Sublingual fentanyl spray has the potential to develop a habit, especially with continued use. Fentanyl sublingual spray should only be used as instructed. Never use more fentanyl than your doctor has prescribed, nor should you take it more frequently or for a longer period of time. Discuss your pain management options, treatment duration, and goals with your healthcare professional while using fentanyl sublingual spray. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you currently have or have ever had any of these conditions, there is a higher chance that you may misuse fentanyl sublingual spray. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

If fentanyl sublingual spray is taken by someone who has not been treated with other narcotic medications or who is not accustomed to the effects of narcotic medications, it may result in major breathing issues or even death. Doctors with competence in managing pain in cancer patients should be able to administer fentanyl sublingual spray. It should only be used in cancer patients who are at least 18 years old, taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications to treat breakthrough cancer pain (sudden episodes of pain that occur despite round-the-clock treatment with pain medication). Other than treating chronic cancer pain, this medication should not be used to treat any other types of pain, particularly acute pain like migraines or other headaches, pain after an injury, or pain following a surgical or dental operation.

If a child or an adult who has not been prescribed the prescription unintentionally uses fentanyl sublingual spray, it could result in serious injury or even death. Even used bottles of fentanyl sublingual spray may still contain enough drug to seriously injure or kill children or other individuals. Keep kids away from fentanyl sublingual spray. To prevent youngsters from obtaining the drug, ask your doctor how to purchase a package from the manufacturer that includes child safety locks and other items. Fentanyl unused doses should be disposed of in accordance with the manufacturer’s instructions. Get emergency medical assistance if fentanyl sublingual spray is used by a kid or adult who has not been prescribed the medicine.

Using fentanyl sublingual spray in conjunction with other painkillers is recommended. When you start receiving treatment with fentanyl sublingual spray, do not stop using your other painkiller(s). You must stop using fentanyl sublingual spray if you stop taking your other painkiller(s).

Fentanyl sublingual spray may raise your chance of developing serious or life-threatening respiratory issues, sedation, or coma when combined with certain drugs. Inform your doctor if you are taking any of the following drugs: certain antibiotics such erythromycin (Erythocin, Eryc, Erythrocin, and others), clarithromycin (Biaxin, in PrevPac), certain antifungals, including fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole; Telithromycin (Ketek), and Troleandomycin (TAO) (not available in the United States); aprepitant (Emend); benzodiazepines such triazolam (Halcion), lorazepam (Ativan), oxazepam (Restoril), and clonazepam (Klonopin), as well as estazolam, flurazepam, and lorazepoxide (Librium); diltiazem (Cardizem, Taztia, Tiazac, among others); several anti-HIV drugs as amprenavir (Agenerase), fosamprenavir (Lexiva), and indinavir (Crixivan); nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); antiemetic drugs; nefazodone; sedatives; sleeping pills; drugs for nausea and mental sickness; muscle relaxants; verapamil (Calan, Covera, Verelan in Tarka) or tranquilizers. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms after taking fentanyl with any of these drugs: unusual dizziness, lightheadedness, excessive drowsiness, sluggish or labored breathing, or inability to respond. If you are unable to seek treatment on your own, make sure your caregiver or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

You run a higher chance of developing these severe, sometimes fatal adverse effects while receiving treatment with fentanyl if you consume alcohol, use prescription or over-the-counter drugs that do, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

Fentanyl is available in a variety of various items. One fentanyl product cannot be used in place of another because the drug in each is absorbed by the body differently. Your doctor will recommend the dose that is most suitable for you if you are transitioning from one product to another.

There is a program in place to lessen the risks associated with using this drug. To write a prescription for fentanyl, your doctor must sign up for the program, and you must pick up your medication from a participating drugstore. As part of the program, your doctor will discuss with you the advantages and disadvantages of using fentanyl as well as the proper ways to use, store, and discard the drug. After speaking with your doctor, you will be asked to sign a paper indicating that you understand the dangers of fentanyl use and that you will abide by their recommendations for using the drug safely. Your doctor will answer any questions you have about the program and your fentanyl treatment, as well as provide you with further information about the program and how to acquire your prescription.

When you start therapy with fentanyl and every time you receive extra medication, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/drugs/drugsafety/ucm085729.htm).

Discuss the dangers of using this drug with your doctor.

In cancer patients 18 years of age and older who are taking regularly scheduled doses of another narcotic (opiate) pain medication and who are tolerant (used to the effects of the medication), fentanyl sublingual spray is used to treat breakthrough pain (sudden episodes of pain that happen despite round-the-clock treatment with pain medication). Narcotic (opiate) analgesics are a group of drugs that includes fentanyl. It functions by altering how the brain and nerve system react to pain.

A solution (liquid) form of fentanyl is available for sublingual (under the tongue) spraying. Breakthrough pain is treated with it when needed, but not more frequently than advised by your doctor. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following.

In order to identify the dose of fentanyl sublingual spray that will effectively treat your breakthrough pain, your doctor will likely start you on a low dose and progressively raise it. For breakthrough pain, use one dose of fentanyl sublingual spray. Use a second dose 30 minutes after the first dose if you are still experiencing pain. Use no more than two pills for each episode of breakthrough pain. Wait at least 4 hours before treating a new episode of breakthrough pain after using fentanyl sublingual spray to treat an earlier episode of pain that required one or two doses. Call your doctor if you experience more than four bouts of breakthrough cancer pain in one day.

In order for your doctor to determine whether your dose needs to be adjusted, be sure to discuss how well the medicine is working for you as well as any side effects you may be having. Administer fentanyl precisely as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Stop using fentanyl sublingual spray only after consulting your physician. Your dose could be gradually reduced by your doctor. You can encounter unpleasant withdrawal symptoms if you abruptly stop using fentanyl sublingual spray.

Follow these instructions as well as those on the package label to use the oral spray:

1. Using a pair of scissors, cut along the dashed line to separate the fentanyl sublingual spray unit from the blister container.
2. any saliva in your mouth, swallow it.
3. Your thumb, index, and middle fingers should be used to hold the fentanyl sublingual spray device firmly in place.
4. Put the nozzle under your tongue and into your mouth.
5. To spray the drug under your tongue, firmly squeeze your thumb and fingers together.
6. For 30 to 60 seconds, hold the drug under your tongue. Do not rinse your mouth after taking the drug. After use, the fentanyl sublingual spray will remain locked because it is a single-use device.
7. Put the discarded fentanyl sublingual spray device in one of the disposal bags that are available. To close the bag, fold the flap after removing the backing from the adhesive strip.
8. Put the sealed bag in the trash where it is out of children’s reach.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking fentanyl,

• If you have an allergy to any of the substances in fentanyl sublingual spray, other drugs, fentanyl patches, injection, nasal spray, pills, lozenges, or films, notify your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements that you now take or intend to take. In addition to any of the following medications, make sure to mention those that are listed in the IMPORTANT WARNING section: Buprenorphine (Buprenex, Subutex, in Suboxone), butorphanol, barbiturates such phenobarbital, antihistamines; efavirenz, lithium (Lithobid), dextromethorphan (found in numerous cough medicines, including Nuedexta); such as sumatriptan (Alsuma, Imitrex, in Treximet), almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig); mirtazapine (Remeron); modafinil (Provigil); nalbuphine; drugs for treating seizures such as carbamazepine (Tegretol, Teril), oxcarbazepine (Trileptal), and phenytoin (Dilantin, Phenytek); oral steroids such dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); naloxone (Evzio, Narcan); nevirapine (Viramune); pioglitazone (Actos); 5HT3 serotonin blockers like alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); rifabutin (Mycobutin); fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors; trazodone (Oleptro); serotonin and norepinephrine reuptake inhibitors such milnacipran (Savella), desvenlafaxine (Effexor), duloxetine (Cymbalta), and venlafaxine (Khedezla); tricyclic antidepressants (sometimes known as “mood elevators”) include amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil), as well as doxepin (Silenor) and troglitazone (Rezulin). Additionally, let your doctor or pharmacist know if you’re taking any of the following drugs: monoamine oxidase (MAO) inhibitors like isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), as well as any other medications you receive. Tell your doctor about all of the medications you are taking, including any that do not appear on this list, as many other drugs may also interact with fentanyl. Your doctor might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
• Inform your doctor if you or any members of your family regularly consume significant amounts of alcohol, use illicit drugs, or take excessive amounts of prescription medicine. Asthma, chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull should also be disclosed to your doctor, as should sores, ulcers, or swelling in your mouth, difficulty urinating, breathing issues like asthma, chronic obstructive pulmonary disease, kidney disease, or liver disease.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while using fentanyl.
• You should be aware that this medicine may lower both male and female fertility. Discuss the dangers of fentanyl sublingual spray with your doctor.
  Inform the surgeon or dentist that you are using fentanyl if you are undergoing surgery, including dental surgery.
• The drug fentanyl may cause you to feel sleepy or lightheaded. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
• You should be aware that fentanyl can make you feel weak, lightheaded, and dizzy if you stand up suddenly from a reclining posture. When you initially start using fentanyl, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
• Fentanyl sublingual spray may cause constipation, so you should be aware of it. To treat or prevent constipation, discuss with your doctor modifying your diet and taking additional drugs.

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

As directed, this drug is typically taken as needed.

Side effects from fentanyl could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Itching
• Drowsiness
• Right side of your stomach hurts
• Mouth ache
• Headache
• Body part shaking that is uncontrollable
• Having trouble falling or staying asleep
• Anxiety
• Back ache
• Itching
• Cough

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those noted in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

• Variations in heart rate
• Hallucinations (seeing or hearing things or sounds that are not there), anxiety, perspiration, disorientation, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhea
• Nausea, vomiting, weight loss, anorexia, or lightheadedness
• Failure to achieve or maintain erection
• Irregular periods of time
• Less sexual arousal

Stop using fentanyl and seek emergency medical attention if you suffer any of the following symptoms:

• Fatigue accompanied by slowed breathing
• Shallow, sluggish breathing
• Less need to breathe
• Breathing or swallowing challenges
• Fainting

Other negative effects of fentanyl are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088] if you have a serious side event.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Keep this medication out of the reach of children and in the sealed blister package. To prevent unauthorized or intentional use, store fentanyl in a secure location. To prevent youngsters from accessing the medication, use the child-resistant locks and other equipment that the manufacturer has given. To find out if any fentanyl is missing, keep note of how much is still available. Keep it at room temperature and out of the bathroom and away from light, excessive heat, and moisture.

As soon as fentanyl sublingual spray is consumed or no longer required, dispose of it. Put the used spray device in a trash bag. Close the bag, then throw it away in a child-resistant trash can. Follow the instructions on the container to open any unused spray units. Spray the unit’s contents into the waste container that came with it. Continue by using each empty container. Shake the garbage container after it is closed. Put the disposal container into a trash can after placing it in a disposable bag. Consult your pharmacist for advice on how to properly dispose of your medications.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should speak with your doctor about keeping naloxone on hand at all times when using fentanyl sublingual spray (e.g., at home or at work). To counteract the potentially fatal effects of an overdose, use naloxone. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. Your physician or pharmacist will demonstrate how to utilize the medication for you and your family members. Visit the manufacturer’s website or ask your pharmacist for the instructions. A friend or family member should administer the first dose of naloxone if overdosage symptoms appear, dial 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. Immediately upon receiving naloxone, your symptoms can come back. A second dosage of naloxone should be administered if your symptoms come back. If symptoms come back before aid arrives, further dosages may be given every 2 to 3 minutes.

Overdose signs could include the following:

• Breathing that is irregular, shallow, or nonexistent
• Having trouble breathing
• Sleepiness
• Not able to speak or awaken
• Confusion
• Smaller pupils (eyes have black circles in the middle)

Keep all of your appointments with your physician and the lab. To determine how your body reacts to fentanyl, your doctor will request specific lab tests.

Inform the lab staff and your doctor that you are taking fentanyl prior to any laboratory test (particularly ones involving methylene blue).

Even if someone else has the same symptoms you do, do not let them use your prescription. It’s against the law to sell or distribute this medication because doing so could result in serious injury or death to others.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.