Dsuvia

Generic name: Sufentanil
Drug class: Opioids (narcotic analgesics)

Usage of Dsuvia

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.

Dsuvia 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 troubled 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

troubled breathing

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

weakness

weight gain

Incidence not known

Agitation

cough

darkening of the skin

diarrhea

difficulty swallowing

fever

hives, itching, skin rash

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

tightness in the chest

trembling or shaking

twitching

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 troubled 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.

Before taking Dsuvia

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.

Breast Feeding

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.

Interactions with Medicines

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.

Nalmefene

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

Alfentanil

Almotriptan

Alprazolam

Amifampridine

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anileridine

Aprepitant

Aripiprazole

Armodafinil

Asenapine

Atazanavir

Baclofen

Benperidol

Benzhydrocodone

Benzphetamine

Boceprevir

Bosentan

Bromazepam

Bromopride

Brompheniramine

Buprenorphine

Bupropion

Buspirone

Butabarbital

Butorphanol

Calcium Oxybate

Cannabis

Carphenazine

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpheniramine

Chlorpromazine

Chlorzoxazone

Ciprofloxacin

Citalopram

Clarithromycin

Clobazam

Clomipramine

Clonazepam

Clopidogrel

Clorazepate

Clozapine

Cobicistat

Cocaine

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclosporine

Daridorexant

Darunavir

Delavirdine

Desipramine

Desmopressin

Desvenlafaxine

Dexamethasone

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diazepam

Dibenzepin

Dichloralphenazone

Difenoxin

Dihydrocodeine

Diltiazem

Diphenhydramine

Diphenoxylate

Dolasetron

Donepezil

Doxepin

Doxylamine

Dronedarone

Droperidol

Duloxetine

Efavirenz

Eletriptan

Enflurane

Enzalutamide

Erythromycin

Escitalopram

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethopropazine

Ethylmorphine

Etravirine

Fenfluramine

Fentanyl

Flibanserin

Fluconazole

Fluoxetine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosphenytoin

Fospropofol

Frovatriptan

Furazolidone

Gabapentin

Gabapentin Enacarbil

Gepirone

Granisetron

Halazepam

Haloperidol

Halothane

Hexobarbital

Hydrocodone

Hydromorphone

Hydroxytryptophan

Hydroxyzine

Idelalisib

Imatinib

Imipramine

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ivacaftor

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Lacosamide

Lasmiditan

Lemborexant

Levocetirizine

Levomilnacipran

Levorphanol

Linezolid

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Lorazepam

Lorcaserin

Loxapine

Lumacaftor

Magnesium Oxybate

Meclizine

Melitracen

Melperone

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaxalone

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methylene Blue

Metoclopramide

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirtazapine

Mitotane

Moclobemide

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Nelfinavir

Nevirapine

Nialamide

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Nortriptyline

Olanzapine

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxycodone

Oxymorphone

Ozanimod

Palbociclib

Palonosetron

Papaveretum

Paregoric

Paroxetine

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenelzine

Phenobarbital

Phenytoin

Pimozide

Piperacetazine

Piritramide

Posaconazole

Potassium Oxybate

Prazepam

Prednisone

Pregabalin

Primidone

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propofol

Protriptyline

Quazepam

Quetiapine

Ramelteon

Ranitidine

Ranolazine

Rasagiline

Remifentanil

Remimazolam

Remoxipride

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rizatriptan

Ropeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

Selegiline

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

St John's Wort

Sulpiride

Sumatriptan

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Tianeptine

Tilidine

Tizanidine

Tolonium Chloride

Topiramate

Tramadol

Tranylcypromine

Trazodone

Triazolam

Trifluoperazine

Trifluperidol

Triflupromazine

Trimeprazine

Trimipramine

Tryptophan

Venlafaxine

Verapamil

Vilazodone

Voriconazole

Vortioxetine

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

Interactions with Food/Tobacco/Alcohol

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.

Grapefruit Juice

Relate drugs

How to use Dsuvia

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.

Dosing

For sublingual dosage form (tablets):

For pain:

Adults—30 micrograms (mcg) placed under the tongue as needed with a minimum of 1 hour between doses. The dose is usually not more than 12 tablets per day.

Children—Use and dose must be determined by your doctor.

Warnings

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.

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.

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.

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