Fentanyl Citrate (FEN-ta-nil SIT-rate)
Treats cancer pain in patients whose pain is not always relieved by other pain medicines. This medicine is a narcotic pain reliever.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to fentanyl. You should not use this medicine until after you have tried other narcotic medicines. Do not use this medicine if you need pain medicine for just a short time, such as during a headache or migraine attack, tooth pain, or when recovering from surgery or an injury.
How to Use This Medicine
- 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.
- 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 right away.
- If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release four sprays into the pouch. Now it is ready to use.
- Before using the medicine, gently blow your nose to clear the nostrils.
- Insert the tip of the bottle into the nose. Point towards the bridge of the nose and tilt the bottle slightly.
- Press down firmly on the finger grips until you hear a "click" sound and the number in the dose counter window adds up. This confirms a spray has been taken.
- After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
- Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Lazanda® works differently than other fentanyl products, even at the same dose (number of milligrams). Do not substitute or convert it to other products containing fentanyl.
- This medicine is available only under a registered distribution program called Lazanda® REMS (Risk Evaluation and Mitigation Strategy) Program. You will be asked to sign an agreement form before you take this medicine. This form tells you about the benefits and risks of using this medicine. Make sure you understand what is on the form before you sign it.
- 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.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
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.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. Throw away any unused spray bottle and start using a new one after 5 days or more since it has been used or 14 days or more since it has been primed. 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. If additional assistance is required, call 1-866-435-6775.
- Keep all medicine away from children and never share your medicine with anyone.
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®), or nefazodone (Serzone®). Tell your doctor if you are also using aprepitant (Emend®), cimetidine (Tagamet®), diltiazem (Cardizem®, Dilacor XR®), erythromycin (Ery-Tab®), fluconazole (Diflucan®), telithromycin (Ketek®), or verapamil (Calan®, Isoptin®, 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®), troglitazone (Rezulin®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), medicine for HIV or AIDS (such as efavirenz, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, Sustiva®, Viracept®, or Viramune®), medicine for seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), muscle relaxants, or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
- Tell your doctor if you are using other nasal decongestants (such as oxymetazoline, Afrin®, or Sudafed OM®).
- 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.
- Do not drink alcohol while you are using this medicine.
- Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, lung disease or breathing problems such as asthma or chronic obstructive pulmonary disease (COPD), heart disease, heart rhythm problems (such as slow heart rate), low blood pressure, or if you have had a recent head injury or other problems that could increase the pressure in your head. Tell your doctor if you also have a history of drug or alcohol abuse or addiction.
- Do not breastfeed while you are using this medicine.
- This medicine may cause problems with breathing, which can be serious and life-threatening. This is more likely in patients with lung disorders, the elderly, very weak patients, or those who use large doses of this medicine. Call your doctor right away if you have shortness of breath, or irregular, fast, slow, or shallow breathing after using this medicine.
- After you have been using this medicine for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of nasal fentanyl or other narcotic that you are using without first checking with your doctor.
- This medicine can cause serious illness or even death if used by a child or by anyone who is not already using prescription medicine on a regular schedule for cancer pain.
- This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
- 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.
- If your symptoms do not improve or if they get worse, call your doctor.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
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
- Fast, slow, or uneven heartbeat.
- Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
- Lightheadedness, dizziness, severe drowsiness, or fainting.
- Pain on urination, change in how much or how often you urinate.
- Pain, redness, or swelling in your arm or leg.
- Pale or blue lips, fingernails, or skin.
- Shortness of breath, or irregular, fast, slow, or shallow breathing.
- Sores or white patches on your lips, mouth, or throat.
- Swelling in your hands, ankles, or feet.
- Unusual bleeding or bruising.
- Unusual tiredness or weakness.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Agitation, confusion, or depression.
- Back or joint pain.
- Change or loss of taste.
- Constipation, diarrhea, nausea, vomiting, or stomach pain or upset.
- Dry mouth.
- Increased sweating.
- Loss of appetite.
- Trouble sleeping.
- Weight loss.
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-1088
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