea
- difficulty swallowing
- fever
- hives, itching, skin rash
- increased sensitivity to pain
- mental depression
- overactive
- reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blue lips and fingernails
- blurred vision
- chest pain
- choking
- cold and clammy skin
- constricted pupils
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- difficult or trouble breathing
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- pale or blue lips, fingernails, or skin
- severe sleepiness
- slow heartbeat
- swelling in the legs and ankles
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Headache
Rare
- Anxiety
- belching
- bloated
- confusion about identity, place, and time
- difficulty having a bowel movement (stool)
- drowsiness
- dry mouth
- excess air or gas in the stomach or bowels
- false or unusual sense of well-being
- feeling of warmth
- forgetfulness
- full feeling
- heartburn
- indigestion
- muscle spasm
- passing gas
- redness of the face, neck, arms and occasionally, upper chest
- sleepiness or unusual drowsiness
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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