Fentanyl (Into the mouth)
Treats cancer pain in adult patients whose pain is not relieved by other pain medicines. Used in combination with around-the-clock opioid therapy. This medicine is a narcotic pain reliever.
Actiq, Subsys, Onsolis, Fentora, AbstralThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:Do not use this medicine if you have had an allergic reaction to fentanyl. Do not use this medicine unless directed by your doctor after other pain medicines did not work well for you. You should not use this medicine for minor aches and pains, such as headaches, dental pain, or migraines, or after surgery or injuries.
How to Use This Medicine:
Thin Sheet, Lozenge, Spray, Tablet, Lollipop
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
- Drink plenty of fluids to help avoid constipation.
- Keep the medicine in the original blister or foil package. Open the package right before use.
- Abstral® tablets: Place the tablet under the tongue until it dissolves. Do not chew, suck, or swallow the tablet. Do not eat or drink anything until the tablet has dissolved. If your mouth is dry, use water to rinse your mouth before you place the tablet under your tongue.
- Actiq® lozenges: Place the lozenge in your mouth between the cheek and lower gum. Use the handle to move the lozenge from one side to the other every now and then. Suck the medicine for 15 minutes, and do not chew it.
- Fentora® tablets: Peel the blister back to remove the tablet. Do not push the tablet through the blister because this may damage the tablet. Place the tablet between your upper cheek and gum, above a back molar, until it dissolves. Do not chew, suck, or swallow the tablet. You may swallow the tablet with a glass of water if it does not dissolve completely after 30 minutes.
- Onsolis® film: Use your tongue to wet the side of your cheek, or rinse your mouth with water in the area where you will place the film. Do not cut or tear the film. Hold the film on a clean, dry finger with the pink side facing up. Press the film against your cheek and hold it there for 5 seconds. Leave the film in place until it dissolves, and do not touch or move the film. Do not chew or swallow the film. Place the second film on the other side of your mouth, if you must use more than one film. Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.
- Subsys? spray: Carefully spray the medicine under your tongue immediately after you open the package.
- You should only use this medicine when needed for breakthrough pain.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Keep the medicine in the original blister or foil package. Do not use the medicine if the package has been damaged or opened.
- Abstral® tablets: Dispose of any unopened tablets that are not needed. Remove the tablets from the blister package and flush them down the toilet. Do not flush the blister package or carton down the toilet. If you have questions, call 1-888-227-8725.
- Actiq® lozenges: Place used handles in the temporary storage bottle from the Actiq® Child Safety Kit, and empty the bottle each day. To dispose of the lozenge end of the handle, hold it over the toilet and cut it off with wire-cutting pliers. Flush the toilet twice. Throw the handle away in a place that is out of the reach of children. Use the same process to dispose of any unopened lozenges, but only flush 5 lozenges at a time. Do not flush the entire lozenge unit, the handle, or the blister package down the toilet. If you have questions, call 1-800-896-5855.
- Fentora® tablets: Dispose of any unopened tablets that are not needed. Remove the tablets from the blister package and flush them down the toilet. Do not flush the blister package or carton down the toilet. If you have questions, call 1-800-896-5855.
- Onsolis® film: Dispose of any unopened film that is not needed. Remove the film from the foil package and flush it down the toilet. Do not flush the foil package or carton down the toilet. If you have questions, call 1-800-526-3840.
- Subsys? spray:
- Used spray units: Place the used spray unit into the small disposal bag that came with the medicine. Do this immediately after use. Seal the disposal bag and throw it into a secure trash container, out of the reach of children.
- Unopened or expired spray units: Hold the unused medicine units upside down, with the nozzle inside the disposal bottle. Spray the units inside the bottle until they are empty. Place all empty spray units into the small bags, and seal them. Shake the bottle from side to side. Place the disposal bottle into the large bag and seal it. Throw all disposal bags into a secure trash container, out of the reach of children. Call 1-877-978-2797 if you have questions.
- Keep all medicine away from children and never share your medicine with anyone.Call Poison Control or go to an emergency room right away if a child is exposed to this medicine. This medicine may cause death if shared with others.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using clarithromycin (Biaxin®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone (Serzone®), or troleandomycin (Tao®). Tell your doctor if you are also using aprepitant (Emend®), diltiazem (Cardizem®, Dilacor XR®), erythromycin (Ery-Tab®), telithromycin (Ketek®), fluconazole (Diflucan®), or verapamil (Calan®, Isoptin®, or Verelan®). Make sure your doctor knows if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
- Make sure your doctor knows if you are also using St John's wort, modafinil (Provigil®), pioglitazone (Actos®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), cimetidine (Tagamet®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), medicine for HIV or AIDS (such as amprenavir, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Agenerase®, Crixivan®, Fortovase®, Invirase®, Lexiva®, Norvir®, Sustiva®, Viracept®, or Viramune®), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
- Do not drink alcohol while you are using this medicine.
- Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
Warnings While Using This Medicine:
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney or liver disease, seizures, or a slow heart rate. Tell your doctor if you have had a head injury or brain surgery, or if you have a history of drug addiction or alcohol abuse. Make sure your doctor knows if you have mucositis (sores in your mouth).
- This medicine may cause serious breathing problems. This is more likely in patients who have asthma, chronic obstructive pulmonary disease (COPD), or other lung disorders. Problems are also more likely in patients who are older, weaker, or taking larger doses. Call your doctor if you have trouble breathing or changes in your breathing after you take this medicine.
- This medicine may make you dizzy or drowsy. Stand or sit up slowly if you are dizzy. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.
- This medicine can cause serious harm or death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully and properly dispose of any partially used units or unused medicine.
- Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
- 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 constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
- Actiq® contains 2 grams of sugar in each unit and may increase your chance for tooth decay. Schedule regular dentist visits if you are using Actiq®. Diabetic patients should use this product with caution.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Blue lips, fingernails, or skin
- Chest pain or tightness
- Decrease in how much or how often you urinate
- Extreme weakness, confusion, or dizziness
- Severe drowsiness or sleepiness, fainting
- Sighing, decreased urge to breathe
- Trouble breathing, or irregular, fast, slow, or shallow breathing
If you notice these less serious side effects, talk with your doctor:
- Dry mouth
- Nausea, vomiting, constipation
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088Last Updated:
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