Fentanyl Citrate (FEN-ta-nil SIT-rate)

Treats pain that is not relieved by other pain medicines. This medicine is an opioid pain reliever.

Brand Name(s):

Lazanda

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. 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.
• 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.
• To use:
  • 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.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• If another dose is needed, wait at least 2 hours before treating another episode of breakthrough pain.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how fentanyl works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, linezolid, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, trazodone
  • Blood pressure medicine
  • Diuretic (water pill)
  • Medicine to treat depression (including SNRIs, SSRIs, TCAs)
  • Phenothiazine medicine
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, heart rhythm problems, low blood pressure, lung or breathing problems (including COPD, apnea), adrenal problems, pancreas problems, gallbladder problems, or a history of brain tumor, head injury, seizures, alcohol or drug use disorder.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Serotonin syndrome, when used with certain medicines
  • Adrenal gland problems
  • Low blood pressure
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can cause serious harm or death to a child. Always keep this medicine out of the reach of children. Carefully and properly dispose of used units and medicine that has not been used.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation, stomach pain, or vomiting
• Trouble breathing or slow breathing

If you notice these less serious side effects, talk with your doctor:

• Mild constipation, nausea, vomiting

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