Fentanyl (Nasal Route) Description and Brand Names - Mayo Clinic (مايو كلينك)

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Lazanda

Descriptions

Fentanyl nasal spray is used to treat severe pain in cancer patients. It is used for breakthrough cancer pain, which are flares of pain that “break through” after a routine pain medicine has been used. Fentanyl belongs to the group of medicines called opioid analgesics. It is only used in patients who are already taking opioid analgesics.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When an opioid is used for a long time, it may become habit-forming (causing mental or physical dependence). However, under the close supervision of a healthcare provider, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of nasal fentanyl you should receive.

This medicine is available only under a restricted distribution program called TIRF (Transmucosal Immediate Release Fentanyl) REMS Program.

This product is available in the following dosage forms:

Spray

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

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nasal fentanyl 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 nasal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of opioid analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving nasal fentanyl.

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 taking 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.

Levoketoconazole
Mifepristone
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.

Abametapir
Acepromazine
Aclidinium
Adagrasib
Alefacept
Alfentanil
Almotriptan
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Apalutamide
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asciminib
Asenapine
Atazanavir
Atropine
Avacopan
Baclofen
Belladonna
Belzutifan
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Berotralstat
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cilostazol
Cimetidine
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabrafenib
Dantrolene
Daridorexant
Darifenacin
Darunavir
Delavirdine
Delorazepam
Desipramine
Desmopressin
Desvenlafaxine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicloxacillin
Dicyclomine
Difenoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyrone
Dolasetron
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Duvelisib
Efavirenz
Elagolix
Eletriptan
Enasidenib
Enflurane
Enzalutamide
Ephedrine
Eplerenone
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etravirine
Fedratinib
Fenfluramine
Fesoterodine
Fexinidazole
Flavoxate
Flibanserin
Fluconazole
Flunitrazepam
Fluoxetine
Flurazepam
Fluspirilene
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gepirone
Glycopyrrolate
Glycopyrronium Tosylate
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Ipratropium
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lacosamide
Lanreotide
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lesinurad
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lonafarnib
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Magnesium Oxybate
Maribavir
Mavacamten
Meclizine
Medazepam
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylprednisolone
Metoclopramide
Metolazone
Midazolam
Milnacipran
Mirtazapine
Mitotane
Mobocertinib
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nafcillin
Nalbuphine
Naphazoline
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicardipine
Nicomorphine
Nifedipine
Nilotinib
Nirmatrelvir
Nirogacestat
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Octreotide
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymetazoline
Oxymorphone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paregoric
Paritaprevir
Paroxetine
Pazopanib
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenylephrine
Phenylpropanolamine
Phenytoin
Pimozide
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Pirtobrutinib
Polythiazide
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Propylhexedrine
Protriptyline
Pseudoephedrine
Quazepam
Quetiapine
Quinethazone
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Repotrectinib
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritlecitinib
Ritonavir
Rizatriptan
Ropeginterferon Alfa-2b-njft
Saquinavir
Schisandra sphenanthera
Scopolamine
Secobarbital
Selegiline
Selpercatinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Solifenacin
Sotorasib
Spironolactone
St John's Wort
Stramonium
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Taurursodiol
Telaprevir
Telithromycin
Telotristat Ethyl
Temazepam
Terodiline
Tetrahydrozoline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Ticagrelor
Tilidine
Tiotropium
Tizanidine
Tocilizumab
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Tramazoline
Tranylcypromine
Trazodone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Trofinetide
Tropicamide
Trospium
Tryptophan
Tucatinib
Umeclidinium
Venlafaxine
Verapamil
Vilazodone
Vonoprazan
Voriconazole
Vortioxetine
Voxelotor
Xipamide
Xylometazoline
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuranolone

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

Proper Use

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Fentanyl nasal sprays are for use in opioid-tolerant patients only. If you are not sure whether or not you are opioid-tolerant, check with your doctor before using this medicine.

It is very important that you understand the rules of the TIRF REMS program to prevent addiction, abuse, and misuse of fentanyl. This medicine should also come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.

Fentanyl nasal spray works differently than other fentanyl products, even at the same dose. Do not substitute or convert it to other products containing fentanyl.

To use the nasal spray:

Keep the spray in the child-resistant container until ready to use.
If you are using the nasal spray for the first time, you must prime the spray. Press on the grips and then release. You will hear a "click" and you will see 1 wide red bar in the counting window. Keep pressing and releasing the grip 3 more times. Each time, the red bar will become smaller until you see a green bar in the counting window. Prime the spray if it has not been used for more than 5 days. Re-prime by spraying 1 time into the pouch.
Gently blow your nose before using the spray. Sit up with your head upright and insert the tip of the nose piece into your nostril, and point the tip toward the bridge of your nose.
Close the opposite nostril with a finger. Firmly press down on the finger grips until you hear a "click".
Breathe in gently through your nose and out through your mouth one time after spraying. Do not sniff. Avoid blowing your nose for at least 30 minutes. Sit down for at least 1 minute.
Throw this medicine away after 8 sprays.

If another dose is needed, wait at least 2 hours before treating another episode of breakthrough pain.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

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.

For nasal dosage form (spray):
- For cancer pain:
  - Adults—At first, 100 micrograms (mcg) or 1 spray in one nostril during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed and tolerated. The dose is usually not more than 4 sprays per episode of pain.
  - Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Ask your pharmacist about the best way to dispose of medicine that you do not use. Throw away the spray bottle and start using a new one if you have used 8 sprays or if it has been 60 days or more since it has been used. Dispose any used, partially used, or unneeded spray bottles by emptying and spraying the remaining solution into the pouch. The sealed pouch and the empty bottle should be placed in a child-resistant container before discarding it in the trash can. Wash your hands with soap and water right away after handling the pouch.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check you for any problems or unwanted effects that may be caused by this medicine.

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, do not use more than your prescribed dose. Call your doctor for instructions.

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.

Using too much nasal fentanyl, or taking too much of another opioid while using nasal fentanyl, may cause an overdose. If this occurs, get emergency help right away. Your healthcare provider may prescribe naloxone to treat an overdose. Naloxone is a medicine that can temporarily reverse the effects of an overdose. If you have been prescribed naloxone, or purchased it over-the-counter, make sure your household members know how to use it in the event of an overdose. Emergency help is still needed after naloxone is used because the reversal effects are only temporary. Symptoms of an overdose include: drowsiness, extreme dizziness or weakness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, relaxed and calm, slow heartbeat or breathing, seizures, sleepiness, trouble breathing, or cold, clammy skin. Tell your doctor right away if you notice these symptoms. Your doctor may also give naloxone to treat an overdose.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Fentanyl is a medicine that can harm or cause death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully dispose of any partially used units or unused medicine properly.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. This effect may last for a few days after you stop using this medicine. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, benzodiazepines, sleeping medicines, other prescription pain medicine or opioids, barbiturates or seizure medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are 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.

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. These may be symptoms of adrenal gland problems.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.

Using opioids for a long time may cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Using too much of this medicine may cause reduced 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 immediately if any of the following side effects occur:

More common

Fever

Less common

Anxiety
black, tarry stools
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody nose
bloody or cloudy urine
blurred vision
body aches or pain
chest pain or tightness
chills
clay-colored stools
confusion
cough
cough producing mucus
dark urine
decreased urination
decreased weight
difficult or labored breathing
difficult, burning, or painful urination
difficulty with breathing
dizziness or lightheadedness
dry mouth
ear congestion
fainting
frequent urge to urinate
headache
hives
hoarseness
increase in heart rate
increased sweating
irritation
itching
joint pain, stiffness, or swelling
loss of appetite
loss of voice
lower back or side pain
nausea
nervousness
pain, redness, or swelling in the arm or leg
pale skin
pounding in the ears
rapid breathing
rapid weight gain
rash
redness of the skin
runny or stuffy nose
slow or fast heartbeat
sneezing
sore throat
stomach pain
sunken eyes
swelling of the eyelids, face, lips, hands, or feet
thirst
tingling of the hands or feet
trouble breathing or swallowing
ulcers, sores, or white spots in the mouth
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
vomiting of blood
wrinkled skin
yellow eyes or skin

Incidence not known

Irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin

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

Difficulty having a bowel movement (stool)
sleepiness or unusual drowsiness
vomiting

Less common

Acid or sour stomach
arm or leg pain
back pain
belching
burning feeling in the chest or stomach
change in taste
confusion about identity, place, and time
decreased appetite
depression
diarrhea
difficulty with moving
drooping upper eyelids
dry eyes
flushed, dry skin
fruit-like breath odor
heartburn
hyperventilation
increased hunger
increased thirst
increased urination
indigestion
irregular heartbeats
irritability
irritation or soreness of the mouth
lack or loss of strength
loss of taste
muscle aches
muscle pain or stiffness
pain in the rectum
restlessness
shaking
sleeplessness
stomach discomfort or upset
stomach bloating
sweating
tenderness in the stomach area
trouble with sleeping
unable to sleep
unexplained weight loss

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.

Portions of this document last updated: June 01, 2024

Original article: https://www.mayoclinic.org/ar/drugs-supplements/fentanyl-nasal-route/description/drg-20075020

الأدوية والمكملات الغذائية

Description and Brand Names

US Brand Name

Descriptions

Before Using

Allergies

Pediatric

Geriatric

Breastfeeding

Drug Interactions

Other Interactions

Other Medical Problems

Proper Use

Dosing

Storage

Precautions

Side Effects

More common

Less common

Incidence not known

More common

Less common

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